ADA Advanced Postgraduate Course

NEW YORK – A traditional Mediterranean-style diet does not appear to be better at controlling glycemia, but its other healthy effects make it a worthwhile alternative to other diet plans for people with diabetes, according to nutritionist Jackie L. Boucher.

Definitions vary somewhat, but the Mediterranean dietary pattern – fruits and vegetables, whole grains, fish, olive oil, nuts and legumes, and red wine – is consistent with other nutritional plans for patients with diabetes, including Dietary Approaches to Stop Hypertension (DASH) and the American Diabetes Association (ADA) diet, she said at the annual advanced postgraduate course held by the American Diabetes Association.

©Dušan Zidar/Fotolia.com

"I think the Mediterranean-style diet can fit with recommendations for the prevention and treatment of diabetes," said Ms. Boucher, vice president for education and director of the Heart of New Ulm Project for the Minneapolis Heart Institute Foundation.

Both the ADA and Mediterranean eating plans encourage patients to be active and eat foods lower in saturated and trans fats, and combined with the dietary guidance provided by diabetes educators and nutritionists, can help to prevent some of the more dire complications associated with diabetes, she said.

Her presentation coincided with the online publication in the New England Journal of Medicine of a randomized clinical trial from Spain, showing that among persons at high risk for cardiovascular disease, including many with type 2 diabetes, a Mediterranean diet supplemented with extravirgin olive oil or nuts significantly reduced the incidence of major cardiovascular events. The study did not look at the effect of diet on glycemia, however.

Call it an ‘eating pattern’

A Mediterranean diet, as defined in 1993 in a European consensus conference, is rich in plant-based foods (vegetables, fruits, grains, nuts, and seeds); uses minimally processed and seasonal locally grown foods; and includes fruit as the typical daily dessert, supplemented with sweets based on nuts, olive oil, and honey or concentrated sugars on special occasions. Dairy products are eaten in low to moderate quantities, red meat is consumed infrequently, and meals are usually accompanied by wine in low to moderate amounts.

There are different regional flavors of the diet, with Greeks getting about 40% of total energy from fat, compared with about 30% from fat for Italians. Italians eat more pasta than the Greeks or Spaniards, and Spaniards typically eat more fish. Therefore, it makes sense to think of it more as an eating pattern than as a diet, Ms. Boucher said.

Evidence-based studies have hinted that such dietary patterns may protect against coronary heart disease, type 2 diabetes, hypertension, thromboembolic events, osteoporosis, and cancers of the breast, stomach, colorectal tract, and prostate, she said.

However, different study methodologies and definitions of a Mediterranean-style eating pattern have made it hard to tease out specific effects of following such a pattern. Additionally, some studies do not control for physical activity or for social engagement during meals, while others may exclude wine, which has been shown to offset lipid peroxidation from red meat consumption when the wine is taken with the meal.

Mixed results

A recently published systematic review of studies of macronutrients, food groups, and eating patterns in the management of diabetes noted that most studies leave out energy balance and healthy eating patterns, which are considered to be essential components of medical nutrition therapy.

Regarding the question of an optimal macronutrient ration for glycemic management and cardiovascular risk reduction in people with diabetes, the authors found that although "in many instances there were not statistically significant differences between dietary approaches, improvements were often seen from baseline to follow-up in both intervention groups, supporting the idea that several different macronutrient distributions may lead to improvements in glycemic and/or [cardiovascular disease] risk factors."

Although the Mediterranean diet pattern does not appear to have specific benefits on glycemic control when compared with other diet plans or healthy eating patterns, the general principles of eating whole foods, eating in moderation, and eating a variety of plant-based foods can be safely recommended to patients with diabetes, Ms. Boucher said.

She reported having no relevant financial disclosures.

NEW YORK – A traditional Mediterranean-style diet does not appear to be better at controlling glycemia, but its other healthy effects make it a worthwhile alternative to other diet plans for people with diabetes, according to nutritionist Jackie L. Boucher.

Definitions vary somewhat, but the Mediterranean dietary pattern – fruits and vegetables, whole grains, fish, olive oil, nuts and legumes, and red wine – is consistent with other nutritional plans for patients with diabetes, including Dietary Approaches to Stop Hypertension (DASH) and the American Diabetes Association (ADA) diet, she said at the annual advanced postgraduate course held by the American Diabetes Association.

©Dušan Zidar/Fotolia.com

"I think the Mediterranean-style diet can fit with recommendations for the prevention and treatment of diabetes," said Ms. Boucher, vice president for education and director of the Heart of New Ulm Project for the Minneapolis Heart Institute Foundation.

Both the ADA and Mediterranean eating plans encourage patients to be active and eat foods lower in saturated and trans fats, and combined with the dietary guidance provided by diabetes educators and nutritionists, can help to prevent some of the more dire complications associated with diabetes, she said.

Her presentation coincided with the online publication in the New England Journal of Medicine of a randomized clinical trial from Spain, showing that among persons at high risk for cardiovascular disease, including many with type 2 diabetes, a Mediterranean diet supplemented with extravirgin olive oil or nuts significantly reduced the incidence of major cardiovascular events. The study did not look at the effect of diet on glycemia, however.

Call it an ‘eating pattern’

A Mediterranean diet, as defined in 1993 in a European consensus conference, is rich in plant-based foods (vegetables, fruits, grains, nuts, and seeds); uses minimally processed and seasonal locally grown foods; and includes fruit as the typical daily dessert, supplemented with sweets based on nuts, olive oil, and honey or concentrated sugars on special occasions. Dairy products are eaten in low to moderate quantities, red meat is consumed infrequently, and meals are usually accompanied by wine in low to moderate amounts.

There are different regional flavors of the diet, with Greeks getting about 40% of total energy from fat, compared with about 30% from fat for Italians. Italians eat more pasta than the Greeks or Spaniards, and Spaniards typically eat more fish. Therefore, it makes sense to think of it more as an eating pattern than as a diet, Ms. Boucher said.

Evidence-based studies have hinted that such dietary patterns may protect against coronary heart disease, type 2 diabetes, hypertension, thromboembolic events, osteoporosis, and cancers of the breast, stomach, colorectal tract, and prostate, she said.

However, different study methodologies and definitions of a Mediterranean-style eating pattern have made it hard to tease out specific effects of following such a pattern. Additionally, some studies do not control for physical activity or for social engagement during meals, while others may exclude wine, which has been shown to offset lipid peroxidation from red meat consumption when the wine is taken with the meal.

Mixed results

A recently published systematic review of studies of macronutrients, food groups, and eating patterns in the management of diabetes noted that most studies leave out energy balance and healthy eating patterns, which are considered to be essential components of medical nutrition therapy.

Regarding the question of an optimal macronutrient ration for glycemic management and cardiovascular risk reduction in people with diabetes, the authors found that although "in many instances there were not statistically significant differences between dietary approaches, improvements were often seen from baseline to follow-up in both intervention groups, supporting the idea that several different macronutrient distributions may lead to improvements in glycemic and/or [cardiovascular disease] risk factors."

Although the Mediterranean diet pattern does not appear to have specific benefits on glycemic control when compared with other diet plans or healthy eating patterns, the general principles of eating whole foods, eating in moderation, and eating a variety of plant-based foods can be safely recommended to patients with diabetes, Ms. Boucher said.

She reported having no relevant financial disclosures.

NEW YORK – A traditional Mediterranean-style diet does not appear to be better at controlling glycemia, but its other healthy effects make it a worthwhile alternative to other diet plans for people with diabetes, according to nutritionist Jackie L. Boucher.

Definitions vary somewhat, but the Mediterranean dietary pattern – fruits and vegetables, whole grains, fish, olive oil, nuts and legumes, and red wine – is consistent with other nutritional plans for patients with diabetes, including Dietary Approaches to Stop Hypertension (DASH) and the American Diabetes Association (ADA) diet, she said at the annual advanced postgraduate course held by the American Diabetes Association.

©Dušan Zidar/Fotolia.com

"I think the Mediterranean-style diet can fit with recommendations for the prevention and treatment of diabetes," said Ms. Boucher, vice president for education and director of the Heart of New Ulm Project for the Minneapolis Heart Institute Foundation.

Both the ADA and Mediterranean eating plans encourage patients to be active and eat foods lower in saturated and trans fats, and combined with the dietary guidance provided by diabetes educators and nutritionists, can help to prevent some of the more dire complications associated with diabetes, she said.

Her presentation coincided with the online publication in the New England Journal of Medicine of a randomized clinical trial from Spain, showing that among persons at high risk for cardiovascular disease, including many with type 2 diabetes, a Mediterranean diet supplemented with extravirgin olive oil or nuts significantly reduced the incidence of major cardiovascular events. The study did not look at the effect of diet on glycemia, however.

Call it an ‘eating pattern’

A Mediterranean diet, as defined in 1993 in a European consensus conference, is rich in plant-based foods (vegetables, fruits, grains, nuts, and seeds); uses minimally processed and seasonal locally grown foods; and includes fruit as the typical daily dessert, supplemented with sweets based on nuts, olive oil, and honey or concentrated sugars on special occasions. Dairy products are eaten in low to moderate quantities, red meat is consumed infrequently, and meals are usually accompanied by wine in low to moderate amounts.

There are different regional flavors of the diet, with Greeks getting about 40% of total energy from fat, compared with about 30% from fat for Italians. Italians eat more pasta than the Greeks or Spaniards, and Spaniards typically eat more fish. Therefore, it makes sense to think of it more as an eating pattern than as a diet, Ms. Boucher said.

Evidence-based studies have hinted that such dietary patterns may protect against coronary heart disease, type 2 diabetes, hypertension, thromboembolic events, osteoporosis, and cancers of the breast, stomach, colorectal tract, and prostate, she said.

However, different study methodologies and definitions of a Mediterranean-style eating pattern have made it hard to tease out specific effects of following such a pattern. Additionally, some studies do not control for physical activity or for social engagement during meals, while others may exclude wine, which has been shown to offset lipid peroxidation from red meat consumption when the wine is taken with the meal.

Mixed results

A recently published systematic review of studies of macronutrients, food groups, and eating patterns in the management of diabetes noted that most studies leave out energy balance and healthy eating patterns, which are considered to be essential components of medical nutrition therapy.

Regarding the question of an optimal macronutrient ration for glycemic management and cardiovascular risk reduction in people with diabetes, the authors found that although "in many instances there were not statistically significant differences between dietary approaches, improvements were often seen from baseline to follow-up in both intervention groups, supporting the idea that several different macronutrient distributions may lead to improvements in glycemic and/or [cardiovascular disease] risk factors."

Although the Mediterranean diet pattern does not appear to have specific benefits on glycemic control when compared with other diet plans or healthy eating patterns, the general principles of eating whole foods, eating in moderation, and eating a variety of plant-based foods can be safely recommended to patients with diabetes, Ms. Boucher said.

She reported having no relevant financial disclosures.

NEW YORK – More than 40% of Americans with type 2 diabetes never receive any formal education in self-management of their disease, a situation that is likely to only get worse as the population gets older and more obese, according to diabetes educator Dr. Sandra Drozdz Burke.

The Affordable Care Act is expected to bring millions more patients – many with diabetes – into the health care system through the expansion of Medicaid rolls. "When we have that much diabetes to deal with, we’re going to need to have lots of people who know how to take care of themselves," said Dr. Burke, director of the University of Illinois College of Nursing at Urbana-Champaign.

She noted that the number of Americans with diabetes is projected to grow from 23.7 million in 2008 to 44.1 million in 2034, and annual U.S. spending on diabetes is projected to triple – from $113 billion to $336 billion – over the same period (Diabetes Care 2009;32:2225-9).

In 2011, approximately 30,000 people were working as diabetes educators in the United States, which is 24,000 short of the estimated 54,000 projected to be needed by the year 2025, Dr. Burke said at the annual advanced postgraduate course held by the American Diabetes Association.

Most diabetes patients get their care from primary care practitioners, and many are typically referred to specialty care "only at the end of the road," when complications of diabetes are advanced and irreversible, she said. But in clinical practice – in the 8- to 12-minute encounter – there is little time to cram in everything a patient with diabetes needs to know about healthy eating, exercise and physical activity, medication, self-monitoring of blood glucose, risk reduction, and mental health.

"We know that diabetes educators, when they are embedded in primary care, work. We’ve seen research about that for the last several years," she said. "If we want to improve the care of patients with diabetes, we need to be in primary care," she said.

As the health care economy makes the transition from the fee-for-service model to accountable care organizations and patient-centered medical homes, diabetes educators will become even more important, Dr. Burke said. She proposed a patient-centered medical home model designed specifically for patients with diabetes, the metabolic syndrome, or people who are at risk for diabetes. Such a system could include diabetes educators, nutritionists, endocrinologists, physician assistants, pharmacists, and other clinicians who could help patients to manage their health and reduce the need for specialty care.

National standards revised

In a separate talk, Janice L. Koshinsky, diabetes program manager for the University of Pittsburgh’s Lions Diabetes Center in McKeesport, Pa., highlighted changes to recently published national standards for diabetes self-management education (DSME) and diabetes self-management support (DSMS) that may help to increase the ranks of diabetes educators.

The new standards include emphasis on ongoing self-management support and diabetes prevention (including treatment of gestational diabetes and prediabetes). Although most of the changes are minor, generally involving clarification of terms, one of the standards broadens the definition for instructional staff.

Previously, the standards held that at least one of the instructors in a diabetes self-management program should be a registered nurse, dietitian, or pharmacist.

The new standard, however, states that "one or more instructors will provide DSME, and, when applicable, DSMS. At least one of the instructors responsible for designing and planning DSME and DSMS will be an registered nurse, registered dietitian, or pharmacist with training and experience pertinent to DSME, or another professional with certification in diabetes care and education, such as a CDE [certified diabetes educator] or BC-ADM [board-certified advanced diabetes manager]. Other health workers can contribute to DSME and provide DSMS with appropriate training in diabetes, and with supervision and support."

With the previous standards, "we were really excluding some other health care professionals who may be certified in diabetes education, especially if they were in a standalone program," Ms. Koshinsky said.

Dr. Burke reported being a consultant to Janssen Pharmaceuticals and Genentech. Ms. Koshinsky reported being a consultant to Healthy Interactions and Merck.

NEW YORK – More than 40% of Americans with type 2 diabetes never receive any formal education in self-management of their disease, a situation that is likely to only get worse as the population gets older and more obese, according to diabetes educator Dr. Sandra Drozdz Burke.

The Affordable Care Act is expected to bring millions more patients – many with diabetes – into the health care system through the expansion of Medicaid rolls. "When we have that much diabetes to deal with, we’re going to need to have lots of people who know how to take care of themselves," said Dr. Burke, director of the University of Illinois College of Nursing at Urbana-Champaign.

She noted that the number of Americans with diabetes is projected to grow from 23.7 million in 2008 to 44.1 million in 2034, and annual U.S. spending on diabetes is projected to triple – from $113 billion to $336 billion – over the same period (Diabetes Care 2009;32:2225-9).

In 2011, approximately 30,000 people were working as diabetes educators in the United States, which is 24,000 short of the estimated 54,000 projected to be needed by the year 2025, Dr. Burke said at the annual advanced postgraduate course held by the American Diabetes Association.

Most diabetes patients get their care from primary care practitioners, and many are typically referred to specialty care "only at the end of the road," when complications of diabetes are advanced and irreversible, she said. But in clinical practice – in the 8- to 12-minute encounter – there is little time to cram in everything a patient with diabetes needs to know about healthy eating, exercise and physical activity, medication, self-monitoring of blood glucose, risk reduction, and mental health.

"We know that diabetes educators, when they are embedded in primary care, work. We’ve seen research about that for the last several years," she said. "If we want to improve the care of patients with diabetes, we need to be in primary care," she said.

As the health care economy makes the transition from the fee-for-service model to accountable care organizations and patient-centered medical homes, diabetes educators will become even more important, Dr. Burke said. She proposed a patient-centered medical home model designed specifically for patients with diabetes, the metabolic syndrome, or people who are at risk for diabetes. Such a system could include diabetes educators, nutritionists, endocrinologists, physician assistants, pharmacists, and other clinicians who could help patients to manage their health and reduce the need for specialty care.

National standards revised

In a separate talk, Janice L. Koshinsky, diabetes program manager for the University of Pittsburgh’s Lions Diabetes Center in McKeesport, Pa., highlighted changes to recently published national standards for diabetes self-management education (DSME) and diabetes self-management support (DSMS) that may help to increase the ranks of diabetes educators.

The new standards include emphasis on ongoing self-management support and diabetes prevention (including treatment of gestational diabetes and prediabetes). Although most of the changes are minor, generally involving clarification of terms, one of the standards broadens the definition for instructional staff.

Previously, the standards held that at least one of the instructors in a diabetes self-management program should be a registered nurse, dietitian, or pharmacist.

The new standard, however, states that "one or more instructors will provide DSME, and, when applicable, DSMS. At least one of the instructors responsible for designing and planning DSME and DSMS will be an registered nurse, registered dietitian, or pharmacist with training and experience pertinent to DSME, or another professional with certification in diabetes care and education, such as a CDE [certified diabetes educator] or BC-ADM [board-certified advanced diabetes manager]. Other health workers can contribute to DSME and provide DSMS with appropriate training in diabetes, and with supervision and support."

With the previous standards, "we were really excluding some other health care professionals who may be certified in diabetes education, especially if they were in a standalone program," Ms. Koshinsky said.

Dr. Burke reported being a consultant to Janssen Pharmaceuticals and Genentech. Ms. Koshinsky reported being a consultant to Healthy Interactions and Merck.

NEW YORK – More than 40% of Americans with type 2 diabetes never receive any formal education in self-management of their disease, a situation that is likely to only get worse as the population gets older and more obese, according to diabetes educator Dr. Sandra Drozdz Burke.

The Affordable Care Act is expected to bring millions more patients – many with diabetes – into the health care system through the expansion of Medicaid rolls. "When we have that much diabetes to deal with, we’re going to need to have lots of people who know how to take care of themselves," said Dr. Burke, director of the University of Illinois College of Nursing at Urbana-Champaign.

She noted that the number of Americans with diabetes is projected to grow from 23.7 million in 2008 to 44.1 million in 2034, and annual U.S. spending on diabetes is projected to triple – from $113 billion to $336 billion – over the same period (Diabetes Care 2009;32:2225-9).

In 2011, approximately 30,000 people were working as diabetes educators in the United States, which is 24,000 short of the estimated 54,000 projected to be needed by the year 2025, Dr. Burke said at the annual advanced postgraduate course held by the American Diabetes Association.

Most diabetes patients get their care from primary care practitioners, and many are typically referred to specialty care "only at the end of the road," when complications of diabetes are advanced and irreversible, she said. But in clinical practice – in the 8- to 12-minute encounter – there is little time to cram in everything a patient with diabetes needs to know about healthy eating, exercise and physical activity, medication, self-monitoring of blood glucose, risk reduction, and mental health.

"We know that diabetes educators, when they are embedded in primary care, work. We’ve seen research about that for the last several years," she said. "If we want to improve the care of patients with diabetes, we need to be in primary care," she said.

As the health care economy makes the transition from the fee-for-service model to accountable care organizations and patient-centered medical homes, diabetes educators will become even more important, Dr. Burke said. She proposed a patient-centered medical home model designed specifically for patients with diabetes, the metabolic syndrome, or people who are at risk for diabetes. Such a system could include diabetes educators, nutritionists, endocrinologists, physician assistants, pharmacists, and other clinicians who could help patients to manage their health and reduce the need for specialty care.

National standards revised

In a separate talk, Janice L. Koshinsky, diabetes program manager for the University of Pittsburgh’s Lions Diabetes Center in McKeesport, Pa., highlighted changes to recently published national standards for diabetes self-management education (DSME) and diabetes self-management support (DSMS) that may help to increase the ranks of diabetes educators.

The new standards include emphasis on ongoing self-management support and diabetes prevention (including treatment of gestational diabetes and prediabetes). Although most of the changes are minor, generally involving clarification of terms, one of the standards broadens the definition for instructional staff.

Previously, the standards held that at least one of the instructors in a diabetes self-management program should be a registered nurse, dietitian, or pharmacist.

The new standard, however, states that "one or more instructors will provide DSME, and, when applicable, DSMS. At least one of the instructors responsible for designing and planning DSME and DSMS will be an registered nurse, registered dietitian, or pharmacist with training and experience pertinent to DSME, or another professional with certification in diabetes care and education, such as a CDE [certified diabetes educator] or BC-ADM [board-certified advanced diabetes manager]. Other health workers can contribute to DSME and provide DSMS with appropriate training in diabetes, and with supervision and support."

With the previous standards, "we were really excluding some other health care professionals who may be certified in diabetes education, especially if they were in a standalone program," Ms. Koshinsky said.

Dr. Burke reported being a consultant to Janssen Pharmaceuticals and Genentech. Ms. Koshinsky reported being a consultant to Healthy Interactions and Merck.

NEW YORK – Studies continue to examine approaches that might reduce the well-known increased risk for cognitive decline and dementia in people with type 2 diabetes.

A combination of hyperglycemia, insulin resistance, oxidative stress, and other diabetes-related factors appears to play a part in the cognitive impairment associated with type 2 diabetes, said Dr. Jeff D. Williamson, chief of gerontology and geriatric medicine and director of the Kulynych Brain Research Center at Wake Forest University in Winston-Salem, N.C.

But, to date, there hasn’t been much success in intervening in type 2 diabetes patients to affect cognitive outcomes.

"Brain disease is prevalent in type 2 diabetes, and the risk for progression to dementia is high. There’s really no evidence that intensive medication can change that rate, at least at this point, but there may be some evidence that behavioral interventions are effective," Dr. Williamson said at the annual advanced postgraduate course held by the American Diabetes Association.

He advised that "monitoring cognitive function should take its place alongside lipid monitoring, kidney function monitoring, and eye monitoring in your assessments of patients coming through. Diabetes education may be adapted in people who are showing cognitive frailty, and we really need more work to show what works best in this population, but we certainly know that they are going to need more backup strategies."

Pathways to dementia

Diabetes interacts with the brain through two primary pathways: neuronal factors, including advanced glycated end products (with the apt acronym AGES), altered metabolism of neurotransmitters, and hypoglycemia; and vascular factors, including hypertension, endothelial damage, infarction, white-matter lesions, and disruption of the blood-brain barrier.

Both pathways contribute to inflammation, oxidative stress, and altered energy metabolism, which in turn lead to small- and large-vessel disease in the case of vascular damage factors, and to cortical atrophy in the case of neuronal degeneration. The end result of these processes may be vascular or Alzheimer’s type cognitive impairment and dementia, Dr. Williamson said.

Imaging studies conducted as part of the ACCORD-Memory in Diabetes Study (ACCORD-MIND, a substudy of the ACCORD [Action to Control Cardiovascular Risk in Diabetes] Study), showed increased white-matter lesions and brain atrophy in some people with type 2 diabetes, he noted.

In addition, a 2011 study, which Dr. Williamson coauthored, found that postmenopausal women with type 2 diabetes had deficits in verbal knowledge and verbal memory relative to similar women with no diabetes. Deficits in fine motor speed, a marker of cognitive impairment, also were more common in women with longer diabetes duration. Insulin use, indicative of diabetes severity, was associated with greater cognitive deficits, whereas oral medications were associated with better relative cognitive function.

Similarly, a 2009 systematic review and meta-analysis detected significant relative risks (RRs) associated with all diabetes types and all dementia types (RR, 1.47), Alzheimer’s disease (RR, 1.39), and vascular dementia (RR, 2.38).

Disappointing results

As in the parent trial, the ACCORD-MIND trial investigators found that an intensive glucose control intervention did not affect patients’ scores on the Digital Symbol Substitution Test, the primary endpoint. Among the nearly 3,000 patients randomized in that study, those assigned to intensive glucose control had significantly greater total brain volume than did patients assigned to standard control, but no difference in cognitive outcomes.

"Combined with the unfavorable effects on other ACCORD outcomes, MIND findings do not support using intensive therapy to reduce the adverse effects of diabetes on the brain in patients similar to MIND participants," they wrote.

The fact that there was a reduction in the rate of brain volume loss in the intensive glucose control arm, however, gives hope to the investigators that there might be a "legacy" effect for a slower decline in cognitive function with better control over longer follow-up, Dr. Williamson said.

Researchers are now focusing on the Look AHEAD (Action for Health in Diabetes) study on the question of whether lifestyle interventions might be able to accomplish what drugs could not in ACCORD. Alternatively, it may be possible that the type of drug treatment is more important than a specific numeric target, he said.

Dr. Williamson reported having no financial disclosures.

NEW YORK – Studies continue to examine approaches that might reduce the well-known increased risk for cognitive decline and dementia in people with type 2 diabetes.

A combination of hyperglycemia, insulin resistance, oxidative stress, and other diabetes-related factors appears to play a part in the cognitive impairment associated with type 2 diabetes, said Dr. Jeff D. Williamson, chief of gerontology and geriatric medicine and director of the Kulynych Brain Research Center at Wake Forest University in Winston-Salem, N.C.

But, to date, there hasn’t been much success in intervening in type 2 diabetes patients to affect cognitive outcomes.

"Brain disease is prevalent in type 2 diabetes, and the risk for progression to dementia is high. There’s really no evidence that intensive medication can change that rate, at least at this point, but there may be some evidence that behavioral interventions are effective," Dr. Williamson said at the annual advanced postgraduate course held by the American Diabetes Association.

He advised that "monitoring cognitive function should take its place alongside lipid monitoring, kidney function monitoring, and eye monitoring in your assessments of patients coming through. Diabetes education may be adapted in people who are showing cognitive frailty, and we really need more work to show what works best in this population, but we certainly know that they are going to need more backup strategies."

Pathways to dementia

Diabetes interacts with the brain through two primary pathways: neuronal factors, including advanced glycated end products (with the apt acronym AGES), altered metabolism of neurotransmitters, and hypoglycemia; and vascular factors, including hypertension, endothelial damage, infarction, white-matter lesions, and disruption of the blood-brain barrier.

Both pathways contribute to inflammation, oxidative stress, and altered energy metabolism, which in turn lead to small- and large-vessel disease in the case of vascular damage factors, and to cortical atrophy in the case of neuronal degeneration. The end result of these processes may be vascular or Alzheimer’s type cognitive impairment and dementia, Dr. Williamson said.

Imaging studies conducted as part of the ACCORD-Memory in Diabetes Study (ACCORD-MIND, a substudy of the ACCORD [Action to Control Cardiovascular Risk in Diabetes] Study), showed increased white-matter lesions and brain atrophy in some people with type 2 diabetes, he noted.

In addition, a 2011 study, which Dr. Williamson coauthored, found that postmenopausal women with type 2 diabetes had deficits in verbal knowledge and verbal memory relative to similar women with no diabetes. Deficits in fine motor speed, a marker of cognitive impairment, also were more common in women with longer diabetes duration. Insulin use, indicative of diabetes severity, was associated with greater cognitive deficits, whereas oral medications were associated with better relative cognitive function.

Similarly, a 2009 systematic review and meta-analysis detected significant relative risks (RRs) associated with all diabetes types and all dementia types (RR, 1.47), Alzheimer’s disease (RR, 1.39), and vascular dementia (RR, 2.38).

Disappointing results

As in the parent trial, the ACCORD-MIND trial investigators found that an intensive glucose control intervention did not affect patients’ scores on the Digital Symbol Substitution Test, the primary endpoint. Among the nearly 3,000 patients randomized in that study, those assigned to intensive glucose control had significantly greater total brain volume than did patients assigned to standard control, but no difference in cognitive outcomes.

"Combined with the unfavorable effects on other ACCORD outcomes, MIND findings do not support using intensive therapy to reduce the adverse effects of diabetes on the brain in patients similar to MIND participants," they wrote.

The fact that there was a reduction in the rate of brain volume loss in the intensive glucose control arm, however, gives hope to the investigators that there might be a "legacy" effect for a slower decline in cognitive function with better control over longer follow-up, Dr. Williamson said.

Researchers are now focusing on the Look AHEAD (Action for Health in Diabetes) study on the question of whether lifestyle interventions might be able to accomplish what drugs could not in ACCORD. Alternatively, it may be possible that the type of drug treatment is more important than a specific numeric target, he said.

Dr. Williamson reported having no financial disclosures.

NEW YORK – Studies continue to examine approaches that might reduce the well-known increased risk for cognitive decline and dementia in people with type 2 diabetes.

A combination of hyperglycemia, insulin resistance, oxidative stress, and other diabetes-related factors appears to play a part in the cognitive impairment associated with type 2 diabetes, said Dr. Jeff D. Williamson, chief of gerontology and geriatric medicine and director of the Kulynych Brain Research Center at Wake Forest University in Winston-Salem, N.C.

But, to date, there hasn’t been much success in intervening in type 2 diabetes patients to affect cognitive outcomes.

"Brain disease is prevalent in type 2 diabetes, and the risk for progression to dementia is high. There’s really no evidence that intensive medication can change that rate, at least at this point, but there may be some evidence that behavioral interventions are effective," Dr. Williamson said at the annual advanced postgraduate course held by the American Diabetes Association.

He advised that "monitoring cognitive function should take its place alongside lipid monitoring, kidney function monitoring, and eye monitoring in your assessments of patients coming through. Diabetes education may be adapted in people who are showing cognitive frailty, and we really need more work to show what works best in this population, but we certainly know that they are going to need more backup strategies."

Pathways to dementia

Diabetes interacts with the brain through two primary pathways: neuronal factors, including advanced glycated end products (with the apt acronym AGES), altered metabolism of neurotransmitters, and hypoglycemia; and vascular factors, including hypertension, endothelial damage, infarction, white-matter lesions, and disruption of the blood-brain barrier.

Both pathways contribute to inflammation, oxidative stress, and altered energy metabolism, which in turn lead to small- and large-vessel disease in the case of vascular damage factors, and to cortical atrophy in the case of neuronal degeneration. The end result of these processes may be vascular or Alzheimer’s type cognitive impairment and dementia, Dr. Williamson said.

Imaging studies conducted as part of the ACCORD-Memory in Diabetes Study (ACCORD-MIND, a substudy of the ACCORD [Action to Control Cardiovascular Risk in Diabetes] Study), showed increased white-matter lesions and brain atrophy in some people with type 2 diabetes, he noted.

In addition, a 2011 study, which Dr. Williamson coauthored, found that postmenopausal women with type 2 diabetes had deficits in verbal knowledge and verbal memory relative to similar women with no diabetes. Deficits in fine motor speed, a marker of cognitive impairment, also were more common in women with longer diabetes duration. Insulin use, indicative of diabetes severity, was associated with greater cognitive deficits, whereas oral medications were associated with better relative cognitive function.

Similarly, a 2009 systematic review and meta-analysis detected significant relative risks (RRs) associated with all diabetes types and all dementia types (RR, 1.47), Alzheimer’s disease (RR, 1.39), and vascular dementia (RR, 2.38).

Disappointing results

As in the parent trial, the ACCORD-MIND trial investigators found that an intensive glucose control intervention did not affect patients’ scores on the Digital Symbol Substitution Test, the primary endpoint. Among the nearly 3,000 patients randomized in that study, those assigned to intensive glucose control had significantly greater total brain volume than did patients assigned to standard control, but no difference in cognitive outcomes.

"Combined with the unfavorable effects on other ACCORD outcomes, MIND findings do not support using intensive therapy to reduce the adverse effects of diabetes on the brain in patients similar to MIND participants," they wrote.

The fact that there was a reduction in the rate of brain volume loss in the intensive glucose control arm, however, gives hope to the investigators that there might be a "legacy" effect for a slower decline in cognitive function with better control over longer follow-up, Dr. Williamson said.

Researchers are now focusing on the Look AHEAD (Action for Health in Diabetes) study on the question of whether lifestyle interventions might be able to accomplish what drugs could not in ACCORD. Alternatively, it may be possible that the type of drug treatment is more important than a specific numeric target, he said.

Dr. Williamson reported having no financial disclosures.

NEW YORK – All sugars are not created equal, and the difference in the effects on the body between different types of sugar added to processed foods may explain at least some of the spike in type 2 diabetes incidence, an investigator said at the annual advanced postgraduate course held by the American Diabetes Association.

Most sweetened foods do not contain either pure fructose or pure glucose, but animal and human studies of their differential effects show that macronutrient components of diet can conspire with increased body weight and fat to cause metabolic disease, said Kimber L. Stanhope, Ph.D., associate research nutritional biologist in the department of molecular bioscience at the University of California, Davis, School of Veterinary Medicine.

©thinkstockphotos.com

"Fructose compared to glucose increases visceral adiposity [and] lipid dysregulation and decreases insulin sensitivity," she said.

Both epidemiologic data and recent experimental evidence suggest that consumption of 25% of daily energy as beverages sweetened with high-fructose corn syrup (HFCS), or 12.5% of energy as sucrose-sweetened beverages can increase cardiovascular disease (CVD) risk factors in young adults in as little as 2-3 weeks, she said.

Other evidence suggests that, among middle-aged overweight or obese adults, consumption of sucrose-sweetened drinks at about 20% of energy intakes increases levels of fat in the liver and viscera and increases CVD risk factors over 6 months.

The findings also suggest that current USDA guidelines, which recommend no more than 25% of energy intake from added sugars, need to be revised to lower the acceptable upper limit for sugar, Dr. Stanhope said.

"However, obtaining absolutely definitive evidence that even the sugar industry cannot criticize will require clinical studies in which we provide every gram of food to our subjects, and that will ensure there are absolutely no confounders among the diets of the various groups that could undermine our conclusions," she said.

But even assuming that study funding is available, definitive results may not be available for another 6 or 7 years.

"Do we really want to wait that long before we do something about our dietary guidelines, or before we really start educating the public?" she added.

Different sugars, different results

Dr. Stanhope and other researchers look at fructose and glucose because both have been shown to cause metabolic dysregulation and have been implicated as contributors to metabolic disease. To tease out the possible causes, it is necessary to study their separate mechanistic effects, she said.

She and colleagues conducted a study in 2009 in which men and women aged 40-72 years were given either glucose- or fructose-sweetened beverages as part of energy-balance meals, with the sugars comprising 25% of energy requirements for 10 weeks. The subjects were in the overweight to moderately obese range, with body mass indices (BMIs) ranging from 25 to 35 kg/m².

The investigators hypothesized that fructose would lead to greater weight gain than glucose because fructose dose not stimulate production of the satiety hormone leptin, but the hypothesis was not borne out. Patients in each group gained a mean of about 1.5 kg, and an identical amount of body fat as measured by dual-energy x-ray absorptiometry (DEXA) scan.

"However, there was a surprise: the subjects consuming fructose tended to deposit the new fat that they gained in the visceral adipose, whereas the subjects consuming glucose deposited more of their new fat in the subcutaneous adipose," Dr. Stanhope said.

The mechanism for the different fat distribution may involve lipoprotein lipase (LPL), the rate-limiting enzyme that clears triglycerides from circulation and deposits them into adipose for storage or to muscle for energy use. The enzyme is activated by insulin, and LPL associated with subcutaneous fat has been shown to be much more sensitive to insulin activation than LPL associated with visceral fat.

Compared with glucose, consumption of fructose is associated with lower postmeal glucose peaks, lower postmeal insulin peaks, and lesser activation of LPL in subcutaneous fats, which therefore leaves more fat in circulation for uptake by visceral adipose tissue, Dr. Stanhope explained, noting that this model is hypothetical and needs to be confirmed with further studies.

Asked in an interview whether naturally occurring fructose was associated with similar effects to that of fructose added to processed foods, Dr. Stanhope said that fresh fruits actually contain only small amounts of fructose and have healthy components such as antioxidant compounds that far outweigh any negligible metabolic effects of fructose.

Dr. Stanhope reported having no financial disclosures.

NEW YORK – All sugars are not created equal, and the difference in the effects on the body between different types of sugar added to processed foods may explain at least some of the spike in type 2 diabetes incidence, an investigator said at the annual advanced postgraduate course held by the American Diabetes Association.

Most sweetened foods do not contain either pure fructose or pure glucose, but animal and human studies of their differential effects show that macronutrient components of diet can conspire with increased body weight and fat to cause metabolic disease, said Kimber L. Stanhope, Ph.D., associate research nutritional biologist in the department of molecular bioscience at the University of California, Davis, School of Veterinary Medicine.

©thinkstockphotos.com

"Fructose compared to glucose increases visceral adiposity [and] lipid dysregulation and decreases insulin sensitivity," she said.

Both epidemiologic data and recent experimental evidence suggest that consumption of 25% of daily energy as beverages sweetened with high-fructose corn syrup (HFCS), or 12.5% of energy as sucrose-sweetened beverages can increase cardiovascular disease (CVD) risk factors in young adults in as little as 2-3 weeks, she said.

Other evidence suggests that, among middle-aged overweight or obese adults, consumption of sucrose-sweetened drinks at about 20% of energy intakes increases levels of fat in the liver and viscera and increases CVD risk factors over 6 months.

The findings also suggest that current USDA guidelines, which recommend no more than 25% of energy intake from added sugars, need to be revised to lower the acceptable upper limit for sugar, Dr. Stanhope said.

"However, obtaining absolutely definitive evidence that even the sugar industry cannot criticize will require clinical studies in which we provide every gram of food to our subjects, and that will ensure there are absolutely no confounders among the diets of the various groups that could undermine our conclusions," she said.

But even assuming that study funding is available, definitive results may not be available for another 6 or 7 years.

"Do we really want to wait that long before we do something about our dietary guidelines, or before we really start educating the public?" she added.

Different sugars, different results

Dr. Stanhope and other researchers look at fructose and glucose because both have been shown to cause metabolic dysregulation and have been implicated as contributors to metabolic disease. To tease out the possible causes, it is necessary to study their separate mechanistic effects, she said.

She and colleagues conducted a study in 2009 in which men and women aged 40-72 years were given either glucose- or fructose-sweetened beverages as part of energy-balance meals, with the sugars comprising 25% of energy requirements for 10 weeks. The subjects were in the overweight to moderately obese range, with body mass indices (BMIs) ranging from 25 to 35 kg/m².

The investigators hypothesized that fructose would lead to greater weight gain than glucose because fructose dose not stimulate production of the satiety hormone leptin, but the hypothesis was not borne out. Patients in each group gained a mean of about 1.5 kg, and an identical amount of body fat as measured by dual-energy x-ray absorptiometry (DEXA) scan.

"However, there was a surprise: the subjects consuming fructose tended to deposit the new fat that they gained in the visceral adipose, whereas the subjects consuming glucose deposited more of their new fat in the subcutaneous adipose," Dr. Stanhope said.

The mechanism for the different fat distribution may involve lipoprotein lipase (LPL), the rate-limiting enzyme that clears triglycerides from circulation and deposits them into adipose for storage or to muscle for energy use. The enzyme is activated by insulin, and LPL associated with subcutaneous fat has been shown to be much more sensitive to insulin activation than LPL associated with visceral fat.

Compared with glucose, consumption of fructose is associated with lower postmeal glucose peaks, lower postmeal insulin peaks, and lesser activation of LPL in subcutaneous fats, which therefore leaves more fat in circulation for uptake by visceral adipose tissue, Dr. Stanhope explained, noting that this model is hypothetical and needs to be confirmed with further studies.

Asked in an interview whether naturally occurring fructose was associated with similar effects to that of fructose added to processed foods, Dr. Stanhope said that fresh fruits actually contain only small amounts of fructose and have healthy components such as antioxidant compounds that far outweigh any negligible metabolic effects of fructose.

Dr. Stanhope reported having no financial disclosures.

NEW YORK – All sugars are not created equal, and the difference in the effects on the body between different types of sugar added to processed foods may explain at least some of the spike in type 2 diabetes incidence, an investigator said at the annual advanced postgraduate course held by the American Diabetes Association.

Most sweetened foods do not contain either pure fructose or pure glucose, but animal and human studies of their differential effects show that macronutrient components of diet can conspire with increased body weight and fat to cause metabolic disease, said Kimber L. Stanhope, Ph.D., associate research nutritional biologist in the department of molecular bioscience at the University of California, Davis, School of Veterinary Medicine.

©thinkstockphotos.com

"Fructose compared to glucose increases visceral adiposity [and] lipid dysregulation and decreases insulin sensitivity," she said.

Both epidemiologic data and recent experimental evidence suggest that consumption of 25% of daily energy as beverages sweetened with high-fructose corn syrup (HFCS), or 12.5% of energy as sucrose-sweetened beverages can increase cardiovascular disease (CVD) risk factors in young adults in as little as 2-3 weeks, she said.

Other evidence suggests that, among middle-aged overweight or obese adults, consumption of sucrose-sweetened drinks at about 20% of energy intakes increases levels of fat in the liver and viscera and increases CVD risk factors over 6 months.

The findings also suggest that current USDA guidelines, which recommend no more than 25% of energy intake from added sugars, need to be revised to lower the acceptable upper limit for sugar, Dr. Stanhope said.

"However, obtaining absolutely definitive evidence that even the sugar industry cannot criticize will require clinical studies in which we provide every gram of food to our subjects, and that will ensure there are absolutely no confounders among the diets of the various groups that could undermine our conclusions," she said.

But even assuming that study funding is available, definitive results may not be available for another 6 or 7 years.

"Do we really want to wait that long before we do something about our dietary guidelines, or before we really start educating the public?" she added.

Different sugars, different results

Dr. Stanhope and other researchers look at fructose and glucose because both have been shown to cause metabolic dysregulation and have been implicated as contributors to metabolic disease. To tease out the possible causes, it is necessary to study their separate mechanistic effects, she said.

She and colleagues conducted a study in 2009 in which men and women aged 40-72 years were given either glucose- or fructose-sweetened beverages as part of energy-balance meals, with the sugars comprising 25% of energy requirements for 10 weeks. The subjects were in the overweight to moderately obese range, with body mass indices (BMIs) ranging from 25 to 35 kg/m².

The investigators hypothesized that fructose would lead to greater weight gain than glucose because fructose dose not stimulate production of the satiety hormone leptin, but the hypothesis was not borne out. Patients in each group gained a mean of about 1.5 kg, and an identical amount of body fat as measured by dual-energy x-ray absorptiometry (DEXA) scan.

"However, there was a surprise: the subjects consuming fructose tended to deposit the new fat that they gained in the visceral adipose, whereas the subjects consuming glucose deposited more of their new fat in the subcutaneous adipose," Dr. Stanhope said.

The mechanism for the different fat distribution may involve lipoprotein lipase (LPL), the rate-limiting enzyme that clears triglycerides from circulation and deposits them into adipose for storage or to muscle for energy use. The enzyme is activated by insulin, and LPL associated with subcutaneous fat has been shown to be much more sensitive to insulin activation than LPL associated with visceral fat.

Compared with glucose, consumption of fructose is associated with lower postmeal glucose peaks, lower postmeal insulin peaks, and lesser activation of LPL in subcutaneous fats, which therefore leaves more fat in circulation for uptake by visceral adipose tissue, Dr. Stanhope explained, noting that this model is hypothetical and needs to be confirmed with further studies.

Asked in an interview whether naturally occurring fructose was associated with similar effects to that of fructose added to processed foods, Dr. Stanhope said that fresh fruits actually contain only small amounts of fructose and have healthy components such as antioxidant compounds that far outweigh any negligible metabolic effects of fructose.

Dr. Stanhope reported having no financial disclosures.

NEW YORK – Add diabetes management to the standard cell phone repertoire of talking, texting, browsing, and playing "Fruit Ninja," an e-health advocate said at the annual advanced postgraduate course held by the American Diabetes Association.

"The phone is no longer really a phone. We call it a ‘cell phone’ or ‘mobile’ in Europe, but here we’re really holding a handheld computer, which has tremendous capabilities for communication between individuals as well as tremendous opportunities for exchange of information," said Dr. Richard J. Katz, professor of medicine and director of the division of cardiology at George Washington University Medical Center in Washington, D.C.

General, patient-centric mobile health applications (apps) empower patients and help them become better partners in their own health maintenance, Dr. Katz said.

Integrated mobile health systems can help providers with clinical decision support, get access to real-time clinical data, analyze and recognize treatment and disease patterns, and improve adherence to evidence-based guidelines.

For patients with diabetes, apps and diabetes-specific programs can help to improve treatment adherence and can provide reinforcement of treatment goals, better understanding of the effect of specific behaviors on disease control, reminders and coaching, and easy access to diabetes education resources.

Although there are hundreds of simple text-based, unidirectional apps that push messages such as treatment or appointment reminders to the phones of patients or caregivers, better apps are devoted to promoting behavior change, either with bidirectional communication between patients and their health care teams or, better still, with a multidirectional system involving all members of a health care team, including endocrinologists or primary care physicians, case managers, nurses, physician assistants, disease management services, hospital discharge teams, and community health workers.

What do patients want?

Ideally, technology should help patients with real-time decision making tools and give them the ability to share information with their health care team and connect to others for support, Dr. Katz said.

For example, a medication-reminder app can list diabetes medications, remind patients about when and how to take specific drugs, remind them when a refill is needed, and, if desired, click to send a refill order to the patient’s chosen pharmacy.

Dr. Katz and colleagues conducted a study (not published) to see whether a unidirectional drug app could improve adherence to hypertension medications among 50 patients on Medicaid. They found that a pill-reminder program showed a trend toward improving adherence (P = .098) from about 75% at baseline to about 82%. When the reminder was turned off, adherence significantly declined to about 72% (P = .001).

"There’s some potential for improvement there, but it’s short term and you have to keep patients engaged," Dr. Katz said.

A more promising approach, he noted, is a comprehensive chronic disease management program such as WellDoc’s mHealth Solution. The program uses a cell phone–resident app that the patient can use to record blood glucose, receive real-time coaching and out-of-bounds alerts, testing and medication reminders, metabolic target ranges, and caregiver alerts and support. The system can be customized to provide a range of support services – from simple reminders to more complex management and self-management support.

For the clinical care team, the system provides a dashboard that shows glucose readings by day and time, highlighting both hypo- and hyperglycemic excursions, and provides a checklist for comparing individual patient parameters (blood pressure, lipids, renal, etc.) and their medical specialty visits against evidence-based standards of care. For example, the list can highlight abnormal urine microalbuminuria-to-creatinine ratios and alert providers that a patient is overdue for eye or foot exams.

Apps put to the test

Dr. Katz cited a 2011 meta-analysis by Chinese investigators, who found that, among 22 trials with a total of 1,657 participants, mobile-phone interventions for diabetes self-management were associated with a mean 0.5% reduction in hemoglobin A_1c over a median of 6 months’ follow-up. The effect was stronger among patients with type 2 diabetes than among those with type 1, the authors found (Diabet. Med. 2011;28:455-63).

More dramatic results were seen in a cluster-randomized trial in which 26 primary care practices were randomly assigned to treat 163 adults with type 2 diabetes and an HbA_1c of 7.5% or greater with either standard therapy (controls) or with one of three combinations of interventions: a diabetes coach only; a coach and a diabetes-specific mobile-phone portal between the primary care practitioner (PCP) and patient; or a coach and PCP portal with decision support, include access to patient data and links to evidence-based guidelines (Diabetes Care 2011;34:1934-42).

The mean decline in HbA_1c levels was 1.9% in the PCP portal with decision-support group, compared with 0.7% in the usual-care group, a difference of 1.2% (P less than .001) over 12 months.

"The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year," the authors reported.

Dr. Katz reported having no financial disclosures.

NEW YORK – Add diabetes management to the standard cell phone repertoire of talking, texting, browsing, and playing "Fruit Ninja," an e-health advocate said at the annual advanced postgraduate course held by the American Diabetes Association.

"The phone is no longer really a phone. We call it a ‘cell phone’ or ‘mobile’ in Europe, but here we’re really holding a handheld computer, which has tremendous capabilities for communication between individuals as well as tremendous opportunities for exchange of information," said Dr. Richard J. Katz, professor of medicine and director of the division of cardiology at George Washington University Medical Center in Washington, D.C.

General, patient-centric mobile health applications (apps) empower patients and help them become better partners in their own health maintenance, Dr. Katz said.

Integrated mobile health systems can help providers with clinical decision support, get access to real-time clinical data, analyze and recognize treatment and disease patterns, and improve adherence to evidence-based guidelines.

For patients with diabetes, apps and diabetes-specific programs can help to improve treatment adherence and can provide reinforcement of treatment goals, better understanding of the effect of specific behaviors on disease control, reminders and coaching, and easy access to diabetes education resources.

Although there are hundreds of simple text-based, unidirectional apps that push messages such as treatment or appointment reminders to the phones of patients or caregivers, better apps are devoted to promoting behavior change, either with bidirectional communication between patients and their health care teams or, better still, with a multidirectional system involving all members of a health care team, including endocrinologists or primary care physicians, case managers, nurses, physician assistants, disease management services, hospital discharge teams, and community health workers.

What do patients want?

Ideally, technology should help patients with real-time decision making tools and give them the ability to share information with their health care team and connect to others for support, Dr. Katz said.

For example, a medication-reminder app can list diabetes medications, remind patients about when and how to take specific drugs, remind them when a refill is needed, and, if desired, click to send a refill order to the patient’s chosen pharmacy.

Dr. Katz and colleagues conducted a study (not published) to see whether a unidirectional drug app could improve adherence to hypertension medications among 50 patients on Medicaid. They found that a pill-reminder program showed a trend toward improving adherence (P = .098) from about 75% at baseline to about 82%. When the reminder was turned off, adherence significantly declined to about 72% (P = .001).

"There’s some potential for improvement there, but it’s short term and you have to keep patients engaged," Dr. Katz said.

A more promising approach, he noted, is a comprehensive chronic disease management program such as WellDoc’s mHealth Solution. The program uses a cell phone–resident app that the patient can use to record blood glucose, receive real-time coaching and out-of-bounds alerts, testing and medication reminders, metabolic target ranges, and caregiver alerts and support. The system can be customized to provide a range of support services – from simple reminders to more complex management and self-management support.

For the clinical care team, the system provides a dashboard that shows glucose readings by day and time, highlighting both hypo- and hyperglycemic excursions, and provides a checklist for comparing individual patient parameters (blood pressure, lipids, renal, etc.) and their medical specialty visits against evidence-based standards of care. For example, the list can highlight abnormal urine microalbuminuria-to-creatinine ratios and alert providers that a patient is overdue for eye or foot exams.

Apps put to the test

Dr. Katz cited a 2011 meta-analysis by Chinese investigators, who found that, among 22 trials with a total of 1,657 participants, mobile-phone interventions for diabetes self-management were associated with a mean 0.5% reduction in hemoglobin A_1c over a median of 6 months’ follow-up. The effect was stronger among patients with type 2 diabetes than among those with type 1, the authors found (Diabet. Med. 2011;28:455-63).

More dramatic results were seen in a cluster-randomized trial in which 26 primary care practices were randomly assigned to treat 163 adults with type 2 diabetes and an HbA_1c of 7.5% or greater with either standard therapy (controls) or with one of three combinations of interventions: a diabetes coach only; a coach and a diabetes-specific mobile-phone portal between the primary care practitioner (PCP) and patient; or a coach and PCP portal with decision support, include access to patient data and links to evidence-based guidelines (Diabetes Care 2011;34:1934-42).

The mean decline in HbA_1c levels was 1.9% in the PCP portal with decision-support group, compared with 0.7% in the usual-care group, a difference of 1.2% (P less than .001) over 12 months.

"The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year," the authors reported.

Dr. Katz reported having no financial disclosures.

NEW YORK – Add diabetes management to the standard cell phone repertoire of talking, texting, browsing, and playing "Fruit Ninja," an e-health advocate said at the annual advanced postgraduate course held by the American Diabetes Association.

"The phone is no longer really a phone. We call it a ‘cell phone’ or ‘mobile’ in Europe, but here we’re really holding a handheld computer, which has tremendous capabilities for communication between individuals as well as tremendous opportunities for exchange of information," said Dr. Richard J. Katz, professor of medicine and director of the division of cardiology at George Washington University Medical Center in Washington, D.C.

General, patient-centric mobile health applications (apps) empower patients and help them become better partners in their own health maintenance, Dr. Katz said.

Integrated mobile health systems can help providers with clinical decision support, get access to real-time clinical data, analyze and recognize treatment and disease patterns, and improve adherence to evidence-based guidelines.

For patients with diabetes, apps and diabetes-specific programs can help to improve treatment adherence and can provide reinforcement of treatment goals, better understanding of the effect of specific behaviors on disease control, reminders and coaching, and easy access to diabetes education resources.

Although there are hundreds of simple text-based, unidirectional apps that push messages such as treatment or appointment reminders to the phones of patients or caregivers, better apps are devoted to promoting behavior change, either with bidirectional communication between patients and their health care teams or, better still, with a multidirectional system involving all members of a health care team, including endocrinologists or primary care physicians, case managers, nurses, physician assistants, disease management services, hospital discharge teams, and community health workers.

What do patients want?

Ideally, technology should help patients with real-time decision making tools and give them the ability to share information with their health care team and connect to others for support, Dr. Katz said.

For example, a medication-reminder app can list diabetes medications, remind patients about when and how to take specific drugs, remind them when a refill is needed, and, if desired, click to send a refill order to the patient’s chosen pharmacy.

Dr. Katz and colleagues conducted a study (not published) to see whether a unidirectional drug app could improve adherence to hypertension medications among 50 patients on Medicaid. They found that a pill-reminder program showed a trend toward improving adherence (P = .098) from about 75% at baseline to about 82%. When the reminder was turned off, adherence significantly declined to about 72% (P = .001).

"There’s some potential for improvement there, but it’s short term and you have to keep patients engaged," Dr. Katz said.

A more promising approach, he noted, is a comprehensive chronic disease management program such as WellDoc’s mHealth Solution. The program uses a cell phone–resident app that the patient can use to record blood glucose, receive real-time coaching and out-of-bounds alerts, testing and medication reminders, metabolic target ranges, and caregiver alerts and support. The system can be customized to provide a range of support services – from simple reminders to more complex management and self-management support.

For the clinical care team, the system provides a dashboard that shows glucose readings by day and time, highlighting both hypo- and hyperglycemic excursions, and provides a checklist for comparing individual patient parameters (blood pressure, lipids, renal, etc.) and their medical specialty visits against evidence-based standards of care. For example, the list can highlight abnormal urine microalbuminuria-to-creatinine ratios and alert providers that a patient is overdue for eye or foot exams.

Apps put to the test

Dr. Katz cited a 2011 meta-analysis by Chinese investigators, who found that, among 22 trials with a total of 1,657 participants, mobile-phone interventions for diabetes self-management were associated with a mean 0.5% reduction in hemoglobin A_1c over a median of 6 months’ follow-up. The effect was stronger among patients with type 2 diabetes than among those with type 1, the authors found (Diabet. Med. 2011;28:455-63).

More dramatic results were seen in a cluster-randomized trial in which 26 primary care practices were randomly assigned to treat 163 adults with type 2 diabetes and an HbA_1c of 7.5% or greater with either standard therapy (controls) or with one of three combinations of interventions: a diabetes coach only; a coach and a diabetes-specific mobile-phone portal between the primary care practitioner (PCP) and patient; or a coach and PCP portal with decision support, include access to patient data and links to evidence-based guidelines (Diabetes Care 2011;34:1934-42).

The mean decline in HbA_1c levels was 1.9% in the PCP portal with decision-support group, compared with 0.7% in the usual-care group, a difference of 1.2% (P less than .001) over 12 months.

"The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year," the authors reported.

Dr. Katz reported having no financial disclosures.

NEW YORK – Insulin pumps, continuous glucose monitors, and controller algorithms are all available off the shelf, but the reality of assembling them into a "set-and-forget" artificial pancreas is still some time away, according to Dr. William Tamborlane.

Postprandial hyperglycemia and nocturnal hypoglycemia excursions remain obstacles to the full implementation of "closed-loop" artificial pancreas systems that closely mimic the function of the human pancreas, said Dr. Tamborlane, professor of pediatrics at Yale University in New Haven, Conn.

In the past 2 decades, there have been substantial improvements in diabetes care, with the advent of insulin analogues, pramlintide as an aid in the absorption of glucose, smart insulin pumps, and continuous glucose monitoring systems, Dr. Tamborlane said at the annual advanced postgraduate course held by the American Diabetes Association.

However, as long-term follow-up data from the Type 1 Diabetes Exchange consortium show, "the findings are particularly disheartening for pediatrics, in that adolescents still have a mean hemoglobin A_1c at the best centers of 8.7%. Too many type 1 diabetes patients fail to achieve target A_1c goals," he commented.

In addition, while the relative risk of severe hypoglycemia with good glucose management has declined, it is an ever-present danger, and new diabetes technologies implemented in clinical practice have only added to the already high burden of care for both patients and practitioners.

"Certainly we would be delighted if there was a biological solution to type 1 diabetes that we could just cook up in our laboratories: [Grow] large numbers of beta [islet] cells based on stem-cell technology, infuse them into patients, and take away the problem of type 1 diabetes entirely. But the truth is that current transplant technologies, both whole pancreas and islet transplants, have their challenges and are only limited to a small segment of the population," he said.

Parts of the whole

The best current alternative, therefore, is a closed-loop artificial pancreas consisting of proven technologies combined into a single system.

For example, insulin pumps have been in use for decades, are continually being improved, and are now used by many children, adolescents, and young adults with type 1 diabetes. Continuous glucose monitors have been commercially available for more than 10 years, and have been shown to work in open-loop systems. Controller algorithms for dispensing insulin according to varying physiologic demands are also available, including PID (proportional-integral-derivative), MPC (Model Predictive Control), and fuzzy logic.

"Airplanes run on controller algorithms [as do] electrical generating plants, so there is plenty of information that could be applied to running an insulin pump based on basic engineering controller algorithms," Dr. Tamborlane said.

But early experience with a closed-loop system (Diabetes 2006;55:3344-50) showed exaggerated postmeal hyperglycemia excursions and a tendency toward late postprandial hypoglycemia from time lags in carbohydrate absorption, insulin absorption from the cutaneous infusion site (rather than the normal anatomic site, the portal vein of the liver), and from late increases in interstitial glucose concentrations.

"Overnight control was excellent, but you always worry that when you have thousands of patients on this treatment, you’re going to get some problems with sensors that are overreading which can cause hypoglycemia," he said.

Possible solutions to these problems include a hybrid design, for a semiautomatic control that will allow the patient to "prime" the pump with a conventional premeal bolus to account for some of the carbohydrate in a meal, and adjusting the sensor to a slightly higher-than-normal target glucose to prevent nocturnal hypoglycemia.

"Instead of trying to shoot for a morning serum glucose of 80 [mg/dL], why don’t we try to shoot for 120? Would you mind if, on average, your patients woke up every morning with a mean glucose of 120 mg/dL? I don’t think so."

Real-life conditions

Current artificial pancreas research is focused on testing the devices used in real-world situations but in a controlled inpatient testing environment.

In one such study, Dr. Tamborlane and his colleagues investigated whether the use of a closed-loop system can reduce the risk of delayed nocturnal hypoglycemia following exercise during the day. They enrolled 12 adolescents with type 1 diabetes and mean HbA_1c levels of 7.4%, and admitted them to the research unit on two separate occasions for two overnight evaluations on both a closed-loop system and open-loop pump therapy.

The teens were evaluated on the night after an afternoon exercise period, and on a second night after being sedentary during the same time of day as the exercise. Investigators found that with the closed-loop system, there were only three episodes of hypoglycemia requiring treatment during all test nights, and only one on a night following exercise. In contrast, there were 22 total hypoglycemic excursions requiring treatment among the patients when they were on the open-loop system, including 14 on the night following exercise. (This study has been submitted for publication.)

Researchers are also investigating whether the addition of pramlintide to insulin could improve the performance of a closed-loop system by reducing peak postprandial glucose excursions. Another line of investigation is seeking to determine whether a combination of insulin and glucagon through a dual-hormone infusion pump could reduce the risk of late postmeal and nocturnal hypoglycemia by feedback-controlled infusion of minidoses.

In addition, investigators are focusing on techniques to increase the rate of insulin absorption by warming the insulin site, using faster-acting insulins, and coformulating insulins with hyaluronidase to reduce the variability of absorption of rapid analogue insulins such as insulin lispro (Humalog) or insulin aspart (NovoLog).

But before closed-loop systems can be confidently used in the outpatient setting, several kinks still need to be worked out.

"The major obstacle, without a doubt in my mind, is that every safeguard must be in place to prevent injury to a patient due to insulin overdelivery as a result of a system error," Dr. Tamborlane said.

He disclosed serving as a consultant to Boehringer Ingelheim, Halozyme, Insuluine, LifeScan/Animas, Medtronic, Novo Nordisk, and Unomedical, and serving on the Novo Nordisk speakers bureau.

cardiologynews@frontlinemedcom.com

NEW YORK – Insulin pumps, continuous glucose monitors, and controller algorithms are all available off the shelf, but the reality of assembling them into a "set-and-forget" artificial pancreas is still some time away, according to Dr. William Tamborlane.

Postprandial hyperglycemia and nocturnal hypoglycemia excursions remain obstacles to the full implementation of "closed-loop" artificial pancreas systems that closely mimic the function of the human pancreas, said Dr. Tamborlane, professor of pediatrics at Yale University in New Haven, Conn.

In the past 2 decades, there have been substantial improvements in diabetes care, with the advent of insulin analogues, pramlintide as an aid in the absorption of glucose, smart insulin pumps, and continuous glucose monitoring systems, Dr. Tamborlane said at the annual advanced postgraduate course held by the American Diabetes Association.

However, as long-term follow-up data from the Type 1 Diabetes Exchange consortium show, "the findings are particularly disheartening for pediatrics, in that adolescents still have a mean hemoglobin A_1c at the best centers of 8.7%. Too many type 1 diabetes patients fail to achieve target A_1c goals," he commented.

In addition, while the relative risk of severe hypoglycemia with good glucose management has declined, it is an ever-present danger, and new diabetes technologies implemented in clinical practice have only added to the already high burden of care for both patients and practitioners.

"Certainly we would be delighted if there was a biological solution to type 1 diabetes that we could just cook up in our laboratories: [Grow] large numbers of beta [islet] cells based on stem-cell technology, infuse them into patients, and take away the problem of type 1 diabetes entirely. But the truth is that current transplant technologies, both whole pancreas and islet transplants, have their challenges and are only limited to a small segment of the population," he said.

Parts of the whole

The best current alternative, therefore, is a closed-loop artificial pancreas consisting of proven technologies combined into a single system.

For example, insulin pumps have been in use for decades, are continually being improved, and are now used by many children, adolescents, and young adults with type 1 diabetes. Continuous glucose monitors have been commercially available for more than 10 years, and have been shown to work in open-loop systems. Controller algorithms for dispensing insulin according to varying physiologic demands are also available, including PID (proportional-integral-derivative), MPC (Model Predictive Control), and fuzzy logic.

"Airplanes run on controller algorithms [as do] electrical generating plants, so there is plenty of information that could be applied to running an insulin pump based on basic engineering controller algorithms," Dr. Tamborlane said.

But early experience with a closed-loop system (Diabetes 2006;55:3344-50) showed exaggerated postmeal hyperglycemia excursions and a tendency toward late postprandial hypoglycemia from time lags in carbohydrate absorption, insulin absorption from the cutaneous infusion site (rather than the normal anatomic site, the portal vein of the liver), and from late increases in interstitial glucose concentrations.

"Overnight control was excellent, but you always worry that when you have thousands of patients on this treatment, you’re going to get some problems with sensors that are overreading which can cause hypoglycemia," he said.

Possible solutions to these problems include a hybrid design, for a semiautomatic control that will allow the patient to "prime" the pump with a conventional premeal bolus to account for some of the carbohydrate in a meal, and adjusting the sensor to a slightly higher-than-normal target glucose to prevent nocturnal hypoglycemia.

"Instead of trying to shoot for a morning serum glucose of 80 [mg/dL], why don’t we try to shoot for 120? Would you mind if, on average, your patients woke up every morning with a mean glucose of 120 mg/dL? I don’t think so."

Real-life conditions

Current artificial pancreas research is focused on testing the devices used in real-world situations but in a controlled inpatient testing environment.

In one such study, Dr. Tamborlane and his colleagues investigated whether the use of a closed-loop system can reduce the risk of delayed nocturnal hypoglycemia following exercise during the day. They enrolled 12 adolescents with type 1 diabetes and mean HbA_1c levels of 7.4%, and admitted them to the research unit on two separate occasions for two overnight evaluations on both a closed-loop system and open-loop pump therapy.

The teens were evaluated on the night after an afternoon exercise period, and on a second night after being sedentary during the same time of day as the exercise. Investigators found that with the closed-loop system, there were only three episodes of hypoglycemia requiring treatment during all test nights, and only one on a night following exercise. In contrast, there were 22 total hypoglycemic excursions requiring treatment among the patients when they were on the open-loop system, including 14 on the night following exercise. (This study has been submitted for publication.)

Researchers are also investigating whether the addition of pramlintide to insulin could improve the performance of a closed-loop system by reducing peak postprandial glucose excursions. Another line of investigation is seeking to determine whether a combination of insulin and glucagon through a dual-hormone infusion pump could reduce the risk of late postmeal and nocturnal hypoglycemia by feedback-controlled infusion of minidoses.

In addition, investigators are focusing on techniques to increase the rate of insulin absorption by warming the insulin site, using faster-acting insulins, and coformulating insulins with hyaluronidase to reduce the variability of absorption of rapid analogue insulins such as insulin lispro (Humalog) or insulin aspart (NovoLog).

But before closed-loop systems can be confidently used in the outpatient setting, several kinks still need to be worked out.

"The major obstacle, without a doubt in my mind, is that every safeguard must be in place to prevent injury to a patient due to insulin overdelivery as a result of a system error," Dr. Tamborlane said.

He disclosed serving as a consultant to Boehringer Ingelheim, Halozyme, Insuluine, LifeScan/Animas, Medtronic, Novo Nordisk, and Unomedical, and serving on the Novo Nordisk speakers bureau.

cardiologynews@frontlinemedcom.com

NEW YORK – Insulin pumps, continuous glucose monitors, and controller algorithms are all available off the shelf, but the reality of assembling them into a "set-and-forget" artificial pancreas is still some time away, according to Dr. William Tamborlane.

Postprandial hyperglycemia and nocturnal hypoglycemia excursions remain obstacles to the full implementation of "closed-loop" artificial pancreas systems that closely mimic the function of the human pancreas, said Dr. Tamborlane, professor of pediatrics at Yale University in New Haven, Conn.

In the past 2 decades, there have been substantial improvements in diabetes care, with the advent of insulin analogues, pramlintide as an aid in the absorption of glucose, smart insulin pumps, and continuous glucose monitoring systems, Dr. Tamborlane said at the annual advanced postgraduate course held by the American Diabetes Association.

However, as long-term follow-up data from the Type 1 Diabetes Exchange consortium show, "the findings are particularly disheartening for pediatrics, in that adolescents still have a mean hemoglobin A_1c at the best centers of 8.7%. Too many type 1 diabetes patients fail to achieve target A_1c goals," he commented.

In addition, while the relative risk of severe hypoglycemia with good glucose management has declined, it is an ever-present danger, and new diabetes technologies implemented in clinical practice have only added to the already high burden of care for both patients and practitioners.

"Certainly we would be delighted if there was a biological solution to type 1 diabetes that we could just cook up in our laboratories: [Grow] large numbers of beta [islet] cells based on stem-cell technology, infuse them into patients, and take away the problem of type 1 diabetes entirely. But the truth is that current transplant technologies, both whole pancreas and islet transplants, have their challenges and are only limited to a small segment of the population," he said.

Parts of the whole

The best current alternative, therefore, is a closed-loop artificial pancreas consisting of proven technologies combined into a single system.

For example, insulin pumps have been in use for decades, are continually being improved, and are now used by many children, adolescents, and young adults with type 1 diabetes. Continuous glucose monitors have been commercially available for more than 10 years, and have been shown to work in open-loop systems. Controller algorithms for dispensing insulin according to varying physiologic demands are also available, including PID (proportional-integral-derivative), MPC (Model Predictive Control), and fuzzy logic.

"Airplanes run on controller algorithms [as do] electrical generating plants, so there is plenty of information that could be applied to running an insulin pump based on basic engineering controller algorithms," Dr. Tamborlane said.

But early experience with a closed-loop system (Diabetes 2006;55:3344-50) showed exaggerated postmeal hyperglycemia excursions and a tendency toward late postprandial hypoglycemia from time lags in carbohydrate absorption, insulin absorption from the cutaneous infusion site (rather than the normal anatomic site, the portal vein of the liver), and from late increases in interstitial glucose concentrations.

"Overnight control was excellent, but you always worry that when you have thousands of patients on this treatment, you’re going to get some problems with sensors that are overreading which can cause hypoglycemia," he said.

Possible solutions to these problems include a hybrid design, for a semiautomatic control that will allow the patient to "prime" the pump with a conventional premeal bolus to account for some of the carbohydrate in a meal, and adjusting the sensor to a slightly higher-than-normal target glucose to prevent nocturnal hypoglycemia.

"Instead of trying to shoot for a morning serum glucose of 80 [mg/dL], why don’t we try to shoot for 120? Would you mind if, on average, your patients woke up every morning with a mean glucose of 120 mg/dL? I don’t think so."

Real-life conditions

Current artificial pancreas research is focused on testing the devices used in real-world situations but in a controlled inpatient testing environment.

In one such study, Dr. Tamborlane and his colleagues investigated whether the use of a closed-loop system can reduce the risk of delayed nocturnal hypoglycemia following exercise during the day. They enrolled 12 adolescents with type 1 diabetes and mean HbA_1c levels of 7.4%, and admitted them to the research unit on two separate occasions for two overnight evaluations on both a closed-loop system and open-loop pump therapy.

The teens were evaluated on the night after an afternoon exercise period, and on a second night after being sedentary during the same time of day as the exercise. Investigators found that with the closed-loop system, there were only three episodes of hypoglycemia requiring treatment during all test nights, and only one on a night following exercise. In contrast, there were 22 total hypoglycemic excursions requiring treatment among the patients when they were on the open-loop system, including 14 on the night following exercise. (This study has been submitted for publication.)

Researchers are also investigating whether the addition of pramlintide to insulin could improve the performance of a closed-loop system by reducing peak postprandial glucose excursions. Another line of investigation is seeking to determine whether a combination of insulin and glucagon through a dual-hormone infusion pump could reduce the risk of late postmeal and nocturnal hypoglycemia by feedback-controlled infusion of minidoses.

In addition, investigators are focusing on techniques to increase the rate of insulin absorption by warming the insulin site, using faster-acting insulins, and coformulating insulins with hyaluronidase to reduce the variability of absorption of rapid analogue insulins such as insulin lispro (Humalog) or insulin aspart (NovoLog).

But before closed-loop systems can be confidently used in the outpatient setting, several kinks still need to be worked out.

"The major obstacle, without a doubt in my mind, is that every safeguard must be in place to prevent injury to a patient due to insulin overdelivery as a result of a system error," Dr. Tamborlane said.

He disclosed serving as a consultant to Boehringer Ingelheim, Halozyme, Insuluine, LifeScan/Animas, Medtronic, Novo Nordisk, and Unomedical, and serving on the Novo Nordisk speakers bureau.

cardiologynews@frontlinemedcom.com

A diagnosis of diabetes mellitus does not disqualify a person from driving, but symptoms such as peripheral neuropathy and retinopathy, as well as treatment consequences such as hypoglycemia, can increase the risk of driving impairment, said Dr. Daniel Lorber, a specialist in diabetes and the law.

The ADA recommends that when considering the fitness for driving of a patient with diabetes controlled with insulin, the physician should evaluate patients’ hypoglycemia history and risk, ability to detect early hypoglycemia, their ability to self-monitor blood glucose and manage their disease, and whether they have diabetes-related complications that may impair their ability to drive safely, Dr. Lorber, director of endocrinology at New York Hospital, Queens, said at the annual advanced postgraduate course held by the American Diabetes Association.

"There really is a whole variety of variables in diabetes, not merely aging, and not merely hypoglycemia, that affect how people drive, but we do know that moderate hypoglycemia does impair driving safety," said Dr. Lorber, who also serves on the ADA’s legal advocacy subcommittee.

"You can’t make driving safe. Frankly, you can’t make crossing the street safe; you can just make diabetic driving less dangerous," he said.

Fifty-one licensing authorities

There is great variability among patients with diabetes, he noted, and decisions about driving ability have to be made on a case-by-case basis. The clinician’s task is made harder by the jumble of state licensing authorities (51, including the District of Columbia), and, for commercial drivers, federal licensing regulations from the U.S. Department of Transportation and the Federal Motor Carrier Safety Administration (FMCSA).

Regulations vary from one state to the next, but most require evaluation of patients with diabetes following a motor vehicle accident, and a few states, such as Pennsylvania, have specific referral requirements to the department of motor vehicles after a severe hypoglycemic event, with or without a motor vehicle. State mandatory reporting laws may put physicians who care for diabetes patients in a bind, caught between state requirements and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy mandates, Dr. Lorber said.

For commercial drivers who engage in interstate commerce, the federal government bans commercial licensure of people with insulin-treated diabetes, except those who meet stringent requirements that include being on insulin for a minimum of 1-2 months, no severe hypoglycemia in the past 12 months and no more than two severe episodes over the preceding 5 years, and no unstable retinopathy or other disqualifying condition. Additionally, commercial drivers must demonstrate diabetes education and willingness to manage their condition, maintain a driving and blood glucose log, check their blood sugars every 2-4 hours and only drive if their levels are between 100 and 400 mg/dL, submit quarterly and annual reports to the U.S. Department of Transportation, and report all motor vehicle accidents and adverse driving events.

A systematic review of the data on diabetes and driving risk prepared for the FMCSA had equivocal results, finding on the one hand that there was no evidence for a higher risk of crashes among people on insulin, but on the other hand that "hypoglycemia has a significant deleterious effect on the driving ability of some individuals with type 1 DM when measured using a driving simulator."

The review authors noted that in three small studies, there was a suggestion of a deleterious relationship between hypoglycemia and simulated driving tasks, but they saw no consistent pattern of impairment or the sensitivity of task impairments associated with specific levels of hypoglycemia.

Relatively low risk

Based on data from the systematic review, Dr. Lorber estimated the relative risk for motor vehicle accidents in persons with any type of diabetes to be 1.12 to 1.19 times higher than that of controls, and for patients with type 1 DM and a history of severe hypoglycemia within the prior 2 years: 1.5 to 2 times higher.

Both compare favorably to the accident risk for 16-year-old males compared with 35- to 45-year-old females (42-fold), rural vs. urban highways (9.2-fold more accidents on rural highways), and 1 a.m. Sunday vs. 11 a.m. Sunday (142 times higher at 1 am).

Dr. Lorber also pointed out that nondiabetic drivers are also exposed to risks from sedating over-the-counter medications sold in convenience stores and gas station mini marts, such as diphenhydramine (Benadryl)-containing products, Tylenol Allergy (acetaminophen with chlorpheniramine), or NyQuil, a cold medicine that contains the antihistamine doxylamine.

To make driving safer for those at risk for hypoglycemia, he recommends measuring blood glucose before driving and never driving with values from 70 to 90 mg/dL without first having prophylactic carbohydrates, never driving with a blood glucose below 70 mg/dL, and treating prophylactically during long drives,

Additionally, if the driver detects hypoglycemia while driving, he or she should immediately pull off the road and consume a fast-acting carbohydrate with dextrose, and not resume driving until the blood glucose is above 90 mg/dL.

"Have something readily available in the car – not in the trunk, not even in the glove compartment. It ought to be in the little pocket in the seat next to you or where the ashtray used to be," he advised.

The driver should also have a medical alert bracelet to alert police or passersby that they are not intoxicated but instead have diabetes should they lose consciousness, he added.

Dr. Lorber reported having no financial disclosures.

A diagnosis of diabetes mellitus does not disqualify a person from driving, but symptoms such as peripheral neuropathy and retinopathy, as well as treatment consequences such as hypoglycemia, can increase the risk of driving impairment, said Dr. Daniel Lorber, a specialist in diabetes and the law.

The ADA recommends that when considering the fitness for driving of a patient with diabetes controlled with insulin, the physician should evaluate patients’ hypoglycemia history and risk, ability to detect early hypoglycemia, their ability to self-monitor blood glucose and manage their disease, and whether they have diabetes-related complications that may impair their ability to drive safely, Dr. Lorber, director of endocrinology at New York Hospital, Queens, said at the annual advanced postgraduate course held by the American Diabetes Association.

"There really is a whole variety of variables in diabetes, not merely aging, and not merely hypoglycemia, that affect how people drive, but we do know that moderate hypoglycemia does impair driving safety," said Dr. Lorber, who also serves on the ADA’s legal advocacy subcommittee.

"You can’t make driving safe. Frankly, you can’t make crossing the street safe; you can just make diabetic driving less dangerous," he said.

Fifty-one licensing authorities

There is great variability among patients with diabetes, he noted, and decisions about driving ability have to be made on a case-by-case basis. The clinician’s task is made harder by the jumble of state licensing authorities (51, including the District of Columbia), and, for commercial drivers, federal licensing regulations from the U.S. Department of Transportation and the Federal Motor Carrier Safety Administration (FMCSA).

Regulations vary from one state to the next, but most require evaluation of patients with diabetes following a motor vehicle accident, and a few states, such as Pennsylvania, have specific referral requirements to the department of motor vehicles after a severe hypoglycemic event, with or without a motor vehicle. State mandatory reporting laws may put physicians who care for diabetes patients in a bind, caught between state requirements and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy mandates, Dr. Lorber said.

For commercial drivers who engage in interstate commerce, the federal government bans commercial licensure of people with insulin-treated diabetes, except those who meet stringent requirements that include being on insulin for a minimum of 1-2 months, no severe hypoglycemia in the past 12 months and no more than two severe episodes over the preceding 5 years, and no unstable retinopathy or other disqualifying condition. Additionally, commercial drivers must demonstrate diabetes education and willingness to manage their condition, maintain a driving and blood glucose log, check their blood sugars every 2-4 hours and only drive if their levels are between 100 and 400 mg/dL, submit quarterly and annual reports to the U.S. Department of Transportation, and report all motor vehicle accidents and adverse driving events.

A systematic review of the data on diabetes and driving risk prepared for the FMCSA had equivocal results, finding on the one hand that there was no evidence for a higher risk of crashes among people on insulin, but on the other hand that "hypoglycemia has a significant deleterious effect on the driving ability of some individuals with type 1 DM when measured using a driving simulator."

The review authors noted that in three small studies, there was a suggestion of a deleterious relationship between hypoglycemia and simulated driving tasks, but they saw no consistent pattern of impairment or the sensitivity of task impairments associated with specific levels of hypoglycemia.

Relatively low risk

Based on data from the systematic review, Dr. Lorber estimated the relative risk for motor vehicle accidents in persons with any type of diabetes to be 1.12 to 1.19 times higher than that of controls, and for patients with type 1 DM and a history of severe hypoglycemia within the prior 2 years: 1.5 to 2 times higher.

Both compare favorably to the accident risk for 16-year-old males compared with 35- to 45-year-old females (42-fold), rural vs. urban highways (9.2-fold more accidents on rural highways), and 1 a.m. Sunday vs. 11 a.m. Sunday (142 times higher at 1 am).

Dr. Lorber also pointed out that nondiabetic drivers are also exposed to risks from sedating over-the-counter medications sold in convenience stores and gas station mini marts, such as diphenhydramine (Benadryl)-containing products, Tylenol Allergy (acetaminophen with chlorpheniramine), or NyQuil, a cold medicine that contains the antihistamine doxylamine.

To make driving safer for those at risk for hypoglycemia, he recommends measuring blood glucose before driving and never driving with values from 70 to 90 mg/dL without first having prophylactic carbohydrates, never driving with a blood glucose below 70 mg/dL, and treating prophylactically during long drives,

Additionally, if the driver detects hypoglycemia while driving, he or she should immediately pull off the road and consume a fast-acting carbohydrate with dextrose, and not resume driving until the blood glucose is above 90 mg/dL.

"Have something readily available in the car – not in the trunk, not even in the glove compartment. It ought to be in the little pocket in the seat next to you or where the ashtray used to be," he advised.

The driver should also have a medical alert bracelet to alert police or passersby that they are not intoxicated but instead have diabetes should they lose consciousness, he added.

Dr. Lorber reported having no financial disclosures.

A diagnosis of diabetes mellitus does not disqualify a person from driving, but symptoms such as peripheral neuropathy and retinopathy, as well as treatment consequences such as hypoglycemia, can increase the risk of driving impairment, said Dr. Daniel Lorber, a specialist in diabetes and the law.

The ADA recommends that when considering the fitness for driving of a patient with diabetes controlled with insulin, the physician should evaluate patients’ hypoglycemia history and risk, ability to detect early hypoglycemia, their ability to self-monitor blood glucose and manage their disease, and whether they have diabetes-related complications that may impair their ability to drive safely, Dr. Lorber, director of endocrinology at New York Hospital, Queens, said at the annual advanced postgraduate course held by the American Diabetes Association.

"There really is a whole variety of variables in diabetes, not merely aging, and not merely hypoglycemia, that affect how people drive, but we do know that moderate hypoglycemia does impair driving safety," said Dr. Lorber, who also serves on the ADA’s legal advocacy subcommittee.

"You can’t make driving safe. Frankly, you can’t make crossing the street safe; you can just make diabetic driving less dangerous," he said.

Fifty-one licensing authorities

There is great variability among patients with diabetes, he noted, and decisions about driving ability have to be made on a case-by-case basis. The clinician’s task is made harder by the jumble of state licensing authorities (51, including the District of Columbia), and, for commercial drivers, federal licensing regulations from the U.S. Department of Transportation and the Federal Motor Carrier Safety Administration (FMCSA).

Regulations vary from one state to the next, but most require evaluation of patients with diabetes following a motor vehicle accident, and a few states, such as Pennsylvania, have specific referral requirements to the department of motor vehicles after a severe hypoglycemic event, with or without a motor vehicle. State mandatory reporting laws may put physicians who care for diabetes patients in a bind, caught between state requirements and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy mandates, Dr. Lorber said.

For commercial drivers who engage in interstate commerce, the federal government bans commercial licensure of people with insulin-treated diabetes, except those who meet stringent requirements that include being on insulin for a minimum of 1-2 months, no severe hypoglycemia in the past 12 months and no more than two severe episodes over the preceding 5 years, and no unstable retinopathy or other disqualifying condition. Additionally, commercial drivers must demonstrate diabetes education and willingness to manage their condition, maintain a driving and blood glucose log, check their blood sugars every 2-4 hours and only drive if their levels are between 100 and 400 mg/dL, submit quarterly and annual reports to the U.S. Department of Transportation, and report all motor vehicle accidents and adverse driving events.

A systematic review of the data on diabetes and driving risk prepared for the FMCSA had equivocal results, finding on the one hand that there was no evidence for a higher risk of crashes among people on insulin, but on the other hand that "hypoglycemia has a significant deleterious effect on the driving ability of some individuals with type 1 DM when measured using a driving simulator."

The review authors noted that in three small studies, there was a suggestion of a deleterious relationship between hypoglycemia and simulated driving tasks, but they saw no consistent pattern of impairment or the sensitivity of task impairments associated with specific levels of hypoglycemia.

Relatively low risk

Based on data from the systematic review, Dr. Lorber estimated the relative risk for motor vehicle accidents in persons with any type of diabetes to be 1.12 to 1.19 times higher than that of controls, and for patients with type 1 DM and a history of severe hypoglycemia within the prior 2 years: 1.5 to 2 times higher.

Both compare favorably to the accident risk for 16-year-old males compared with 35- to 45-year-old females (42-fold), rural vs. urban highways (9.2-fold more accidents on rural highways), and 1 a.m. Sunday vs. 11 a.m. Sunday (142 times higher at 1 am).

Dr. Lorber also pointed out that nondiabetic drivers are also exposed to risks from sedating over-the-counter medications sold in convenience stores and gas station mini marts, such as diphenhydramine (Benadryl)-containing products, Tylenol Allergy (acetaminophen with chlorpheniramine), or NyQuil, a cold medicine that contains the antihistamine doxylamine.

To make driving safer for those at risk for hypoglycemia, he recommends measuring blood glucose before driving and never driving with values from 70 to 90 mg/dL without first having prophylactic carbohydrates, never driving with a blood glucose below 70 mg/dL, and treating prophylactically during long drives,

Additionally, if the driver detects hypoglycemia while driving, he or she should immediately pull off the road and consume a fast-acting carbohydrate with dextrose, and not resume driving until the blood glucose is above 90 mg/dL.

"Have something readily available in the car – not in the trunk, not even in the glove compartment. It ought to be in the little pocket in the seat next to you or where the ashtray used to be," he advised.

The driver should also have a medical alert bracelet to alert police or passersby that they are not intoxicated but instead have diabetes should they lose consciousness, he added.

Dr. Lorber reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.