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Cystic fibrosis–related diabetes requires unique treatment
SAN DIEGO – according to Katie Larson Ode, MD.
Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”
“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.
But as they age, CF patients’ risk for CFRD also increases.
A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.
CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.
The specialists said patients with CFRD are unique among diabetics for several reasons:
• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.
• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.
• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”
Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”
Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.
The physicians offered these tips about tracking and treating CF patients:
• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”
• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”
The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”
The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.
Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.
SAN DIEGO – according to Katie Larson Ode, MD.
Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”
“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.
But as they age, CF patients’ risk for CFRD also increases.
A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.
CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.
The specialists said patients with CFRD are unique among diabetics for several reasons:
• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.
• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.
• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”
Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”
Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.
The physicians offered these tips about tracking and treating CF patients:
• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”
• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”
The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”
The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.
Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.
SAN DIEGO – according to Katie Larson Ode, MD.
Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”
“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.
But as they age, CF patients’ risk for CFRD also increases.
A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.
CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.
The specialists said patients with CFRD are unique among diabetics for several reasons:
• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.
• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.
• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”
Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”
Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.
The physicians offered these tips about tracking and treating CF patients:
• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”
• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”
The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”
The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.
Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.
EXPERT ANALYSIS FROM AADE 16
Pharmacists: Weight-loss drugs and diabetes can mix
SAN DIEGO –
In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.
The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”
Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.
These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”
According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”
Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).
There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.
Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”
As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.
Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”
Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.
If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”
Dr. Rochester and Dr. Meade report no relevant disclosures.
SAN DIEGO –
In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.
The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”
Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.
These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”
According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”
Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).
There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.
Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”
As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.
Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”
Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.
If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”
Dr. Rochester and Dr. Meade report no relevant disclosures.
SAN DIEGO –
In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.
The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”
Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.
These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”
According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”
Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).
There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.
Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”
As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.
Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”
Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.
If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”
Dr. Rochester and Dr. Meade report no relevant disclosures.
EXPERT ANALYSIS FROM AADE 16
Give guidance, not just Viagra, to men with diabetes and related impotence
Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.
“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”
In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:
• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.
• Long-term uncontrolled diabetes can make ED permanent.
• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.
How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.
“Diabetes has a devastating effect on the muscle tissue inside the penis,” he said. “All the tiny little arteries that feed blood to the muscle get occluded. Little by little, the muscle inside the penis shrinks.” Indeed, some diabetics with ED complain that their penises have shrunk, he said.
Diabetic damage doesn’t stop with these small vessels, he said. “You really have two parallel situations: You need blood flow that feeds the muscle of the penis, and you need an artery dedicated to bringing blood rapidly when a man becomes aroused and wants to be sexually active,” he said. “That artery is also affected by diabetes. They’ll say ‘I can get a partial erection, but I can’t maintain it.’ ”
What comes after an ED diagnosis in diabetic patients? Often, Dr. Eid will instantly refer these men to a cardiologist. “If a patient has diabetes and is newly diagnosed, a significant portion of these men are going to develop coronary artery disease in the next 2-3 years,” he said. “One of the things we do is recommend is that they see a cardiologist and perhaps have a stress test or some sort of evaluation.”
Dr. Eid also urges these patients to treat their diabetes in order to avoid developing ED for life. “They need to manage their diabetes and make sure they control it so the ED will not progress and will stabilize, as a result,” he said. “If the diabetes is controlled after the patient is first diagnosed, then the erections will come back. But if the patient has diabetes for many years, and suddenly decides it’s time to control it, they cannot prevent the damage that’s already been done.”
As for treatments, patients with diabetes and related ED should begin with medications like sildenafil and tadalafil, he recommended. But research findings suggest that the drugs will fail in half of men with type 2 diabetes, he said.
Other options include penile self-injections, vacuum devices, and penile implants.
The injections “can work well and are painless, but men detest having to inject themselves before sexual activity,” Dr. Eid said. And he said men rarely have success using vacuum devices, which are available over the counter.
By contrast, penis implants can successfully treat erectile dysfunction in many cases, Dr. Eid said. Men trigger erections by squeezing a pump that is implanted into the scrotum. Fluid then flows from an implanted reservoir into a cylinder implanted in the penis.
Men are often pleased by penis implants because they can have sex spontaneously without having to plan for it ahead of time, as required by medications. “They’re completely transformed,” Dr. Eid said. “They feel that they’re cured.”
Dr. Eid receives or has received research support/grants from American Medical Systems, Coloplast, Lilly ICOS, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer. He is or was a consultant and on the speakers bureau for Coloplast, American Medical Systems, Lilly ICOS, Bayer and Pfizer.
Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.
“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”
In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:
• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.
• Long-term uncontrolled diabetes can make ED permanent.
• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.
How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.
“Diabetes has a devastating effect on the muscle tissue inside the penis,” he said. “All the tiny little arteries that feed blood to the muscle get occluded. Little by little, the muscle inside the penis shrinks.” Indeed, some diabetics with ED complain that their penises have shrunk, he said.
Diabetic damage doesn’t stop with these small vessels, he said. “You really have two parallel situations: You need blood flow that feeds the muscle of the penis, and you need an artery dedicated to bringing blood rapidly when a man becomes aroused and wants to be sexually active,” he said. “That artery is also affected by diabetes. They’ll say ‘I can get a partial erection, but I can’t maintain it.’ ”
What comes after an ED diagnosis in diabetic patients? Often, Dr. Eid will instantly refer these men to a cardiologist. “If a patient has diabetes and is newly diagnosed, a significant portion of these men are going to develop coronary artery disease in the next 2-3 years,” he said. “One of the things we do is recommend is that they see a cardiologist and perhaps have a stress test or some sort of evaluation.”
Dr. Eid also urges these patients to treat their diabetes in order to avoid developing ED for life. “They need to manage their diabetes and make sure they control it so the ED will not progress and will stabilize, as a result,” he said. “If the diabetes is controlled after the patient is first diagnosed, then the erections will come back. But if the patient has diabetes for many years, and suddenly decides it’s time to control it, they cannot prevent the damage that’s already been done.”
As for treatments, patients with diabetes and related ED should begin with medications like sildenafil and tadalafil, he recommended. But research findings suggest that the drugs will fail in half of men with type 2 diabetes, he said.
Other options include penile self-injections, vacuum devices, and penile implants.
The injections “can work well and are painless, but men detest having to inject themselves before sexual activity,” Dr. Eid said. And he said men rarely have success using vacuum devices, which are available over the counter.
By contrast, penis implants can successfully treat erectile dysfunction in many cases, Dr. Eid said. Men trigger erections by squeezing a pump that is implanted into the scrotum. Fluid then flows from an implanted reservoir into a cylinder implanted in the penis.
Men are often pleased by penis implants because they can have sex spontaneously without having to plan for it ahead of time, as required by medications. “They’re completely transformed,” Dr. Eid said. “They feel that they’re cured.”
Dr. Eid receives or has received research support/grants from American Medical Systems, Coloplast, Lilly ICOS, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer. He is or was a consultant and on the speakers bureau for Coloplast, American Medical Systems, Lilly ICOS, Bayer and Pfizer.
Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.
“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”
In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:
• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.
• Long-term uncontrolled diabetes can make ED permanent.
• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.
How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.
“Diabetes has a devastating effect on the muscle tissue inside the penis,” he said. “All the tiny little arteries that feed blood to the muscle get occluded. Little by little, the muscle inside the penis shrinks.” Indeed, some diabetics with ED complain that their penises have shrunk, he said.
Diabetic damage doesn’t stop with these small vessels, he said. “You really have two parallel situations: You need blood flow that feeds the muscle of the penis, and you need an artery dedicated to bringing blood rapidly when a man becomes aroused and wants to be sexually active,” he said. “That artery is also affected by diabetes. They’ll say ‘I can get a partial erection, but I can’t maintain it.’ ”
What comes after an ED diagnosis in diabetic patients? Often, Dr. Eid will instantly refer these men to a cardiologist. “If a patient has diabetes and is newly diagnosed, a significant portion of these men are going to develop coronary artery disease in the next 2-3 years,” he said. “One of the things we do is recommend is that they see a cardiologist and perhaps have a stress test or some sort of evaluation.”
Dr. Eid also urges these patients to treat their diabetes in order to avoid developing ED for life. “They need to manage their diabetes and make sure they control it so the ED will not progress and will stabilize, as a result,” he said. “If the diabetes is controlled after the patient is first diagnosed, then the erections will come back. But if the patient has diabetes for many years, and suddenly decides it’s time to control it, they cannot prevent the damage that’s already been done.”
As for treatments, patients with diabetes and related ED should begin with medications like sildenafil and tadalafil, he recommended. But research findings suggest that the drugs will fail in half of men with type 2 diabetes, he said.
Other options include penile self-injections, vacuum devices, and penile implants.
The injections “can work well and are painless, but men detest having to inject themselves before sexual activity,” Dr. Eid said. And he said men rarely have success using vacuum devices, which are available over the counter.
By contrast, penis implants can successfully treat erectile dysfunction in many cases, Dr. Eid said. Men trigger erections by squeezing a pump that is implanted into the scrotum. Fluid then flows from an implanted reservoir into a cylinder implanted in the penis.
Men are often pleased by penis implants because they can have sex spontaneously without having to plan for it ahead of time, as required by medications. “They’re completely transformed,” Dr. Eid said. “They feel that they’re cured.”
Dr. Eid receives or has received research support/grants from American Medical Systems, Coloplast, Lilly ICOS, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer. He is or was a consultant and on the speakers bureau for Coloplast, American Medical Systems, Lilly ICOS, Bayer and Pfizer.
EXPERT ANALYSIS FROM AADE 16
Pharmacists urge more focus on kidney disease indicator
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
AT THE ANNUAL MEETING OF AADE
Experts: Insulin apps can pose major risks
SAN DIEGO – How much damage could a diabetes app do? Plenty. That was the word from a Food and Drug Administration official and a technology guru who spoke to a crowd of diabetes educators about the dangers lurking in apps that promise to track things like insulin dosing.
An app could jeopardize the safety of a patient and provide inaccurate data, advised Molly McElwee, RN, CDE, head of Patient Engagement at TypeZero Technologies. “Vet the app that your patient is using or wants to use. Really vet your apps for these patients.”
Ms. McElwee told an audience at the annual meeting of the American Association of Diabetes Educators that more than 84 “bolus calculator” apps are available for iPhone and Android. But only one, the Accu-Check Connect app, is cleared by the FDA for use with a prescription, she confirmed in an interview. Some app makers claim that their technology has been cleared in their countries of origin, but that raises questions about whether the technology has gone through proper vetting, she said.
“The idea you’d let someone with no medical experience just design [an app], put it out there for you, and then tell you how to dose seems a bit odd,” but that’s the way things work in the “murky, uncharted territory” of apps, she said.
Why is there a need for diabetes apps in the first place? As Ms. McElwee noted, many diabetes patients make crucial decisions about their insulin injections each day. “There aren’t a lot of other diseases where you’re dosing something that could kill you if you dose it incorrectly.” That is exactly why “people look for things like an app that can help them,” she noted.
The FDA does indeed regulate medical apps but far from all of them. It doesn’t regulate apps such as calorie counters and exercise trackers because they’re considered to be low risk, said Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices. “They don’t give advice or tell patients what action to take,” she said. Nor does the FDA regulate apps that retrospectively analyze data from insulin pumps, she said.
The FDA regulates apps such as insulin-dosing calculators and those used to calculate the levels of insulin injections via a pump, she said. But Apple’s App Store and Google’s Google Play, both of which sell apps, aren’t required to take down apps that don’t comply with FDA regulations, according to Ms. McElwee. Indeed, the FDA says it doesn’t regulate app stores, nor does it regulate manufacturers of devices such as smartphones, although the stores may set their own policies. Instead, “the onus is on the company, the developer, to take the correct regulatory pathway,” Ms. McElwee said.
What’s next? Dr. Lias noted that the FDA will monitor apps that command and control insulin pumps, especially as automated insulin delivery systems loom on the horizon. But there are a variety of technical challenges. How will operating systems be updated? What will happen to critical functions when a phone call interrupts the operation of a diabetes app? What about warnings when the phone is muted? Dr. Lias wondered.
One thing is clear, she said: “The explosion of apps is directly related to how much they’re needed.”
Ms. McElwee and Dr. Lias reported having no relevant financial disclosures.
SAN DIEGO – How much damage could a diabetes app do? Plenty. That was the word from a Food and Drug Administration official and a technology guru who spoke to a crowd of diabetes educators about the dangers lurking in apps that promise to track things like insulin dosing.
An app could jeopardize the safety of a patient and provide inaccurate data, advised Molly McElwee, RN, CDE, head of Patient Engagement at TypeZero Technologies. “Vet the app that your patient is using or wants to use. Really vet your apps for these patients.”
Ms. McElwee told an audience at the annual meeting of the American Association of Diabetes Educators that more than 84 “bolus calculator” apps are available for iPhone and Android. But only one, the Accu-Check Connect app, is cleared by the FDA for use with a prescription, she confirmed in an interview. Some app makers claim that their technology has been cleared in their countries of origin, but that raises questions about whether the technology has gone through proper vetting, she said.
“The idea you’d let someone with no medical experience just design [an app], put it out there for you, and then tell you how to dose seems a bit odd,” but that’s the way things work in the “murky, uncharted territory” of apps, she said.
Why is there a need for diabetes apps in the first place? As Ms. McElwee noted, many diabetes patients make crucial decisions about their insulin injections each day. “There aren’t a lot of other diseases where you’re dosing something that could kill you if you dose it incorrectly.” That is exactly why “people look for things like an app that can help them,” she noted.
The FDA does indeed regulate medical apps but far from all of them. It doesn’t regulate apps such as calorie counters and exercise trackers because they’re considered to be low risk, said Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices. “They don’t give advice or tell patients what action to take,” she said. Nor does the FDA regulate apps that retrospectively analyze data from insulin pumps, she said.
The FDA regulates apps such as insulin-dosing calculators and those used to calculate the levels of insulin injections via a pump, she said. But Apple’s App Store and Google’s Google Play, both of which sell apps, aren’t required to take down apps that don’t comply with FDA regulations, according to Ms. McElwee. Indeed, the FDA says it doesn’t regulate app stores, nor does it regulate manufacturers of devices such as smartphones, although the stores may set their own policies. Instead, “the onus is on the company, the developer, to take the correct regulatory pathway,” Ms. McElwee said.
What’s next? Dr. Lias noted that the FDA will monitor apps that command and control insulin pumps, especially as automated insulin delivery systems loom on the horizon. But there are a variety of technical challenges. How will operating systems be updated? What will happen to critical functions when a phone call interrupts the operation of a diabetes app? What about warnings when the phone is muted? Dr. Lias wondered.
One thing is clear, she said: “The explosion of apps is directly related to how much they’re needed.”
Ms. McElwee and Dr. Lias reported having no relevant financial disclosures.
SAN DIEGO – How much damage could a diabetes app do? Plenty. That was the word from a Food and Drug Administration official and a technology guru who spoke to a crowd of diabetes educators about the dangers lurking in apps that promise to track things like insulin dosing.
An app could jeopardize the safety of a patient and provide inaccurate data, advised Molly McElwee, RN, CDE, head of Patient Engagement at TypeZero Technologies. “Vet the app that your patient is using or wants to use. Really vet your apps for these patients.”
Ms. McElwee told an audience at the annual meeting of the American Association of Diabetes Educators that more than 84 “bolus calculator” apps are available for iPhone and Android. But only one, the Accu-Check Connect app, is cleared by the FDA for use with a prescription, she confirmed in an interview. Some app makers claim that their technology has been cleared in their countries of origin, but that raises questions about whether the technology has gone through proper vetting, she said.
“The idea you’d let someone with no medical experience just design [an app], put it out there for you, and then tell you how to dose seems a bit odd,” but that’s the way things work in the “murky, uncharted territory” of apps, she said.
Why is there a need for diabetes apps in the first place? As Ms. McElwee noted, many diabetes patients make crucial decisions about their insulin injections each day. “There aren’t a lot of other diseases where you’re dosing something that could kill you if you dose it incorrectly.” That is exactly why “people look for things like an app that can help them,” she noted.
The FDA does indeed regulate medical apps but far from all of them. It doesn’t regulate apps such as calorie counters and exercise trackers because they’re considered to be low risk, said Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices. “They don’t give advice or tell patients what action to take,” she said. Nor does the FDA regulate apps that retrospectively analyze data from insulin pumps, she said.
The FDA regulates apps such as insulin-dosing calculators and those used to calculate the levels of insulin injections via a pump, she said. But Apple’s App Store and Google’s Google Play, both of which sell apps, aren’t required to take down apps that don’t comply with FDA regulations, according to Ms. McElwee. Indeed, the FDA says it doesn’t regulate app stores, nor does it regulate manufacturers of devices such as smartphones, although the stores may set their own policies. Instead, “the onus is on the company, the developer, to take the correct regulatory pathway,” Ms. McElwee said.
What’s next? Dr. Lias noted that the FDA will monitor apps that command and control insulin pumps, especially as automated insulin delivery systems loom on the horizon. But there are a variety of technical challenges. How will operating systems be updated? What will happen to critical functions when a phone call interrupts the operation of a diabetes app? What about warnings when the phone is muted? Dr. Lias wondered.
One thing is clear, she said: “The explosion of apps is directly related to how much they’re needed.”
Ms. McElwee and Dr. Lias reported having no relevant financial disclosures.
AT AADE 16
Sleep doctor: Less than 7 hours can worsen diabetes
SAN DIEGO – A sleep specialist told an audience of diabetes educators that quality sleep is “profoundly important” to the health of their patients, and regularly sleeping fewer than 7 hours a night can wreak havoc on glucose levels and insulin resistance.
There’s even evidence of a link between lack of sleep, diabetes, and heart disease, according to Terese C. Hammond, MD, medical director of the Keck Hospital of the University of Southern California Sleep Disorders Center in Los Angeles. “We don’t know which way the cause goes, but we know there’s a connection,” she said.
Dr. Hammond, who spoke at the annual meeting of the American Association of Diabetes Educators, noted that the vast majority of adults need 7-9 hours of sleep a night.
If you repeatedly don’t reach 7 hours, “there is ample evidence that some metabolic and biologic things happen to your body. Glucose goes up and insulin is secreted. Leptin decreases – the protein that tells us when we’re sated, when our hunger is satisfied. It’s a pretty potent combination, and this is associated with increases in weight and carbohydrate intake,” Dr. Hammond said.
Indeed, findings from one small study suggest a link between chronic insufficient sleep to consumption of more calories, mostly carbohydrates. The study authors speculated this may be because people eat extra food to account for being awake more but take in more than they need (Proc Natl Acad Sci USA. 2013 Apr;110[14]:5695-700).
It is possible for people to pay off a “sleep debt” by catching up on sleep, Dr. Hammond said, but only if the sleep is lost temporarily, as during a heavy medical rotation or after a personal tragedy. When sleep loss is chronic, she said, “it’s becoming apparent that the end-organ consequences are not fully recoverable.”
In regard to diabetes specifically, she said, research has linked insufficient sleep to higher rates of central obesity, higher rates of diabetes in blacks and whites, impaired glucose tolerance, decreased insulin, metabolic syndrome, and high lipids. Too much sleep has also been linked to poor health outcomes.
How can medical professionals help patients improve sleep? “The most important thing to remember about sleep is that it’s a very primitive process,” according to Dr. Hammond. “You can’t think yourself into better sleep. You have to act yourself into better sleep through light, temperature, sound, and repetitive behaviors.”
Controversial research has linked sleeping pills to higher mortality rates, she says.“I try to avoid them long term for insomnia, and not only because there’s probably an increased risk. They stop working eventually.”
Another approach, cognitive behavioral therapy (CBT), is “the most potent way to change behavior,” she said.
“CBT improves sleep efficiency in a vast majority of chronic medical diseases,” she said. “It does just as well as drugs and better than most sleeping pills.”
According to Dr. Hammond, CBT focuses on several strategies:
• Education about sleep hygiene, such as limiting the bedroom to nighttime sleep and intimacy, going to bed at the same time every night, and focusing on a dark, cool, quiet environment.
• Increasing the “sleep drive” through temporary sleep deprivation.
• Relaxation training through techniques like guided imagery, biofeedback, progressive muscle relaxation, and self-hypnosis.
Dr. Hammond reported having no relevant financial disclosures.
SAN DIEGO – A sleep specialist told an audience of diabetes educators that quality sleep is “profoundly important” to the health of their patients, and regularly sleeping fewer than 7 hours a night can wreak havoc on glucose levels and insulin resistance.
There’s even evidence of a link between lack of sleep, diabetes, and heart disease, according to Terese C. Hammond, MD, medical director of the Keck Hospital of the University of Southern California Sleep Disorders Center in Los Angeles. “We don’t know which way the cause goes, but we know there’s a connection,” she said.
Dr. Hammond, who spoke at the annual meeting of the American Association of Diabetes Educators, noted that the vast majority of adults need 7-9 hours of sleep a night.
If you repeatedly don’t reach 7 hours, “there is ample evidence that some metabolic and biologic things happen to your body. Glucose goes up and insulin is secreted. Leptin decreases – the protein that tells us when we’re sated, when our hunger is satisfied. It’s a pretty potent combination, and this is associated with increases in weight and carbohydrate intake,” Dr. Hammond said.
Indeed, findings from one small study suggest a link between chronic insufficient sleep to consumption of more calories, mostly carbohydrates. The study authors speculated this may be because people eat extra food to account for being awake more but take in more than they need (Proc Natl Acad Sci USA. 2013 Apr;110[14]:5695-700).
It is possible for people to pay off a “sleep debt” by catching up on sleep, Dr. Hammond said, but only if the sleep is lost temporarily, as during a heavy medical rotation or after a personal tragedy. When sleep loss is chronic, she said, “it’s becoming apparent that the end-organ consequences are not fully recoverable.”
In regard to diabetes specifically, she said, research has linked insufficient sleep to higher rates of central obesity, higher rates of diabetes in blacks and whites, impaired glucose tolerance, decreased insulin, metabolic syndrome, and high lipids. Too much sleep has also been linked to poor health outcomes.
How can medical professionals help patients improve sleep? “The most important thing to remember about sleep is that it’s a very primitive process,” according to Dr. Hammond. “You can’t think yourself into better sleep. You have to act yourself into better sleep through light, temperature, sound, and repetitive behaviors.”
Controversial research has linked sleeping pills to higher mortality rates, she says.“I try to avoid them long term for insomnia, and not only because there’s probably an increased risk. They stop working eventually.”
Another approach, cognitive behavioral therapy (CBT), is “the most potent way to change behavior,” she said.
“CBT improves sleep efficiency in a vast majority of chronic medical diseases,” she said. “It does just as well as drugs and better than most sleeping pills.”
According to Dr. Hammond, CBT focuses on several strategies:
• Education about sleep hygiene, such as limiting the bedroom to nighttime sleep and intimacy, going to bed at the same time every night, and focusing on a dark, cool, quiet environment.
• Increasing the “sleep drive” through temporary sleep deprivation.
• Relaxation training through techniques like guided imagery, biofeedback, progressive muscle relaxation, and self-hypnosis.
Dr. Hammond reported having no relevant financial disclosures.
SAN DIEGO – A sleep specialist told an audience of diabetes educators that quality sleep is “profoundly important” to the health of their patients, and regularly sleeping fewer than 7 hours a night can wreak havoc on glucose levels and insulin resistance.
There’s even evidence of a link between lack of sleep, diabetes, and heart disease, according to Terese C. Hammond, MD, medical director of the Keck Hospital of the University of Southern California Sleep Disorders Center in Los Angeles. “We don’t know which way the cause goes, but we know there’s a connection,” she said.
Dr. Hammond, who spoke at the annual meeting of the American Association of Diabetes Educators, noted that the vast majority of adults need 7-9 hours of sleep a night.
If you repeatedly don’t reach 7 hours, “there is ample evidence that some metabolic and biologic things happen to your body. Glucose goes up and insulin is secreted. Leptin decreases – the protein that tells us when we’re sated, when our hunger is satisfied. It’s a pretty potent combination, and this is associated with increases in weight and carbohydrate intake,” Dr. Hammond said.
Indeed, findings from one small study suggest a link between chronic insufficient sleep to consumption of more calories, mostly carbohydrates. The study authors speculated this may be because people eat extra food to account for being awake more but take in more than they need (Proc Natl Acad Sci USA. 2013 Apr;110[14]:5695-700).
It is possible for people to pay off a “sleep debt” by catching up on sleep, Dr. Hammond said, but only if the sleep is lost temporarily, as during a heavy medical rotation or after a personal tragedy. When sleep loss is chronic, she said, “it’s becoming apparent that the end-organ consequences are not fully recoverable.”
In regard to diabetes specifically, she said, research has linked insufficient sleep to higher rates of central obesity, higher rates of diabetes in blacks and whites, impaired glucose tolerance, decreased insulin, metabolic syndrome, and high lipids. Too much sleep has also been linked to poor health outcomes.
How can medical professionals help patients improve sleep? “The most important thing to remember about sleep is that it’s a very primitive process,” according to Dr. Hammond. “You can’t think yourself into better sleep. You have to act yourself into better sleep through light, temperature, sound, and repetitive behaviors.”
Controversial research has linked sleeping pills to higher mortality rates, she says.“I try to avoid them long term for insomnia, and not only because there’s probably an increased risk. They stop working eventually.”
Another approach, cognitive behavioral therapy (CBT), is “the most potent way to change behavior,” she said.
“CBT improves sleep efficiency in a vast majority of chronic medical diseases,” she said. “It does just as well as drugs and better than most sleeping pills.”
According to Dr. Hammond, CBT focuses on several strategies:
• Education about sleep hygiene, such as limiting the bedroom to nighttime sleep and intimacy, going to bed at the same time every night, and focusing on a dark, cool, quiet environment.
• Increasing the “sleep drive” through temporary sleep deprivation.
• Relaxation training through techniques like guided imagery, biofeedback, progressive muscle relaxation, and self-hypnosis.
Dr. Hammond reported having no relevant financial disclosures.
AT AADE 16
Endocrinologist links nighttime hypoglycemia to many ills
SAN DIEGO – A top endocrinologist cautioned diabetes educators that research is linking nighttime hypoglycemia to a variety of ills, and technology isn’t providing much hope – yet.
Patients with nocturnal low blood sugar “say this is the hardest thing they have to deal with. It upsets their whole day and they feel terrible,” said Anthony L. McCall, MD, PhD, James M. Moss Professor of Diabetes at the University of Virginia, Charlottesville, and vice president of clinical science with the Endocrine Society.
Dr. McCall told an audience at the annual meeting of the American Association of Diabetes Educators that half of hypoglycemia is nocturnal and unrecognized despite its dangers. According to him, hypoglycemia represents a blood glucose level of at or under 70 mg/dL (3.9 mmol/L). This is higher than the threshold for hypoglycemia in nondiabetics and those with well controlled diabetes.
Even as few as two values in a week in the range of the 60s (mg/dL) can go unrecognized and lead to full-blown hypoglycemia-associated autonomic failure, he said. There are other possible risks: “impaired sleep quality, daytime drowsiness, mood changes, risk for nocturnal falls,” he said.
Cognitive dysfunction is possible, especially in children, he added. “Neurological dysfunction may be temporary, but those who can answer simple questions may not be OK.”
There’s a potential for a vicious cycle here, he said, because people with diabetes can also develop impaired hypoglycemia awareness, making it less likely they’ll notice the low blood sugar levels that contribute to autonomic failure.
Dr. McCall reported that nighttime hypoglycemia may also:
• Trigger neurologic symptoms like those of strokes or temporary ischemic attacks. “Someone’s got check to their blood sugar,” he says.
• Lengthen the QT interval and boost the risk of irregular heartbeats.
• Contribute to “dead in bed” syndrome in which young people with type 1 diabetes are discovered dead despite not having any complications or showing signs of convulsion.
What can be done to help these patients? One approach is to combat impaired hypoglycemia awareness. Bedtime snacks, caffeine, and uncooked cornstarch are among the many nutrition supplements (and medications) that have shown inconsistent results at best on this front, Dr. McCall said. If they work, he said, they often lead to hyperglycemia.
Another strategy is to look for factors that raise the risk of nighttime hypoglycemia, such as basal insulin overtreatment, long periods between meals, delayed effects of exercise, and higher insulin sensitivity overnight.
Insulin pumps may be helpful, he said, and he generally favors their use. However, he cautioned that it’s hard to show that they reduce hypoglycemia, and some patients don’t use them properly.
Data have been mixed until recently regarding real-time continuous glucose monitoring, he said, and the devices must be worn 75%-85% of the time to show benefit. As for sensor-augmented insulin pumps, he said they’ve shown mixed results.
Dr. McCall said the artificial pancreas, once it makes it to market, could mark the beginning of a new era. “This was around the corner 40 years ago. But it’s closer now,” he said. “I have great hope that we’re going to do better.”
Dr. McCall reported being a consultant to Sanofi regarding new insulin studies and serving on the advisory board of DexCom/Google regarding the use of continuous glucose monitoring.
SAN DIEGO – A top endocrinologist cautioned diabetes educators that research is linking nighttime hypoglycemia to a variety of ills, and technology isn’t providing much hope – yet.
Patients with nocturnal low blood sugar “say this is the hardest thing they have to deal with. It upsets their whole day and they feel terrible,” said Anthony L. McCall, MD, PhD, James M. Moss Professor of Diabetes at the University of Virginia, Charlottesville, and vice president of clinical science with the Endocrine Society.
Dr. McCall told an audience at the annual meeting of the American Association of Diabetes Educators that half of hypoglycemia is nocturnal and unrecognized despite its dangers. According to him, hypoglycemia represents a blood glucose level of at or under 70 mg/dL (3.9 mmol/L). This is higher than the threshold for hypoglycemia in nondiabetics and those with well controlled diabetes.
Even as few as two values in a week in the range of the 60s (mg/dL) can go unrecognized and lead to full-blown hypoglycemia-associated autonomic failure, he said. There are other possible risks: “impaired sleep quality, daytime drowsiness, mood changes, risk for nocturnal falls,” he said.
Cognitive dysfunction is possible, especially in children, he added. “Neurological dysfunction may be temporary, but those who can answer simple questions may not be OK.”
There’s a potential for a vicious cycle here, he said, because people with diabetes can also develop impaired hypoglycemia awareness, making it less likely they’ll notice the low blood sugar levels that contribute to autonomic failure.
Dr. McCall reported that nighttime hypoglycemia may also:
• Trigger neurologic symptoms like those of strokes or temporary ischemic attacks. “Someone’s got check to their blood sugar,” he says.
• Lengthen the QT interval and boost the risk of irregular heartbeats.
• Contribute to “dead in bed” syndrome in which young people with type 1 diabetes are discovered dead despite not having any complications or showing signs of convulsion.
What can be done to help these patients? One approach is to combat impaired hypoglycemia awareness. Bedtime snacks, caffeine, and uncooked cornstarch are among the many nutrition supplements (and medications) that have shown inconsistent results at best on this front, Dr. McCall said. If they work, he said, they often lead to hyperglycemia.
Another strategy is to look for factors that raise the risk of nighttime hypoglycemia, such as basal insulin overtreatment, long periods between meals, delayed effects of exercise, and higher insulin sensitivity overnight.
Insulin pumps may be helpful, he said, and he generally favors their use. However, he cautioned that it’s hard to show that they reduce hypoglycemia, and some patients don’t use them properly.
Data have been mixed until recently regarding real-time continuous glucose monitoring, he said, and the devices must be worn 75%-85% of the time to show benefit. As for sensor-augmented insulin pumps, he said they’ve shown mixed results.
Dr. McCall said the artificial pancreas, once it makes it to market, could mark the beginning of a new era. “This was around the corner 40 years ago. But it’s closer now,” he said. “I have great hope that we’re going to do better.”
Dr. McCall reported being a consultant to Sanofi regarding new insulin studies and serving on the advisory board of DexCom/Google regarding the use of continuous glucose monitoring.
SAN DIEGO – A top endocrinologist cautioned diabetes educators that research is linking nighttime hypoglycemia to a variety of ills, and technology isn’t providing much hope – yet.
Patients with nocturnal low blood sugar “say this is the hardest thing they have to deal with. It upsets their whole day and they feel terrible,” said Anthony L. McCall, MD, PhD, James M. Moss Professor of Diabetes at the University of Virginia, Charlottesville, and vice president of clinical science with the Endocrine Society.
Dr. McCall told an audience at the annual meeting of the American Association of Diabetes Educators that half of hypoglycemia is nocturnal and unrecognized despite its dangers. According to him, hypoglycemia represents a blood glucose level of at or under 70 mg/dL (3.9 mmol/L). This is higher than the threshold for hypoglycemia in nondiabetics and those with well controlled diabetes.
Even as few as two values in a week in the range of the 60s (mg/dL) can go unrecognized and lead to full-blown hypoglycemia-associated autonomic failure, he said. There are other possible risks: “impaired sleep quality, daytime drowsiness, mood changes, risk for nocturnal falls,” he said.
Cognitive dysfunction is possible, especially in children, he added. “Neurological dysfunction may be temporary, but those who can answer simple questions may not be OK.”
There’s a potential for a vicious cycle here, he said, because people with diabetes can also develop impaired hypoglycemia awareness, making it less likely they’ll notice the low blood sugar levels that contribute to autonomic failure.
Dr. McCall reported that nighttime hypoglycemia may also:
• Trigger neurologic symptoms like those of strokes or temporary ischemic attacks. “Someone’s got check to their blood sugar,” he says.
• Lengthen the QT interval and boost the risk of irregular heartbeats.
• Contribute to “dead in bed” syndrome in which young people with type 1 diabetes are discovered dead despite not having any complications or showing signs of convulsion.
What can be done to help these patients? One approach is to combat impaired hypoglycemia awareness. Bedtime snacks, caffeine, and uncooked cornstarch are among the many nutrition supplements (and medications) that have shown inconsistent results at best on this front, Dr. McCall said. If they work, he said, they often lead to hyperglycemia.
Another strategy is to look for factors that raise the risk of nighttime hypoglycemia, such as basal insulin overtreatment, long periods between meals, delayed effects of exercise, and higher insulin sensitivity overnight.
Insulin pumps may be helpful, he said, and he generally favors their use. However, he cautioned that it’s hard to show that they reduce hypoglycemia, and some patients don’t use them properly.
Data have been mixed until recently regarding real-time continuous glucose monitoring, he said, and the devices must be worn 75%-85% of the time to show benefit. As for sensor-augmented insulin pumps, he said they’ve shown mixed results.
Dr. McCall said the artificial pancreas, once it makes it to market, could mark the beginning of a new era. “This was around the corner 40 years ago. But it’s closer now,” he said. “I have great hope that we’re going to do better.”
Dr. McCall reported being a consultant to Sanofi regarding new insulin studies and serving on the advisory board of DexCom/Google regarding the use of continuous glucose monitoring.
AT AADE 16
FDA official: We’re monitoring DIY artificial pancreas boom
SAN DIEGO – A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.
While the homemade insulin pumps are serving a need that has been unmet by manufacturers, the unregulated devices can be dangerous, according to Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices, who spoke at the annual meeting of the American Association of Diabetes Educators. “As they go toward a larger community, we see that the risk is raised.”
Still, “people are doing this because they feel this is the best way for them to help themselves or their children. We understand why people are doing it, but we want to make sure they do it safely,” Dr. Lias said.
At issue: The need for a “closed loop” artificial pancreas that needs little or no human intervention to measure blood sugar levels and deliver insulin as needed.
While current insulin pumps can deliver basal insulin continuously, users must program them to deliver an insulin bolus after meals or to address high blood sugar. Manufacturers are trying to develop a closed-loop artificial pancreas (also known as a bionic pancreas) that will simplify the process.
On their own, computer experts have been experimenting with jury-rigged homemade do-it-yourself (DIY) systems. “We recognize that for many PWDs [people with diabetes] the available help is not yet enough, so we are not waiting,” according to Dana Lewis and Scott Leibrand, two bloggers on a site called DIYPS.org.
In May 2016, The Wall Street Journal profiled a San Diego third-grader who uses a homemade “robotic pancreas” designed by his software engineer father. “More than 50 people have soldered, tinkered, and written software to make such devices for themselves or their children,” according to the Wall Street Journal report.
In her talk at the American Association of Diabetes Educators meeting, Dr. Lias noted that “there are a lot of questions about whether this is something that should be done.”
The algorithm behind a homemade device is one of area of concern, she said. “Who developed it and who’s responsible for having developed it? You may not understand how the algorithm is developed and what information is behind it. If something goes wrong, there’s no recourse.”
There are also questions about quality control, she noted: “Is there a responsible party for understanding things, for collecting information and making corrections?”
Dr. Lias said physicians should ask these questions if patients say they are using a DIY artificial pancreas: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double-checked? When new, modified versions of code are shared, have you re-validated your entire system before implementing it?
It’s also important, she said, to note that these devices have not been determined to be safe and effective.
As the FDA monitors these DIY devices, Dr. Lias said, it’s also working to be ready to consider the work of manufacturers who are trying to develop the first commercial artificial pancreas device.
“Artificial pancreas devices do not have to be perfect with zero risk to be beneficial,” she says. “The approval decision is a benefit/risk decision. We make this decision in the context of the high risks that people with diabetes face every day.”
For now, she says, one focus is to make it easier for companies to work together to create the components of an artificial pancreas device.
The FDA is also concerned about what newly diagnosed people with diabetes will do if their devices break down, and they don’t know how to give themselves an insulin injection. “That’s a scenario that we will need to work out,” she said. “We’re talking with manufacturers about how they plan to work with that.”
SAN DIEGO – A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.
While the homemade insulin pumps are serving a need that has been unmet by manufacturers, the unregulated devices can be dangerous, according to Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices, who spoke at the annual meeting of the American Association of Diabetes Educators. “As they go toward a larger community, we see that the risk is raised.”
Still, “people are doing this because they feel this is the best way for them to help themselves or their children. We understand why people are doing it, but we want to make sure they do it safely,” Dr. Lias said.
At issue: The need for a “closed loop” artificial pancreas that needs little or no human intervention to measure blood sugar levels and deliver insulin as needed.
While current insulin pumps can deliver basal insulin continuously, users must program them to deliver an insulin bolus after meals or to address high blood sugar. Manufacturers are trying to develop a closed-loop artificial pancreas (also known as a bionic pancreas) that will simplify the process.
On their own, computer experts have been experimenting with jury-rigged homemade do-it-yourself (DIY) systems. “We recognize that for many PWDs [people with diabetes] the available help is not yet enough, so we are not waiting,” according to Dana Lewis and Scott Leibrand, two bloggers on a site called DIYPS.org.
In May 2016, The Wall Street Journal profiled a San Diego third-grader who uses a homemade “robotic pancreas” designed by his software engineer father. “More than 50 people have soldered, tinkered, and written software to make such devices for themselves or their children,” according to the Wall Street Journal report.
In her talk at the American Association of Diabetes Educators meeting, Dr. Lias noted that “there are a lot of questions about whether this is something that should be done.”
The algorithm behind a homemade device is one of area of concern, she said. “Who developed it and who’s responsible for having developed it? You may not understand how the algorithm is developed and what information is behind it. If something goes wrong, there’s no recourse.”
There are also questions about quality control, she noted: “Is there a responsible party for understanding things, for collecting information and making corrections?”
Dr. Lias said physicians should ask these questions if patients say they are using a DIY artificial pancreas: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double-checked? When new, modified versions of code are shared, have you re-validated your entire system before implementing it?
It’s also important, she said, to note that these devices have not been determined to be safe and effective.
As the FDA monitors these DIY devices, Dr. Lias said, it’s also working to be ready to consider the work of manufacturers who are trying to develop the first commercial artificial pancreas device.
“Artificial pancreas devices do not have to be perfect with zero risk to be beneficial,” she says. “The approval decision is a benefit/risk decision. We make this decision in the context of the high risks that people with diabetes face every day.”
For now, she says, one focus is to make it easier for companies to work together to create the components of an artificial pancreas device.
The FDA is also concerned about what newly diagnosed people with diabetes will do if their devices break down, and they don’t know how to give themselves an insulin injection. “That’s a scenario that we will need to work out,” she said. “We’re talking with manufacturers about how they plan to work with that.”
SAN DIEGO – A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.
While the homemade insulin pumps are serving a need that has been unmet by manufacturers, the unregulated devices can be dangerous, according to Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices, who spoke at the annual meeting of the American Association of Diabetes Educators. “As they go toward a larger community, we see that the risk is raised.”
Still, “people are doing this because they feel this is the best way for them to help themselves or their children. We understand why people are doing it, but we want to make sure they do it safely,” Dr. Lias said.
At issue: The need for a “closed loop” artificial pancreas that needs little or no human intervention to measure blood sugar levels and deliver insulin as needed.
While current insulin pumps can deliver basal insulin continuously, users must program them to deliver an insulin bolus after meals or to address high blood sugar. Manufacturers are trying to develop a closed-loop artificial pancreas (also known as a bionic pancreas) that will simplify the process.
On their own, computer experts have been experimenting with jury-rigged homemade do-it-yourself (DIY) systems. “We recognize that for many PWDs [people with diabetes] the available help is not yet enough, so we are not waiting,” according to Dana Lewis and Scott Leibrand, two bloggers on a site called DIYPS.org.
In May 2016, The Wall Street Journal profiled a San Diego third-grader who uses a homemade “robotic pancreas” designed by his software engineer father. “More than 50 people have soldered, tinkered, and written software to make such devices for themselves or their children,” according to the Wall Street Journal report.
In her talk at the American Association of Diabetes Educators meeting, Dr. Lias noted that “there are a lot of questions about whether this is something that should be done.”
The algorithm behind a homemade device is one of area of concern, she said. “Who developed it and who’s responsible for having developed it? You may not understand how the algorithm is developed and what information is behind it. If something goes wrong, there’s no recourse.”
There are also questions about quality control, she noted: “Is there a responsible party for understanding things, for collecting information and making corrections?”
Dr. Lias said physicians should ask these questions if patients say they are using a DIY artificial pancreas: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double-checked? When new, modified versions of code are shared, have you re-validated your entire system before implementing it?
It’s also important, she said, to note that these devices have not been determined to be safe and effective.
As the FDA monitors these DIY devices, Dr. Lias said, it’s also working to be ready to consider the work of manufacturers who are trying to develop the first commercial artificial pancreas device.
“Artificial pancreas devices do not have to be perfect with zero risk to be beneficial,” she says. “The approval decision is a benefit/risk decision. We make this decision in the context of the high risks that people with diabetes face every day.”
For now, she says, one focus is to make it easier for companies to work together to create the components of an artificial pancreas device.
The FDA is also concerned about what newly diagnosed people with diabetes will do if their devices break down, and they don’t know how to give themselves an insulin injection. “That’s a scenario that we will need to work out,” she said. “We’re talking with manufacturers about how they plan to work with that.”
AT AADE 16
Rethinking diabetes nutrition: No more carb mixes?
SAN DIEGO – Weight loss isn’t always a top priority for people with diabetes. Patients can figure out their proper carb intake. And don’t fret over an optimal percentage mix of carbs, fat and proteins.
A nutrition consultant gave this advice to colleagues at the annual meeting of the American Association of Diabetes Educators, startling some of those in the audience. And no wonder: A few years ago, these kinds of tips would have surprised the educator herself, Mary Ann Hodorowicz, RN, MBA, a licensed registered dietitian and certified diabetes educator based in the Chicago area.
For instance, she was taught that specific percentages of our diets must come from carbohydrates, protein, and fat. “If you didn’t do it that way, you committed the most major mortal sin,” she said. “You’ll go to diabetes jail, and you’ll probably be fired from your job, and the patient will die.”
In fact, “there’s no evidence to support those percentages,” she said. “They don’t mean anything in terms of blood glucose control, although we do have percentages of fat to control lipids and percentages of protein for health and well-being.”
So how many carbs should diabetics eat? She acknowledges to patients that she doesn’t know: “I don’t have a clue.” Instead, she urges them to figure it out themselves: “How many can you get away with and reach your 2-hour post-meal target? My job is to teach you what how to measure, whether it’s by handfuls, exchanges, servings, or grams. Here’s a log sheet, go home and write about how many carbs you’re eating, and test your blood sugar 2 hours later. You’ll find out really quickly how many carbs you can eat to reach that post-meal target.”
Ms. Hodorowicz provided other “evidence-based” tips about nutrition for diabetes patients:
• Assess the need for weight loss in overweight and obese patients, and don’t assume that weight loss is always the top priority.
In new patients with type 2 diabetes, weight loss of 7% is optimal and can typically be achieved with an energy deficit of 500-750 calories a day: a limit of 1,200-1,500 calories for women and 1,500-1,800 for men.
However, “studies of sustained weight loss at 1 or more years have shown inconsistent effects on hemoglobin A1c, even though modest weight loss is shown to improve insulin resistance in overweight and obese insulin-resistant persons. This blows out what we’ve been taught in our careers,” she said.
Why? Weight reduction does improve blood glucose in these type 2 patients at first, she said, but they’ll go into insulin deficiency if they live long enough.
After that happens, she said, “weight loss is not that effective in controlling blood glucose. At that point, the gurus are saying that we really want to prevent weight gain and seek blood glucose control.”
• Don’t go overboard on the glycemic index.
Ms. Hodorowicz advises patients to substitute low-glycemic foods for high-glycemic foods. However, “the evidence does not support the glycemic index as the best meal planning strategy for a patient with diabetes. It doesn’t do better than controlling carbs.”
In addition, she said, teaching patients about the confusing glycemic index is a drag: “Good luck!” But, she said, “substituting foods is a good thing.”
• Be aware of the limited evidence supporting supplements for glucose control.
On the supplement front, chromium, cinnamon, herbs and vitamin D haven’t been clearly demonstrated to control glucose, she says.
• Encourage consumption – even via supplementation – of fiber and plant stanols and sterols.
Ms. Hodorowicz encourages patients to consume 1.6-3.0 grams a day in plant stanols and sterols, which can be purchased in over-the-counter capsules and via fortified foods like certain Minute Maid and Benecol products.
“You’re fooling the body into thinking it’s cholesterol,” she said, “but it’s innocuous.”
She also advises patients to boost viscous soluble fiber to 7-13 g/day. Since it’s not feasible to do this through food, she recommends supplements: “You really need to supplement your diet with psyllium fiber that you get in a bottle.”
Ms. Hodorowicz reported having no relevant financial disclosures.
SAN DIEGO – Weight loss isn’t always a top priority for people with diabetes. Patients can figure out their proper carb intake. And don’t fret over an optimal percentage mix of carbs, fat and proteins.
A nutrition consultant gave this advice to colleagues at the annual meeting of the American Association of Diabetes Educators, startling some of those in the audience. And no wonder: A few years ago, these kinds of tips would have surprised the educator herself, Mary Ann Hodorowicz, RN, MBA, a licensed registered dietitian and certified diabetes educator based in the Chicago area.
For instance, she was taught that specific percentages of our diets must come from carbohydrates, protein, and fat. “If you didn’t do it that way, you committed the most major mortal sin,” she said. “You’ll go to diabetes jail, and you’ll probably be fired from your job, and the patient will die.”
In fact, “there’s no evidence to support those percentages,” she said. “They don’t mean anything in terms of blood glucose control, although we do have percentages of fat to control lipids and percentages of protein for health and well-being.”
So how many carbs should diabetics eat? She acknowledges to patients that she doesn’t know: “I don’t have a clue.” Instead, she urges them to figure it out themselves: “How many can you get away with and reach your 2-hour post-meal target? My job is to teach you what how to measure, whether it’s by handfuls, exchanges, servings, or grams. Here’s a log sheet, go home and write about how many carbs you’re eating, and test your blood sugar 2 hours later. You’ll find out really quickly how many carbs you can eat to reach that post-meal target.”
Ms. Hodorowicz provided other “evidence-based” tips about nutrition for diabetes patients:
• Assess the need for weight loss in overweight and obese patients, and don’t assume that weight loss is always the top priority.
In new patients with type 2 diabetes, weight loss of 7% is optimal and can typically be achieved with an energy deficit of 500-750 calories a day: a limit of 1,200-1,500 calories for women and 1,500-1,800 for men.
However, “studies of sustained weight loss at 1 or more years have shown inconsistent effects on hemoglobin A1c, even though modest weight loss is shown to improve insulin resistance in overweight and obese insulin-resistant persons. This blows out what we’ve been taught in our careers,” she said.
Why? Weight reduction does improve blood glucose in these type 2 patients at first, she said, but they’ll go into insulin deficiency if they live long enough.
After that happens, she said, “weight loss is not that effective in controlling blood glucose. At that point, the gurus are saying that we really want to prevent weight gain and seek blood glucose control.”
• Don’t go overboard on the glycemic index.
Ms. Hodorowicz advises patients to substitute low-glycemic foods for high-glycemic foods. However, “the evidence does not support the glycemic index as the best meal planning strategy for a patient with diabetes. It doesn’t do better than controlling carbs.”
In addition, she said, teaching patients about the confusing glycemic index is a drag: “Good luck!” But, she said, “substituting foods is a good thing.”
• Be aware of the limited evidence supporting supplements for glucose control.
On the supplement front, chromium, cinnamon, herbs and vitamin D haven’t been clearly demonstrated to control glucose, she says.
• Encourage consumption – even via supplementation – of fiber and plant stanols and sterols.
Ms. Hodorowicz encourages patients to consume 1.6-3.0 grams a day in plant stanols and sterols, which can be purchased in over-the-counter capsules and via fortified foods like certain Minute Maid and Benecol products.
“You’re fooling the body into thinking it’s cholesterol,” she said, “but it’s innocuous.”
She also advises patients to boost viscous soluble fiber to 7-13 g/day. Since it’s not feasible to do this through food, she recommends supplements: “You really need to supplement your diet with psyllium fiber that you get in a bottle.”
Ms. Hodorowicz reported having no relevant financial disclosures.
SAN DIEGO – Weight loss isn’t always a top priority for people with diabetes. Patients can figure out their proper carb intake. And don’t fret over an optimal percentage mix of carbs, fat and proteins.
A nutrition consultant gave this advice to colleagues at the annual meeting of the American Association of Diabetes Educators, startling some of those in the audience. And no wonder: A few years ago, these kinds of tips would have surprised the educator herself, Mary Ann Hodorowicz, RN, MBA, a licensed registered dietitian and certified diabetes educator based in the Chicago area.
For instance, she was taught that specific percentages of our diets must come from carbohydrates, protein, and fat. “If you didn’t do it that way, you committed the most major mortal sin,” she said. “You’ll go to diabetes jail, and you’ll probably be fired from your job, and the patient will die.”
In fact, “there’s no evidence to support those percentages,” she said. “They don’t mean anything in terms of blood glucose control, although we do have percentages of fat to control lipids and percentages of protein for health and well-being.”
So how many carbs should diabetics eat? She acknowledges to patients that she doesn’t know: “I don’t have a clue.” Instead, she urges them to figure it out themselves: “How many can you get away with and reach your 2-hour post-meal target? My job is to teach you what how to measure, whether it’s by handfuls, exchanges, servings, or grams. Here’s a log sheet, go home and write about how many carbs you’re eating, and test your blood sugar 2 hours later. You’ll find out really quickly how many carbs you can eat to reach that post-meal target.”
Ms. Hodorowicz provided other “evidence-based” tips about nutrition for diabetes patients:
• Assess the need for weight loss in overweight and obese patients, and don’t assume that weight loss is always the top priority.
In new patients with type 2 diabetes, weight loss of 7% is optimal and can typically be achieved with an energy deficit of 500-750 calories a day: a limit of 1,200-1,500 calories for women and 1,500-1,800 for men.
However, “studies of sustained weight loss at 1 or more years have shown inconsistent effects on hemoglobin A1c, even though modest weight loss is shown to improve insulin resistance in overweight and obese insulin-resistant persons. This blows out what we’ve been taught in our careers,” she said.
Why? Weight reduction does improve blood glucose in these type 2 patients at first, she said, but they’ll go into insulin deficiency if they live long enough.
After that happens, she said, “weight loss is not that effective in controlling blood glucose. At that point, the gurus are saying that we really want to prevent weight gain and seek blood glucose control.”
• Don’t go overboard on the glycemic index.
Ms. Hodorowicz advises patients to substitute low-glycemic foods for high-glycemic foods. However, “the evidence does not support the glycemic index as the best meal planning strategy for a patient with diabetes. It doesn’t do better than controlling carbs.”
In addition, she said, teaching patients about the confusing glycemic index is a drag: “Good luck!” But, she said, “substituting foods is a good thing.”
• Be aware of the limited evidence supporting supplements for glucose control.
On the supplement front, chromium, cinnamon, herbs and vitamin D haven’t been clearly demonstrated to control glucose, she says.
• Encourage consumption – even via supplementation – of fiber and plant stanols and sterols.
Ms. Hodorowicz encourages patients to consume 1.6-3.0 grams a day in plant stanols and sterols, which can be purchased in over-the-counter capsules and via fortified foods like certain Minute Maid and Benecol products.
“You’re fooling the body into thinking it’s cholesterol,” she said, “but it’s innocuous.”
She also advises patients to boost viscous soluble fiber to 7-13 g/day. Since it’s not feasible to do this through food, she recommends supplements: “You really need to supplement your diet with psyllium fiber that you get in a bottle.”
Ms. Hodorowicz reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM THE AADE ANNUAL MEETING
Former chief of Endocrine Society: Send HbA1c packing
SAN DIEGO – The former president of the Endocrine Society told diabetes educators that it’s time to replace the much-used hemoglobin A1c level with a measurement that better reflects how diabetes patients are faring.
The problem is that the HbA1c is “woefully inadequate,” said Robert Vigersky, MD, the medical director of Medtronic Diabetes and president of the Endocrine Society in 2009-2010. “It doesn’t tell you about time-in-range or the frequency, duration, and severity of hypoglycemia or hyperglycemia. And there’s nothing about glycemic variability.”
These measurements are important, he told an audience at the annual meeting of the American Association of Diabetes Educators. For example, “there are several new classes of medication and new technologies. Some decrease HbA1c with no effect on hypoglycemia. Some affect hypoglycemia with no effect on HbA1c. How do we think about these globally and compare them to one another?”
To shed more light on the true condition of patients, he said, it’s time to “change the conversation from HbA1c alone to one that is more glucose-centric. It’s about thinking about glucose as a vital sign, not HbA1c. This may help health care providers, regulators, and payers better understand what is best for patients.”
He is also thinking about going beyond sugar levels. “Maybe a future composite metric will have more than just glucose numbers,” he said.
Indeed, last hear Dr. Vigersky proposed a composite metric known as “the hypoglycemia-A1C score” that can also take factors like weight, quality of life and costs into account (J Diabetes Sci Technol. 2015 Feb 19;9[5]:1148-51).
But he acknowledged there are challenges. For one, there are at least a dozen different ways to measure hypoglycemia, he said, “and every paper cherry-picks the method they want to show their data in the best light.”
It’s also not clear how best to represent the data once researchers figure out which statistics should be included. Should the overall measurement be a single number? Or should there be multiple numbers? In that case, should the numbers be represented graphically?
Dr. Vigersky said he is working on an approach that illustrates various measurements through a pentagon shape. Its appearance reflects measurements such as mean glucose and duration of high glucose.
However, he predicted the future will produce a simpler measurement: “a multicomponent single value.”
What’s next? “We need to educate the payers about how we can’t stay with HbA1c. This will take an effort with professional societies. Once everyone agrees, we need to get some consensus about what the elements of the composite metric are.”
Dr. Vigersky is hopeful that the HbA1c is on its way out, although he acknowledges that it won’t be a rapid process. “It took 20 or more years for everyone to buy into A1C and understand what it represented,” he said. “Changing the conversation isn’t going to happen overnight. But unless we start to address it, it will never happen.”
Dr. Vigersky reported having no relevant financial disclosures.
SAN DIEGO – The former president of the Endocrine Society told diabetes educators that it’s time to replace the much-used hemoglobin A1c level with a measurement that better reflects how diabetes patients are faring.
The problem is that the HbA1c is “woefully inadequate,” said Robert Vigersky, MD, the medical director of Medtronic Diabetes and president of the Endocrine Society in 2009-2010. “It doesn’t tell you about time-in-range or the frequency, duration, and severity of hypoglycemia or hyperglycemia. And there’s nothing about glycemic variability.”
These measurements are important, he told an audience at the annual meeting of the American Association of Diabetes Educators. For example, “there are several new classes of medication and new technologies. Some decrease HbA1c with no effect on hypoglycemia. Some affect hypoglycemia with no effect on HbA1c. How do we think about these globally and compare them to one another?”
To shed more light on the true condition of patients, he said, it’s time to “change the conversation from HbA1c alone to one that is more glucose-centric. It’s about thinking about glucose as a vital sign, not HbA1c. This may help health care providers, regulators, and payers better understand what is best for patients.”
He is also thinking about going beyond sugar levels. “Maybe a future composite metric will have more than just glucose numbers,” he said.
Indeed, last hear Dr. Vigersky proposed a composite metric known as “the hypoglycemia-A1C score” that can also take factors like weight, quality of life and costs into account (J Diabetes Sci Technol. 2015 Feb 19;9[5]:1148-51).
But he acknowledged there are challenges. For one, there are at least a dozen different ways to measure hypoglycemia, he said, “and every paper cherry-picks the method they want to show their data in the best light.”
It’s also not clear how best to represent the data once researchers figure out which statistics should be included. Should the overall measurement be a single number? Or should there be multiple numbers? In that case, should the numbers be represented graphically?
Dr. Vigersky said he is working on an approach that illustrates various measurements through a pentagon shape. Its appearance reflects measurements such as mean glucose and duration of high glucose.
However, he predicted the future will produce a simpler measurement: “a multicomponent single value.”
What’s next? “We need to educate the payers about how we can’t stay with HbA1c. This will take an effort with professional societies. Once everyone agrees, we need to get some consensus about what the elements of the composite metric are.”
Dr. Vigersky is hopeful that the HbA1c is on its way out, although he acknowledges that it won’t be a rapid process. “It took 20 or more years for everyone to buy into A1C and understand what it represented,” he said. “Changing the conversation isn’t going to happen overnight. But unless we start to address it, it will never happen.”
Dr. Vigersky reported having no relevant financial disclosures.
SAN DIEGO – The former president of the Endocrine Society told diabetes educators that it’s time to replace the much-used hemoglobin A1c level with a measurement that better reflects how diabetes patients are faring.
The problem is that the HbA1c is “woefully inadequate,” said Robert Vigersky, MD, the medical director of Medtronic Diabetes and president of the Endocrine Society in 2009-2010. “It doesn’t tell you about time-in-range or the frequency, duration, and severity of hypoglycemia or hyperglycemia. And there’s nothing about glycemic variability.”
These measurements are important, he told an audience at the annual meeting of the American Association of Diabetes Educators. For example, “there are several new classes of medication and new technologies. Some decrease HbA1c with no effect on hypoglycemia. Some affect hypoglycemia with no effect on HbA1c. How do we think about these globally and compare them to one another?”
To shed more light on the true condition of patients, he said, it’s time to “change the conversation from HbA1c alone to one that is more glucose-centric. It’s about thinking about glucose as a vital sign, not HbA1c. This may help health care providers, regulators, and payers better understand what is best for patients.”
He is also thinking about going beyond sugar levels. “Maybe a future composite metric will have more than just glucose numbers,” he said.
Indeed, last hear Dr. Vigersky proposed a composite metric known as “the hypoglycemia-A1C score” that can also take factors like weight, quality of life and costs into account (J Diabetes Sci Technol. 2015 Feb 19;9[5]:1148-51).
But he acknowledged there are challenges. For one, there are at least a dozen different ways to measure hypoglycemia, he said, “and every paper cherry-picks the method they want to show their data in the best light.”
It’s also not clear how best to represent the data once researchers figure out which statistics should be included. Should the overall measurement be a single number? Or should there be multiple numbers? In that case, should the numbers be represented graphically?
Dr. Vigersky said he is working on an approach that illustrates various measurements through a pentagon shape. Its appearance reflects measurements such as mean glucose and duration of high glucose.
However, he predicted the future will produce a simpler measurement: “a multicomponent single value.”
What’s next? “We need to educate the payers about how we can’t stay with HbA1c. This will take an effort with professional societies. Once everyone agrees, we need to get some consensus about what the elements of the composite metric are.”
Dr. Vigersky is hopeful that the HbA1c is on its way out, although he acknowledges that it won’t be a rapid process. “It took 20 or more years for everyone to buy into A1C and understand what it represented,” he said. “Changing the conversation isn’t going to happen overnight. But unless we start to address it, it will never happen.”
Dr. Vigersky reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM AADE 16