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Contact allergens lurk in diabetes devices
in a presentation at the annual meeting of the American Contact Dermatitis Society.
Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.
Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”
Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.
Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
Consider isobornyl acrylate
An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.
Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.
An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.
Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.
IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.
In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.
Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
Patch testing
When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.
Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.
Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
Management strategies
For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.
For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system
Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.
Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
A version of this article first appeared on Medscape.com.
in a presentation at the annual meeting of the American Contact Dermatitis Society.
Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.
Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”
Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.
Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
Consider isobornyl acrylate
An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.
Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.
An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.
Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.
IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.
In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.
Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
Patch testing
When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.
Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.
Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
Management strategies
For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.
For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system
Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.
Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
A version of this article first appeared on Medscape.com.
in a presentation at the annual meeting of the American Contact Dermatitis Society.
Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.
Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”
Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.
Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
Consider isobornyl acrylate
An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.
Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.
An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.
Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.
IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.
In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.
Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
Patch testing
When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.
Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.
Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
Management strategies
For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.
For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system
Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.
Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
A version of this article first appeared on Medscape.com.
FROM ACDS 2023
Why the approval of MiniMed 780G is a ‘quantum leap’ forward
This transcript has been edited for clarity.
There is wonderful news in the field of hybrid closed-loop pump technology because the Medtronic 780G system was just approved. I can’t tell you how happy this makes me because we’ve all been waiting for this seemingly forever and ever. This isn’t just a small upgrade from the 770G. It’s a quantum leap from the 770G to the 780G. The 780G has newer algorithms, a new sensor, and a longer-lasting infusion set.
It’s been used since 2020 in Europe, so we have good data on how well it works. Frankly, I think it works really well. We’ve seen nice improvements in [hemoglobin] A1c, time in range, other glycemic metrics, and patient satisfaction in studies done in Europe.
Now, I’ve never had the system to use in one of my patients. I always say I never know a system until I see it in use in my own patients, but let me tell you what I’ve read.
First, it has something called meal-detection technology with autocorrection boluses every 5 minutes. If this works, it can be a huge win for our patients because the problem my patients have is with mealtime dosing. They often dose late, or they may not dose enough insulin for the carbohydrates. That’s where the issues are.
All these hybrid closed-loop systems, this one included, show that the best improvements in glycemia are overnight. I’m hoping that this one shows some nice improvements in daytime glycemia as well. Stay tuned and I’ll let you know once I’ve been using it.
Next, it has adjustable targets down to 100. This is the lowest target for any hybrid closed-loop system. It has an extended-wear infusion set that lasts for 7 days. This infusion set is already available but works with this new system.
Finally, it has a new sensor. It looks like the old sensors, but it’s the Guardian 4, which requires much fewer finger sticks. Now, I’m not entirely sure about how often one has to do a finger stick. I know one has to do with finger sticking to initiate auto mode, or what they call SmartGuard, but I don’t know whether you ever have to do it again. I know for sure that you have to do it again if you fall out of the automated mode into manual mode. Once you’re in SmartGuard, I believe there are no further finger-stick calibrations required.
If people are already on the 770G system, this is just a software update that is presumably easy to upgrade to the 780G. Now, the physical pieces ... If someone doesn’t already have the Guardian 4 sensor or the extended-wear infusion set, they’ll have to get those. The software update to make the 770G increase to the 780G should just come through the cloud. I don’t know when that’s going to happen.
I do know that preorders for this system, if you want to buy the new physical system, start on May 15. The shipping of the new 780G system should occur in the United States toward the end of this summer.
I’m so excited. I think this is really going to benefit my patients. I can’t wait to start using it and letting patients see how these algorithms work and how they really help patients improve their glucose control.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There is wonderful news in the field of hybrid closed-loop pump technology because the Medtronic 780G system was just approved. I can’t tell you how happy this makes me because we’ve all been waiting for this seemingly forever and ever. This isn’t just a small upgrade from the 770G. It’s a quantum leap from the 770G to the 780G. The 780G has newer algorithms, a new sensor, and a longer-lasting infusion set.
It’s been used since 2020 in Europe, so we have good data on how well it works. Frankly, I think it works really well. We’ve seen nice improvements in [hemoglobin] A1c, time in range, other glycemic metrics, and patient satisfaction in studies done in Europe.
Now, I’ve never had the system to use in one of my patients. I always say I never know a system until I see it in use in my own patients, but let me tell you what I’ve read.
First, it has something called meal-detection technology with autocorrection boluses every 5 minutes. If this works, it can be a huge win for our patients because the problem my patients have is with mealtime dosing. They often dose late, or they may not dose enough insulin for the carbohydrates. That’s where the issues are.
All these hybrid closed-loop systems, this one included, show that the best improvements in glycemia are overnight. I’m hoping that this one shows some nice improvements in daytime glycemia as well. Stay tuned and I’ll let you know once I’ve been using it.
Next, it has adjustable targets down to 100. This is the lowest target for any hybrid closed-loop system. It has an extended-wear infusion set that lasts for 7 days. This infusion set is already available but works with this new system.
Finally, it has a new sensor. It looks like the old sensors, but it’s the Guardian 4, which requires much fewer finger sticks. Now, I’m not entirely sure about how often one has to do a finger stick. I know one has to do with finger sticking to initiate auto mode, or what they call SmartGuard, but I don’t know whether you ever have to do it again. I know for sure that you have to do it again if you fall out of the automated mode into manual mode. Once you’re in SmartGuard, I believe there are no further finger-stick calibrations required.
If people are already on the 770G system, this is just a software update that is presumably easy to upgrade to the 780G. Now, the physical pieces ... If someone doesn’t already have the Guardian 4 sensor or the extended-wear infusion set, they’ll have to get those. The software update to make the 770G increase to the 780G should just come through the cloud. I don’t know when that’s going to happen.
I do know that preorders for this system, if you want to buy the new physical system, start on May 15. The shipping of the new 780G system should occur in the United States toward the end of this summer.
I’m so excited. I think this is really going to benefit my patients. I can’t wait to start using it and letting patients see how these algorithms work and how they really help patients improve their glucose control.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There is wonderful news in the field of hybrid closed-loop pump technology because the Medtronic 780G system was just approved. I can’t tell you how happy this makes me because we’ve all been waiting for this seemingly forever and ever. This isn’t just a small upgrade from the 770G. It’s a quantum leap from the 770G to the 780G. The 780G has newer algorithms, a new sensor, and a longer-lasting infusion set.
It’s been used since 2020 in Europe, so we have good data on how well it works. Frankly, I think it works really well. We’ve seen nice improvements in [hemoglobin] A1c, time in range, other glycemic metrics, and patient satisfaction in studies done in Europe.
Now, I’ve never had the system to use in one of my patients. I always say I never know a system until I see it in use in my own patients, but let me tell you what I’ve read.
First, it has something called meal-detection technology with autocorrection boluses every 5 minutes. If this works, it can be a huge win for our patients because the problem my patients have is with mealtime dosing. They often dose late, or they may not dose enough insulin for the carbohydrates. That’s where the issues are.
All these hybrid closed-loop systems, this one included, show that the best improvements in glycemia are overnight. I’m hoping that this one shows some nice improvements in daytime glycemia as well. Stay tuned and I’ll let you know once I’ve been using it.
Next, it has adjustable targets down to 100. This is the lowest target for any hybrid closed-loop system. It has an extended-wear infusion set that lasts for 7 days. This infusion set is already available but works with this new system.
Finally, it has a new sensor. It looks like the old sensors, but it’s the Guardian 4, which requires much fewer finger sticks. Now, I’m not entirely sure about how often one has to do a finger stick. I know one has to do with finger sticking to initiate auto mode, or what they call SmartGuard, but I don’t know whether you ever have to do it again. I know for sure that you have to do it again if you fall out of the automated mode into manual mode. Once you’re in SmartGuard, I believe there are no further finger-stick calibrations required.
If people are already on the 770G system, this is just a software update that is presumably easy to upgrade to the 780G. Now, the physical pieces ... If someone doesn’t already have the Guardian 4 sensor or the extended-wear infusion set, they’ll have to get those. The software update to make the 770G increase to the 780G should just come through the cloud. I don’t know when that’s going to happen.
I do know that preorders for this system, if you want to buy the new physical system, start on May 15. The shipping of the new 780G system should occur in the United States toward the end of this summer.
I’m so excited. I think this is really going to benefit my patients. I can’t wait to start using it and letting patients see how these algorithms work and how they really help patients improve their glucose control.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.
A version of this article first appeared on Medscape.com.
Expert discusses which diets are best, based on the evidence
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
AT INTERNAL MEDICINE 2023
Should CGM be used for those without diabetes?
Dallas Waldon doesn’t have diabetes, but she says she benefits from continuous glucose monitoring (CGM). “I’m a huge fan of CGMs and used them before, during, and after my pregnancy, [up to] 6 months postpartum, I’m down 11 pounds from my prepregnancy weight,” said Ms. Waldon, a manager for a land-buying company who lives in El Dorado, Calif.
“CGMs bring a certain level of accountability to what you’re eating. You can’t pretend you didn’t eat that cookie while making the kids’ lunch, or that the latte you had was ‘just coffee,’ ” she said. “You have the hard numbers to answer to, and that makes you think twice before putting anything in your mouth.”
Ms. Waldon is not alone. Although CGMs are typically used by people with type 1 diabetes, and increasingly those with type 2 diabetes, some endocrinologists say they are seeing an increased demand for CGM use from individuals who don’t have diabetes.
This allows users to monitor the glucose level and see how eating and exercise affects it. The companies claim that CGM use will help motivate individuals to eat better and maximize their exercise, and therefore consequently lose weight.
These lifestyle programs typically offer users the FreeStyle Libre (Abbott Laboratories). It uses a coin-sized sensor, generally worn on the upper arm, which lasts 14 days and measures glucose in the interstitial fluid. Users can read their glucose levels via an app on their smartphones as many times a day as they want. The FreeStyle Libre is worn by many people with diabetes and is a simple CGM to use, said Anne Peters, MD, professor of clinical medicine, University of Southern California, Los Angeles.
This growing demand for CGM use among healthy people is driven by an increasing “fascination” for monitoring every bodily function, as can be seen by the popularity of smart devices such as Fitbits and Apple watches, Dr. Peters added. These devices allow users to see their heart rates, review their sleep patterns, and monitor their pulses in real time; a CGM is an extension of that by providing up-to-the-minute glucose monitoring.
‘Everyone wants a CGM’
“Everyone wants a CGM,” Dr. Peters said, noting that even family members of her patients with diabetes are asking for them. She admits that their use can be effective for those who are prediabetic so they can see their glycemic responses to food. For instance, someone who typically eats oatmeal for breakfast may see their blood glucose increase, meaning they might want to lower their carbs.
David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., agrees that there has been an increase in use by people who don’t have diabetes as CGMs offer information they wouldn’t otherwise have access to “without having to prick themselves many times.”
People are using CGMs to monitor how high their blood glucose rises after eating certain foods, the length of time it takes to reach peak levels, and how quickly levels drop, he added. Elite athletes are using CGMs to ensure that they are consuming enough calories to avoid hypoglycemia, Dr. Klonoff said.
David T. Ahn, MD, program director at the Mary & Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, Calif., also believes that the devices can provide useful information. “I find that CGM helps people learn a lot about nutrition and how lifestyle choices like food, activity, and stress impact their own physiology,” he stated.
“For example, comparing glucose spikes after different [types of] meals can deepen people’s understanding of carbohydrates vs. protein, or high glycemic index foods vs. low glycemic index foods,” he continued. “In addition, if a patient chooses to follow a very low-carbohydrate diet and/or an intermittent fasting diet, a CGM can be a powerful tool to measure consistency with that lifestyle choice.”
And for a person without diabetes, wearing a CGM provides a way to have personalized information on other physiologic measures, part of the quantified self movement where users log and track their blood pressure, urine output, and oxygen saturation, among other things, Dr. Klonoff said.
But does knowing all this result in behavioral changes?
Dr. Ahn isn’t sure. “For many people, being able to see glucose excursions throughout the day and after meals can be extremely educational and motivating. But much like the Fitbit or Apple Watch, simply wearing [a CGM] ... does not translate to behavior change. The CGM data patterns in someone without diabetes can start to become predictable over time, leading to a drop-off in utility/adherence after the initial education period,” he said.
Dr. Peters said she too isn’t convinced about the long-term worth of CGM in promoting or sustaining behavioral change, as the “novelty” of tracking may wear off after a few months.
And there’s no scientific proof that CGM use in those without diabetes has any impact.
“While there are many programs that offer coaching with CGM data, we need more studies to determine if this leads to improved outcomes like weight loss and prevention, or delay in the development of diabetes,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, director of education and training in diabetes technology at Cleveland Clinic Diabetes Center.
A 2019 study published in the Journal of Clinical Endocrinology and Metabolism found that the blood glucose of individuals without diabetes using a CGM was in the “ideal” range between 70 mg/dL and 140 mg/dL 96% of the time. “Their glucose was beautifully controlled,” said Dr. Peters, who was one of the study authors.
Currently there aren’t any studies evaluating patterns among healthy individuals wearing CGMs, Dr. Klonoff noted, but he predicts that those studies will be done in the future to examine metabolic patterns that might contribute to someone developing prediabetes or diabetes.
“More data are needed from studies that focus on individuals at risk for diabetes to better understand the role of CGM in these cases, and how to best interpret and utilize the results,” said Fida Bacha, MD, a diabetes and endocrinology specialist and associate professor of pediatrics at Baylor College of Medicine in Houston.
“If clear metrics are identified to predict the progression to diabetes, then this would be worthwhile for early detection and prevention of the disease,” Dr. Bacha said.
Are CGMs too expensive, and can the information overwhelm some?
The biggest obstacle to many people using CGM is cost. “The main downside of using a CGM without diabetes is cost, since insurance won’t usually cover a CGM if the patient does not have diabetes,” said Marilyn Tan, MD, FACE, chief of the Endocrine Clinic, Stanford Health Clinic, Palo Alto, Calif. “Even for patients with diabetes but not on insulin, CGM coverage can be challenging, as out-of-pocket costs for CGM are variable.”
The lifestyle companies mentioned above charge $139-$399 per month, which covers two CGM sensors, each one good for 14 days. Users need to subscribe to a plan for service and delivery. Additional services such as nutrition counseling may be available at an additional cost. Because CGMs in the United States require a prescription, these companies offer web screening and access to a web-based provider.
If healthy patients feel that the informational value of CGMs is worth the money, then they shouldn’t be discouraged, the experts believe.
“There’s little risk of harm with wearing a CGM,” Dr. Tan said, although she acknowledges that “[t]oo much information can also be overwhelming for some individuals.”
Users need to consult with their clinicians to ensure they understand the readings, Dr. Peters said. “You have to tell them not to overreact if the device reads low [glucose] or not to freak out if they get an alarm.” A high glucose reading, indicating hyperglycemia, can be caused by a steroid injection, or older people may experience a postprandial high after eating, she added. “They need to talk to their healthcare provider to interpret the data especially if they are out of [the ideal glucose] range.”
Dr. Klonoff agreed that there is a risk of people trying to “medicalize” too much information. “If you have a fever, you don’t have to go to a doctor to know you have an infection,” he said.
And the point, he added, is not to obsess over the individual numbers but to look for patterns particularly as predictors of metabolic syndrome. If a patient’s glucose is primarily in range, he or she wouldn’t necessarily worry about diabetes. But if it’s out of range more than 10% of the time, it might mean that patient is at risk for diabetes. “It might be time to counsel the patient to eat healthier and exercise more,” he said. “It’s never wrong to steer people to a healthier lifestyle.”
But another issue is whether the numbers from CGMs are entirely accurate in people without diabetes. A 2020 study published in the American Journal of Clinical Nutrition had 16 adults without diabetes wear both the Dexcom G4 Platinum CGM and Abbott FreeStyle Libre Pro for 28 days.
Researchers found that mean postprandial glucose was higher with the Dexcom than with the Abbott system, suggesting that “postprandial glycemic excursions were somewhat inconsistent between the CGMs.” The authors concluded that it may be too early to personalize meal recommendations via CGM.
Dr. Isaacs said perhaps the happy medium is for those without diabetes to just use CGMs occasionally. “It’s ... unclear [if] the right [use] of CGM needs to be continuous or if periodic use, such as once every 3 months, is enough for benefits,” she concluded.
A version of this article first appeared on Medscape.com.
Dallas Waldon doesn’t have diabetes, but she says she benefits from continuous glucose monitoring (CGM). “I’m a huge fan of CGMs and used them before, during, and after my pregnancy, [up to] 6 months postpartum, I’m down 11 pounds from my prepregnancy weight,” said Ms. Waldon, a manager for a land-buying company who lives in El Dorado, Calif.
“CGMs bring a certain level of accountability to what you’re eating. You can’t pretend you didn’t eat that cookie while making the kids’ lunch, or that the latte you had was ‘just coffee,’ ” she said. “You have the hard numbers to answer to, and that makes you think twice before putting anything in your mouth.”
Ms. Waldon is not alone. Although CGMs are typically used by people with type 1 diabetes, and increasingly those with type 2 diabetes, some endocrinologists say they are seeing an increased demand for CGM use from individuals who don’t have diabetes.
This allows users to monitor the glucose level and see how eating and exercise affects it. The companies claim that CGM use will help motivate individuals to eat better and maximize their exercise, and therefore consequently lose weight.
These lifestyle programs typically offer users the FreeStyle Libre (Abbott Laboratories). It uses a coin-sized sensor, generally worn on the upper arm, which lasts 14 days and measures glucose in the interstitial fluid. Users can read their glucose levels via an app on their smartphones as many times a day as they want. The FreeStyle Libre is worn by many people with diabetes and is a simple CGM to use, said Anne Peters, MD, professor of clinical medicine, University of Southern California, Los Angeles.
This growing demand for CGM use among healthy people is driven by an increasing “fascination” for monitoring every bodily function, as can be seen by the popularity of smart devices such as Fitbits and Apple watches, Dr. Peters added. These devices allow users to see their heart rates, review their sleep patterns, and monitor their pulses in real time; a CGM is an extension of that by providing up-to-the-minute glucose monitoring.
‘Everyone wants a CGM’
“Everyone wants a CGM,” Dr. Peters said, noting that even family members of her patients with diabetes are asking for them. She admits that their use can be effective for those who are prediabetic so they can see their glycemic responses to food. For instance, someone who typically eats oatmeal for breakfast may see their blood glucose increase, meaning they might want to lower their carbs.
David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., agrees that there has been an increase in use by people who don’t have diabetes as CGMs offer information they wouldn’t otherwise have access to “without having to prick themselves many times.”
People are using CGMs to monitor how high their blood glucose rises after eating certain foods, the length of time it takes to reach peak levels, and how quickly levels drop, he added. Elite athletes are using CGMs to ensure that they are consuming enough calories to avoid hypoglycemia, Dr. Klonoff said.
David T. Ahn, MD, program director at the Mary & Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, Calif., also believes that the devices can provide useful information. “I find that CGM helps people learn a lot about nutrition and how lifestyle choices like food, activity, and stress impact their own physiology,” he stated.
“For example, comparing glucose spikes after different [types of] meals can deepen people’s understanding of carbohydrates vs. protein, or high glycemic index foods vs. low glycemic index foods,” he continued. “In addition, if a patient chooses to follow a very low-carbohydrate diet and/or an intermittent fasting diet, a CGM can be a powerful tool to measure consistency with that lifestyle choice.”
And for a person without diabetes, wearing a CGM provides a way to have personalized information on other physiologic measures, part of the quantified self movement where users log and track their blood pressure, urine output, and oxygen saturation, among other things, Dr. Klonoff said.
But does knowing all this result in behavioral changes?
Dr. Ahn isn’t sure. “For many people, being able to see glucose excursions throughout the day and after meals can be extremely educational and motivating. But much like the Fitbit or Apple Watch, simply wearing [a CGM] ... does not translate to behavior change. The CGM data patterns in someone without diabetes can start to become predictable over time, leading to a drop-off in utility/adherence after the initial education period,” he said.
Dr. Peters said she too isn’t convinced about the long-term worth of CGM in promoting or sustaining behavioral change, as the “novelty” of tracking may wear off after a few months.
And there’s no scientific proof that CGM use in those without diabetes has any impact.
“While there are many programs that offer coaching with CGM data, we need more studies to determine if this leads to improved outcomes like weight loss and prevention, or delay in the development of diabetes,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, director of education and training in diabetes technology at Cleveland Clinic Diabetes Center.
A 2019 study published in the Journal of Clinical Endocrinology and Metabolism found that the blood glucose of individuals without diabetes using a CGM was in the “ideal” range between 70 mg/dL and 140 mg/dL 96% of the time. “Their glucose was beautifully controlled,” said Dr. Peters, who was one of the study authors.
Currently there aren’t any studies evaluating patterns among healthy individuals wearing CGMs, Dr. Klonoff noted, but he predicts that those studies will be done in the future to examine metabolic patterns that might contribute to someone developing prediabetes or diabetes.
“More data are needed from studies that focus on individuals at risk for diabetes to better understand the role of CGM in these cases, and how to best interpret and utilize the results,” said Fida Bacha, MD, a diabetes and endocrinology specialist and associate professor of pediatrics at Baylor College of Medicine in Houston.
“If clear metrics are identified to predict the progression to diabetes, then this would be worthwhile for early detection and prevention of the disease,” Dr. Bacha said.
Are CGMs too expensive, and can the information overwhelm some?
The biggest obstacle to many people using CGM is cost. “The main downside of using a CGM without diabetes is cost, since insurance won’t usually cover a CGM if the patient does not have diabetes,” said Marilyn Tan, MD, FACE, chief of the Endocrine Clinic, Stanford Health Clinic, Palo Alto, Calif. “Even for patients with diabetes but not on insulin, CGM coverage can be challenging, as out-of-pocket costs for CGM are variable.”
The lifestyle companies mentioned above charge $139-$399 per month, which covers two CGM sensors, each one good for 14 days. Users need to subscribe to a plan for service and delivery. Additional services such as nutrition counseling may be available at an additional cost. Because CGMs in the United States require a prescription, these companies offer web screening and access to a web-based provider.
If healthy patients feel that the informational value of CGMs is worth the money, then they shouldn’t be discouraged, the experts believe.
“There’s little risk of harm with wearing a CGM,” Dr. Tan said, although she acknowledges that “[t]oo much information can also be overwhelming for some individuals.”
Users need to consult with their clinicians to ensure they understand the readings, Dr. Peters said. “You have to tell them not to overreact if the device reads low [glucose] or not to freak out if they get an alarm.” A high glucose reading, indicating hyperglycemia, can be caused by a steroid injection, or older people may experience a postprandial high after eating, she added. “They need to talk to their healthcare provider to interpret the data especially if they are out of [the ideal glucose] range.”
Dr. Klonoff agreed that there is a risk of people trying to “medicalize” too much information. “If you have a fever, you don’t have to go to a doctor to know you have an infection,” he said.
And the point, he added, is not to obsess over the individual numbers but to look for patterns particularly as predictors of metabolic syndrome. If a patient’s glucose is primarily in range, he or she wouldn’t necessarily worry about diabetes. But if it’s out of range more than 10% of the time, it might mean that patient is at risk for diabetes. “It might be time to counsel the patient to eat healthier and exercise more,” he said. “It’s never wrong to steer people to a healthier lifestyle.”
But another issue is whether the numbers from CGMs are entirely accurate in people without diabetes. A 2020 study published in the American Journal of Clinical Nutrition had 16 adults without diabetes wear both the Dexcom G4 Platinum CGM and Abbott FreeStyle Libre Pro for 28 days.
Researchers found that mean postprandial glucose was higher with the Dexcom than with the Abbott system, suggesting that “postprandial glycemic excursions were somewhat inconsistent between the CGMs.” The authors concluded that it may be too early to personalize meal recommendations via CGM.
Dr. Isaacs said perhaps the happy medium is for those without diabetes to just use CGMs occasionally. “It’s ... unclear [if] the right [use] of CGM needs to be continuous or if periodic use, such as once every 3 months, is enough for benefits,” she concluded.
A version of this article first appeared on Medscape.com.
Dallas Waldon doesn’t have diabetes, but she says she benefits from continuous glucose monitoring (CGM). “I’m a huge fan of CGMs and used them before, during, and after my pregnancy, [up to] 6 months postpartum, I’m down 11 pounds from my prepregnancy weight,” said Ms. Waldon, a manager for a land-buying company who lives in El Dorado, Calif.
“CGMs bring a certain level of accountability to what you’re eating. You can’t pretend you didn’t eat that cookie while making the kids’ lunch, or that the latte you had was ‘just coffee,’ ” she said. “You have the hard numbers to answer to, and that makes you think twice before putting anything in your mouth.”
Ms. Waldon is not alone. Although CGMs are typically used by people with type 1 diabetes, and increasingly those with type 2 diabetes, some endocrinologists say they are seeing an increased demand for CGM use from individuals who don’t have diabetes.
This allows users to monitor the glucose level and see how eating and exercise affects it. The companies claim that CGM use will help motivate individuals to eat better and maximize their exercise, and therefore consequently lose weight.
These lifestyle programs typically offer users the FreeStyle Libre (Abbott Laboratories). It uses a coin-sized sensor, generally worn on the upper arm, which lasts 14 days and measures glucose in the interstitial fluid. Users can read their glucose levels via an app on their smartphones as many times a day as they want. The FreeStyle Libre is worn by many people with diabetes and is a simple CGM to use, said Anne Peters, MD, professor of clinical medicine, University of Southern California, Los Angeles.
This growing demand for CGM use among healthy people is driven by an increasing “fascination” for monitoring every bodily function, as can be seen by the popularity of smart devices such as Fitbits and Apple watches, Dr. Peters added. These devices allow users to see their heart rates, review their sleep patterns, and monitor their pulses in real time; a CGM is an extension of that by providing up-to-the-minute glucose monitoring.
‘Everyone wants a CGM’
“Everyone wants a CGM,” Dr. Peters said, noting that even family members of her patients with diabetes are asking for them. She admits that their use can be effective for those who are prediabetic so they can see their glycemic responses to food. For instance, someone who typically eats oatmeal for breakfast may see their blood glucose increase, meaning they might want to lower their carbs.
David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., agrees that there has been an increase in use by people who don’t have diabetes as CGMs offer information they wouldn’t otherwise have access to “without having to prick themselves many times.”
People are using CGMs to monitor how high their blood glucose rises after eating certain foods, the length of time it takes to reach peak levels, and how quickly levels drop, he added. Elite athletes are using CGMs to ensure that they are consuming enough calories to avoid hypoglycemia, Dr. Klonoff said.
David T. Ahn, MD, program director at the Mary & Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, Calif., also believes that the devices can provide useful information. “I find that CGM helps people learn a lot about nutrition and how lifestyle choices like food, activity, and stress impact their own physiology,” he stated.
“For example, comparing glucose spikes after different [types of] meals can deepen people’s understanding of carbohydrates vs. protein, or high glycemic index foods vs. low glycemic index foods,” he continued. “In addition, if a patient chooses to follow a very low-carbohydrate diet and/or an intermittent fasting diet, a CGM can be a powerful tool to measure consistency with that lifestyle choice.”
And for a person without diabetes, wearing a CGM provides a way to have personalized information on other physiologic measures, part of the quantified self movement where users log and track their blood pressure, urine output, and oxygen saturation, among other things, Dr. Klonoff said.
But does knowing all this result in behavioral changes?
Dr. Ahn isn’t sure. “For many people, being able to see glucose excursions throughout the day and after meals can be extremely educational and motivating. But much like the Fitbit or Apple Watch, simply wearing [a CGM] ... does not translate to behavior change. The CGM data patterns in someone without diabetes can start to become predictable over time, leading to a drop-off in utility/adherence after the initial education period,” he said.
Dr. Peters said she too isn’t convinced about the long-term worth of CGM in promoting or sustaining behavioral change, as the “novelty” of tracking may wear off after a few months.
And there’s no scientific proof that CGM use in those without diabetes has any impact.
“While there are many programs that offer coaching with CGM data, we need more studies to determine if this leads to improved outcomes like weight loss and prevention, or delay in the development of diabetes,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, director of education and training in diabetes technology at Cleveland Clinic Diabetes Center.
A 2019 study published in the Journal of Clinical Endocrinology and Metabolism found that the blood glucose of individuals without diabetes using a CGM was in the “ideal” range between 70 mg/dL and 140 mg/dL 96% of the time. “Their glucose was beautifully controlled,” said Dr. Peters, who was one of the study authors.
Currently there aren’t any studies evaluating patterns among healthy individuals wearing CGMs, Dr. Klonoff noted, but he predicts that those studies will be done in the future to examine metabolic patterns that might contribute to someone developing prediabetes or diabetes.
“More data are needed from studies that focus on individuals at risk for diabetes to better understand the role of CGM in these cases, and how to best interpret and utilize the results,” said Fida Bacha, MD, a diabetes and endocrinology specialist and associate professor of pediatrics at Baylor College of Medicine in Houston.
“If clear metrics are identified to predict the progression to diabetes, then this would be worthwhile for early detection and prevention of the disease,” Dr. Bacha said.
Are CGMs too expensive, and can the information overwhelm some?
The biggest obstacle to many people using CGM is cost. “The main downside of using a CGM without diabetes is cost, since insurance won’t usually cover a CGM if the patient does not have diabetes,” said Marilyn Tan, MD, FACE, chief of the Endocrine Clinic, Stanford Health Clinic, Palo Alto, Calif. “Even for patients with diabetes but not on insulin, CGM coverage can be challenging, as out-of-pocket costs for CGM are variable.”
The lifestyle companies mentioned above charge $139-$399 per month, which covers two CGM sensors, each one good for 14 days. Users need to subscribe to a plan for service and delivery. Additional services such as nutrition counseling may be available at an additional cost. Because CGMs in the United States require a prescription, these companies offer web screening and access to a web-based provider.
If healthy patients feel that the informational value of CGMs is worth the money, then they shouldn’t be discouraged, the experts believe.
“There’s little risk of harm with wearing a CGM,” Dr. Tan said, although she acknowledges that “[t]oo much information can also be overwhelming for some individuals.”
Users need to consult with their clinicians to ensure they understand the readings, Dr. Peters said. “You have to tell them not to overreact if the device reads low [glucose] or not to freak out if they get an alarm.” A high glucose reading, indicating hyperglycemia, can be caused by a steroid injection, or older people may experience a postprandial high after eating, she added. “They need to talk to their healthcare provider to interpret the data especially if they are out of [the ideal glucose] range.”
Dr. Klonoff agreed that there is a risk of people trying to “medicalize” too much information. “If you have a fever, you don’t have to go to a doctor to know you have an infection,” he said.
And the point, he added, is not to obsess over the individual numbers but to look for patterns particularly as predictors of metabolic syndrome. If a patient’s glucose is primarily in range, he or she wouldn’t necessarily worry about diabetes. But if it’s out of range more than 10% of the time, it might mean that patient is at risk for diabetes. “It might be time to counsel the patient to eat healthier and exercise more,” he said. “It’s never wrong to steer people to a healthier lifestyle.”
But another issue is whether the numbers from CGMs are entirely accurate in people without diabetes. A 2020 study published in the American Journal of Clinical Nutrition had 16 adults without diabetes wear both the Dexcom G4 Platinum CGM and Abbott FreeStyle Libre Pro for 28 days.
Researchers found that mean postprandial glucose was higher with the Dexcom than with the Abbott system, suggesting that “postprandial glycemic excursions were somewhat inconsistent between the CGMs.” The authors concluded that it may be too early to personalize meal recommendations via CGM.
Dr. Isaacs said perhaps the happy medium is for those without diabetes to just use CGMs occasionally. “It’s ... unclear [if] the right [use] of CGM needs to be continuous or if periodic use, such as once every 3 months, is enough for benefits,” she concluded.
A version of this article first appeared on Medscape.com.
Lifestyle med experts tell how to deprescribe diabetes meds
Nine lifestyle medicine practitioners describe how they safely and effectively deprescribe glucose-lowering medications after patients demonstrate a reduced need for such medications following lifestyle changes.
The report by Michael D. Bradley, PharmD, and colleagues was recently published as a feature article in Clinical Diabetes.
“Lifestyle medicine uses an evidence-based lifestyle therapeutic approach to treat lifestyle-related chronic disease,” they wrote, and it includes “a whole-food, predominantly plant-based eating plan, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection.”
“Medication deprescribing,” senior author Micaela C. Karlsen, PhD, said in an email, “is a planned and supervised process of dose reduction or discontinuation of a medication that may be causing harm, or no longer providing benefit to a patient.”
According to the authors, the article “is the first account published of the medication de-escalation methods used by lifestyle medicine providers when patients demonstrate a decreased need for pharmacotherapy.” It “supports the feasibility of de-escalating glucose-lowering medications in this context and provides pilot data on protocols from individual practitioners experienced in deprescribing glucose-lowering medications.”
The study was not designed to cover deprescribing glucose-lowering medications following weight loss and diabetes remission after bariatric surgery.
“A key takeaway [from the current study] for general practitioners and endocrinologists is that, while deprescribing is already known to be beneficial to reduce polypharmacy, it may be appropriate following lifestyle interventions,” said Dr. Karlsen, who is senior director of the American College of Lifestyle Medicine in Chesterfield, Md.
“The protocols presented can serve as a model for how to do so,” she continued.
The American Diabetes Association and the American Association of Clinical Endocrinology recommend lifestyle optimization as part of medical care for type 2 diabetes.
According to the ACLM, “remission of type 2 diabetes should be a clinical goal and may be achieved with a whole-food, plant-based dietary pattern coupled with moderate exercise,” the researchers noted.
“Remission,” they wrote, “can be defined as attainment of a [hemoglobin] A1c less than 6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose.”
In ACLM’s recent expert consensus statement on dietary interventions for type 2 diabetes remission, which was also endorsed by AACE, supported by the Academy of Nutrition and Dietetics, and cosponsored by the Endocrine Society, panel members agreed that remission is a realistic and achievable goal for some adults with type 2 diabetes, and a high-intensity dietary intervention can result in remission, Dr. Karlsen said.
To avoid hypoglycemia when deprescribing antiglycemic drugs, medications known to cause hypoglycemia – notably sulfonylurea and insulin – are often deprescribed first, she noted.
“Our biggest hope,” she said, “is that [type 2 diabetes] remission may come to the forefront as a clinical goal in treatment and that other organizations will more strongly emphasize lifestyle in standards of care.”
“We hope that clinicians reading this paper will be made aware that de-escalation of glucose-lowering medications is feasible, is a desirable outcome, and can be necessary in a lifestyle medicine context,” she added.
Further research is needed to prospectively track the likelihood of type 2 diabetes remission, factors that predict successful remission, and decision-making protocols followed by practitioners, Dr. Karlsen said.
Deprescribing antiglycemic meds in lifestyle medicine
Researchers at the Bruyère Research Institute, Ottawa, and Université de Montréal provide algorithms for deprescribing antihyperglycemic medications specifically for older individuals.
In the current study, the authors conducted individual, 30-minute to 1-hour interviews with nine lifestyle medicine practitioners to document their protocols for deprescribing glucose-lowering medications after lifestyle interventions with a goal of potential type 2 diabetes remission.
Three practitioners reported medication deprescribing in an intensive therapeutic lifestyle program (longer, more frequent treatment with greater monitoring). The others provide deprescribing in a nonintensive program (similar to primary care practice) or both.
Deprescribing is necessary when using intensive therapeutic lifestyle change, as substantial and rapid drops in glucose levels aren’t adjusted for, the authors noted.
Most practitioners work with a team of allied health care providers.
During the deprescribing process, most protocols require that patients get a basic or comprehensive metabolic panel of blood tests, with variations in laboratory tests for A1c, C-peptide, and renal function.
Most practitioners recommend a target blood glucose less than 120 mg/dL for further deprescribing.
Currently, there is no clinical guidance for use of continuous glucose monitoring (CGM) during medication de-escalation, the authors note.
Most practitioners reported they consider patient expenses associated with CGM and third-party payor coverage in their decision-making.
Most practitioners prefer to deprescribe sulfonylureas, insulin, and other medications known to cause hypoglycemia first.
Conversely, most prefer to defer deprescribing medications that have demonstrated cardiovascular and/or renal benefits (that is, glucagonlike peptide–1 receptor agonists and sodium-glucose cotransporter 2 inhibitors), as well as those with a less severe adverse effect profile (that is, metformin and GLP-1 receptor agonists) until after other medications are deprescribed.
The study was funded by the Ardmore Institute of Health. The authors reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Nine lifestyle medicine practitioners describe how they safely and effectively deprescribe glucose-lowering medications after patients demonstrate a reduced need for such medications following lifestyle changes.
The report by Michael D. Bradley, PharmD, and colleagues was recently published as a feature article in Clinical Diabetes.
“Lifestyle medicine uses an evidence-based lifestyle therapeutic approach to treat lifestyle-related chronic disease,” they wrote, and it includes “a whole-food, predominantly plant-based eating plan, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection.”
“Medication deprescribing,” senior author Micaela C. Karlsen, PhD, said in an email, “is a planned and supervised process of dose reduction or discontinuation of a medication that may be causing harm, or no longer providing benefit to a patient.”
According to the authors, the article “is the first account published of the medication de-escalation methods used by lifestyle medicine providers when patients demonstrate a decreased need for pharmacotherapy.” It “supports the feasibility of de-escalating glucose-lowering medications in this context and provides pilot data on protocols from individual practitioners experienced in deprescribing glucose-lowering medications.”
The study was not designed to cover deprescribing glucose-lowering medications following weight loss and diabetes remission after bariatric surgery.
“A key takeaway [from the current study] for general practitioners and endocrinologists is that, while deprescribing is already known to be beneficial to reduce polypharmacy, it may be appropriate following lifestyle interventions,” said Dr. Karlsen, who is senior director of the American College of Lifestyle Medicine in Chesterfield, Md.
“The protocols presented can serve as a model for how to do so,” she continued.
The American Diabetes Association and the American Association of Clinical Endocrinology recommend lifestyle optimization as part of medical care for type 2 diabetes.
According to the ACLM, “remission of type 2 diabetes should be a clinical goal and may be achieved with a whole-food, plant-based dietary pattern coupled with moderate exercise,” the researchers noted.
“Remission,” they wrote, “can be defined as attainment of a [hemoglobin] A1c less than 6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose.”
In ACLM’s recent expert consensus statement on dietary interventions for type 2 diabetes remission, which was also endorsed by AACE, supported by the Academy of Nutrition and Dietetics, and cosponsored by the Endocrine Society, panel members agreed that remission is a realistic and achievable goal for some adults with type 2 diabetes, and a high-intensity dietary intervention can result in remission, Dr. Karlsen said.
To avoid hypoglycemia when deprescribing antiglycemic drugs, medications known to cause hypoglycemia – notably sulfonylurea and insulin – are often deprescribed first, she noted.
“Our biggest hope,” she said, “is that [type 2 diabetes] remission may come to the forefront as a clinical goal in treatment and that other organizations will more strongly emphasize lifestyle in standards of care.”
“We hope that clinicians reading this paper will be made aware that de-escalation of glucose-lowering medications is feasible, is a desirable outcome, and can be necessary in a lifestyle medicine context,” she added.
Further research is needed to prospectively track the likelihood of type 2 diabetes remission, factors that predict successful remission, and decision-making protocols followed by practitioners, Dr. Karlsen said.
Deprescribing antiglycemic meds in lifestyle medicine
Researchers at the Bruyère Research Institute, Ottawa, and Université de Montréal provide algorithms for deprescribing antihyperglycemic medications specifically for older individuals.
In the current study, the authors conducted individual, 30-minute to 1-hour interviews with nine lifestyle medicine practitioners to document their protocols for deprescribing glucose-lowering medications after lifestyle interventions with a goal of potential type 2 diabetes remission.
Three practitioners reported medication deprescribing in an intensive therapeutic lifestyle program (longer, more frequent treatment with greater monitoring). The others provide deprescribing in a nonintensive program (similar to primary care practice) or both.
Deprescribing is necessary when using intensive therapeutic lifestyle change, as substantial and rapid drops in glucose levels aren’t adjusted for, the authors noted.
Most practitioners work with a team of allied health care providers.
During the deprescribing process, most protocols require that patients get a basic or comprehensive metabolic panel of blood tests, with variations in laboratory tests for A1c, C-peptide, and renal function.
Most practitioners recommend a target blood glucose less than 120 mg/dL for further deprescribing.
Currently, there is no clinical guidance for use of continuous glucose monitoring (CGM) during medication de-escalation, the authors note.
Most practitioners reported they consider patient expenses associated with CGM and third-party payor coverage in their decision-making.
Most practitioners prefer to deprescribe sulfonylureas, insulin, and other medications known to cause hypoglycemia first.
Conversely, most prefer to defer deprescribing medications that have demonstrated cardiovascular and/or renal benefits (that is, glucagonlike peptide–1 receptor agonists and sodium-glucose cotransporter 2 inhibitors), as well as those with a less severe adverse effect profile (that is, metformin and GLP-1 receptor agonists) until after other medications are deprescribed.
The study was funded by the Ardmore Institute of Health. The authors reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Nine lifestyle medicine practitioners describe how they safely and effectively deprescribe glucose-lowering medications after patients demonstrate a reduced need for such medications following lifestyle changes.
The report by Michael D. Bradley, PharmD, and colleagues was recently published as a feature article in Clinical Diabetes.
“Lifestyle medicine uses an evidence-based lifestyle therapeutic approach to treat lifestyle-related chronic disease,” they wrote, and it includes “a whole-food, predominantly plant-based eating plan, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection.”
“Medication deprescribing,” senior author Micaela C. Karlsen, PhD, said in an email, “is a planned and supervised process of dose reduction or discontinuation of a medication that may be causing harm, or no longer providing benefit to a patient.”
According to the authors, the article “is the first account published of the medication de-escalation methods used by lifestyle medicine providers when patients demonstrate a decreased need for pharmacotherapy.” It “supports the feasibility of de-escalating glucose-lowering medications in this context and provides pilot data on protocols from individual practitioners experienced in deprescribing glucose-lowering medications.”
The study was not designed to cover deprescribing glucose-lowering medications following weight loss and diabetes remission after bariatric surgery.
“A key takeaway [from the current study] for general practitioners and endocrinologists is that, while deprescribing is already known to be beneficial to reduce polypharmacy, it may be appropriate following lifestyle interventions,” said Dr. Karlsen, who is senior director of the American College of Lifestyle Medicine in Chesterfield, Md.
“The protocols presented can serve as a model for how to do so,” she continued.
The American Diabetes Association and the American Association of Clinical Endocrinology recommend lifestyle optimization as part of medical care for type 2 diabetes.
According to the ACLM, “remission of type 2 diabetes should be a clinical goal and may be achieved with a whole-food, plant-based dietary pattern coupled with moderate exercise,” the researchers noted.
“Remission,” they wrote, “can be defined as attainment of a [hemoglobin] A1c less than 6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose.”
In ACLM’s recent expert consensus statement on dietary interventions for type 2 diabetes remission, which was also endorsed by AACE, supported by the Academy of Nutrition and Dietetics, and cosponsored by the Endocrine Society, panel members agreed that remission is a realistic and achievable goal for some adults with type 2 diabetes, and a high-intensity dietary intervention can result in remission, Dr. Karlsen said.
To avoid hypoglycemia when deprescribing antiglycemic drugs, medications known to cause hypoglycemia – notably sulfonylurea and insulin – are often deprescribed first, she noted.
“Our biggest hope,” she said, “is that [type 2 diabetes] remission may come to the forefront as a clinical goal in treatment and that other organizations will more strongly emphasize lifestyle in standards of care.”
“We hope that clinicians reading this paper will be made aware that de-escalation of glucose-lowering medications is feasible, is a desirable outcome, and can be necessary in a lifestyle medicine context,” she added.
Further research is needed to prospectively track the likelihood of type 2 diabetes remission, factors that predict successful remission, and decision-making protocols followed by practitioners, Dr. Karlsen said.
Deprescribing antiglycemic meds in lifestyle medicine
Researchers at the Bruyère Research Institute, Ottawa, and Université de Montréal provide algorithms for deprescribing antihyperglycemic medications specifically for older individuals.
In the current study, the authors conducted individual, 30-minute to 1-hour interviews with nine lifestyle medicine practitioners to document their protocols for deprescribing glucose-lowering medications after lifestyle interventions with a goal of potential type 2 diabetes remission.
Three practitioners reported medication deprescribing in an intensive therapeutic lifestyle program (longer, more frequent treatment with greater monitoring). The others provide deprescribing in a nonintensive program (similar to primary care practice) or both.
Deprescribing is necessary when using intensive therapeutic lifestyle change, as substantial and rapid drops in glucose levels aren’t adjusted for, the authors noted.
Most practitioners work with a team of allied health care providers.
During the deprescribing process, most protocols require that patients get a basic or comprehensive metabolic panel of blood tests, with variations in laboratory tests for A1c, C-peptide, and renal function.
Most practitioners recommend a target blood glucose less than 120 mg/dL for further deprescribing.
Currently, there is no clinical guidance for use of continuous glucose monitoring (CGM) during medication de-escalation, the authors note.
Most practitioners reported they consider patient expenses associated with CGM and third-party payor coverage in their decision-making.
Most practitioners prefer to deprescribe sulfonylureas, insulin, and other medications known to cause hypoglycemia first.
Conversely, most prefer to defer deprescribing medications that have demonstrated cardiovascular and/or renal benefits (that is, glucagonlike peptide–1 receptor agonists and sodium-glucose cotransporter 2 inhibitors), as well as those with a less severe adverse effect profile (that is, metformin and GLP-1 receptor agonists) until after other medications are deprescribed.
The study was funded by the Ardmore Institute of Health. The authors reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM CLINICAL DIABETES
Medications provide best risk-to-benefit ratio for weight loss, says expert
Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.
New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.
Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
Older FDA-approved antiobesity medications
Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.
Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.
“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.
Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
Newer anti‐obesity medications
Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”
Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”
Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.
Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
Emerging antiobesity medications
Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.
A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
A ‘holistic approach’
When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.
He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.
Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.
“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”
Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.
Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.
Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.
New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.
Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
Older FDA-approved antiobesity medications
Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.
Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.
“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.
Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
Newer anti‐obesity medications
Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”
Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”
Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.
Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
Emerging antiobesity medications
Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.
A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
A ‘holistic approach’
When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.
He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.
Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.
“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”
Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.
Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.
Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.
New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.
Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
Older FDA-approved antiobesity medications
Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.
Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.
“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.
Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
Newer anti‐obesity medications
Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”
Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”
Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.
Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
Emerging antiobesity medications
Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.
A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
A ‘holistic approach’
When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.
He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.
Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.
“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”
Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.
Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.
AT INTERNAL MEDICINE 2023
Can an endoscopic procedure treat type 2 diabetes?
Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.
In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.
“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.
Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”
ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
Is semaglutide muddying the findings?
Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.
“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”
However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”
Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.
Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.
Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”
But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
All patients stopped insulin, most for a year
The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.
Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.
Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”
Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
A version of this article first appeared on Medscape.com.
Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.
In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.
“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.
Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”
ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
Is semaglutide muddying the findings?
Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.
“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”
However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”
Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.
Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.
Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”
But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
All patients stopped insulin, most for a year
The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.
Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.
Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”
Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
A version of this article first appeared on Medscape.com.
Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.
In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.
“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.
Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”
ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
Is semaglutide muddying the findings?
Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.
“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”
However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”
Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.
Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.
Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”
But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
All patients stopped insulin, most for a year
The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.
Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.
Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”
Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
A version of this article first appeared on Medscape.com.
FROM DDW 2023
Personalizing treatment plans for older patients with T2D
In the United States, type 2 diabetes (T2D) more commonly affects people older than 40 years, but it is most prevalent among adults over age 65, affecting more than 29% of this population. The heterogeneity in the health and functional status of older adults presents a challenge in the management and treatment of older patients with T2D. Moreover, there is an increased risk for health-related comorbidities and complications from diabetes treatment (for example, hypoglycemia) in older adults. Physiologic changes, such as decreased renal function, cognitive decline, and sarcopenia, may lead to an increased risk for adverse reactions to medications and require an individualized treatment approach. Although there have been a limited number of randomized controlled studies targeting older adults with multiple comorbidities and poor health status, subanalyses of diabetes trials with a subpopulation of older adults have provided additional evidence to better guide therapeutic approaches in caring for older patients with T2D.
Here’s a guide to developing personalized therapeutic regimens for older patients with T2D using lifestyle interventions, pharmacotherapy, and diabetes technology.
Determining an optimal glycemic target
An important first step in diabetes treatment is to determine the optimal glycemic target for patients. Although data support intensive glycemic control (hemoglobin A1c < 7%) to prevent complications from diabetes in younger patients with recently diagnosed disease, the data are less compelling in trials involving older populations with longer durations of T2D. One observational study with 71,092 older adults over age 60 reported a U-shaped correlation between A1c and mortality, with higher risks for mortality in those with A1c levels < 6% and ≥ 11%, compared with those with A1c levels of 6%-9%. Risks for any diabetes complications were higher at an A1c level ≥ 8%. Another observational study reported a U-shaped association between A1c and mortality, with the lowest hazard ratio for mortality at an A1c level of about 7.5%. Similarly, the ACCORD trial, which included older and middle-aged patients with T2D who had or were at risk for atherosclerotic cardiovascular disease, found that mortality followed a U-shaped curve at the low (A1c < 7%) and high (A1c > 8%) ends in patients who were given standard glycemic therapy. Hence, there has been a general trend to recommend less strict glycemic control in older adults.
However, it is important to remember that older patients with T2D are a heterogeneous group. The spectrum includes adults with recent-onset diabetes with no or few complications, those with long-standing diabetes and many complications, and frail older adults with multiple comorbidities and complications. Determining the optimal glycemic target for an older patient with T2D requires assessment not only of the patient’s medical status and comorbidities but also functional status, cognitive and psychological health, social situation, individual preferences, and life expectancy. The American Diabetes Association Standards of Medical Care in Diabetes provides the following guidance in determining the optimal glycemic control for older adults:
- Healthy adults with few coexisting chronic illnesses and intact cognitive and functional status should have an A1c level < 7.0%-7.5%.
- Adults with complex or intermediate comorbidities (multiple coexisting chronic illnesses, or two or more instrumental activities of daily living impairments, or mild to moderate cognitive impairment) should have an A1c level < 8.0%.
- Patients with poor health (long-term care or end-stage chronic illnesses or moderate to severe cognitive impairment or two or more activities of daily living impairments) should avoid reliance on A1c, and the goal is to avoid hypoglycemia and symptomatic hyperglycemia.
Because older patients are at a higher risk for complications and adverse effects from polypharmacy, regular assessments are recommended and treatment plans should be routinely reviewed and modified to avoid overtreatment.
Lifestyle interventions and pharmacotherapy
Lifestyle interventions, such as exercise, optimal nutrition, and protein intake, are integral in treating older patients with T2D. Older adults should engage in regular exercise (that is, aerobic activity, weight-bearing exercise, or resistance training), and the activity should be customized to frailty status. Regular exercise improves insulin sensitivity and glucose control, enhances functional status, and provides cardiometabolic benefits. Optimal nutrition and adequate protein intake are also important to prevent the development or worsening of sarcopenia and frailty.
Several factors must be considered when choosing pharmacotherapy for T2D treatment in older adults. These patients are at higher risk for adverse reactions to medications that can trigger hypoglycemia and serious cardiovascular events, and worsen cognitive function. Therefore, side effects should always be reviewed when choosing antidiabetic drugs. The complexity of treatment plans needs to be matched with the patients’ self-management abilities and available social support. Medication costs and insurance coverage should be considered because many older adults live on a fixed income. Although limited, data exist on the safety and efficacy of some glucose-lowering agents in older adults, which can provide guidance for choosing the optimal therapy for these patients.
Among the insulin sensitizers, metformin is most commonly used because of its efficacy, low risk for hypoglycemia, and affordability. Metformin can be safely used in the setting of reduced renal function down to the estimated glomerular filtration rate ≥ 30 mL/min per 1.73 m2. However, metformin should be avoided in patients with more advanced renal disease, liver failure, or heart failure. In older patients with T2D, potential concerns of metformin include gastrointestinal side effects, leading to reduced appetite, mild weight loss, and risk for vitamin B12 deficiency.
Pioglitazone, an oral antidiabetic in the thiazolidinedione (TZD) class, also targets insulin resistance and may provide some cardiovascular benefits. However, these agents are not commonly used in treating older patients with T2D owing to associated risk for edema, heart failure, osteoporosis/fractures, and bladder cancer.
Sulfonylureas and meglitinides are insulin secretagogues, which can promote insulin release independent of glucose levels. Sulfonylureas are typically avoided in older patients because they are associated with high risk for hypoglycemia. Meglitinides have a lower hypoglycemia risk than sulfonylureas because of their short duration of action; however, they are more expensive and require multiple daily administration, which can lead to issues with adherence.
Since 2008, there have been numerous cardiovascular outcomes trials assessing the safety and efficacy of T2D therapies that included a subpopulation of older patients either with cardiovascular disease or at high risk for cardiovascular disease. Post hoc analysis of data from these trials and smaller studies dedicated to older adults demonstrated the safety and efficacy of most incretin-based therapies and sodium-glucose cotransporter 2 (SGLT2) inhibitors in these patients. These newer medications have low hypoglycemia risk if not used in combination with insulin or insulin secretagogues.
Dipeptidyl peptidase 4 (DPP-4) inhibitors have the mildest side effect profile. However, they can be expensive and not reduce major adverse cardiovascular outcomes, and one agent, saxagliptin, has been associated with increased risk for heart failure hospitalization. Some glucagon-like peptide 1 (GLP-1) receptor agonists are effective in reducing major adverse cardiovascular events (cardiovascular deaths, stroke, and myocardial infarction) in patients older and younger than age 65. However, the gastrointestinal side effects and weight loss associated with this medication can be problematic for older patients. Most of the GLP-1 receptor agonists are injectables, which require good visual, motor, and cognitive skills for administration. SGLT2 inhibitors offer benefits for patients with T2D who have established cardiovascular disease, heart failure, and chronic kidney disease, with possible greater cardiovascular benefits in older adults. Adverse effects associated with SGLT2 inhibitors, such as weight loss, volume depletion, urinary incontinence, and genitourinary infections, may be a concern in older patients with T2D who are using these medications.
Because the insulin-secreting capacity of the pancreas declines with age, insulin therapy may be required for treatment of T2D in older patients. Insulin therapy can be complex and consideration must be given to patients’ social circumstances, as well as their physical and cognitive abilities. Older adults may need adaptive strategies, such as additional lighting, magnification glass, and premixed syringes. Simplification of complex insulin therapy (discontinuation of prandial insulin or sliding scale, changing timing of basal insulin) and use of insulin analogs with lower hypoglycemia risks should be considered. Weight gain as a result of insulin therapy may be beneficial in older adults with sarcopenia or frailty.
T2D technology for glycemic improvement
There have been major technological advancements in diabetes therapy. Continuous glucose monitors (CGMs) and automated insulin delivery systems can improve glycemic control, decrease the rate of hypoglycemia, and enhance the quality of life of older patients. Most of the studies evaluating the use of automated insulin delivery systems in older patients have focused on those with type 1 diabetes and demonstrated improvement in glycemic control and/or reduced hypoglycemia. The DIAMOND trial demonstrated improved A1c and reduced glycemic variability with the use of CGM in adults older than 60 years with either type 1 or type 2 diabetes on multiple daily injections. Bluetooth-enabled “smart” insulin pens, which record the time and dose of insulin administrations, can also be a great asset in caring for older patients, especially those with cognitive impairment. With better insurance coverage, diabetes technologies may become more accessible and an asset in treating older patients with T2D.
In conclusion, management of T2D in older adults requires an individualized approach because of the heterogeneity in their health and functional status. Because cardiovascular disease is the leading cause of mortality in older patients with T2D, treatment plans should also address frequently coexisting cardiovascular risk factors, such as hypertension and hyperlipidemia. Clinicians should consider patients’ overall health, comorbidities, cognitive and functional status, social support systems, preferences, and life expectancy when developing individualized therapeutic plans.
Dr. Gunawan is an assistant professor in the department of internal medicine at UT Southwestern Medical Center, Dallas. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
In the United States, type 2 diabetes (T2D) more commonly affects people older than 40 years, but it is most prevalent among adults over age 65, affecting more than 29% of this population. The heterogeneity in the health and functional status of older adults presents a challenge in the management and treatment of older patients with T2D. Moreover, there is an increased risk for health-related comorbidities and complications from diabetes treatment (for example, hypoglycemia) in older adults. Physiologic changes, such as decreased renal function, cognitive decline, and sarcopenia, may lead to an increased risk for adverse reactions to medications and require an individualized treatment approach. Although there have been a limited number of randomized controlled studies targeting older adults with multiple comorbidities and poor health status, subanalyses of diabetes trials with a subpopulation of older adults have provided additional evidence to better guide therapeutic approaches in caring for older patients with T2D.
Here’s a guide to developing personalized therapeutic regimens for older patients with T2D using lifestyle interventions, pharmacotherapy, and diabetes technology.
Determining an optimal glycemic target
An important first step in diabetes treatment is to determine the optimal glycemic target for patients. Although data support intensive glycemic control (hemoglobin A1c < 7%) to prevent complications from diabetes in younger patients with recently diagnosed disease, the data are less compelling in trials involving older populations with longer durations of T2D. One observational study with 71,092 older adults over age 60 reported a U-shaped correlation between A1c and mortality, with higher risks for mortality in those with A1c levels < 6% and ≥ 11%, compared with those with A1c levels of 6%-9%. Risks for any diabetes complications were higher at an A1c level ≥ 8%. Another observational study reported a U-shaped association between A1c and mortality, with the lowest hazard ratio for mortality at an A1c level of about 7.5%. Similarly, the ACCORD trial, which included older and middle-aged patients with T2D who had or were at risk for atherosclerotic cardiovascular disease, found that mortality followed a U-shaped curve at the low (A1c < 7%) and high (A1c > 8%) ends in patients who were given standard glycemic therapy. Hence, there has been a general trend to recommend less strict glycemic control in older adults.
However, it is important to remember that older patients with T2D are a heterogeneous group. The spectrum includes adults with recent-onset diabetes with no or few complications, those with long-standing diabetes and many complications, and frail older adults with multiple comorbidities and complications. Determining the optimal glycemic target for an older patient with T2D requires assessment not only of the patient’s medical status and comorbidities but also functional status, cognitive and psychological health, social situation, individual preferences, and life expectancy. The American Diabetes Association Standards of Medical Care in Diabetes provides the following guidance in determining the optimal glycemic control for older adults:
- Healthy adults with few coexisting chronic illnesses and intact cognitive and functional status should have an A1c level < 7.0%-7.5%.
- Adults with complex or intermediate comorbidities (multiple coexisting chronic illnesses, or two or more instrumental activities of daily living impairments, or mild to moderate cognitive impairment) should have an A1c level < 8.0%.
- Patients with poor health (long-term care or end-stage chronic illnesses or moderate to severe cognitive impairment or two or more activities of daily living impairments) should avoid reliance on A1c, and the goal is to avoid hypoglycemia and symptomatic hyperglycemia.
Because older patients are at a higher risk for complications and adverse effects from polypharmacy, regular assessments are recommended and treatment plans should be routinely reviewed and modified to avoid overtreatment.
Lifestyle interventions and pharmacotherapy
Lifestyle interventions, such as exercise, optimal nutrition, and protein intake, are integral in treating older patients with T2D. Older adults should engage in regular exercise (that is, aerobic activity, weight-bearing exercise, or resistance training), and the activity should be customized to frailty status. Regular exercise improves insulin sensitivity and glucose control, enhances functional status, and provides cardiometabolic benefits. Optimal nutrition and adequate protein intake are also important to prevent the development or worsening of sarcopenia and frailty.
Several factors must be considered when choosing pharmacotherapy for T2D treatment in older adults. These patients are at higher risk for adverse reactions to medications that can trigger hypoglycemia and serious cardiovascular events, and worsen cognitive function. Therefore, side effects should always be reviewed when choosing antidiabetic drugs. The complexity of treatment plans needs to be matched with the patients’ self-management abilities and available social support. Medication costs and insurance coverage should be considered because many older adults live on a fixed income. Although limited, data exist on the safety and efficacy of some glucose-lowering agents in older adults, which can provide guidance for choosing the optimal therapy for these patients.
Among the insulin sensitizers, metformin is most commonly used because of its efficacy, low risk for hypoglycemia, and affordability. Metformin can be safely used in the setting of reduced renal function down to the estimated glomerular filtration rate ≥ 30 mL/min per 1.73 m2. However, metformin should be avoided in patients with more advanced renal disease, liver failure, or heart failure. In older patients with T2D, potential concerns of metformin include gastrointestinal side effects, leading to reduced appetite, mild weight loss, and risk for vitamin B12 deficiency.
Pioglitazone, an oral antidiabetic in the thiazolidinedione (TZD) class, also targets insulin resistance and may provide some cardiovascular benefits. However, these agents are not commonly used in treating older patients with T2D owing to associated risk for edema, heart failure, osteoporosis/fractures, and bladder cancer.
Sulfonylureas and meglitinides are insulin secretagogues, which can promote insulin release independent of glucose levels. Sulfonylureas are typically avoided in older patients because they are associated with high risk for hypoglycemia. Meglitinides have a lower hypoglycemia risk than sulfonylureas because of their short duration of action; however, they are more expensive and require multiple daily administration, which can lead to issues with adherence.
Since 2008, there have been numerous cardiovascular outcomes trials assessing the safety and efficacy of T2D therapies that included a subpopulation of older patients either with cardiovascular disease or at high risk for cardiovascular disease. Post hoc analysis of data from these trials and smaller studies dedicated to older adults demonstrated the safety and efficacy of most incretin-based therapies and sodium-glucose cotransporter 2 (SGLT2) inhibitors in these patients. These newer medications have low hypoglycemia risk if not used in combination with insulin or insulin secretagogues.
Dipeptidyl peptidase 4 (DPP-4) inhibitors have the mildest side effect profile. However, they can be expensive and not reduce major adverse cardiovascular outcomes, and one agent, saxagliptin, has been associated with increased risk for heart failure hospitalization. Some glucagon-like peptide 1 (GLP-1) receptor agonists are effective in reducing major adverse cardiovascular events (cardiovascular deaths, stroke, and myocardial infarction) in patients older and younger than age 65. However, the gastrointestinal side effects and weight loss associated with this medication can be problematic for older patients. Most of the GLP-1 receptor agonists are injectables, which require good visual, motor, and cognitive skills for administration. SGLT2 inhibitors offer benefits for patients with T2D who have established cardiovascular disease, heart failure, and chronic kidney disease, with possible greater cardiovascular benefits in older adults. Adverse effects associated with SGLT2 inhibitors, such as weight loss, volume depletion, urinary incontinence, and genitourinary infections, may be a concern in older patients with T2D who are using these medications.
Because the insulin-secreting capacity of the pancreas declines with age, insulin therapy may be required for treatment of T2D in older patients. Insulin therapy can be complex and consideration must be given to patients’ social circumstances, as well as their physical and cognitive abilities. Older adults may need adaptive strategies, such as additional lighting, magnification glass, and premixed syringes. Simplification of complex insulin therapy (discontinuation of prandial insulin or sliding scale, changing timing of basal insulin) and use of insulin analogs with lower hypoglycemia risks should be considered. Weight gain as a result of insulin therapy may be beneficial in older adults with sarcopenia or frailty.
T2D technology for glycemic improvement
There have been major technological advancements in diabetes therapy. Continuous glucose monitors (CGMs) and automated insulin delivery systems can improve glycemic control, decrease the rate of hypoglycemia, and enhance the quality of life of older patients. Most of the studies evaluating the use of automated insulin delivery systems in older patients have focused on those with type 1 diabetes and demonstrated improvement in glycemic control and/or reduced hypoglycemia. The DIAMOND trial demonstrated improved A1c and reduced glycemic variability with the use of CGM in adults older than 60 years with either type 1 or type 2 diabetes on multiple daily injections. Bluetooth-enabled “smart” insulin pens, which record the time and dose of insulin administrations, can also be a great asset in caring for older patients, especially those with cognitive impairment. With better insurance coverage, diabetes technologies may become more accessible and an asset in treating older patients with T2D.
In conclusion, management of T2D in older adults requires an individualized approach because of the heterogeneity in their health and functional status. Because cardiovascular disease is the leading cause of mortality in older patients with T2D, treatment plans should also address frequently coexisting cardiovascular risk factors, such as hypertension and hyperlipidemia. Clinicians should consider patients’ overall health, comorbidities, cognitive and functional status, social support systems, preferences, and life expectancy when developing individualized therapeutic plans.
Dr. Gunawan is an assistant professor in the department of internal medicine at UT Southwestern Medical Center, Dallas. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
In the United States, type 2 diabetes (T2D) more commonly affects people older than 40 years, but it is most prevalent among adults over age 65, affecting more than 29% of this population. The heterogeneity in the health and functional status of older adults presents a challenge in the management and treatment of older patients with T2D. Moreover, there is an increased risk for health-related comorbidities and complications from diabetes treatment (for example, hypoglycemia) in older adults. Physiologic changes, such as decreased renal function, cognitive decline, and sarcopenia, may lead to an increased risk for adverse reactions to medications and require an individualized treatment approach. Although there have been a limited number of randomized controlled studies targeting older adults with multiple comorbidities and poor health status, subanalyses of diabetes trials with a subpopulation of older adults have provided additional evidence to better guide therapeutic approaches in caring for older patients with T2D.
Here’s a guide to developing personalized therapeutic regimens for older patients with T2D using lifestyle interventions, pharmacotherapy, and diabetes technology.
Determining an optimal glycemic target
An important first step in diabetes treatment is to determine the optimal glycemic target for patients. Although data support intensive glycemic control (hemoglobin A1c < 7%) to prevent complications from diabetes in younger patients with recently diagnosed disease, the data are less compelling in trials involving older populations with longer durations of T2D. One observational study with 71,092 older adults over age 60 reported a U-shaped correlation between A1c and mortality, with higher risks for mortality in those with A1c levels < 6% and ≥ 11%, compared with those with A1c levels of 6%-9%. Risks for any diabetes complications were higher at an A1c level ≥ 8%. Another observational study reported a U-shaped association between A1c and mortality, with the lowest hazard ratio for mortality at an A1c level of about 7.5%. Similarly, the ACCORD trial, which included older and middle-aged patients with T2D who had or were at risk for atherosclerotic cardiovascular disease, found that mortality followed a U-shaped curve at the low (A1c < 7%) and high (A1c > 8%) ends in patients who were given standard glycemic therapy. Hence, there has been a general trend to recommend less strict glycemic control in older adults.
However, it is important to remember that older patients with T2D are a heterogeneous group. The spectrum includes adults with recent-onset diabetes with no or few complications, those with long-standing diabetes and many complications, and frail older adults with multiple comorbidities and complications. Determining the optimal glycemic target for an older patient with T2D requires assessment not only of the patient’s medical status and comorbidities but also functional status, cognitive and psychological health, social situation, individual preferences, and life expectancy. The American Diabetes Association Standards of Medical Care in Diabetes provides the following guidance in determining the optimal glycemic control for older adults:
- Healthy adults with few coexisting chronic illnesses and intact cognitive and functional status should have an A1c level < 7.0%-7.5%.
- Adults with complex or intermediate comorbidities (multiple coexisting chronic illnesses, or two or more instrumental activities of daily living impairments, or mild to moderate cognitive impairment) should have an A1c level < 8.0%.
- Patients with poor health (long-term care or end-stage chronic illnesses or moderate to severe cognitive impairment or two or more activities of daily living impairments) should avoid reliance on A1c, and the goal is to avoid hypoglycemia and symptomatic hyperglycemia.
Because older patients are at a higher risk for complications and adverse effects from polypharmacy, regular assessments are recommended and treatment plans should be routinely reviewed and modified to avoid overtreatment.
Lifestyle interventions and pharmacotherapy
Lifestyle interventions, such as exercise, optimal nutrition, and protein intake, are integral in treating older patients with T2D. Older adults should engage in regular exercise (that is, aerobic activity, weight-bearing exercise, or resistance training), and the activity should be customized to frailty status. Regular exercise improves insulin sensitivity and glucose control, enhances functional status, and provides cardiometabolic benefits. Optimal nutrition and adequate protein intake are also important to prevent the development or worsening of sarcopenia and frailty.
Several factors must be considered when choosing pharmacotherapy for T2D treatment in older adults. These patients are at higher risk for adverse reactions to medications that can trigger hypoglycemia and serious cardiovascular events, and worsen cognitive function. Therefore, side effects should always be reviewed when choosing antidiabetic drugs. The complexity of treatment plans needs to be matched with the patients’ self-management abilities and available social support. Medication costs and insurance coverage should be considered because many older adults live on a fixed income. Although limited, data exist on the safety and efficacy of some glucose-lowering agents in older adults, which can provide guidance for choosing the optimal therapy for these patients.
Among the insulin sensitizers, metformin is most commonly used because of its efficacy, low risk for hypoglycemia, and affordability. Metformin can be safely used in the setting of reduced renal function down to the estimated glomerular filtration rate ≥ 30 mL/min per 1.73 m2. However, metformin should be avoided in patients with more advanced renal disease, liver failure, or heart failure. In older patients with T2D, potential concerns of metformin include gastrointestinal side effects, leading to reduced appetite, mild weight loss, and risk for vitamin B12 deficiency.
Pioglitazone, an oral antidiabetic in the thiazolidinedione (TZD) class, also targets insulin resistance and may provide some cardiovascular benefits. However, these agents are not commonly used in treating older patients with T2D owing to associated risk for edema, heart failure, osteoporosis/fractures, and bladder cancer.
Sulfonylureas and meglitinides are insulin secretagogues, which can promote insulin release independent of glucose levels. Sulfonylureas are typically avoided in older patients because they are associated with high risk for hypoglycemia. Meglitinides have a lower hypoglycemia risk than sulfonylureas because of their short duration of action; however, they are more expensive and require multiple daily administration, which can lead to issues with adherence.
Since 2008, there have been numerous cardiovascular outcomes trials assessing the safety and efficacy of T2D therapies that included a subpopulation of older patients either with cardiovascular disease or at high risk for cardiovascular disease. Post hoc analysis of data from these trials and smaller studies dedicated to older adults demonstrated the safety and efficacy of most incretin-based therapies and sodium-glucose cotransporter 2 (SGLT2) inhibitors in these patients. These newer medications have low hypoglycemia risk if not used in combination with insulin or insulin secretagogues.
Dipeptidyl peptidase 4 (DPP-4) inhibitors have the mildest side effect profile. However, they can be expensive and not reduce major adverse cardiovascular outcomes, and one agent, saxagliptin, has been associated with increased risk for heart failure hospitalization. Some glucagon-like peptide 1 (GLP-1) receptor agonists are effective in reducing major adverse cardiovascular events (cardiovascular deaths, stroke, and myocardial infarction) in patients older and younger than age 65. However, the gastrointestinal side effects and weight loss associated with this medication can be problematic for older patients. Most of the GLP-1 receptor agonists are injectables, which require good visual, motor, and cognitive skills for administration. SGLT2 inhibitors offer benefits for patients with T2D who have established cardiovascular disease, heart failure, and chronic kidney disease, with possible greater cardiovascular benefits in older adults. Adverse effects associated with SGLT2 inhibitors, such as weight loss, volume depletion, urinary incontinence, and genitourinary infections, may be a concern in older patients with T2D who are using these medications.
Because the insulin-secreting capacity of the pancreas declines with age, insulin therapy may be required for treatment of T2D in older patients. Insulin therapy can be complex and consideration must be given to patients’ social circumstances, as well as their physical and cognitive abilities. Older adults may need adaptive strategies, such as additional lighting, magnification glass, and premixed syringes. Simplification of complex insulin therapy (discontinuation of prandial insulin or sliding scale, changing timing of basal insulin) and use of insulin analogs with lower hypoglycemia risks should be considered. Weight gain as a result of insulin therapy may be beneficial in older adults with sarcopenia or frailty.
T2D technology for glycemic improvement
There have been major technological advancements in diabetes therapy. Continuous glucose monitors (CGMs) and automated insulin delivery systems can improve glycemic control, decrease the rate of hypoglycemia, and enhance the quality of life of older patients. Most of the studies evaluating the use of automated insulin delivery systems in older patients have focused on those with type 1 diabetes and demonstrated improvement in glycemic control and/or reduced hypoglycemia. The DIAMOND trial demonstrated improved A1c and reduced glycemic variability with the use of CGM in adults older than 60 years with either type 1 or type 2 diabetes on multiple daily injections. Bluetooth-enabled “smart” insulin pens, which record the time and dose of insulin administrations, can also be a great asset in caring for older patients, especially those with cognitive impairment. With better insurance coverage, diabetes technologies may become more accessible and an asset in treating older patients with T2D.
In conclusion, management of T2D in older adults requires an individualized approach because of the heterogeneity in their health and functional status. Because cardiovascular disease is the leading cause of mortality in older patients with T2D, treatment plans should also address frequently coexisting cardiovascular risk factors, such as hypertension and hyperlipidemia. Clinicians should consider patients’ overall health, comorbidities, cognitive and functional status, social support systems, preferences, and life expectancy when developing individualized therapeutic plans.
Dr. Gunawan is an assistant professor in the department of internal medicine at UT Southwestern Medical Center, Dallas. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Smoking cessation has many benefits in diabetes
MONTPELLIER, FRANCE – The first expert consensus on smoking and diabetes, coauthored by the Francophone Diabetes Society (SFD) and the French Society for the Study of Nicotine Addiction (SFT), was presented at the SFD’s annual conference.
Alexia Rouland, MD, an endocrinologist at Dijon Bourgogne University Hospital, Dijon, France, took the conference as an opportunity to list the many benefits of smoking cessation for patients with diabetes, despite the “slight and temporary” risk for blood sugar imbalance.
Societies target smoking
Diabetes societies around Europe have set their sights on the topic of smoking. Indeed, the guidelines published in 2019 by the European Association for the Study of Diabetes and the European Society of Cardiology state that “smoking cessation is obligatory for all prediabetic and diabetic patients” (class I, level A).
This year, the France-based SFD and SFT dedicated an expert consensus to the major problem of smoking in patients with diabetes. The aim was to provide health care professionals with convincing, well-supported arguments in favor of smoking cessation in their patients with type 1 and type 2 diabetes.
“Before anything else, diabetic patients need to be made aware of the risks of smoking,” said Dr. Rouland. “It’s not just about the fear factor, though. It’s also about providing a positive incentive – they need to be told about the ways they’ll benefit from quitting smoking. For example, you have all-cause mortality, macro- and microangiopathic complications, and so on.”
Duration of abstinence
“Diabetic patients who have stopped smoking have a relative risk for all-cause mortality of 1.28 (1.09-1.51), which is less than what you see in active smokers (relative risk = 1.58; 1.42-1.77), but still above that of nonsmokers,” said Dr. Rouland.
A previous study revealed that although the risk does indeed go down after stopping smoking, it is linked to how long ago the person stopped. Patients who stopped smoking less than 10 years ago still had a slightly raised all-cause mortality risk, and this was even higher if they had smoked for 20 years or more.
After 10 years of not smoking, however, the greater all-cause mortality risk was no longer significant in any of the groups monitored (smoking duration, number of cigarettes/day). Concrete evidence of the link between all-cause mortality and the length of time since a person stopped smoking also emerged from the large cohort in the American Nurses’ Health Study.
The relative risk for all-cause mortality in women who stopped smoking less than 5 years ago remained high (RR = 1.96, 1.47-2.67), then decreased over time. After 10 years, it was no longer significant (RR = 1.11, 0.92-1.35).
Macro- and microangiopathic risks
Smoking cessation also has a real benefit in terms of the increased macro- and microangiopathic risks. In type 2 diabetes, a study found an increased relative risk for macro- and microalbuminuria of 1.86 (95% confidence interval, 1.37-2.52) in former smokers, compared with an increased relative risk of 2.61 (95% CI, 1.86-2.64) in current smokers.
In type 1 diabetes, the cumulative risk for microalbuminuria in former smokers was 15.1% vs. 18.9% in smokers and 10% in nonsmokers.
A 2019 meta-analysis of prospective cohort studies determined that smoking is an independent risk factor for diabetic nephropathy, especially in patients with type 1 diabetes.
Yet, most of the data for this condition come from subjects with type 2 diabetes. One publication estimated its prevalence after a 1-year follow-up of the smoking cessation program as 10.9% in former smokers and 15% in those who continued smoking.
In regard to macroangiopathy in the context of type 2 diabetes, the aforementioned 2019 meta-analysis focused on coronary artery disease, cerebrovascular accident (CVA), cardiovascular mortality, and myocardial infarction (MI). It found that smokers face an increased risk for all these outcomes.
The relative risks wavered between 1.53 and 1.66 and decreased after smoking cessation. For coronary artery disease and MI, they became insignificant. There was still a risk for CVA (RR = 1.34; 1.07-1.67) and fatal cardiovascular events (RR = 1.19; 0.02-1.39).
The data are slightly more heterogeneous for type 1 diabetes, where, despite smoking cessation, the increased risk for heart failure and CVA persists in men, yet the same risk for coronary heart disease and CVA drops in women.
Risk for weight gain
Dr. Rouland tried to reassure patients about the risk for gaining weight. “Weight gain is not inevitable. There is a risk for this, but it’s temporary. And, even with some weight gain, the cardiovascular benefits are still indisputable.”
A study carried out in 2013 focused specifically on this point, with an average post-cessation weight gain of 3.8 kg (8.4 lb) seen in diabetic individuals in the first 4 years after stopping smoking and of 0.1 kg (0.2 lb) thereafter. A time-based effect was observed with regulation of excess weight post-cessation over time, as seen in the general population (3 kg [6.6 lb] on average in nondiabetic individuals).
Weight gain tends to occur mainly in the immediate post-cessation period, essentially in the first 3 months, and there is a large variation in weight change. Some people gain a lot (from 5 to 10 kg [11 to 22 lb], or even more than 10 kg); others lose weight (20% of diabetic former smokers in the first month, 7% after 12 months), and 25% gain less than 5 kg (11 lb).
Blood glucose imbalance
“A risk for blood glucose imbalance has been reported after smoking cessation, although this is very slight and only temporary,” said Dr. Rouland.
A British retrospective study examined this question, focusing on glycated hemoglobin in patients with type 2 diabetes. Hemoglobin A1c increased by 0.21% (95% CI, 0.17-0.25; P < .001) within the first year after quitting. A1c decreased as abstinence continued and became comparable to that of continual smokers after 3 years. This increase in A1c was not mediated by weight change.
Another study published in 2018 on the topic of type 2 diabetes also reported on the risk for poor glycemic control (defined as A1c > 7%) persisting for 10 years after smoking cessation (odds ratio, 1.23; 95% CI, 1.06-1.42). Thereafter, between 10 and 19 years post-cessation, the OR decreased to 0.97 (95% CI, 0.80-1.19, NS). Beyond 20 years post-cessation, the OR was 1.14 (95% CI, 0.89-1.44, NS) and was therefore no longer significant.
Regardless, “the risk for poor glycemic control is lower in quitters than in active smokers,” said Dr. Rouland.
Quitting and diabetes risk
Will a smoker’s increased risk for diabetes drop when he or she stops smoking? “This is essentially what happens,” Dr. Rouland confirmed, “and his or her increased risk for metabolic syndrome also drops. One meta-analysis revealed a time-based effect.
“Patients who had stopped smoking less than 5 years previously had an increased relative risk for type 2 diabetes, and this risk dropped to 1.11 after more than 10 years of not smoking. Moreover, this relative risk for type 2 diabetes remained lower than that of active smokers, at between 1.19 and 1.60, depending on tobacco use.”
In regard to the risk for metabolic syndrome, those who quit smoking seem to have an increased risk of 10%, compared with nonsmokers (RR = 1.10, 1.08-1.11; P < .001). “But yet again, this increased risk is much lower than that of active smokers, whose risk is between 37% (less than 20 cigarettes/day) and 71% (more than 20 cigarettes/day).”
Women with diabetes
“The benefits of quitting appear identical, regardless of the sex of the diabetic person,” said Dr. Rouland. “As in the general population, weight gain after smoking cessation is greater in women. Furthermore, while smoking increases the risk for gestational diabetes (RR, 1.4-1.9) and for the use of insulin in this context, stopping smoking reduces these risks.
“Moreover, smoking during pregnancy not only increases the risk for pregnancy-related complications (early miscarriage, ectopic pregnancy, birth defects, placental abruption, premature birth, intrauterine fetal demise, cesarean birth, low birth weight), but it also increases the risk of type 2 diabetes in the newborn. The risk to the newborn is said to be around 34% in cases in which the mother smokes during pregnancy and 22% in cases in which the mother is a passive smoker, thereby justifying the use of measures to help the mother’s family members to stop smoking.”
Dr. Rouland reports no relevant financial relationships.
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
MONTPELLIER, FRANCE – The first expert consensus on smoking and diabetes, coauthored by the Francophone Diabetes Society (SFD) and the French Society for the Study of Nicotine Addiction (SFT), was presented at the SFD’s annual conference.
Alexia Rouland, MD, an endocrinologist at Dijon Bourgogne University Hospital, Dijon, France, took the conference as an opportunity to list the many benefits of smoking cessation for patients with diabetes, despite the “slight and temporary” risk for blood sugar imbalance.
Societies target smoking
Diabetes societies around Europe have set their sights on the topic of smoking. Indeed, the guidelines published in 2019 by the European Association for the Study of Diabetes and the European Society of Cardiology state that “smoking cessation is obligatory for all prediabetic and diabetic patients” (class I, level A).
This year, the France-based SFD and SFT dedicated an expert consensus to the major problem of smoking in patients with diabetes. The aim was to provide health care professionals with convincing, well-supported arguments in favor of smoking cessation in their patients with type 1 and type 2 diabetes.
“Before anything else, diabetic patients need to be made aware of the risks of smoking,” said Dr. Rouland. “It’s not just about the fear factor, though. It’s also about providing a positive incentive – they need to be told about the ways they’ll benefit from quitting smoking. For example, you have all-cause mortality, macro- and microangiopathic complications, and so on.”
Duration of abstinence
“Diabetic patients who have stopped smoking have a relative risk for all-cause mortality of 1.28 (1.09-1.51), which is less than what you see in active smokers (relative risk = 1.58; 1.42-1.77), but still above that of nonsmokers,” said Dr. Rouland.
A previous study revealed that although the risk does indeed go down after stopping smoking, it is linked to how long ago the person stopped. Patients who stopped smoking less than 10 years ago still had a slightly raised all-cause mortality risk, and this was even higher if they had smoked for 20 years or more.
After 10 years of not smoking, however, the greater all-cause mortality risk was no longer significant in any of the groups monitored (smoking duration, number of cigarettes/day). Concrete evidence of the link between all-cause mortality and the length of time since a person stopped smoking also emerged from the large cohort in the American Nurses’ Health Study.
The relative risk for all-cause mortality in women who stopped smoking less than 5 years ago remained high (RR = 1.96, 1.47-2.67), then decreased over time. After 10 years, it was no longer significant (RR = 1.11, 0.92-1.35).
Macro- and microangiopathic risks
Smoking cessation also has a real benefit in terms of the increased macro- and microangiopathic risks. In type 2 diabetes, a study found an increased relative risk for macro- and microalbuminuria of 1.86 (95% confidence interval, 1.37-2.52) in former smokers, compared with an increased relative risk of 2.61 (95% CI, 1.86-2.64) in current smokers.
In type 1 diabetes, the cumulative risk for microalbuminuria in former smokers was 15.1% vs. 18.9% in smokers and 10% in nonsmokers.
A 2019 meta-analysis of prospective cohort studies determined that smoking is an independent risk factor for diabetic nephropathy, especially in patients with type 1 diabetes.
Yet, most of the data for this condition come from subjects with type 2 diabetes. One publication estimated its prevalence after a 1-year follow-up of the smoking cessation program as 10.9% in former smokers and 15% in those who continued smoking.
In regard to macroangiopathy in the context of type 2 diabetes, the aforementioned 2019 meta-analysis focused on coronary artery disease, cerebrovascular accident (CVA), cardiovascular mortality, and myocardial infarction (MI). It found that smokers face an increased risk for all these outcomes.
The relative risks wavered between 1.53 and 1.66 and decreased after smoking cessation. For coronary artery disease and MI, they became insignificant. There was still a risk for CVA (RR = 1.34; 1.07-1.67) and fatal cardiovascular events (RR = 1.19; 0.02-1.39).
The data are slightly more heterogeneous for type 1 diabetes, where, despite smoking cessation, the increased risk for heart failure and CVA persists in men, yet the same risk for coronary heart disease and CVA drops in women.
Risk for weight gain
Dr. Rouland tried to reassure patients about the risk for gaining weight. “Weight gain is not inevitable. There is a risk for this, but it’s temporary. And, even with some weight gain, the cardiovascular benefits are still indisputable.”
A study carried out in 2013 focused specifically on this point, with an average post-cessation weight gain of 3.8 kg (8.4 lb) seen in diabetic individuals in the first 4 years after stopping smoking and of 0.1 kg (0.2 lb) thereafter. A time-based effect was observed with regulation of excess weight post-cessation over time, as seen in the general population (3 kg [6.6 lb] on average in nondiabetic individuals).
Weight gain tends to occur mainly in the immediate post-cessation period, essentially in the first 3 months, and there is a large variation in weight change. Some people gain a lot (from 5 to 10 kg [11 to 22 lb], or even more than 10 kg); others lose weight (20% of diabetic former smokers in the first month, 7% after 12 months), and 25% gain less than 5 kg (11 lb).
Blood glucose imbalance
“A risk for blood glucose imbalance has been reported after smoking cessation, although this is very slight and only temporary,” said Dr. Rouland.
A British retrospective study examined this question, focusing on glycated hemoglobin in patients with type 2 diabetes. Hemoglobin A1c increased by 0.21% (95% CI, 0.17-0.25; P < .001) within the first year after quitting. A1c decreased as abstinence continued and became comparable to that of continual smokers after 3 years. This increase in A1c was not mediated by weight change.
Another study published in 2018 on the topic of type 2 diabetes also reported on the risk for poor glycemic control (defined as A1c > 7%) persisting for 10 years after smoking cessation (odds ratio, 1.23; 95% CI, 1.06-1.42). Thereafter, between 10 and 19 years post-cessation, the OR decreased to 0.97 (95% CI, 0.80-1.19, NS). Beyond 20 years post-cessation, the OR was 1.14 (95% CI, 0.89-1.44, NS) and was therefore no longer significant.
Regardless, “the risk for poor glycemic control is lower in quitters than in active smokers,” said Dr. Rouland.
Quitting and diabetes risk
Will a smoker’s increased risk for diabetes drop when he or she stops smoking? “This is essentially what happens,” Dr. Rouland confirmed, “and his or her increased risk for metabolic syndrome also drops. One meta-analysis revealed a time-based effect.
“Patients who had stopped smoking less than 5 years previously had an increased relative risk for type 2 diabetes, and this risk dropped to 1.11 after more than 10 years of not smoking. Moreover, this relative risk for type 2 diabetes remained lower than that of active smokers, at between 1.19 and 1.60, depending on tobacco use.”
In regard to the risk for metabolic syndrome, those who quit smoking seem to have an increased risk of 10%, compared with nonsmokers (RR = 1.10, 1.08-1.11; P < .001). “But yet again, this increased risk is much lower than that of active smokers, whose risk is between 37% (less than 20 cigarettes/day) and 71% (more than 20 cigarettes/day).”
Women with diabetes
“The benefits of quitting appear identical, regardless of the sex of the diabetic person,” said Dr. Rouland. “As in the general population, weight gain after smoking cessation is greater in women. Furthermore, while smoking increases the risk for gestational diabetes (RR, 1.4-1.9) and for the use of insulin in this context, stopping smoking reduces these risks.
“Moreover, smoking during pregnancy not only increases the risk for pregnancy-related complications (early miscarriage, ectopic pregnancy, birth defects, placental abruption, premature birth, intrauterine fetal demise, cesarean birth, low birth weight), but it also increases the risk of type 2 diabetes in the newborn. The risk to the newborn is said to be around 34% in cases in which the mother smokes during pregnancy and 22% in cases in which the mother is a passive smoker, thereby justifying the use of measures to help the mother’s family members to stop smoking.”
Dr. Rouland reports no relevant financial relationships.
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
MONTPELLIER, FRANCE – The first expert consensus on smoking and diabetes, coauthored by the Francophone Diabetes Society (SFD) and the French Society for the Study of Nicotine Addiction (SFT), was presented at the SFD’s annual conference.
Alexia Rouland, MD, an endocrinologist at Dijon Bourgogne University Hospital, Dijon, France, took the conference as an opportunity to list the many benefits of smoking cessation for patients with diabetes, despite the “slight and temporary” risk for blood sugar imbalance.
Societies target smoking
Diabetes societies around Europe have set their sights on the topic of smoking. Indeed, the guidelines published in 2019 by the European Association for the Study of Diabetes and the European Society of Cardiology state that “smoking cessation is obligatory for all prediabetic and diabetic patients” (class I, level A).
This year, the France-based SFD and SFT dedicated an expert consensus to the major problem of smoking in patients with diabetes. The aim was to provide health care professionals with convincing, well-supported arguments in favor of smoking cessation in their patients with type 1 and type 2 diabetes.
“Before anything else, diabetic patients need to be made aware of the risks of smoking,” said Dr. Rouland. “It’s not just about the fear factor, though. It’s also about providing a positive incentive – they need to be told about the ways they’ll benefit from quitting smoking. For example, you have all-cause mortality, macro- and microangiopathic complications, and so on.”
Duration of abstinence
“Diabetic patients who have stopped smoking have a relative risk for all-cause mortality of 1.28 (1.09-1.51), which is less than what you see in active smokers (relative risk = 1.58; 1.42-1.77), but still above that of nonsmokers,” said Dr. Rouland.
A previous study revealed that although the risk does indeed go down after stopping smoking, it is linked to how long ago the person stopped. Patients who stopped smoking less than 10 years ago still had a slightly raised all-cause mortality risk, and this was even higher if they had smoked for 20 years or more.
After 10 years of not smoking, however, the greater all-cause mortality risk was no longer significant in any of the groups monitored (smoking duration, number of cigarettes/day). Concrete evidence of the link between all-cause mortality and the length of time since a person stopped smoking also emerged from the large cohort in the American Nurses’ Health Study.
The relative risk for all-cause mortality in women who stopped smoking less than 5 years ago remained high (RR = 1.96, 1.47-2.67), then decreased over time. After 10 years, it was no longer significant (RR = 1.11, 0.92-1.35).
Macro- and microangiopathic risks
Smoking cessation also has a real benefit in terms of the increased macro- and microangiopathic risks. In type 2 diabetes, a study found an increased relative risk for macro- and microalbuminuria of 1.86 (95% confidence interval, 1.37-2.52) in former smokers, compared with an increased relative risk of 2.61 (95% CI, 1.86-2.64) in current smokers.
In type 1 diabetes, the cumulative risk for microalbuminuria in former smokers was 15.1% vs. 18.9% in smokers and 10% in nonsmokers.
A 2019 meta-analysis of prospective cohort studies determined that smoking is an independent risk factor for diabetic nephropathy, especially in patients with type 1 diabetes.
Yet, most of the data for this condition come from subjects with type 2 diabetes. One publication estimated its prevalence after a 1-year follow-up of the smoking cessation program as 10.9% in former smokers and 15% in those who continued smoking.
In regard to macroangiopathy in the context of type 2 diabetes, the aforementioned 2019 meta-analysis focused on coronary artery disease, cerebrovascular accident (CVA), cardiovascular mortality, and myocardial infarction (MI). It found that smokers face an increased risk for all these outcomes.
The relative risks wavered between 1.53 and 1.66 and decreased after smoking cessation. For coronary artery disease and MI, they became insignificant. There was still a risk for CVA (RR = 1.34; 1.07-1.67) and fatal cardiovascular events (RR = 1.19; 0.02-1.39).
The data are slightly more heterogeneous for type 1 diabetes, where, despite smoking cessation, the increased risk for heart failure and CVA persists in men, yet the same risk for coronary heart disease and CVA drops in women.
Risk for weight gain
Dr. Rouland tried to reassure patients about the risk for gaining weight. “Weight gain is not inevitable. There is a risk for this, but it’s temporary. And, even with some weight gain, the cardiovascular benefits are still indisputable.”
A study carried out in 2013 focused specifically on this point, with an average post-cessation weight gain of 3.8 kg (8.4 lb) seen in diabetic individuals in the first 4 years after stopping smoking and of 0.1 kg (0.2 lb) thereafter. A time-based effect was observed with regulation of excess weight post-cessation over time, as seen in the general population (3 kg [6.6 lb] on average in nondiabetic individuals).
Weight gain tends to occur mainly in the immediate post-cessation period, essentially in the first 3 months, and there is a large variation in weight change. Some people gain a lot (from 5 to 10 kg [11 to 22 lb], or even more than 10 kg); others lose weight (20% of diabetic former smokers in the first month, 7% after 12 months), and 25% gain less than 5 kg (11 lb).
Blood glucose imbalance
“A risk for blood glucose imbalance has been reported after smoking cessation, although this is very slight and only temporary,” said Dr. Rouland.
A British retrospective study examined this question, focusing on glycated hemoglobin in patients with type 2 diabetes. Hemoglobin A1c increased by 0.21% (95% CI, 0.17-0.25; P < .001) within the first year after quitting. A1c decreased as abstinence continued and became comparable to that of continual smokers after 3 years. This increase in A1c was not mediated by weight change.
Another study published in 2018 on the topic of type 2 diabetes also reported on the risk for poor glycemic control (defined as A1c > 7%) persisting for 10 years after smoking cessation (odds ratio, 1.23; 95% CI, 1.06-1.42). Thereafter, between 10 and 19 years post-cessation, the OR decreased to 0.97 (95% CI, 0.80-1.19, NS). Beyond 20 years post-cessation, the OR was 1.14 (95% CI, 0.89-1.44, NS) and was therefore no longer significant.
Regardless, “the risk for poor glycemic control is lower in quitters than in active smokers,” said Dr. Rouland.
Quitting and diabetes risk
Will a smoker’s increased risk for diabetes drop when he or she stops smoking? “This is essentially what happens,” Dr. Rouland confirmed, “and his or her increased risk for metabolic syndrome also drops. One meta-analysis revealed a time-based effect.
“Patients who had stopped smoking less than 5 years previously had an increased relative risk for type 2 diabetes, and this risk dropped to 1.11 after more than 10 years of not smoking. Moreover, this relative risk for type 2 diabetes remained lower than that of active smokers, at between 1.19 and 1.60, depending on tobacco use.”
In regard to the risk for metabolic syndrome, those who quit smoking seem to have an increased risk of 10%, compared with nonsmokers (RR = 1.10, 1.08-1.11; P < .001). “But yet again, this increased risk is much lower than that of active smokers, whose risk is between 37% (less than 20 cigarettes/day) and 71% (more than 20 cigarettes/day).”
Women with diabetes
“The benefits of quitting appear identical, regardless of the sex of the diabetic person,” said Dr. Rouland. “As in the general population, weight gain after smoking cessation is greater in women. Furthermore, while smoking increases the risk for gestational diabetes (RR, 1.4-1.9) and for the use of insulin in this context, stopping smoking reduces these risks.
“Moreover, smoking during pregnancy not only increases the risk for pregnancy-related complications (early miscarriage, ectopic pregnancy, birth defects, placental abruption, premature birth, intrauterine fetal demise, cesarean birth, low birth weight), but it also increases the risk of type 2 diabetes in the newborn. The risk to the newborn is said to be around 34% in cases in which the mother smokes during pregnancy and 22% in cases in which the mother is a passive smoker, thereby justifying the use of measures to help the mother’s family members to stop smoking.”
Dr. Rouland reports no relevant financial relationships.
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
Should youth with type 1 diabetes use closed-loop systems?
Would closed-loop systems be a good option for young patients with type 1 diabetes?
International and French recommendations on closed-loop systems state that the use of an “artificial pancreas” should be reserved for adults who are fully engaged with their treatment. This means that young patients, especially adolescents, who are less likely to comply with treatment and are more likely to experience suboptimal blood glucose control, are often excluded from the use of such systems for managing their diabetes.
Several recent studies seem to call this approach into question.
One such study, which was presented at a Francophone Diabetes Society conference and was published in Nature Communications, showed that adolescents with poorly controlled diabetes who were equipped with closed-loop systems gained IQ points and reasoning capacity and experienced a reduction in edematous tissue in the brain cortex. Furthermore, with the closed-loop system, patients spent 13% more time in a target range, and there was a significant reduction in time spent in hyperglycemia.
In the same vein, a small prospective study published in Diabetes Care showed that the closed-loop system with the Minimed 780G pump improved glycemic control for 20 young patients with type 1 diabetes aged 13-25 years whose diabetes was poorly controlled (hemoglobin A1c ≥ 8.5%). At the end of the 3-month study period, the average A1c had decreased from 10.5% (±2.1%) to 7.6% (±1.1%), an average decrease of 2.9%. The time spent in target A1c, which was set from 0.70 g/L to 1.80 g/L, was increased by almost 40%.
With respect to very young children, a study published in The New England Journal of Medicine also showed a favorable risk-benefit ratio for closed-loop systems. The trial, which enrolled 102 children aged 2 years to less than 6 years who had type 1 diabetes, showed that the amount of time that the glucose level was within the target range during the 13-week study period was higher (+3 hours) for those who had been randomly assigned to receive the hybrid closed-loop system (n = 68) than for those who had received the standard treatment (n = 34), either with an insulin pump or multiple daily injections or a Dexcom G6 continuous glucose monitoring device.
A previous study carried out by the Paris Public Hospital System had already shown that the French Diabeloop system could reduce episodes of hypoglycemia and achieve good glycemic control for prepubescent children (n = 21; aged 6-12 years) with type 1 diabetes in real-life conditions.
Eric Renard, MD, PhD, head of the department of endocrinology and diabetes at Lapeyronie Hospital in Montpellier, France, was not surprised at the findings from the study, especially in adolescents with poorly controlled diabetes.
“We have already seen studies in which those patients who had the most poorly controlled diabetes at the start were the ones who improved the most with the closed-loop system, by at least 20% in terms of time in target. These findings resonate with what I see in my clinic,” said Dr. Renard in an interview.
“In my experience, these young adolescents, who neglected their diabetes when they had no devices to help control it, when they had to inject themselves, et cetera ... well, they’re just not the same people when they’re put on a closed-loop system,” he added. “They rise to the challenge, and for the first time, they succeed without making a huge effort, since the algorithm does what they weren’t doing. It’s astonishing to see near-total engagement in these young people when explaining the technology to them and saying, ‘Let’s give it a go.’ These are the very same youngsters who didn’t want to hear about their diabetes in the past. They are delighted and once again involved in managing their condition.”
That’s why Dr. Renard recommends keeping an open mind when considering treatment options for young patients with poorly controlled type 1 diabetes.
“When young people have very poorly controlled diabetes, they risk having cardiovascular complications and damaging their retinas and kidneys,” he said. “If we can get them from 25% to 45% time in target, even if that hasn’t been easy to achieve, this will help save their blood vessels! The only thing we have to be careful of is that we don’t set up a closed-loop system in someone who doesn’t want one. But, if it can manage to spark the interest of a young patient, in most cases, it’s beneficial.”
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
Would closed-loop systems be a good option for young patients with type 1 diabetes?
International and French recommendations on closed-loop systems state that the use of an “artificial pancreas” should be reserved for adults who are fully engaged with their treatment. This means that young patients, especially adolescents, who are less likely to comply with treatment and are more likely to experience suboptimal blood glucose control, are often excluded from the use of such systems for managing their diabetes.
Several recent studies seem to call this approach into question.
One such study, which was presented at a Francophone Diabetes Society conference and was published in Nature Communications, showed that adolescents with poorly controlled diabetes who were equipped with closed-loop systems gained IQ points and reasoning capacity and experienced a reduction in edematous tissue in the brain cortex. Furthermore, with the closed-loop system, patients spent 13% more time in a target range, and there was a significant reduction in time spent in hyperglycemia.
In the same vein, a small prospective study published in Diabetes Care showed that the closed-loop system with the Minimed 780G pump improved glycemic control for 20 young patients with type 1 diabetes aged 13-25 years whose diabetes was poorly controlled (hemoglobin A1c ≥ 8.5%). At the end of the 3-month study period, the average A1c had decreased from 10.5% (±2.1%) to 7.6% (±1.1%), an average decrease of 2.9%. The time spent in target A1c, which was set from 0.70 g/L to 1.80 g/L, was increased by almost 40%.
With respect to very young children, a study published in The New England Journal of Medicine also showed a favorable risk-benefit ratio for closed-loop systems. The trial, which enrolled 102 children aged 2 years to less than 6 years who had type 1 diabetes, showed that the amount of time that the glucose level was within the target range during the 13-week study period was higher (+3 hours) for those who had been randomly assigned to receive the hybrid closed-loop system (n = 68) than for those who had received the standard treatment (n = 34), either with an insulin pump or multiple daily injections or a Dexcom G6 continuous glucose monitoring device.
A previous study carried out by the Paris Public Hospital System had already shown that the French Diabeloop system could reduce episodes of hypoglycemia and achieve good glycemic control for prepubescent children (n = 21; aged 6-12 years) with type 1 diabetes in real-life conditions.
Eric Renard, MD, PhD, head of the department of endocrinology and diabetes at Lapeyronie Hospital in Montpellier, France, was not surprised at the findings from the study, especially in adolescents with poorly controlled diabetes.
“We have already seen studies in which those patients who had the most poorly controlled diabetes at the start were the ones who improved the most with the closed-loop system, by at least 20% in terms of time in target. These findings resonate with what I see in my clinic,” said Dr. Renard in an interview.
“In my experience, these young adolescents, who neglected their diabetes when they had no devices to help control it, when they had to inject themselves, et cetera ... well, they’re just not the same people when they’re put on a closed-loop system,” he added. “They rise to the challenge, and for the first time, they succeed without making a huge effort, since the algorithm does what they weren’t doing. It’s astonishing to see near-total engagement in these young people when explaining the technology to them and saying, ‘Let’s give it a go.’ These are the very same youngsters who didn’t want to hear about their diabetes in the past. They are delighted and once again involved in managing their condition.”
That’s why Dr. Renard recommends keeping an open mind when considering treatment options for young patients with poorly controlled type 1 diabetes.
“When young people have very poorly controlled diabetes, they risk having cardiovascular complications and damaging their retinas and kidneys,” he said. “If we can get them from 25% to 45% time in target, even if that hasn’t been easy to achieve, this will help save their blood vessels! The only thing we have to be careful of is that we don’t set up a closed-loop system in someone who doesn’t want one. But, if it can manage to spark the interest of a young patient, in most cases, it’s beneficial.”
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
Would closed-loop systems be a good option for young patients with type 1 diabetes?
International and French recommendations on closed-loop systems state that the use of an “artificial pancreas” should be reserved for adults who are fully engaged with their treatment. This means that young patients, especially adolescents, who are less likely to comply with treatment and are more likely to experience suboptimal blood glucose control, are often excluded from the use of such systems for managing their diabetes.
Several recent studies seem to call this approach into question.
One such study, which was presented at a Francophone Diabetes Society conference and was published in Nature Communications, showed that adolescents with poorly controlled diabetes who were equipped with closed-loop systems gained IQ points and reasoning capacity and experienced a reduction in edematous tissue in the brain cortex. Furthermore, with the closed-loop system, patients spent 13% more time in a target range, and there was a significant reduction in time spent in hyperglycemia.
In the same vein, a small prospective study published in Diabetes Care showed that the closed-loop system with the Minimed 780G pump improved glycemic control for 20 young patients with type 1 diabetes aged 13-25 years whose diabetes was poorly controlled (hemoglobin A1c ≥ 8.5%). At the end of the 3-month study period, the average A1c had decreased from 10.5% (±2.1%) to 7.6% (±1.1%), an average decrease of 2.9%. The time spent in target A1c, which was set from 0.70 g/L to 1.80 g/L, was increased by almost 40%.
With respect to very young children, a study published in The New England Journal of Medicine also showed a favorable risk-benefit ratio for closed-loop systems. The trial, which enrolled 102 children aged 2 years to less than 6 years who had type 1 diabetes, showed that the amount of time that the glucose level was within the target range during the 13-week study period was higher (+3 hours) for those who had been randomly assigned to receive the hybrid closed-loop system (n = 68) than for those who had received the standard treatment (n = 34), either with an insulin pump or multiple daily injections or a Dexcom G6 continuous glucose monitoring device.
A previous study carried out by the Paris Public Hospital System had already shown that the French Diabeloop system could reduce episodes of hypoglycemia and achieve good glycemic control for prepubescent children (n = 21; aged 6-12 years) with type 1 diabetes in real-life conditions.
Eric Renard, MD, PhD, head of the department of endocrinology and diabetes at Lapeyronie Hospital in Montpellier, France, was not surprised at the findings from the study, especially in adolescents with poorly controlled diabetes.
“We have already seen studies in which those patients who had the most poorly controlled diabetes at the start were the ones who improved the most with the closed-loop system, by at least 20% in terms of time in target. These findings resonate with what I see in my clinic,” said Dr. Renard in an interview.
“In my experience, these young adolescents, who neglected their diabetes when they had no devices to help control it, when they had to inject themselves, et cetera ... well, they’re just not the same people when they’re put on a closed-loop system,” he added. “They rise to the challenge, and for the first time, they succeed without making a huge effort, since the algorithm does what they weren’t doing. It’s astonishing to see near-total engagement in these young people when explaining the technology to them and saying, ‘Let’s give it a go.’ These are the very same youngsters who didn’t want to hear about their diabetes in the past. They are delighted and once again involved in managing their condition.”
That’s why Dr. Renard recommends keeping an open mind when considering treatment options for young patients with poorly controlled type 1 diabetes.
“When young people have very poorly controlled diabetes, they risk having cardiovascular complications and damaging their retinas and kidneys,” he said. “If we can get them from 25% to 45% time in target, even if that hasn’t been easy to achieve, this will help save their blood vessels! The only thing we have to be careful of is that we don’t set up a closed-loop system in someone who doesn’t want one. But, if it can manage to spark the interest of a young patient, in most cases, it’s beneficial.”
This article was translated from the Medscape French edition. A version appeared on Medscape.com.