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Could love hormone help psychological symptoms in AVD?
.
Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.
It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.
Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.
“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.
“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.
The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.
“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.
“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.
However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.
“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.
In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
Eightfold increase in plasma oxytocin levels in patients vs. control persons
The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.
All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.
Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.
In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.
The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).
The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.
The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.
“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.
Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.
A version of this article first appeared on Medscape.com.
.
Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.
It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.
Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.
“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.
“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.
The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.
“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.
“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.
However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.
“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.
In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
Eightfold increase in plasma oxytocin levels in patients vs. control persons
The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.
All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.
Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.
In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.
The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).
The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.
The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.
“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.
Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.
A version of this article first appeared on Medscape.com.
.
Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.
It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.
Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.
“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.
“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.
The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.
“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.
“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.
However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.
“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.
In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
Eightfold increase in plasma oxytocin levels in patients vs. control persons
The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.
All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.
Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.
In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.
The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).
The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.
The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.
“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.
Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.
A version of this article first appeared on Medscape.com.
FROM THE LANCET DIABETES & ENDOCRINOLOGY
FDA clears iLet bionic pancreas insulin delivery system
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
‘Staggering’ weight loss and benefits in body composition with tirzepatide
DUBLIN – , according to the latest results of the SURMOUNT-1 study.
The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.
Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.
Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.
Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.
“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.
“This is staggering weight loss,” remarked Dr. Aronne. “To put it in perspective, mean weight loss in people having Lap-Band surgery is 17%, mean weight loss for sleeve gastrectomy is 25%, and gastric bypass is 33%, which puts the effects of tirzepatide squarely in the realm of bariatric surgery.”
“Something we have sought for decades, we have finally been able to achieve,” he asserted. “I still remember exactly where I was when I saw these results for the first time last April. I knew something big was happening,” declared Dr. Aronne when presenting the latest analyses at the 2023 European Congress on Obesity. Full study results were published in the New England Journal of Medicine.
Moderator Gabriella Lieberman, MD, endocrinologist and head of the Israeli Center for Weight Management, Sheba Medical Center, Ramat-Gan, Israel, welcomed the study but also expressed caution. “It’s very potent, but as we see generally with potent therapies, I think it will change how we look at nutritional advice and the role of the dietician will change. I’m a bit worried the drug is running fast and the support, which is crucial with these treatments, is not keeping up, and we’ll have to deal with some effects later, such as sarcopenia,” she pointed out in an interview.
“We have to treat these drugs as if they are bariatric surgery. I see patients on these types of drugs in clinic and their appetite is so suppressed that they think they can afford to eat things that are unhealthy because they lose weight, and that’s what they want. There has to be a responsible adult looking at what they’re eating, and not just clapping their hands for the weight loss, but ensuring they are not deprived of anything,” she said.
Weight loss and body composition explored
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization.
The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m2 (class I, II, III obesity) or greater than or equal to 27 kg/m2 (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m2, and 94.5% of participants had BMI greater than or equal to 30 kg/m2.
Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m2, greater than or equal to 30 to less than 35 kg/m2 (class 1 obesity), greater than or equal to 35 to less than 40 kg/m2 (class 2 obesity), and greater than or equal to 40 kg/m2 (class 3 obesity).
In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).
The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).
The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.
By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category.
“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m2,” he explained. “It’s the higher BMI categories where we need the higher dose.”
As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.
“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”
Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported.
Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.
With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.
“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.
Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.
“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”
“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”
The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.
A version of this article first appeared on Medscape.com.
DUBLIN – , according to the latest results of the SURMOUNT-1 study.
The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.
Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.
Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.
Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.
“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.
“This is staggering weight loss,” remarked Dr. Aronne. “To put it in perspective, mean weight loss in people having Lap-Band surgery is 17%, mean weight loss for sleeve gastrectomy is 25%, and gastric bypass is 33%, which puts the effects of tirzepatide squarely in the realm of bariatric surgery.”
“Something we have sought for decades, we have finally been able to achieve,” he asserted. “I still remember exactly where I was when I saw these results for the first time last April. I knew something big was happening,” declared Dr. Aronne when presenting the latest analyses at the 2023 European Congress on Obesity. Full study results were published in the New England Journal of Medicine.
Moderator Gabriella Lieberman, MD, endocrinologist and head of the Israeli Center for Weight Management, Sheba Medical Center, Ramat-Gan, Israel, welcomed the study but also expressed caution. “It’s very potent, but as we see generally with potent therapies, I think it will change how we look at nutritional advice and the role of the dietician will change. I’m a bit worried the drug is running fast and the support, which is crucial with these treatments, is not keeping up, and we’ll have to deal with some effects later, such as sarcopenia,” she pointed out in an interview.
“We have to treat these drugs as if they are bariatric surgery. I see patients on these types of drugs in clinic and their appetite is so suppressed that they think they can afford to eat things that are unhealthy because they lose weight, and that’s what they want. There has to be a responsible adult looking at what they’re eating, and not just clapping their hands for the weight loss, but ensuring they are not deprived of anything,” she said.
Weight loss and body composition explored
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization.
The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m2 (class I, II, III obesity) or greater than or equal to 27 kg/m2 (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m2, and 94.5% of participants had BMI greater than or equal to 30 kg/m2.
Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m2, greater than or equal to 30 to less than 35 kg/m2 (class 1 obesity), greater than or equal to 35 to less than 40 kg/m2 (class 2 obesity), and greater than or equal to 40 kg/m2 (class 3 obesity).
In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).
The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).
The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.
By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category.
“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m2,” he explained. “It’s the higher BMI categories where we need the higher dose.”
As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.
“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”
Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported.
Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.
With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.
“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.
Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.
“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”
“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”
The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.
A version of this article first appeared on Medscape.com.
DUBLIN – , according to the latest results of the SURMOUNT-1 study.
The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.
Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.
Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.
Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.
“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.
“This is staggering weight loss,” remarked Dr. Aronne. “To put it in perspective, mean weight loss in people having Lap-Band surgery is 17%, mean weight loss for sleeve gastrectomy is 25%, and gastric bypass is 33%, which puts the effects of tirzepatide squarely in the realm of bariatric surgery.”
“Something we have sought for decades, we have finally been able to achieve,” he asserted. “I still remember exactly where I was when I saw these results for the first time last April. I knew something big was happening,” declared Dr. Aronne when presenting the latest analyses at the 2023 European Congress on Obesity. Full study results were published in the New England Journal of Medicine.
Moderator Gabriella Lieberman, MD, endocrinologist and head of the Israeli Center for Weight Management, Sheba Medical Center, Ramat-Gan, Israel, welcomed the study but also expressed caution. “It’s very potent, but as we see generally with potent therapies, I think it will change how we look at nutritional advice and the role of the dietician will change. I’m a bit worried the drug is running fast and the support, which is crucial with these treatments, is not keeping up, and we’ll have to deal with some effects later, such as sarcopenia,” she pointed out in an interview.
“We have to treat these drugs as if they are bariatric surgery. I see patients on these types of drugs in clinic and their appetite is so suppressed that they think they can afford to eat things that are unhealthy because they lose weight, and that’s what they want. There has to be a responsible adult looking at what they’re eating, and not just clapping their hands for the weight loss, but ensuring they are not deprived of anything,” she said.
Weight loss and body composition explored
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization.
The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m2 (class I, II, III obesity) or greater than or equal to 27 kg/m2 (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m2, and 94.5% of participants had BMI greater than or equal to 30 kg/m2.
Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m2, greater than or equal to 30 to less than 35 kg/m2 (class 1 obesity), greater than or equal to 35 to less than 40 kg/m2 (class 2 obesity), and greater than or equal to 40 kg/m2 (class 3 obesity).
In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).
The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).
The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.
By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category.
“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m2,” he explained. “It’s the higher BMI categories where we need the higher dose.”
As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.
“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”
Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported.
Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.
With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.
“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.
Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.
“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”
“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”
The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.
A version of this article first appeared on Medscape.com.
Glucagon Prescription Rates for Individuals With Type 1 Diabetes Mellitus Following Implementation of an Electronic Health Records Intervention
From Vanderbilt University School of Medicine, and Vanderbilt University Medical Center, Nashville, TN.
ABSTRACT
Objective: Severe hypoglycemia can alter consciousness and inhibit oral intake, requiring nonoral rescue glucagon administration to raise blood glucose to safe levels. Thus, current guidelines recommend glucagon kit prescriptions for all patients at risk for hypoglycemia, especially patients with type 1 diabetes mellitus (T1DM). At the diabetes outpatient clinic at a tertiary medical center, glucagon prescription rates for T1DM patients remained suboptimal.
Methods: A quality improvement team analyzed patient flow through the endocrinology clinic and identified the lack of a systematic approach to assessing patients for home glucagon prescriptions as a major barrier. The team implemented 2 successive interventions. First, intake staff indicated whether patients lacked an active glucagon prescription on patients’ face sheets. Second, clinical pharmacists reviewed patient prescriptions prior to scheduled visits and pended glucagon orders for patients without active prescriptions. Of note, when a pharmacy pends an order, the pharmacist enters an order into the electronic health record (EHR) but does not sign it. The order is saved for a provider to later access and sign. A statistical process control p-chart tracked monthly prescription rates.
Results: After 7 months, glucagon prescription rates increased from a baseline of 59% to 72% as the new steady state.
Conclusion: This project demonstrates that a series of interventions can improve glucagon prescription rates for patients at risk for hypoglycemia. The project’s success stemmed from combining an EHR-generated report and interdisciplinary staff members’ involvement. Other endocrinology clinics may incorporate this approach to implement similar processes and improve glucagon prescription rates.
Keywords: diabetes, hypoglycemia, glucagon, quality improvement, prescription rates, medical student.
Hypoglycemia limits the management of blood glucose in patients with type 1 diabetes mellitus (T1DM). Severe hypoglycemia, characterized by altered mental status (AMS) or physical status requiring assistance for recovery, can lead to seizure, coma, or death.1 Hypoglycemia in diabetes often occurs iatrogenically, primarily from insulin therapy: 30% to 40% of patients with T1DM and 10% to 30% of patients with insulin-treated type 2 diabetes mellitus experience severe hypoglycemia in a given year.2 One study estimated that nearly 100,000 emergency department visits for hypoglycemia occur in the United States per year, with almost one-third resulting in hospitalization.3
Most patients self-treat mild hypoglycemia with oral intake of carbohydrates. However, since hypoglycemia-induced nausea and AMS can make oral intake more difficult or prevent it entirely, patients require a treatment that family, friends, or coworkers can administer. Rescue glucagon, prescribed as intramuscular injections or intranasal sprays, raises blood glucose to safe levels in 10 to 15 minutes.4 Therefore, the American Diabetes Association (ADA) recommends glucagon for all patients at risk for hypoglycemia, especially patients with T1DM.5 Despite the ADA’s recommendation, current evidence suggests suboptimal glucagon prescription rates, particularly in patients with T1DM. One study reported that, although 85% of US adults with T1DM had formerly been prescribed glucagon, only 68% of these patients (57.8% overall) had a current prescription.4 Few quality improvement efforts have tackled increasing prescription rates. Prior successful studies have attempted to do so via pharmacist-led educational interventions for providers6 and via electronic health record (EHR) notifications for patient risk.7 The project described here aimed to expand upon prior studies with a quality improvement project to increase glucagon prescription rates among patients at risk for severe hypoglycemia.
This study was conducted at a tertiary medical center’s outpatient diabetes clinic; the clinic treats more than 9500 patients with DM annually, more than 2700 of whom have T1DM. In the clinic’s multidisciplinary care model, patients typically follow up every 3 to 6 months, alternating between appointments with fellowship-trained endocrinologists and advanced practice providers (APPs). In addition to having certified diabetes educators, the clinic employs 2 dedicated clinical pharmacists whose duties include assisting providers in prescription management, helping patients identify the most affordable way to obtain their medications, and educating patients regarding their medications.
Patient flow through the clinic involves close coordination with multiple health professionals. Medical assistants (MAs) and licensed practical nurses (LPNs) perform patient intake, document vital signs, and ask screening questions, including dates of patients’ last hemoglobin A1c tests and diabetic eye examination. After intake, the provider (endocrinologist or APP) sees the patient. Once the appointment concludes, patients proceed to the in-house phlebotomy laboratory as indicated and check out with administrative staff to schedule future appointments.
From August 2021 through June 2022, teams of medical students at the tertiary center completed this project as part of a 4-week integrated science course on diabetes. Longitudinal supervision by an endocrinology faculty member ensured project continuity. The project employed the Standards for QUality Improvement Reporting Excellence (SQUIRE 2.0) method for reporting.8
Stakeholder analysis took place in August 2021. Surveyed clinic providers identified patients with T1DM as the most appropriate population and the outpatient setting as the most appropriate site for intervention. A fishbone diagram illustrated stakeholders to interview, impacts of the clinical flow, information technology to leverage, and potential holes contributing to glucagon prescription conversations falling through.
Interviews with T1DM patients, clinical pharmacists, APPs, MAs/LPNs, and endocrinologists identified barriers to glucagon prescription. The interviews and a process map analysis revealed several themes. While patients and providers understood the importance of glucagon prescription, barriers included glucagon cost, prescription fill burden, and, most pervasively, providers forgetting to ask patients whether they have a glucagon prescription and failing to consider glucagon prescriptions.For this study, each team of medical students worked on the project for 1 month. The revolving teams of medical students met approximately once per week for the duration of the project to review data and implementation phases. At the end of each month, the current team recorded the steps they had taken and information they had analyzed in a shared document, prepared short videos summarizing the work completed, and proposed next steps for the incoming team to support knowledge generation and continuity. Students from outgoing teams were available to contact if incoming teams had any questions.
Interventions
In the first implementation phase, which was carried out over 4 months (December 2021 to March 2022), the patient care manager trained MAs/LPNs to write a glucagon reminder on patients’ face sheets. At check-in, MAs/LPNs screened for a current glucagon prescription. If the patient lacked an up-to-date prescription, the MAs/LPNs hand-wrote a reminder on the patient’s face sheet, which was given to the provider immediately prior to seeing the patient. The clinical staff received an email explaining the intervention beforehand; the daily intake staff email included project reminders.
In the second implementation phase, which started in April 2022, had been carried out for 3 months at the time of this report, and is ongoing, clinical pharmacists have been pending glucagon prescriptions ahead of patients’ appointments. Each week, the pharmacists generate an EHR report that includes all patients with T1DM who have attended at least 1 appointment at the clinic within the past year (regardless of whether each patient possessed an active and up-to-date glucagon prescription) and the date of each patient’s next appointment. For patients who have an appointment in the upcoming week and lack an active glucagon prescription, the pharmacists run a benefits investigation to determine the insurance-preferred glucagon formulation and then pend the appropriate order in the EHR. During the patient’s next appointment, the EHR prompts the provider to review and sign the pharmacist’s pended order (Figure 1).
This project used a process measure in its analysis: the percentage of patients with T1DM with an active glucagon prescription at the time of their visit to the clinic. The patient population included all patients with a visit diagnosis of T1DM seen by an APP at the clinic during the time scope of the project. The project’s scope was limited to patients seen by APPs to help standardize appointment comparisons, with the intent to expand to the endocrinologist staff if the interventions proved successful with APPs. Patients seen by APPs were also under the care of endocrinologists and seen by them during this time period. The project excluded no patients.
Each individual patient appointment represented a data point: a time at which an APP could prescribe glucagon for a patient with T1DM. Thus, a single patient who had multiple appointments during the study period would generate multiple data points in this study.
For all T1DM patients at the clinic seen by an APP during the study period, the project aimed to increase the percentage with an active and up-to-date glucagon prescription from 58.8% to 70% over a 6-month period, a relatively modest goal appropriate for the time constraints and that would be similar to the changes seen in previous work in the same clinic.9
This project analyzed de-identified data using a statistical process control chart (specifically, a p-chart) and standard rules for assessing special-cause signals and thus statistical significance.
Results
Baseline data were collected from October 2020 to September 2021. During this time, APPs saw 1959 T1DM patients, of whom 1152 (58.8%) had an active glucagon prescription at the time of visit and 41.2% lacked a glucagon prescription (Figure 2). During the 4 months of implementation phase 1, analysis of the statistical process control chart identified no special cause signal. Therefore, the project moved to a second intervention with implementation phase 2 in April 2022 (3 months of postintervention data are reported). During the entire intervention, 731 of 1080 (67.7%) patients had a glucagon prescription. The average for the last 2 months, with phase 2 fully implemented, was 72.3%, surpassing the 70% threshold identified as the study target (Figure 3).
Interviews with clinical pharmacists during implementation phase 2 revealed that generating the EHR report and reviewing patients with glucagon prescription indications resulted in variable daily workload increases ranging from approximately 15 to 45 minutes, depending on the number of patients requiring intervention that day. During the first month of implementation phase 2, the EHR report required repeated modification to fulfill the intervention needs. Staffing changes over the intervention period potentially impacted the pattern of glucagon prescribing. This project excluded the 2 months immediately prior to implementation phase 1, from October 2021 to November 2021, because the staff had begun having discussions about this initiative, which may have influenced glucagon prescription rates.
Discussion
This project evaluated 2 interventions over the course of 7 months to determine their efficacy in increasing the frequency of glucagon prescribing for individuals with T1DM in an endocrinology clinic. These interventions were associated with increased prescribing from a baseline of 58.8% to 72.3% over the last 2 months of the project. In the first intervention, performed over 4 months, MAs/LPNs wrote reminders on the appropriate patients’ face sheets, which were given to providers prior to appointments. This project adapted the approach from a successful previous quality improvement study on increasing microalbuminuria screening rates.9 However, glucagon prescription rates did not increase significantly, likely because, unlike with microalbuminuria screenings, MAs/LPNs could not pend glucagon prescriptions.
In the second intervention, performed over 3 months, clinical pharmacists pended glucagon prescriptions for identified eligible patients. Glucagon prescribing rates increased considerably, with rates of 72.3% and 72.4% over May and June 2021, respectively, indicating that the intervention successfully established a new higher steady state of proportion of patient visits with active glucagon prescriptions compared with the baseline rate of 58.8%. Given that the baseline data for this clinic were higher than the baseline glucagon prescription rates reported in other studies (49.3%),10 this intervention could have a major impact in clinics with a baseline more comparable to conditions in that study.
This project demonstrated how a combination of an EHR-generated report and interdisciplinary involvement provides an actionable process to increase glucagon prescription rates for patients with T1DM. Compared to prior studies that implemented passive interventions, such as a note template that relies on provider adherence,7 this project emphasizes the benefit of implementing an active systems-level intervention with a pre-pended order.
Regarding prior studies, 1 large, 2-arm study of clinical pharmacists proactively pending orders for appropriate patients showed a 56% glucagon prescription rate in the intervention group, compared with 0.9% in the control group with no pharmacist intervention.11 Our project had a much higher baseline rate: 58.8% prior to intervention vs 0.9% in the nonintervention group for the previous study—likely due to its chosen location’s status as an endocrinology clinic rather than a general health care setting.
A different study that focused on patient education rather than glucagon prescription rates used similar EHR-generated reports to identify appropriate patients and assessed glucagon prescription needs during check-in. Following the educational interventions in that study, patients reporting self-comfort and education with glucagon administration significantly increased from 66.2% to 83.2%, and household member comfort and education with glucagon administration increased from 50.8% to 79.7%. This suggests the possibility of expanding the use of the EHR-generated report to assist not only with increasing glucagon prescription rates, but also with patient education on glucagon use rates and possibly fill rates.7 While novel glucagon products may change uptake rates, no new glucagon products arose or were prescribed at this clinic during the course of data collection.
Of note, our project increased the workload on clinical pharmacists. The pharmacists agreed to participate, despite the increased work, after a collaborative discussion about how to best address the need to increase glucagon prescriptions or patient safety; the pharmacy department had initially agreed to collaborate specifically to identify and attend to unmet needs such as this one. Although this project greatly benefited from the expertise and enthusiasm of the clinical pharmacists involved, this tradeoff requires further study to determine sustainability.
This project had several limitations. Because of the structure in which this intervention occurred (a year-long course with rotating groups of medical students), there was a necessary component of time constraint, and this project had just 2 implementation phases, for a total of 7 months of postintervention data. The clinic has permanently implemented these changes into its workflow, but subsequent assessments are needed to monitor the effects and assess sustainability.
The specific clinical site chosen for this study benefited from dedicated onsite clinical pharmacists, who are not available at all comparable clinical sites. Due to feasibility, this project only assessed whether the providers prescribed the glucagon, not whether the patients filled the prescriptions and used the glucagon when necessary. Although prescribing rates increased in our study, it cannot be assumed that fill rates increased identically.
Finally, interventions relying on EHR-generated reports carry inherent limitations, such as the risk of misidentification or omission of patients who had indications for a glucagon prescription. The project attempted to mitigate this limitation through random sampling of the EHR report to ensure accuracy. Additionally, EHR-generated reports encourage sustainability and expansion to all clinic patients, with far less required overhead work compared to manually derived data.
Future investigations may focus on expanding this intervention to all patients at risk for hypoglycemia, as well as to study further interventions into prescription fill rates and glucagon use rates.
Conclusion
This project indicates that a proactive, interdisciplinary quality improvement project can increase glucagon prescription rates for patients with T1DM in the outpatient setting. The most effective intervention mobilized clinical pharmacists to identify patients with indications for a glucagon prescription using an integrated EHR-generated report and subsequently pend a glucagon order for the endocrinology provider to sign during the visit. The strengths of the approach included using a multidisciplinary team, minimizing costs to patients by leveraging the pharmacists’ expertise to ensure insurance coverage of specific formulations, and utilizing automatic EHR reporting to streamline patient identification. Ideally, improvements in glucagon prescription rates should ultimately decrease hospitalizations and improve treatment of severe hypoglycemia for at-risk patients.
Corresponding author: Chase D. Hendrickson, MD, MPH; [email protected]
Disclosures: None reported.
1. Weinstock RS, Aleppo G, Bailey TS, et al. The Role of Blood Glucose Monitoring in Diabetes Management. American Diabetes Association; 2020.
2. Lamounier RN, Geloneze B, Leite SO, et al. Hypoglycemia incidence and awareness among insulin-treated patients with diabetes: the HAT study in Brazil. Diabetol Metab Syndr. 2018;10:83. doi:10.1186/s13098-018-0379-5
3. Li P, Geng Z, Ladage VP, et al. Early hypoglycaemia and adherence after basal insulin initiation in a nationally representative sample of Medicare beneficiaries with type 2 diabetes. Diabetes Obes Metab. 2019;21(11):2486-2495. doi:10.1111/dom.13832
4. Haymond MW, Liu J, Bispham J, et al. Use of glucagon in patients with type 1 diabetes. Clin Diabetes. 2019;37(2):162-166. doi:10.2337/cd18-0028
5. American Diabetes Association Professional Practice Committee. 6. Glycemic targets: standards of medical care in diabetes-2022. Diabetes Care. 2022; 45(Suppl 1):S83-S96. doi:10.2337/dc22-S006
6. O’Reilly EA, Cross LV, Hayes JS, et al. Impact of pharmacist intervention on glucagon prescribing patterns in an outpatient internal medicine teaching clinic. J Am Pharm Assoc (2003). 2020;60(2):384-390. doi:10.1016/j.japh.2019.04.0097.
7. Cobb EC, Watson NA, Wardian J, et al. Diabetes Center of Excellence Hypoglycemia Emergency Preparedness Project. Clin Diabetes. 2018;36(2):184-186. doi:10.2337/cd17-0040
8. Ogrinc G, Davies L, Goodman D, et al. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411
9. Kam S, Angaramo S, Antoun J, et al. Improving annual albuminuria testing for individuals with diabetes. BMJ Open Qual. 2022;11(1):e001591. doi:10.1136/bmjoq-2021-001591
10. Mitchell BD, He X, Sturdy IM, et al. Glucagon prescription patterns in patients with either type 1 or 2 diabetes with newly prescribed insulin. Endocr Pract. 2016;22(2):123-135. doi:10.4158/EP15831.OR
11. Whitfield N, Gregory P, Liu B, et al. Impact of pharmacist outreach on glucagon prescribing. J Am Pharm Assoc. 2022;62(4):1384-1388.e.1. doi:10.1016/j.japh.2022.01.017
From Vanderbilt University School of Medicine, and Vanderbilt University Medical Center, Nashville, TN.
ABSTRACT
Objective: Severe hypoglycemia can alter consciousness and inhibit oral intake, requiring nonoral rescue glucagon administration to raise blood glucose to safe levels. Thus, current guidelines recommend glucagon kit prescriptions for all patients at risk for hypoglycemia, especially patients with type 1 diabetes mellitus (T1DM). At the diabetes outpatient clinic at a tertiary medical center, glucagon prescription rates for T1DM patients remained suboptimal.
Methods: A quality improvement team analyzed patient flow through the endocrinology clinic and identified the lack of a systematic approach to assessing patients for home glucagon prescriptions as a major barrier. The team implemented 2 successive interventions. First, intake staff indicated whether patients lacked an active glucagon prescription on patients’ face sheets. Second, clinical pharmacists reviewed patient prescriptions prior to scheduled visits and pended glucagon orders for patients without active prescriptions. Of note, when a pharmacy pends an order, the pharmacist enters an order into the electronic health record (EHR) but does not sign it. The order is saved for a provider to later access and sign. A statistical process control p-chart tracked monthly prescription rates.
Results: After 7 months, glucagon prescription rates increased from a baseline of 59% to 72% as the new steady state.
Conclusion: This project demonstrates that a series of interventions can improve glucagon prescription rates for patients at risk for hypoglycemia. The project’s success stemmed from combining an EHR-generated report and interdisciplinary staff members’ involvement. Other endocrinology clinics may incorporate this approach to implement similar processes and improve glucagon prescription rates.
Keywords: diabetes, hypoglycemia, glucagon, quality improvement, prescription rates, medical student.
Hypoglycemia limits the management of blood glucose in patients with type 1 diabetes mellitus (T1DM). Severe hypoglycemia, characterized by altered mental status (AMS) or physical status requiring assistance for recovery, can lead to seizure, coma, or death.1 Hypoglycemia in diabetes often occurs iatrogenically, primarily from insulin therapy: 30% to 40% of patients with T1DM and 10% to 30% of patients with insulin-treated type 2 diabetes mellitus experience severe hypoglycemia in a given year.2 One study estimated that nearly 100,000 emergency department visits for hypoglycemia occur in the United States per year, with almost one-third resulting in hospitalization.3
Most patients self-treat mild hypoglycemia with oral intake of carbohydrates. However, since hypoglycemia-induced nausea and AMS can make oral intake more difficult or prevent it entirely, patients require a treatment that family, friends, or coworkers can administer. Rescue glucagon, prescribed as intramuscular injections or intranasal sprays, raises blood glucose to safe levels in 10 to 15 minutes.4 Therefore, the American Diabetes Association (ADA) recommends glucagon for all patients at risk for hypoglycemia, especially patients with T1DM.5 Despite the ADA’s recommendation, current evidence suggests suboptimal glucagon prescription rates, particularly in patients with T1DM. One study reported that, although 85% of US adults with T1DM had formerly been prescribed glucagon, only 68% of these patients (57.8% overall) had a current prescription.4 Few quality improvement efforts have tackled increasing prescription rates. Prior successful studies have attempted to do so via pharmacist-led educational interventions for providers6 and via electronic health record (EHR) notifications for patient risk.7 The project described here aimed to expand upon prior studies with a quality improvement project to increase glucagon prescription rates among patients at risk for severe hypoglycemia.
This study was conducted at a tertiary medical center’s outpatient diabetes clinic; the clinic treats more than 9500 patients with DM annually, more than 2700 of whom have T1DM. In the clinic’s multidisciplinary care model, patients typically follow up every 3 to 6 months, alternating between appointments with fellowship-trained endocrinologists and advanced practice providers (APPs). In addition to having certified diabetes educators, the clinic employs 2 dedicated clinical pharmacists whose duties include assisting providers in prescription management, helping patients identify the most affordable way to obtain their medications, and educating patients regarding their medications.
Patient flow through the clinic involves close coordination with multiple health professionals. Medical assistants (MAs) and licensed practical nurses (LPNs) perform patient intake, document vital signs, and ask screening questions, including dates of patients’ last hemoglobin A1c tests and diabetic eye examination. After intake, the provider (endocrinologist or APP) sees the patient. Once the appointment concludes, patients proceed to the in-house phlebotomy laboratory as indicated and check out with administrative staff to schedule future appointments.
From August 2021 through June 2022, teams of medical students at the tertiary center completed this project as part of a 4-week integrated science course on diabetes. Longitudinal supervision by an endocrinology faculty member ensured project continuity. The project employed the Standards for QUality Improvement Reporting Excellence (SQUIRE 2.0) method for reporting.8
Stakeholder analysis took place in August 2021. Surveyed clinic providers identified patients with T1DM as the most appropriate population and the outpatient setting as the most appropriate site for intervention. A fishbone diagram illustrated stakeholders to interview, impacts of the clinical flow, information technology to leverage, and potential holes contributing to glucagon prescription conversations falling through.
Interviews with T1DM patients, clinical pharmacists, APPs, MAs/LPNs, and endocrinologists identified barriers to glucagon prescription. The interviews and a process map analysis revealed several themes. While patients and providers understood the importance of glucagon prescription, barriers included glucagon cost, prescription fill burden, and, most pervasively, providers forgetting to ask patients whether they have a glucagon prescription and failing to consider glucagon prescriptions.For this study, each team of medical students worked on the project for 1 month. The revolving teams of medical students met approximately once per week for the duration of the project to review data and implementation phases. At the end of each month, the current team recorded the steps they had taken and information they had analyzed in a shared document, prepared short videos summarizing the work completed, and proposed next steps for the incoming team to support knowledge generation and continuity. Students from outgoing teams were available to contact if incoming teams had any questions.
Interventions
In the first implementation phase, which was carried out over 4 months (December 2021 to March 2022), the patient care manager trained MAs/LPNs to write a glucagon reminder on patients’ face sheets. At check-in, MAs/LPNs screened for a current glucagon prescription. If the patient lacked an up-to-date prescription, the MAs/LPNs hand-wrote a reminder on the patient’s face sheet, which was given to the provider immediately prior to seeing the patient. The clinical staff received an email explaining the intervention beforehand; the daily intake staff email included project reminders.
In the second implementation phase, which started in April 2022, had been carried out for 3 months at the time of this report, and is ongoing, clinical pharmacists have been pending glucagon prescriptions ahead of patients’ appointments. Each week, the pharmacists generate an EHR report that includes all patients with T1DM who have attended at least 1 appointment at the clinic within the past year (regardless of whether each patient possessed an active and up-to-date glucagon prescription) and the date of each patient’s next appointment. For patients who have an appointment in the upcoming week and lack an active glucagon prescription, the pharmacists run a benefits investigation to determine the insurance-preferred glucagon formulation and then pend the appropriate order in the EHR. During the patient’s next appointment, the EHR prompts the provider to review and sign the pharmacist’s pended order (Figure 1).
This project used a process measure in its analysis: the percentage of patients with T1DM with an active glucagon prescription at the time of their visit to the clinic. The patient population included all patients with a visit diagnosis of T1DM seen by an APP at the clinic during the time scope of the project. The project’s scope was limited to patients seen by APPs to help standardize appointment comparisons, with the intent to expand to the endocrinologist staff if the interventions proved successful with APPs. Patients seen by APPs were also under the care of endocrinologists and seen by them during this time period. The project excluded no patients.
Each individual patient appointment represented a data point: a time at which an APP could prescribe glucagon for a patient with T1DM. Thus, a single patient who had multiple appointments during the study period would generate multiple data points in this study.
For all T1DM patients at the clinic seen by an APP during the study period, the project aimed to increase the percentage with an active and up-to-date glucagon prescription from 58.8% to 70% over a 6-month period, a relatively modest goal appropriate for the time constraints and that would be similar to the changes seen in previous work in the same clinic.9
This project analyzed de-identified data using a statistical process control chart (specifically, a p-chart) and standard rules for assessing special-cause signals and thus statistical significance.
Results
Baseline data were collected from October 2020 to September 2021. During this time, APPs saw 1959 T1DM patients, of whom 1152 (58.8%) had an active glucagon prescription at the time of visit and 41.2% lacked a glucagon prescription (Figure 2). During the 4 months of implementation phase 1, analysis of the statistical process control chart identified no special cause signal. Therefore, the project moved to a second intervention with implementation phase 2 in April 2022 (3 months of postintervention data are reported). During the entire intervention, 731 of 1080 (67.7%) patients had a glucagon prescription. The average for the last 2 months, with phase 2 fully implemented, was 72.3%, surpassing the 70% threshold identified as the study target (Figure 3).
Interviews with clinical pharmacists during implementation phase 2 revealed that generating the EHR report and reviewing patients with glucagon prescription indications resulted in variable daily workload increases ranging from approximately 15 to 45 minutes, depending on the number of patients requiring intervention that day. During the first month of implementation phase 2, the EHR report required repeated modification to fulfill the intervention needs. Staffing changes over the intervention period potentially impacted the pattern of glucagon prescribing. This project excluded the 2 months immediately prior to implementation phase 1, from October 2021 to November 2021, because the staff had begun having discussions about this initiative, which may have influenced glucagon prescription rates.
Discussion
This project evaluated 2 interventions over the course of 7 months to determine their efficacy in increasing the frequency of glucagon prescribing for individuals with T1DM in an endocrinology clinic. These interventions were associated with increased prescribing from a baseline of 58.8% to 72.3% over the last 2 months of the project. In the first intervention, performed over 4 months, MAs/LPNs wrote reminders on the appropriate patients’ face sheets, which were given to providers prior to appointments. This project adapted the approach from a successful previous quality improvement study on increasing microalbuminuria screening rates.9 However, glucagon prescription rates did not increase significantly, likely because, unlike with microalbuminuria screenings, MAs/LPNs could not pend glucagon prescriptions.
In the second intervention, performed over 3 months, clinical pharmacists pended glucagon prescriptions for identified eligible patients. Glucagon prescribing rates increased considerably, with rates of 72.3% and 72.4% over May and June 2021, respectively, indicating that the intervention successfully established a new higher steady state of proportion of patient visits with active glucagon prescriptions compared with the baseline rate of 58.8%. Given that the baseline data for this clinic were higher than the baseline glucagon prescription rates reported in other studies (49.3%),10 this intervention could have a major impact in clinics with a baseline more comparable to conditions in that study.
This project demonstrated how a combination of an EHR-generated report and interdisciplinary involvement provides an actionable process to increase glucagon prescription rates for patients with T1DM. Compared to prior studies that implemented passive interventions, such as a note template that relies on provider adherence,7 this project emphasizes the benefit of implementing an active systems-level intervention with a pre-pended order.
Regarding prior studies, 1 large, 2-arm study of clinical pharmacists proactively pending orders for appropriate patients showed a 56% glucagon prescription rate in the intervention group, compared with 0.9% in the control group with no pharmacist intervention.11 Our project had a much higher baseline rate: 58.8% prior to intervention vs 0.9% in the nonintervention group for the previous study—likely due to its chosen location’s status as an endocrinology clinic rather than a general health care setting.
A different study that focused on patient education rather than glucagon prescription rates used similar EHR-generated reports to identify appropriate patients and assessed glucagon prescription needs during check-in. Following the educational interventions in that study, patients reporting self-comfort and education with glucagon administration significantly increased from 66.2% to 83.2%, and household member comfort and education with glucagon administration increased from 50.8% to 79.7%. This suggests the possibility of expanding the use of the EHR-generated report to assist not only with increasing glucagon prescription rates, but also with patient education on glucagon use rates and possibly fill rates.7 While novel glucagon products may change uptake rates, no new glucagon products arose or were prescribed at this clinic during the course of data collection.
Of note, our project increased the workload on clinical pharmacists. The pharmacists agreed to participate, despite the increased work, after a collaborative discussion about how to best address the need to increase glucagon prescriptions or patient safety; the pharmacy department had initially agreed to collaborate specifically to identify and attend to unmet needs such as this one. Although this project greatly benefited from the expertise and enthusiasm of the clinical pharmacists involved, this tradeoff requires further study to determine sustainability.
This project had several limitations. Because of the structure in which this intervention occurred (a year-long course with rotating groups of medical students), there was a necessary component of time constraint, and this project had just 2 implementation phases, for a total of 7 months of postintervention data. The clinic has permanently implemented these changes into its workflow, but subsequent assessments are needed to monitor the effects and assess sustainability.
The specific clinical site chosen for this study benefited from dedicated onsite clinical pharmacists, who are not available at all comparable clinical sites. Due to feasibility, this project only assessed whether the providers prescribed the glucagon, not whether the patients filled the prescriptions and used the glucagon when necessary. Although prescribing rates increased in our study, it cannot be assumed that fill rates increased identically.
Finally, interventions relying on EHR-generated reports carry inherent limitations, such as the risk of misidentification or omission of patients who had indications for a glucagon prescription. The project attempted to mitigate this limitation through random sampling of the EHR report to ensure accuracy. Additionally, EHR-generated reports encourage sustainability and expansion to all clinic patients, with far less required overhead work compared to manually derived data.
Future investigations may focus on expanding this intervention to all patients at risk for hypoglycemia, as well as to study further interventions into prescription fill rates and glucagon use rates.
Conclusion
This project indicates that a proactive, interdisciplinary quality improvement project can increase glucagon prescription rates for patients with T1DM in the outpatient setting. The most effective intervention mobilized clinical pharmacists to identify patients with indications for a glucagon prescription using an integrated EHR-generated report and subsequently pend a glucagon order for the endocrinology provider to sign during the visit. The strengths of the approach included using a multidisciplinary team, minimizing costs to patients by leveraging the pharmacists’ expertise to ensure insurance coverage of specific formulations, and utilizing automatic EHR reporting to streamline patient identification. Ideally, improvements in glucagon prescription rates should ultimately decrease hospitalizations and improve treatment of severe hypoglycemia for at-risk patients.
Corresponding author: Chase D. Hendrickson, MD, MPH; [email protected]
Disclosures: None reported.
From Vanderbilt University School of Medicine, and Vanderbilt University Medical Center, Nashville, TN.
ABSTRACT
Objective: Severe hypoglycemia can alter consciousness and inhibit oral intake, requiring nonoral rescue glucagon administration to raise blood glucose to safe levels. Thus, current guidelines recommend glucagon kit prescriptions for all patients at risk for hypoglycemia, especially patients with type 1 diabetes mellitus (T1DM). At the diabetes outpatient clinic at a tertiary medical center, glucagon prescription rates for T1DM patients remained suboptimal.
Methods: A quality improvement team analyzed patient flow through the endocrinology clinic and identified the lack of a systematic approach to assessing patients for home glucagon prescriptions as a major barrier. The team implemented 2 successive interventions. First, intake staff indicated whether patients lacked an active glucagon prescription on patients’ face sheets. Second, clinical pharmacists reviewed patient prescriptions prior to scheduled visits and pended glucagon orders for patients without active prescriptions. Of note, when a pharmacy pends an order, the pharmacist enters an order into the electronic health record (EHR) but does not sign it. The order is saved for a provider to later access and sign. A statistical process control p-chart tracked monthly prescription rates.
Results: After 7 months, glucagon prescription rates increased from a baseline of 59% to 72% as the new steady state.
Conclusion: This project demonstrates that a series of interventions can improve glucagon prescription rates for patients at risk for hypoglycemia. The project’s success stemmed from combining an EHR-generated report and interdisciplinary staff members’ involvement. Other endocrinology clinics may incorporate this approach to implement similar processes and improve glucagon prescription rates.
Keywords: diabetes, hypoglycemia, glucagon, quality improvement, prescription rates, medical student.
Hypoglycemia limits the management of blood glucose in patients with type 1 diabetes mellitus (T1DM). Severe hypoglycemia, characterized by altered mental status (AMS) or physical status requiring assistance for recovery, can lead to seizure, coma, or death.1 Hypoglycemia in diabetes often occurs iatrogenically, primarily from insulin therapy: 30% to 40% of patients with T1DM and 10% to 30% of patients with insulin-treated type 2 diabetes mellitus experience severe hypoglycemia in a given year.2 One study estimated that nearly 100,000 emergency department visits for hypoglycemia occur in the United States per year, with almost one-third resulting in hospitalization.3
Most patients self-treat mild hypoglycemia with oral intake of carbohydrates. However, since hypoglycemia-induced nausea and AMS can make oral intake more difficult or prevent it entirely, patients require a treatment that family, friends, or coworkers can administer. Rescue glucagon, prescribed as intramuscular injections or intranasal sprays, raises blood glucose to safe levels in 10 to 15 minutes.4 Therefore, the American Diabetes Association (ADA) recommends glucagon for all patients at risk for hypoglycemia, especially patients with T1DM.5 Despite the ADA’s recommendation, current evidence suggests suboptimal glucagon prescription rates, particularly in patients with T1DM. One study reported that, although 85% of US adults with T1DM had formerly been prescribed glucagon, only 68% of these patients (57.8% overall) had a current prescription.4 Few quality improvement efforts have tackled increasing prescription rates. Prior successful studies have attempted to do so via pharmacist-led educational interventions for providers6 and via electronic health record (EHR) notifications for patient risk.7 The project described here aimed to expand upon prior studies with a quality improvement project to increase glucagon prescription rates among patients at risk for severe hypoglycemia.
This study was conducted at a tertiary medical center’s outpatient diabetes clinic; the clinic treats more than 9500 patients with DM annually, more than 2700 of whom have T1DM. In the clinic’s multidisciplinary care model, patients typically follow up every 3 to 6 months, alternating between appointments with fellowship-trained endocrinologists and advanced practice providers (APPs). In addition to having certified diabetes educators, the clinic employs 2 dedicated clinical pharmacists whose duties include assisting providers in prescription management, helping patients identify the most affordable way to obtain their medications, and educating patients regarding their medications.
Patient flow through the clinic involves close coordination with multiple health professionals. Medical assistants (MAs) and licensed practical nurses (LPNs) perform patient intake, document vital signs, and ask screening questions, including dates of patients’ last hemoglobin A1c tests and diabetic eye examination. After intake, the provider (endocrinologist or APP) sees the patient. Once the appointment concludes, patients proceed to the in-house phlebotomy laboratory as indicated and check out with administrative staff to schedule future appointments.
From August 2021 through June 2022, teams of medical students at the tertiary center completed this project as part of a 4-week integrated science course on diabetes. Longitudinal supervision by an endocrinology faculty member ensured project continuity. The project employed the Standards for QUality Improvement Reporting Excellence (SQUIRE 2.0) method for reporting.8
Stakeholder analysis took place in August 2021. Surveyed clinic providers identified patients with T1DM as the most appropriate population and the outpatient setting as the most appropriate site for intervention. A fishbone diagram illustrated stakeholders to interview, impacts of the clinical flow, information technology to leverage, and potential holes contributing to glucagon prescription conversations falling through.
Interviews with T1DM patients, clinical pharmacists, APPs, MAs/LPNs, and endocrinologists identified barriers to glucagon prescription. The interviews and a process map analysis revealed several themes. While patients and providers understood the importance of glucagon prescription, barriers included glucagon cost, prescription fill burden, and, most pervasively, providers forgetting to ask patients whether they have a glucagon prescription and failing to consider glucagon prescriptions.For this study, each team of medical students worked on the project for 1 month. The revolving teams of medical students met approximately once per week for the duration of the project to review data and implementation phases. At the end of each month, the current team recorded the steps they had taken and information they had analyzed in a shared document, prepared short videos summarizing the work completed, and proposed next steps for the incoming team to support knowledge generation and continuity. Students from outgoing teams were available to contact if incoming teams had any questions.
Interventions
In the first implementation phase, which was carried out over 4 months (December 2021 to March 2022), the patient care manager trained MAs/LPNs to write a glucagon reminder on patients’ face sheets. At check-in, MAs/LPNs screened for a current glucagon prescription. If the patient lacked an up-to-date prescription, the MAs/LPNs hand-wrote a reminder on the patient’s face sheet, which was given to the provider immediately prior to seeing the patient. The clinical staff received an email explaining the intervention beforehand; the daily intake staff email included project reminders.
In the second implementation phase, which started in April 2022, had been carried out for 3 months at the time of this report, and is ongoing, clinical pharmacists have been pending glucagon prescriptions ahead of patients’ appointments. Each week, the pharmacists generate an EHR report that includes all patients with T1DM who have attended at least 1 appointment at the clinic within the past year (regardless of whether each patient possessed an active and up-to-date glucagon prescription) and the date of each patient’s next appointment. For patients who have an appointment in the upcoming week and lack an active glucagon prescription, the pharmacists run a benefits investigation to determine the insurance-preferred glucagon formulation and then pend the appropriate order in the EHR. During the patient’s next appointment, the EHR prompts the provider to review and sign the pharmacist’s pended order (Figure 1).
This project used a process measure in its analysis: the percentage of patients with T1DM with an active glucagon prescription at the time of their visit to the clinic. The patient population included all patients with a visit diagnosis of T1DM seen by an APP at the clinic during the time scope of the project. The project’s scope was limited to patients seen by APPs to help standardize appointment comparisons, with the intent to expand to the endocrinologist staff if the interventions proved successful with APPs. Patients seen by APPs were also under the care of endocrinologists and seen by them during this time period. The project excluded no patients.
Each individual patient appointment represented a data point: a time at which an APP could prescribe glucagon for a patient with T1DM. Thus, a single patient who had multiple appointments during the study period would generate multiple data points in this study.
For all T1DM patients at the clinic seen by an APP during the study period, the project aimed to increase the percentage with an active and up-to-date glucagon prescription from 58.8% to 70% over a 6-month period, a relatively modest goal appropriate for the time constraints and that would be similar to the changes seen in previous work in the same clinic.9
This project analyzed de-identified data using a statistical process control chart (specifically, a p-chart) and standard rules for assessing special-cause signals and thus statistical significance.
Results
Baseline data were collected from October 2020 to September 2021. During this time, APPs saw 1959 T1DM patients, of whom 1152 (58.8%) had an active glucagon prescription at the time of visit and 41.2% lacked a glucagon prescription (Figure 2). During the 4 months of implementation phase 1, analysis of the statistical process control chart identified no special cause signal. Therefore, the project moved to a second intervention with implementation phase 2 in April 2022 (3 months of postintervention data are reported). During the entire intervention, 731 of 1080 (67.7%) patients had a glucagon prescription. The average for the last 2 months, with phase 2 fully implemented, was 72.3%, surpassing the 70% threshold identified as the study target (Figure 3).
Interviews with clinical pharmacists during implementation phase 2 revealed that generating the EHR report and reviewing patients with glucagon prescription indications resulted in variable daily workload increases ranging from approximately 15 to 45 minutes, depending on the number of patients requiring intervention that day. During the first month of implementation phase 2, the EHR report required repeated modification to fulfill the intervention needs. Staffing changes over the intervention period potentially impacted the pattern of glucagon prescribing. This project excluded the 2 months immediately prior to implementation phase 1, from October 2021 to November 2021, because the staff had begun having discussions about this initiative, which may have influenced glucagon prescription rates.
Discussion
This project evaluated 2 interventions over the course of 7 months to determine their efficacy in increasing the frequency of glucagon prescribing for individuals with T1DM in an endocrinology clinic. These interventions were associated with increased prescribing from a baseline of 58.8% to 72.3% over the last 2 months of the project. In the first intervention, performed over 4 months, MAs/LPNs wrote reminders on the appropriate patients’ face sheets, which were given to providers prior to appointments. This project adapted the approach from a successful previous quality improvement study on increasing microalbuminuria screening rates.9 However, glucagon prescription rates did not increase significantly, likely because, unlike with microalbuminuria screenings, MAs/LPNs could not pend glucagon prescriptions.
In the second intervention, performed over 3 months, clinical pharmacists pended glucagon prescriptions for identified eligible patients. Glucagon prescribing rates increased considerably, with rates of 72.3% and 72.4% over May and June 2021, respectively, indicating that the intervention successfully established a new higher steady state of proportion of patient visits with active glucagon prescriptions compared with the baseline rate of 58.8%. Given that the baseline data for this clinic were higher than the baseline glucagon prescription rates reported in other studies (49.3%),10 this intervention could have a major impact in clinics with a baseline more comparable to conditions in that study.
This project demonstrated how a combination of an EHR-generated report and interdisciplinary involvement provides an actionable process to increase glucagon prescription rates for patients with T1DM. Compared to prior studies that implemented passive interventions, such as a note template that relies on provider adherence,7 this project emphasizes the benefit of implementing an active systems-level intervention with a pre-pended order.
Regarding prior studies, 1 large, 2-arm study of clinical pharmacists proactively pending orders for appropriate patients showed a 56% glucagon prescription rate in the intervention group, compared with 0.9% in the control group with no pharmacist intervention.11 Our project had a much higher baseline rate: 58.8% prior to intervention vs 0.9% in the nonintervention group for the previous study—likely due to its chosen location’s status as an endocrinology clinic rather than a general health care setting.
A different study that focused on patient education rather than glucagon prescription rates used similar EHR-generated reports to identify appropriate patients and assessed glucagon prescription needs during check-in. Following the educational interventions in that study, patients reporting self-comfort and education with glucagon administration significantly increased from 66.2% to 83.2%, and household member comfort and education with glucagon administration increased from 50.8% to 79.7%. This suggests the possibility of expanding the use of the EHR-generated report to assist not only with increasing glucagon prescription rates, but also with patient education on glucagon use rates and possibly fill rates.7 While novel glucagon products may change uptake rates, no new glucagon products arose or were prescribed at this clinic during the course of data collection.
Of note, our project increased the workload on clinical pharmacists. The pharmacists agreed to participate, despite the increased work, after a collaborative discussion about how to best address the need to increase glucagon prescriptions or patient safety; the pharmacy department had initially agreed to collaborate specifically to identify and attend to unmet needs such as this one. Although this project greatly benefited from the expertise and enthusiasm of the clinical pharmacists involved, this tradeoff requires further study to determine sustainability.
This project had several limitations. Because of the structure in which this intervention occurred (a year-long course with rotating groups of medical students), there was a necessary component of time constraint, and this project had just 2 implementation phases, for a total of 7 months of postintervention data. The clinic has permanently implemented these changes into its workflow, but subsequent assessments are needed to monitor the effects and assess sustainability.
The specific clinical site chosen for this study benefited from dedicated onsite clinical pharmacists, who are not available at all comparable clinical sites. Due to feasibility, this project only assessed whether the providers prescribed the glucagon, not whether the patients filled the prescriptions and used the glucagon when necessary. Although prescribing rates increased in our study, it cannot be assumed that fill rates increased identically.
Finally, interventions relying on EHR-generated reports carry inherent limitations, such as the risk of misidentification or omission of patients who had indications for a glucagon prescription. The project attempted to mitigate this limitation through random sampling of the EHR report to ensure accuracy. Additionally, EHR-generated reports encourage sustainability and expansion to all clinic patients, with far less required overhead work compared to manually derived data.
Future investigations may focus on expanding this intervention to all patients at risk for hypoglycemia, as well as to study further interventions into prescription fill rates and glucagon use rates.
Conclusion
This project indicates that a proactive, interdisciplinary quality improvement project can increase glucagon prescription rates for patients with T1DM in the outpatient setting. The most effective intervention mobilized clinical pharmacists to identify patients with indications for a glucagon prescription using an integrated EHR-generated report and subsequently pend a glucagon order for the endocrinology provider to sign during the visit. The strengths of the approach included using a multidisciplinary team, minimizing costs to patients by leveraging the pharmacists’ expertise to ensure insurance coverage of specific formulations, and utilizing automatic EHR reporting to streamline patient identification. Ideally, improvements in glucagon prescription rates should ultimately decrease hospitalizations and improve treatment of severe hypoglycemia for at-risk patients.
Corresponding author: Chase D. Hendrickson, MD, MPH; [email protected]
Disclosures: None reported.
1. Weinstock RS, Aleppo G, Bailey TS, et al. The Role of Blood Glucose Monitoring in Diabetes Management. American Diabetes Association; 2020.
2. Lamounier RN, Geloneze B, Leite SO, et al. Hypoglycemia incidence and awareness among insulin-treated patients with diabetes: the HAT study in Brazil. Diabetol Metab Syndr. 2018;10:83. doi:10.1186/s13098-018-0379-5
3. Li P, Geng Z, Ladage VP, et al. Early hypoglycaemia and adherence after basal insulin initiation in a nationally representative sample of Medicare beneficiaries with type 2 diabetes. Diabetes Obes Metab. 2019;21(11):2486-2495. doi:10.1111/dom.13832
4. Haymond MW, Liu J, Bispham J, et al. Use of glucagon in patients with type 1 diabetes. Clin Diabetes. 2019;37(2):162-166. doi:10.2337/cd18-0028
5. American Diabetes Association Professional Practice Committee. 6. Glycemic targets: standards of medical care in diabetes-2022. Diabetes Care. 2022; 45(Suppl 1):S83-S96. doi:10.2337/dc22-S006
6. O’Reilly EA, Cross LV, Hayes JS, et al. Impact of pharmacist intervention on glucagon prescribing patterns in an outpatient internal medicine teaching clinic. J Am Pharm Assoc (2003). 2020;60(2):384-390. doi:10.1016/j.japh.2019.04.0097.
7. Cobb EC, Watson NA, Wardian J, et al. Diabetes Center of Excellence Hypoglycemia Emergency Preparedness Project. Clin Diabetes. 2018;36(2):184-186. doi:10.2337/cd17-0040
8. Ogrinc G, Davies L, Goodman D, et al. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411
9. Kam S, Angaramo S, Antoun J, et al. Improving annual albuminuria testing for individuals with diabetes. BMJ Open Qual. 2022;11(1):e001591. doi:10.1136/bmjoq-2021-001591
10. Mitchell BD, He X, Sturdy IM, et al. Glucagon prescription patterns in patients with either type 1 or 2 diabetes with newly prescribed insulin. Endocr Pract. 2016;22(2):123-135. doi:10.4158/EP15831.OR
11. Whitfield N, Gregory P, Liu B, et al. Impact of pharmacist outreach on glucagon prescribing. J Am Pharm Assoc. 2022;62(4):1384-1388.e.1. doi:10.1016/j.japh.2022.01.017
1. Weinstock RS, Aleppo G, Bailey TS, et al. The Role of Blood Glucose Monitoring in Diabetes Management. American Diabetes Association; 2020.
2. Lamounier RN, Geloneze B, Leite SO, et al. Hypoglycemia incidence and awareness among insulin-treated patients with diabetes: the HAT study in Brazil. Diabetol Metab Syndr. 2018;10:83. doi:10.1186/s13098-018-0379-5
3. Li P, Geng Z, Ladage VP, et al. Early hypoglycaemia and adherence after basal insulin initiation in a nationally representative sample of Medicare beneficiaries with type 2 diabetes. Diabetes Obes Metab. 2019;21(11):2486-2495. doi:10.1111/dom.13832
4. Haymond MW, Liu J, Bispham J, et al. Use of glucagon in patients with type 1 diabetes. Clin Diabetes. 2019;37(2):162-166. doi:10.2337/cd18-0028
5. American Diabetes Association Professional Practice Committee. 6. Glycemic targets: standards of medical care in diabetes-2022. Diabetes Care. 2022; 45(Suppl 1):S83-S96. doi:10.2337/dc22-S006
6. O’Reilly EA, Cross LV, Hayes JS, et al. Impact of pharmacist intervention on glucagon prescribing patterns in an outpatient internal medicine teaching clinic. J Am Pharm Assoc (2003). 2020;60(2):384-390. doi:10.1016/j.japh.2019.04.0097.
7. Cobb EC, Watson NA, Wardian J, et al. Diabetes Center of Excellence Hypoglycemia Emergency Preparedness Project. Clin Diabetes. 2018;36(2):184-186. doi:10.2337/cd17-0040
8. Ogrinc G, Davies L, Goodman D, et al. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411
9. Kam S, Angaramo S, Antoun J, et al. Improving annual albuminuria testing for individuals with diabetes. BMJ Open Qual. 2022;11(1):e001591. doi:10.1136/bmjoq-2021-001591
10. Mitchell BD, He X, Sturdy IM, et al. Glucagon prescription patterns in patients with either type 1 or 2 diabetes with newly prescribed insulin. Endocr Pract. 2016;22(2):123-135. doi:10.4158/EP15831.OR
11. Whitfield N, Gregory P, Liu B, et al. Impact of pharmacist outreach on glucagon prescribing. J Am Pharm Assoc. 2022;62(4):1384-1388.e.1. doi:10.1016/j.japh.2022.01.017
Nonpharmacologic therapies for T2D: Five things to know
According to the Centers for Disease Control and Prevention National Diabetes Statistic Report, there are more than 37 million adults aged 18 years or older with diabetes in the United States, representing 14.7% of the adult population. Approximately 90%-95% of people diagnosed with diabetes have type 2 diabetes (T2D). An increasing aging population with T2D and a disparate incidence and burden of disease in African American and Hispanic populations raise important care considerations in effective disease assessment and management, especially in primary care, where the majority of diabetes management occurs.
This extends to the need for quality patient education in an effort to give persons with diabetes a better understanding of what it’s like to live with the disease.
Here are five things to know about nonpharmacologic therapies for effective T2D management.
1. Understand and treat the person before the disease.
Diabetes is a complex and unrelenting disease of self-management, requiring an individualized care approach to achieve optimal health outcomes and quality of life for persons living with this condition. Over 90% of care is provided by the person with diabetes, therefore understanding the lived world of the person with diabetes and its connected impact on self-care is critical to establishing effective treatment recommendations, especially for people from racial and ethnic minority groups and lower socioeconomic status where diabetes disparities are highest. Disease prevalence, cost of care, and disease burden are driven by social determinants of health (SDOH) factors that need to be assessed, and strategies addressing causative factors need to be implemented. SDOH factors, including the built environment, safety, financial status, education, food access, health care access, and social support, directly affect the ability of a person with diabetes to effectively implement treatment recommendations, including access to new medications. The adoption of a shared decision-making approach is key to person-centered care. Shared decision-making promotes a positive communication feedback loop, therapeutic patient-care team relationship, and collaborative plan of care between the person with diabetes and the care team. It also supports the establishment of mutual respect between the person with diabetes and the care team members. This cultivates the strong, open, and authentic partnership needed for effective chronic disease management.
2. Quality diabetes education is the foundation for effective self-care.
Diabetes self-management education and support (DSMES) is a fundamental component of diabetes care and ensures patients have the knowledge, skills, motivation, and resources necessary for effectively managing this condition. Despite treatment advances and the evidence base for DSMES, less than 5% of Medicare beneficiaries and 6.8% of privately insured beneficiaries have utilized its services, and this is a likely contributor to the lack of improvement for achieving national diabetes clinical targets. The Association of Diabetes Care and Education Specialists (ADCES7) Self-Care Behaviors provides an evidence-based framework for an optimal DSMES curriculum, incorporating the self-care behaviors of healthy coping (e.g., having a positive attitude toward diabetes self-management), nutritious eating, being active, taking medication, monitoring, reducing risk, and problem-solving.
There are four core times to implement and adapt referral for DSMES: (1) at diagnosis, (2) annually or when not meeting targets, (3) when complications arise, and (4) with transitions in life and care. DSMES referrals should be made for programs accredited by the ADCES or American Diabetes Association (ADA) and led by expert Certified Diabetes Care and Education Specialists (CDCES). The multidisciplinary composition and clinical skill level of CDCES make them a highly valued member of the diabetes care team. CDCES have demonstrated not only diabetes education expertise but are involved in broader health care roles to include population health management, technology integration, mitigation of therapeutic inertia, quality improvement activity, and delivery of cost-effective care.
3. Establish a strong foundation in lifestyle medicine.
Lifestyle medicine encompasses healthy eating, physical activity, restorative sleep, stress management, avoidance of risky behaviors, and positive social connections. It has also been strongly connected as a primary modality to prevent and treat chronic conditions like T2D. Lifestyle modifications have been noted in reducing the incidence of developing diabetes, reversing disease, improving clinical markers such as A1c and lipids, weight reduction, reducing use of medications, and improving quality of life. The multidisciplinary care team and CDCES can support the empowerment of individuals with T2D to develop the life skills and knowledge needed to establish positive self-care behaviors and successfully achieve health goals. Lifestyle medicine is not a replacement for pharmacologic interventions but rather serves as an adjunct when medication management is required.
4. Harness technology in diabetes treatment and care delivery.
Diabetes technology is advancing swiftly and includes glucose monitors, medication delivery devices, data-sharing platforms, and disease self-management applications. Combined with education and support, diabetes technology has been shown to have a positive clinical and personal impact on disease outcomes and quality of life. Regardless of its benefits, at times technology can seem overwhelming for the person with diabetes and the care team. Diabetes Care and Education Specialists (DCES) can support the care team and people living with diabetes to effectively identify, implement, and evaluate patient-centered diabetes technologies, as well as implement processes to drive clinical efficiencies and sustainability. Patient-generated health data reports can provide the care team with effective and proficient evaluation of diabetes care and needed treatment changes.
The expansion of telehealth during the COVID-19 pandemic, including real-time and asynchronous approaches, coupled with in-person care team visits, has resulted in improved access to diabetes care and education. Moreover, there continues to be an expanding health system focus on improving access to care beyond traditional brick and mortar solutions. Telehealth poses one possible access solution for people living with diabetes for whom factors such as transportation, remote geographies, and physical limitations affect their ability to attend in-person care visits.
5. Assess and address diabetes-related distress.
The persistent nature of diabetes self-care expectations and the impact on lifestyle behaviors, medication adherence, and glycemic control demands the need for assessment and treatment of diabetes-related distress (DRD). DRD can be expressed as shame, guilt, anger, fear, and frustration in combination with the everyday context of life priorities and stressors. An assessment of diabetes distress, utilizing a simple scale, should be included as part of an annual therapeutic diabetes care plan. The ADA Standards of Care in Diabetes recommends assessing patients’ psychological and social situations as an ongoing part of medical management, including an annual screening for depression and other psychological problems. The prevalence of depression is nearly twice as high in people with T2D than in the general population and can significantly influence patients’ ability to self-manage their diabetes and achieve healthy outcomes. Assessment and treatment of psychosocial components of care can result in significant improvements in A1c and other positive outcomes, including quality of life.
Kellie M. Rodriguez, director of the global diabetes program at Parkland Health, Dallas, Tex., disclosed ties with the Association of Diabetes Care and Education Specialists.
A version of this article originally appeared on Medscape.com.
According to the Centers for Disease Control and Prevention National Diabetes Statistic Report, there are more than 37 million adults aged 18 years or older with diabetes in the United States, representing 14.7% of the adult population. Approximately 90%-95% of people diagnosed with diabetes have type 2 diabetes (T2D). An increasing aging population with T2D and a disparate incidence and burden of disease in African American and Hispanic populations raise important care considerations in effective disease assessment and management, especially in primary care, where the majority of diabetes management occurs.
This extends to the need for quality patient education in an effort to give persons with diabetes a better understanding of what it’s like to live with the disease.
Here are five things to know about nonpharmacologic therapies for effective T2D management.
1. Understand and treat the person before the disease.
Diabetes is a complex and unrelenting disease of self-management, requiring an individualized care approach to achieve optimal health outcomes and quality of life for persons living with this condition. Over 90% of care is provided by the person with diabetes, therefore understanding the lived world of the person with diabetes and its connected impact on self-care is critical to establishing effective treatment recommendations, especially for people from racial and ethnic minority groups and lower socioeconomic status where diabetes disparities are highest. Disease prevalence, cost of care, and disease burden are driven by social determinants of health (SDOH) factors that need to be assessed, and strategies addressing causative factors need to be implemented. SDOH factors, including the built environment, safety, financial status, education, food access, health care access, and social support, directly affect the ability of a person with diabetes to effectively implement treatment recommendations, including access to new medications. The adoption of a shared decision-making approach is key to person-centered care. Shared decision-making promotes a positive communication feedback loop, therapeutic patient-care team relationship, and collaborative plan of care between the person with diabetes and the care team. It also supports the establishment of mutual respect between the person with diabetes and the care team members. This cultivates the strong, open, and authentic partnership needed for effective chronic disease management.
2. Quality diabetes education is the foundation for effective self-care.
Diabetes self-management education and support (DSMES) is a fundamental component of diabetes care and ensures patients have the knowledge, skills, motivation, and resources necessary for effectively managing this condition. Despite treatment advances and the evidence base for DSMES, less than 5% of Medicare beneficiaries and 6.8% of privately insured beneficiaries have utilized its services, and this is a likely contributor to the lack of improvement for achieving national diabetes clinical targets. The Association of Diabetes Care and Education Specialists (ADCES7) Self-Care Behaviors provides an evidence-based framework for an optimal DSMES curriculum, incorporating the self-care behaviors of healthy coping (e.g., having a positive attitude toward diabetes self-management), nutritious eating, being active, taking medication, monitoring, reducing risk, and problem-solving.
There are four core times to implement and adapt referral for DSMES: (1) at diagnosis, (2) annually or when not meeting targets, (3) when complications arise, and (4) with transitions in life and care. DSMES referrals should be made for programs accredited by the ADCES or American Diabetes Association (ADA) and led by expert Certified Diabetes Care and Education Specialists (CDCES). The multidisciplinary composition and clinical skill level of CDCES make them a highly valued member of the diabetes care team. CDCES have demonstrated not only diabetes education expertise but are involved in broader health care roles to include population health management, technology integration, mitigation of therapeutic inertia, quality improvement activity, and delivery of cost-effective care.
3. Establish a strong foundation in lifestyle medicine.
Lifestyle medicine encompasses healthy eating, physical activity, restorative sleep, stress management, avoidance of risky behaviors, and positive social connections. It has also been strongly connected as a primary modality to prevent and treat chronic conditions like T2D. Lifestyle modifications have been noted in reducing the incidence of developing diabetes, reversing disease, improving clinical markers such as A1c and lipids, weight reduction, reducing use of medications, and improving quality of life. The multidisciplinary care team and CDCES can support the empowerment of individuals with T2D to develop the life skills and knowledge needed to establish positive self-care behaviors and successfully achieve health goals. Lifestyle medicine is not a replacement for pharmacologic interventions but rather serves as an adjunct when medication management is required.
4. Harness technology in diabetes treatment and care delivery.
Diabetes technology is advancing swiftly and includes glucose monitors, medication delivery devices, data-sharing platforms, and disease self-management applications. Combined with education and support, diabetes technology has been shown to have a positive clinical and personal impact on disease outcomes and quality of life. Regardless of its benefits, at times technology can seem overwhelming for the person with diabetes and the care team. Diabetes Care and Education Specialists (DCES) can support the care team and people living with diabetes to effectively identify, implement, and evaluate patient-centered diabetes technologies, as well as implement processes to drive clinical efficiencies and sustainability. Patient-generated health data reports can provide the care team with effective and proficient evaluation of diabetes care and needed treatment changes.
The expansion of telehealth during the COVID-19 pandemic, including real-time and asynchronous approaches, coupled with in-person care team visits, has resulted in improved access to diabetes care and education. Moreover, there continues to be an expanding health system focus on improving access to care beyond traditional brick and mortar solutions. Telehealth poses one possible access solution for people living with diabetes for whom factors such as transportation, remote geographies, and physical limitations affect their ability to attend in-person care visits.
5. Assess and address diabetes-related distress.
The persistent nature of diabetes self-care expectations and the impact on lifestyle behaviors, medication adherence, and glycemic control demands the need for assessment and treatment of diabetes-related distress (DRD). DRD can be expressed as shame, guilt, anger, fear, and frustration in combination with the everyday context of life priorities and stressors. An assessment of diabetes distress, utilizing a simple scale, should be included as part of an annual therapeutic diabetes care plan. The ADA Standards of Care in Diabetes recommends assessing patients’ psychological and social situations as an ongoing part of medical management, including an annual screening for depression and other psychological problems. The prevalence of depression is nearly twice as high in people with T2D than in the general population and can significantly influence patients’ ability to self-manage their diabetes and achieve healthy outcomes. Assessment and treatment of psychosocial components of care can result in significant improvements in A1c and other positive outcomes, including quality of life.
Kellie M. Rodriguez, director of the global diabetes program at Parkland Health, Dallas, Tex., disclosed ties with the Association of Diabetes Care and Education Specialists.
A version of this article originally appeared on Medscape.com.
According to the Centers for Disease Control and Prevention National Diabetes Statistic Report, there are more than 37 million adults aged 18 years or older with diabetes in the United States, representing 14.7% of the adult population. Approximately 90%-95% of people diagnosed with diabetes have type 2 diabetes (T2D). An increasing aging population with T2D and a disparate incidence and burden of disease in African American and Hispanic populations raise important care considerations in effective disease assessment and management, especially in primary care, where the majority of diabetes management occurs.
This extends to the need for quality patient education in an effort to give persons with diabetes a better understanding of what it’s like to live with the disease.
Here are five things to know about nonpharmacologic therapies for effective T2D management.
1. Understand and treat the person before the disease.
Diabetes is a complex and unrelenting disease of self-management, requiring an individualized care approach to achieve optimal health outcomes and quality of life for persons living with this condition. Over 90% of care is provided by the person with diabetes, therefore understanding the lived world of the person with diabetes and its connected impact on self-care is critical to establishing effective treatment recommendations, especially for people from racial and ethnic minority groups and lower socioeconomic status where diabetes disparities are highest. Disease prevalence, cost of care, and disease burden are driven by social determinants of health (SDOH) factors that need to be assessed, and strategies addressing causative factors need to be implemented. SDOH factors, including the built environment, safety, financial status, education, food access, health care access, and social support, directly affect the ability of a person with diabetes to effectively implement treatment recommendations, including access to new medications. The adoption of a shared decision-making approach is key to person-centered care. Shared decision-making promotes a positive communication feedback loop, therapeutic patient-care team relationship, and collaborative plan of care between the person with diabetes and the care team. It also supports the establishment of mutual respect between the person with diabetes and the care team members. This cultivates the strong, open, and authentic partnership needed for effective chronic disease management.
2. Quality diabetes education is the foundation for effective self-care.
Diabetes self-management education and support (DSMES) is a fundamental component of diabetes care and ensures patients have the knowledge, skills, motivation, and resources necessary for effectively managing this condition. Despite treatment advances and the evidence base for DSMES, less than 5% of Medicare beneficiaries and 6.8% of privately insured beneficiaries have utilized its services, and this is a likely contributor to the lack of improvement for achieving national diabetes clinical targets. The Association of Diabetes Care and Education Specialists (ADCES7) Self-Care Behaviors provides an evidence-based framework for an optimal DSMES curriculum, incorporating the self-care behaviors of healthy coping (e.g., having a positive attitude toward diabetes self-management), nutritious eating, being active, taking medication, monitoring, reducing risk, and problem-solving.
There are four core times to implement and adapt referral for DSMES: (1) at diagnosis, (2) annually or when not meeting targets, (3) when complications arise, and (4) with transitions in life and care. DSMES referrals should be made for programs accredited by the ADCES or American Diabetes Association (ADA) and led by expert Certified Diabetes Care and Education Specialists (CDCES). The multidisciplinary composition and clinical skill level of CDCES make them a highly valued member of the diabetes care team. CDCES have demonstrated not only diabetes education expertise but are involved in broader health care roles to include population health management, technology integration, mitigation of therapeutic inertia, quality improvement activity, and delivery of cost-effective care.
3. Establish a strong foundation in lifestyle medicine.
Lifestyle medicine encompasses healthy eating, physical activity, restorative sleep, stress management, avoidance of risky behaviors, and positive social connections. It has also been strongly connected as a primary modality to prevent and treat chronic conditions like T2D. Lifestyle modifications have been noted in reducing the incidence of developing diabetes, reversing disease, improving clinical markers such as A1c and lipids, weight reduction, reducing use of medications, and improving quality of life. The multidisciplinary care team and CDCES can support the empowerment of individuals with T2D to develop the life skills and knowledge needed to establish positive self-care behaviors and successfully achieve health goals. Lifestyle medicine is not a replacement for pharmacologic interventions but rather serves as an adjunct when medication management is required.
4. Harness technology in diabetes treatment and care delivery.
Diabetes technology is advancing swiftly and includes glucose monitors, medication delivery devices, data-sharing platforms, and disease self-management applications. Combined with education and support, diabetes technology has been shown to have a positive clinical and personal impact on disease outcomes and quality of life. Regardless of its benefits, at times technology can seem overwhelming for the person with diabetes and the care team. Diabetes Care and Education Specialists (DCES) can support the care team and people living with diabetes to effectively identify, implement, and evaluate patient-centered diabetes technologies, as well as implement processes to drive clinical efficiencies and sustainability. Patient-generated health data reports can provide the care team with effective and proficient evaluation of diabetes care and needed treatment changes.
The expansion of telehealth during the COVID-19 pandemic, including real-time and asynchronous approaches, coupled with in-person care team visits, has resulted in improved access to diabetes care and education. Moreover, there continues to be an expanding health system focus on improving access to care beyond traditional brick and mortar solutions. Telehealth poses one possible access solution for people living with diabetes for whom factors such as transportation, remote geographies, and physical limitations affect their ability to attend in-person care visits.
5. Assess and address diabetes-related distress.
The persistent nature of diabetes self-care expectations and the impact on lifestyle behaviors, medication adherence, and glycemic control demands the need for assessment and treatment of diabetes-related distress (DRD). DRD can be expressed as shame, guilt, anger, fear, and frustration in combination with the everyday context of life priorities and stressors. An assessment of diabetes distress, utilizing a simple scale, should be included as part of an annual therapeutic diabetes care plan. The ADA Standards of Care in Diabetes recommends assessing patients’ psychological and social situations as an ongoing part of medical management, including an annual screening for depression and other psychological problems. The prevalence of depression is nearly twice as high in people with T2D than in the general population and can significantly influence patients’ ability to self-manage their diabetes and achieve healthy outcomes. Assessment and treatment of psychosocial components of care can result in significant improvements in A1c and other positive outcomes, including quality of life.
Kellie M. Rodriguez, director of the global diabetes program at Parkland Health, Dallas, Tex., disclosed ties with the Association of Diabetes Care and Education Specialists.
A version of this article originally appeared on Medscape.com.
Foot ulcers red flag for eye disease in diabetes
Sores on the feet can signal problems with the eyes in patients with diabetes.
Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur.
David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.
For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.
The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.
“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.
In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.
Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.
Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.
Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.
Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.
Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.
“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.
The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.
To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.
Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sores on the feet can signal problems with the eyes in patients with diabetes.
Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur.
David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.
For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.
The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.
“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.
In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.
Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.
Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.
Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.
Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.
Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.
“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.
The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.
To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.
Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sores on the feet can signal problems with the eyes in patients with diabetes.
Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur.
David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.
For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.
The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.
“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.
In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.
Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.
Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.
Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.
Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.
Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.
“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.
The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.
To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.
Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ARVO 2023
CGM completes picture of A1c in type 2 diabetes
in a post hoc analysis of the SWITCH PRO clinical trial.
TIR was inversely related to A1c, with the strongest correlation following treatment intensification.
However, “there was a wide scatter of data, indicating that TIR (and other metrics) provides information about glycemic control that cannot be discerned from A1c alone, and which at least complements it,” Ronald M. Goldenberg, MD, from LMC Diabetes & Endocrinology in Thornhill, Ont., and colleagues write in their article published in Diabetes Therapy.
Other work has shown that more than a third of people with type 2 diabetes are not achieving the internationally recommended A1c target of < 7% to 8.5%, they note.
When used with A1c, CGM data – such as TIR, time below range (TBR), and time above range (TAR) – “provide a more complete picture of glucose levels throughout the day and night,” they write.
“This may help empower people with diabetes to better manage their condition, giving them practical insights into the factors driving daily fluctuations in glucose levels, such as diet, exercise, insulin dosage, and insulin timing,” they add. “These metrics may also be used to inform treatment decisions by health care professionals.”
“Ultimately,” the researchers conclude, “it is hoped that the use of these new metrics should lead to an improved quality of glycemic control and, in turn, to a reduction in the number of diabetes-related complications.”
‘Important study’
Invited to comment, Celeste C. Thomas, MD, who was not involved with the research, said: “This study is important because it is consistent with previous analyses that found a correlation between TIR and A1c.”
But, “I was surprised by the scatter plots which identified participants with TIR of 70% that also had A1c > 9%,” she added. “This highlights the importance of using multiple glycemic metrics to understand an individual’s risk for diabetes complications and to be aware of the limitations of the metrics.”
Dr. Thomas, from the University of Chicago, also noted that CGM is used in endocrinology clinics and increasingly in primary care clinics, “often to determine glycemic patterns to optimize therapeutic management but also to review TIR and, importantly, time below range to reduce the incidence of hypoglycemia.”
And people with type 2 diabetes are using CGM, Dr. Thomas noted, to understand their individual responses to medications, food choices, sleep quality and duration, exercise, and other day-to-day variables that affect glucose levels. “In my clinical practice, the information provided by personal CGM is empowering,” she said.
Effective April 4, 2023, Medicare “allows for the coverage of CGM in patients [with type 2 diabetes] treated with one injection of insulin daily and those not taking insulin but with a history of hypoglycemia,” Dr. Thomas noted, whereas “previously, patients needed to be prescribed at least three injections of insulin daily. Other insurers will hopefully soon follow.”
“I foresee CGM and TIR being widely used in clinical practice for people living with type 2 diabetes,” she said, “especially those who have ever had an A1c over 8%, those with a history of hypoglycemia, and those treated with medications that are known to cause hypoglycemia.”
How does TIR compare with A1c?
Dr. Goldenberg and colleagues set out to better understand how the emerging TIR metric compares with the traditional A1c value.
They performed a post-hoc analysis of data from the phase 4 SWITCH PRO study of basal insulin–treated patients with type 2 diabetes with at least one risk factor for hypoglycemia.
The patients were treated with insulin degludec or glargine 100 during a 16-week titration and 2-week maintenance phase, and then crossed over to the other treatment for the same time periods.
Glycemic control was evaluated using a blinded professional CGM (Abbott Freestyle Libro Pro). The primary outcome was TIR, which was defined as the percentage of time spent in the blood glucose range of 70-180 mg/dL.
There were 419 participants in the full analysis. Patients were a mean age of 63 and 48% were men. They had a mean body mass index of 32 kg/m2 and had diabetes for a mean of 15 years.
There was a moderate inverse linear correlation between TIR and A1c at baseline, which became stronger following treatment intensification during the maintenance periods in the full cohort, and in a subgroup of patients with median A1c ≥ 7.5% (212 patients).
This correlation between TIR and A1c was poorer in the subgroup of patients with baseline median A1c < 7.5% (307 patients).
The data were widely scattered, “supporting the premise that A1c and TIR can be relatively crude surrogates of each other when it comes to individual patients,” Dr. Goldenberg and colleagues note.
Where individual patients have both low A1c and low TIR values, this might indicate frequent episodes of hypoglycemia.
A few individual patients had TIR > 70% but A1c approaching 9%. These patients may have different red blood cell physiology whereby A1c does not reflect average glycemic values, the researchers suggest.
The study was sponsored by Novo Nordisk and several authors are Novo Nordisk employees. The complete author disclosures are listed with the article. Dr. Thomas has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in a post hoc analysis of the SWITCH PRO clinical trial.
TIR was inversely related to A1c, with the strongest correlation following treatment intensification.
However, “there was a wide scatter of data, indicating that TIR (and other metrics) provides information about glycemic control that cannot be discerned from A1c alone, and which at least complements it,” Ronald M. Goldenberg, MD, from LMC Diabetes & Endocrinology in Thornhill, Ont., and colleagues write in their article published in Diabetes Therapy.
Other work has shown that more than a third of people with type 2 diabetes are not achieving the internationally recommended A1c target of < 7% to 8.5%, they note.
When used with A1c, CGM data – such as TIR, time below range (TBR), and time above range (TAR) – “provide a more complete picture of glucose levels throughout the day and night,” they write.
“This may help empower people with diabetes to better manage their condition, giving them practical insights into the factors driving daily fluctuations in glucose levels, such as diet, exercise, insulin dosage, and insulin timing,” they add. “These metrics may also be used to inform treatment decisions by health care professionals.”
“Ultimately,” the researchers conclude, “it is hoped that the use of these new metrics should lead to an improved quality of glycemic control and, in turn, to a reduction in the number of diabetes-related complications.”
‘Important study’
Invited to comment, Celeste C. Thomas, MD, who was not involved with the research, said: “This study is important because it is consistent with previous analyses that found a correlation between TIR and A1c.”
But, “I was surprised by the scatter plots which identified participants with TIR of 70% that also had A1c > 9%,” she added. “This highlights the importance of using multiple glycemic metrics to understand an individual’s risk for diabetes complications and to be aware of the limitations of the metrics.”
Dr. Thomas, from the University of Chicago, also noted that CGM is used in endocrinology clinics and increasingly in primary care clinics, “often to determine glycemic patterns to optimize therapeutic management but also to review TIR and, importantly, time below range to reduce the incidence of hypoglycemia.”
And people with type 2 diabetes are using CGM, Dr. Thomas noted, to understand their individual responses to medications, food choices, sleep quality and duration, exercise, and other day-to-day variables that affect glucose levels. “In my clinical practice, the information provided by personal CGM is empowering,” she said.
Effective April 4, 2023, Medicare “allows for the coverage of CGM in patients [with type 2 diabetes] treated with one injection of insulin daily and those not taking insulin but with a history of hypoglycemia,” Dr. Thomas noted, whereas “previously, patients needed to be prescribed at least three injections of insulin daily. Other insurers will hopefully soon follow.”
“I foresee CGM and TIR being widely used in clinical practice for people living with type 2 diabetes,” she said, “especially those who have ever had an A1c over 8%, those with a history of hypoglycemia, and those treated with medications that are known to cause hypoglycemia.”
How does TIR compare with A1c?
Dr. Goldenberg and colleagues set out to better understand how the emerging TIR metric compares with the traditional A1c value.
They performed a post-hoc analysis of data from the phase 4 SWITCH PRO study of basal insulin–treated patients with type 2 diabetes with at least one risk factor for hypoglycemia.
The patients were treated with insulin degludec or glargine 100 during a 16-week titration and 2-week maintenance phase, and then crossed over to the other treatment for the same time periods.
Glycemic control was evaluated using a blinded professional CGM (Abbott Freestyle Libro Pro). The primary outcome was TIR, which was defined as the percentage of time spent in the blood glucose range of 70-180 mg/dL.
There were 419 participants in the full analysis. Patients were a mean age of 63 and 48% were men. They had a mean body mass index of 32 kg/m2 and had diabetes for a mean of 15 years.
There was a moderate inverse linear correlation between TIR and A1c at baseline, which became stronger following treatment intensification during the maintenance periods in the full cohort, and in a subgroup of patients with median A1c ≥ 7.5% (212 patients).
This correlation between TIR and A1c was poorer in the subgroup of patients with baseline median A1c < 7.5% (307 patients).
The data were widely scattered, “supporting the premise that A1c and TIR can be relatively crude surrogates of each other when it comes to individual patients,” Dr. Goldenberg and colleagues note.
Where individual patients have both low A1c and low TIR values, this might indicate frequent episodes of hypoglycemia.
A few individual patients had TIR > 70% but A1c approaching 9%. These patients may have different red blood cell physiology whereby A1c does not reflect average glycemic values, the researchers suggest.
The study was sponsored by Novo Nordisk and several authors are Novo Nordisk employees. The complete author disclosures are listed with the article. Dr. Thomas has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in a post hoc analysis of the SWITCH PRO clinical trial.
TIR was inversely related to A1c, with the strongest correlation following treatment intensification.
However, “there was a wide scatter of data, indicating that TIR (and other metrics) provides information about glycemic control that cannot be discerned from A1c alone, and which at least complements it,” Ronald M. Goldenberg, MD, from LMC Diabetes & Endocrinology in Thornhill, Ont., and colleagues write in their article published in Diabetes Therapy.
Other work has shown that more than a third of people with type 2 diabetes are not achieving the internationally recommended A1c target of < 7% to 8.5%, they note.
When used with A1c, CGM data – such as TIR, time below range (TBR), and time above range (TAR) – “provide a more complete picture of glucose levels throughout the day and night,” they write.
“This may help empower people with diabetes to better manage their condition, giving them practical insights into the factors driving daily fluctuations in glucose levels, such as diet, exercise, insulin dosage, and insulin timing,” they add. “These metrics may also be used to inform treatment decisions by health care professionals.”
“Ultimately,” the researchers conclude, “it is hoped that the use of these new metrics should lead to an improved quality of glycemic control and, in turn, to a reduction in the number of diabetes-related complications.”
‘Important study’
Invited to comment, Celeste C. Thomas, MD, who was not involved with the research, said: “This study is important because it is consistent with previous analyses that found a correlation between TIR and A1c.”
But, “I was surprised by the scatter plots which identified participants with TIR of 70% that also had A1c > 9%,” she added. “This highlights the importance of using multiple glycemic metrics to understand an individual’s risk for diabetes complications and to be aware of the limitations of the metrics.”
Dr. Thomas, from the University of Chicago, also noted that CGM is used in endocrinology clinics and increasingly in primary care clinics, “often to determine glycemic patterns to optimize therapeutic management but also to review TIR and, importantly, time below range to reduce the incidence of hypoglycemia.”
And people with type 2 diabetes are using CGM, Dr. Thomas noted, to understand their individual responses to medications, food choices, sleep quality and duration, exercise, and other day-to-day variables that affect glucose levels. “In my clinical practice, the information provided by personal CGM is empowering,” she said.
Effective April 4, 2023, Medicare “allows for the coverage of CGM in patients [with type 2 diabetes] treated with one injection of insulin daily and those not taking insulin but with a history of hypoglycemia,” Dr. Thomas noted, whereas “previously, patients needed to be prescribed at least three injections of insulin daily. Other insurers will hopefully soon follow.”
“I foresee CGM and TIR being widely used in clinical practice for people living with type 2 diabetes,” she said, “especially those who have ever had an A1c over 8%, those with a history of hypoglycemia, and those treated with medications that are known to cause hypoglycemia.”
How does TIR compare with A1c?
Dr. Goldenberg and colleagues set out to better understand how the emerging TIR metric compares with the traditional A1c value.
They performed a post-hoc analysis of data from the phase 4 SWITCH PRO study of basal insulin–treated patients with type 2 diabetes with at least one risk factor for hypoglycemia.
The patients were treated with insulin degludec or glargine 100 during a 16-week titration and 2-week maintenance phase, and then crossed over to the other treatment for the same time periods.
Glycemic control was evaluated using a blinded professional CGM (Abbott Freestyle Libro Pro). The primary outcome was TIR, which was defined as the percentage of time spent in the blood glucose range of 70-180 mg/dL.
There were 419 participants in the full analysis. Patients were a mean age of 63 and 48% were men. They had a mean body mass index of 32 kg/m2 and had diabetes for a mean of 15 years.
There was a moderate inverse linear correlation between TIR and A1c at baseline, which became stronger following treatment intensification during the maintenance periods in the full cohort, and in a subgroup of patients with median A1c ≥ 7.5% (212 patients).
This correlation between TIR and A1c was poorer in the subgroup of patients with baseline median A1c < 7.5% (307 patients).
The data were widely scattered, “supporting the premise that A1c and TIR can be relatively crude surrogates of each other when it comes to individual patients,” Dr. Goldenberg and colleagues note.
Where individual patients have both low A1c and low TIR values, this might indicate frequent episodes of hypoglycemia.
A few individual patients had TIR > 70% but A1c approaching 9%. These patients may have different red blood cell physiology whereby A1c does not reflect average glycemic values, the researchers suggest.
The study was sponsored by Novo Nordisk and several authors are Novo Nordisk employees. The complete author disclosures are listed with the article. Dr. Thomas has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM DIABETES THERAPY
Early gestational diabetes treatment may improve neonatal outcomes
Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.
“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.
In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.
The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.
The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.
Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.
Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.
Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).
No differences in serious adverse events related to either screening or treatment were noted between the groups.
Impact on neonatal outcomes merits further study
Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.
“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.
“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.
The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.
The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.
Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
Findings support early screening
Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.
“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.
The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.
The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.
“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.
Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.
The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.
Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.
“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.
In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.
The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.
The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.
Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.
Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.
Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).
No differences in serious adverse events related to either screening or treatment were noted between the groups.
Impact on neonatal outcomes merits further study
Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.
“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.
“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.
The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.
The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.
Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
Findings support early screening
Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.
“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.
The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.
The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.
“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.
Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.
The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.
Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.
“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.
In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.
The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.
The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.
Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.
Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.
Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).
No differences in serious adverse events related to either screening or treatment were noted between the groups.
Impact on neonatal outcomes merits further study
Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.
“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.
“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.
The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.
The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.
Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
Findings support early screening
Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.
“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.
The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.
The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.
“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.
Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.
The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Sulfonylureas as street drugs: Hidden hypoglycemia cause
SEATTLE – .
“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.
Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.
“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
Similar cases go back nearly two decades
Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”
Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.
The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
Persistent hypoglycemia led to the source
In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.
Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?
Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.
She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
Ocreotide: A ‘unique antidote’
In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.
“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.
However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”
Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SEATTLE – .
“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.
Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.
“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
Similar cases go back nearly two decades
Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”
Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.
The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
Persistent hypoglycemia led to the source
In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.
Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?
Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.
She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
Ocreotide: A ‘unique antidote’
In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.
“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.
However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”
Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SEATTLE – .
“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.
Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.
“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
Similar cases go back nearly two decades
Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”
Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.
The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
Persistent hypoglycemia led to the source
In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.
Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?
Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.
She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
Ocreotide: A ‘unique antidote’
In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.
“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.
However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”
Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AACE 2023
New AACE type 2 diabetes algorithm individualizes care
SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.
The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.
Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.
lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.
Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
Eleven separate algorithms with text and graphics
Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”
Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.
Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.
Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”
And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.
Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.
Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.
“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.
The end of the document includes a full page of each graphic, meant for wall posting.
Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.
“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.
Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”
“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.
Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.
A version of this article originally appeared on Medscape.com.
SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.
The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.
Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.
lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.
Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
Eleven separate algorithms with text and graphics
Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”
Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.
Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.
Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”
And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.
Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.
Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.
“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.
The end of the document includes a full page of each graphic, meant for wall posting.
Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.
“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.
Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”
“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.
Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.
A version of this article originally appeared on Medscape.com.
SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.
The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.
Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.
lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.
Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
Eleven separate algorithms with text and graphics
Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”
Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.
Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.
Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”
And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.
Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.
Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.
“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.
The end of the document includes a full page of each graphic, meant for wall posting.
Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.
“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.
Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”
“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.
Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.
A version of this article originally appeared on Medscape.com.
AT AACE 2023