Miriam E. Tucker

AMSTERDAM — More than 90% of all teenagers with type 1 diabetes omit insulin doses at least occasionally to prevent weight gain, according to the results of an international observational study presented by Dr. Soren E. Skovlund at the annual meeting of the European Association for the Study of Diabetes.

The practice is associated with significantly poorer glycemic control. “Screening for and dialog with adolescents about omission of insulin injections may be particularly warranted in those who exhibit concern about their weight or engage in weight-reducing activities,” said Dr. Skovlund, global director of patient-focused programs at Novo Nordisk A/S, Bagsvaerd, Denmark.

A total of 2,062 adolescents aged 11–18 years with type 1 diabetes of at least 1 year's duration completed the survey, conducted in 2005 by the Novo-Nordisk-funded Hvidoere Study Group. The respondents were from 21 centers in Europe, Australia, Japan, and North America. There was one U.S. center, at Children's Hospital, Los Angeles.

The study group was equally divided between genders. Both genders had a mean age of 14.5 years, and mean diabetes duration of 6.3 years for the females and 5.9 years for the males. Mean body mass indices were 22.8 kg/m

Each was asked to complete an extensive questionnaire covering topics such as lifestyle, self-management and health behaviors, treatment goals, family dynamics, well-being and quality of life, diabetes burden, and weight perception/dieting. Also included was the question: “How often do you miss insulin to control your weight?” Possible responses were “never,” “once a month,” “once a week,” or “every day.”

The majority—91.7% of the females and 93.0% of the males—checked “once a month.” “Never” was a distant second, reported by 5.1% of females and 4.2% of males, followed by “once a week” (2.5% female/1.9% male) and “every day” (0.7% female/0.9% male).

“This was not just in general, but specifically to avoid weight gain. Clearly, people are connecting the two aspects,” Dr. Skovlund said.

The nearly equal proportion of males and females is striking. “A lot of the insulin omission literature has focused on this being a female phenomenon. … But we have certainly also seen it in boys.”

Those who reported omitting insulin doses either daily or weekly (“high omitters”) had poorer metabolic control, and averaged a significant difference of half a percentage point in hemoglobin A_1c values, compared with the “low omitters,” those who omitted never or monthly (8.99% female/8.61% male vs. 8.24% female/8.08% male). Insulin omission remained significantly correlated with HbA_1c after controlling for age and diabetes duration, but not gender.

Insulin omission also was highly correlated with other weight-loss behaviors, such as fasting, restricting certain food groups, vomiting, and use of diet pills/laxatives, as well as reduced well-being and quality of life. None of the associations significantly differed by center. Insulin omission was reported both by patients on multiple daily injections as well as those on insulin pumps (who made up approximately 20% of the overall group).

Dr. Francine R. Kaufman, a pediatric endocrinologist who heads the Los Angeles center said: “Kids miss doses all the time. … The question is why.” In the United States the practice of omitting insulin for weight control has been dubbed “diabulemia,” she noted in an interview.

But the thought process may not always be straightforward. Teens might rationalize that they didn't eat as much as they did, or that they don't need as much insulin as they actually do. Often, it's not about completely omitting a dose but of not taking enough for the amount of food consumed. “A lot of it is not totally willful, [more like] miscalculating the dose.”

The literature has focused on this as a female phenomenon, but 'we have certainly also seen it in boys.' DR. SKOVLUND

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — More than 90% of all teenagers with type 1 diabetes omit insulin doses at least occasionally to prevent weight gain, according to the results of an international observational study presented by Dr. Soren E. Skovlund at the annual meeting of the European Association for the Study of Diabetes.

The practice is associated with significantly poorer glycemic control. “Screening for and dialog with adolescents about omission of insulin injections may be particularly warranted in those who exhibit concern about their weight or engage in weight-reducing activities,” said Dr. Skovlund, global director of patient-focused programs at Novo Nordisk A/S, Bagsvaerd, Denmark.

A total of 2,062 adolescents aged 11–18 years with type 1 diabetes of at least 1 year's duration completed the survey, conducted in 2005 by the Novo-Nordisk-funded Hvidoere Study Group. The respondents were from 21 centers in Europe, Australia, Japan, and North America. There was one U.S. center, at Children's Hospital, Los Angeles.

The study group was equally divided between genders. Both genders had a mean age of 14.5 years, and mean diabetes duration of 6.3 years for the females and 5.9 years for the males. Mean body mass indices were 22.8 kg/m

Each was asked to complete an extensive questionnaire covering topics such as lifestyle, self-management and health behaviors, treatment goals, family dynamics, well-being and quality of life, diabetes burden, and weight perception/dieting. Also included was the question: “How often do you miss insulin to control your weight?” Possible responses were “never,” “once a month,” “once a week,” or “every day.”

The majority—91.7% of the females and 93.0% of the males—checked “once a month.” “Never” was a distant second, reported by 5.1% of females and 4.2% of males, followed by “once a week” (2.5% female/1.9% male) and “every day” (0.7% female/0.9% male).

“This was not just in general, but specifically to avoid weight gain. Clearly, people are connecting the two aspects,” Dr. Skovlund said.

The nearly equal proportion of males and females is striking. “A lot of the insulin omission literature has focused on this being a female phenomenon. … But we have certainly also seen it in boys.”

Those who reported omitting insulin doses either daily or weekly (“high omitters”) had poorer metabolic control, and averaged a significant difference of half a percentage point in hemoglobin A_1c values, compared with the “low omitters,” those who omitted never or monthly (8.99% female/8.61% male vs. 8.24% female/8.08% male). Insulin omission remained significantly correlated with HbA_1c after controlling for age and diabetes duration, but not gender.

Insulin omission also was highly correlated with other weight-loss behaviors, such as fasting, restricting certain food groups, vomiting, and use of diet pills/laxatives, as well as reduced well-being and quality of life. None of the associations significantly differed by center. Insulin omission was reported both by patients on multiple daily injections as well as those on insulin pumps (who made up approximately 20% of the overall group).

Dr. Francine R. Kaufman, a pediatric endocrinologist who heads the Los Angeles center said: “Kids miss doses all the time. … The question is why.” In the United States the practice of omitting insulin for weight control has been dubbed “diabulemia,” she noted in an interview.

But the thought process may not always be straightforward. Teens might rationalize that they didn't eat as much as they did, or that they don't need as much insulin as they actually do. Often, it's not about completely omitting a dose but of not taking enough for the amount of food consumed. “A lot of it is not totally willful, [more like] miscalculating the dose.”

The literature has focused on this as a female phenomenon, but 'we have certainly also seen it in boys.' DR. SKOVLUND

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — More than 90% of all teenagers with type 1 diabetes omit insulin doses at least occasionally to prevent weight gain, according to the results of an international observational study presented by Dr. Soren E. Skovlund at the annual meeting of the European Association for the Study of Diabetes.

The practice is associated with significantly poorer glycemic control. “Screening for and dialog with adolescents about omission of insulin injections may be particularly warranted in those who exhibit concern about their weight or engage in weight-reducing activities,” said Dr. Skovlund, global director of patient-focused programs at Novo Nordisk A/S, Bagsvaerd, Denmark.

A total of 2,062 adolescents aged 11–18 years with type 1 diabetes of at least 1 year's duration completed the survey, conducted in 2005 by the Novo-Nordisk-funded Hvidoere Study Group. The respondents were from 21 centers in Europe, Australia, Japan, and North America. There was one U.S. center, at Children's Hospital, Los Angeles.

The study group was equally divided between genders. Both genders had a mean age of 14.5 years, and mean diabetes duration of 6.3 years for the females and 5.9 years for the males. Mean body mass indices were 22.8 kg/m

Each was asked to complete an extensive questionnaire covering topics such as lifestyle, self-management and health behaviors, treatment goals, family dynamics, well-being and quality of life, diabetes burden, and weight perception/dieting. Also included was the question: “How often do you miss insulin to control your weight?” Possible responses were “never,” “once a month,” “once a week,” or “every day.”

The majority—91.7% of the females and 93.0% of the males—checked “once a month.” “Never” was a distant second, reported by 5.1% of females and 4.2% of males, followed by “once a week” (2.5% female/1.9% male) and “every day” (0.7% female/0.9% male).

“This was not just in general, but specifically to avoid weight gain. Clearly, people are connecting the two aspects,” Dr. Skovlund said.

The nearly equal proportion of males and females is striking. “A lot of the insulin omission literature has focused on this being a female phenomenon. … But we have certainly also seen it in boys.”

Those who reported omitting insulin doses either daily or weekly (“high omitters”) had poorer metabolic control, and averaged a significant difference of half a percentage point in hemoglobin A_1c values, compared with the “low omitters,” those who omitted never or monthly (8.99% female/8.61% male vs. 8.24% female/8.08% male). Insulin omission remained significantly correlated with HbA_1c after controlling for age and diabetes duration, but not gender.

Insulin omission also was highly correlated with other weight-loss behaviors, such as fasting, restricting certain food groups, vomiting, and use of diet pills/laxatives, as well as reduced well-being and quality of life. None of the associations significantly differed by center. Insulin omission was reported both by patients on multiple daily injections as well as those on insulin pumps (who made up approximately 20% of the overall group).

Dr. Francine R. Kaufman, a pediatric endocrinologist who heads the Los Angeles center said: “Kids miss doses all the time. … The question is why.” In the United States the practice of omitting insulin for weight control has been dubbed “diabulemia,” she noted in an interview.

But the thought process may not always be straightforward. Teens might rationalize that they didn't eat as much as they did, or that they don't need as much insulin as they actually do. Often, it's not about completely omitting a dose but of not taking enough for the amount of food consumed. “A lot of it is not totally willful, [more like] miscalculating the dose.”

The literature has focused on this as a female phenomenon, but 'we have certainly also seen it in boys.' DR. SKOVLUND

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — More than 90% of all teenagers with type 1 diabetes omit insulin doses at least occasionally in order to prevent weight gain, according to the results of an international observational study presented by Dr. Soren E. Skovlund at the annual meeting of the European Association for the Study of Diabetes.

Of concern, the practice is associated with significantly poorer glycemic control. “Screening for and dialog with adolescents about omission of insulin injections may be particularly warranted in those who exhibit concern about their weight or engage in weight-reducing activities,” said Dr. Skovlund, global director of patient-focused programs at Novo Nordisk A/S, Bagsvaerd, Denmark.

A total of 2,062 adolescents aged 11–18 years with type 1 diabetes of at least 1 year's duration completed the survey, conducted in 2005 by the Novo-Nordisk-funded Hvidoere Study Group. Respondents were from 21 centers in Europe, Australia, Japan, and North America. There was one U.S. center at Children's Hospital, Los Angeles.

The study group was 49.4% female and 50.6% male. Both genders had a mean age of 14.5 years, and mean diabetes duration of 6.3 years for the females and 5.9 years for the males. Mean body mass indices were 22.8 kg/m

Each adolescent was asked to complete an extensive questionnaire covering topics such as self-management and health behaviors, treatment goals, family dynamics, well-being and quality of life, diabetes burden, and weight perception/dieting. Also included was the question: “How often do you miss insulin to control your weight?” Possible responses were “never,” “once a month,” “once a week,” or “every day.”

The majority—91.7% of the females and 93.0% of the males—checked “once a month.” “Never” was a distant second, reported by 5.1% of females and 4.2% of males, followed by “once a week” (2.5% female/1.9% male) and “every day” (0.7% female/0.9% male).

“This was not just in general, but specifically to avoid weight gain. Clearly, people are connecting the two aspects,” Dr. Skovlund commented.

The nearly equal proportion of males and females is striking. “A lot of the insulin omission literature has focused on this being a female phenomenon. … But we have certainly also seen it in boys,” he said.

Not surprisingly, those who reported omitting insulin doses either daily or weekly (“high omitters”) had poorer metabolic control, and averaged a significant difference of half a percentage point in hemoglobin A_1c values, compared with the “low omitters,” those who omitted never or monthly (8.99% female/8.61% male vs. 8.24% female/8.08% male). Insulin omission remained significantly correlated with HbA_1c after controlling for age and diabetes duration, but not gender.

Insulin omission also was highly correlated with other weight-loss behaviors, such as fasting, vomiting, and use of diet pills/laxatives, as well as reduced well-being. Insulin omission was reported both by patients on multiple daily injections as well as those on insulin pumps (who made up about 20% of the overall group).

The findings are not all that surprising to pediatric endocrinologist Dr. Francine R. Kaufman, who heads the Los Angeles center: “Kids miss doses all the time. … The question is why.”

Her adolescent patient population with type 1 diabetes tends to be well educated and aware that insulin omission can control weight via glycosuria. In fact, in the United States the practice of omitting insulin by young people with type 1 diabetes in order to control weight has been dubbed “Diabulemia” and is currently a hot topic in the lay press, she noted in an interview.

But the thought process may not always be so straightforward. Rather, teens might rationalize to themselves that perhaps they didn't eat as much as they did, or that they don't need as much insulin as they actually do. “A lot of it is not totally willful, but kind of miscalculating the dose,” she remarked.

AMSTERDAM — More than 90% of all teenagers with type 1 diabetes omit insulin doses at least occasionally in order to prevent weight gain, according to the results of an international observational study presented by Dr. Soren E. Skovlund at the annual meeting of the European Association for the Study of Diabetes.

Of concern, the practice is associated with significantly poorer glycemic control. “Screening for and dialog with adolescents about omission of insulin injections may be particularly warranted in those who exhibit concern about their weight or engage in weight-reducing activities,” said Dr. Skovlund, global director of patient-focused programs at Novo Nordisk A/S, Bagsvaerd, Denmark.

A total of 2,062 adolescents aged 11–18 years with type 1 diabetes of at least 1 year's duration completed the survey, conducted in 2005 by the Novo-Nordisk-funded Hvidoere Study Group. Respondents were from 21 centers in Europe, Australia, Japan, and North America. There was one U.S. center at Children's Hospital, Los Angeles.

The study group was 49.4% female and 50.6% male. Both genders had a mean age of 14.5 years, and mean diabetes duration of 6.3 years for the females and 5.9 years for the males. Mean body mass indices were 22.8 kg/m

Each adolescent was asked to complete an extensive questionnaire covering topics such as self-management and health behaviors, treatment goals, family dynamics, well-being and quality of life, diabetes burden, and weight perception/dieting. Also included was the question: “How often do you miss insulin to control your weight?” Possible responses were “never,” “once a month,” “once a week,” or “every day.”

The majority—91.7% of the females and 93.0% of the males—checked “once a month.” “Never” was a distant second, reported by 5.1% of females and 4.2% of males, followed by “once a week” (2.5% female/1.9% male) and “every day” (0.7% female/0.9% male).

“This was not just in general, but specifically to avoid weight gain. Clearly, people are connecting the two aspects,” Dr. Skovlund commented.

The nearly equal proportion of males and females is striking. “A lot of the insulin omission literature has focused on this being a female phenomenon. … But we have certainly also seen it in boys,” he said.

Not surprisingly, those who reported omitting insulin doses either daily or weekly (“high omitters”) had poorer metabolic control, and averaged a significant difference of half a percentage point in hemoglobin A_1c values, compared with the “low omitters,” those who omitted never or monthly (8.99% female/8.61% male vs. 8.24% female/8.08% male). Insulin omission remained significantly correlated with HbA_1c after controlling for age and diabetes duration, but not gender.

Insulin omission also was highly correlated with other weight-loss behaviors, such as fasting, vomiting, and use of diet pills/laxatives, as well as reduced well-being. Insulin omission was reported both by patients on multiple daily injections as well as those on insulin pumps (who made up about 20% of the overall group).

The findings are not all that surprising to pediatric endocrinologist Dr. Francine R. Kaufman, who heads the Los Angeles center: “Kids miss doses all the time. … The question is why.”

Her adolescent patient population with type 1 diabetes tends to be well educated and aware that insulin omission can control weight via glycosuria. In fact, in the United States the practice of omitting insulin by young people with type 1 diabetes in order to control weight has been dubbed “Diabulemia” and is currently a hot topic in the lay press, she noted in an interview.

But the thought process may not always be so straightforward. Rather, teens might rationalize to themselves that perhaps they didn't eat as much as they did, or that they don't need as much insulin as they actually do. “A lot of it is not totally willful, but kind of miscalculating the dose,” she remarked.

AMSTERDAM — More than 90% of all teenagers with type 1 diabetes omit insulin doses at least occasionally in order to prevent weight gain, according to the results of an international observational study presented by Dr. Soren E. Skovlund at the annual meeting of the European Association for the Study of Diabetes.

Of concern, the practice is associated with significantly poorer glycemic control. “Screening for and dialog with adolescents about omission of insulin injections may be particularly warranted in those who exhibit concern about their weight or engage in weight-reducing activities,” said Dr. Skovlund, global director of patient-focused programs at Novo Nordisk A/S, Bagsvaerd, Denmark.

A total of 2,062 adolescents aged 11–18 years with type 1 diabetes of at least 1 year's duration completed the survey, conducted in 2005 by the Novo-Nordisk-funded Hvidoere Study Group. Respondents were from 21 centers in Europe, Australia, Japan, and North America. There was one U.S. center at Children's Hospital, Los Angeles.

The study group was 49.4% female and 50.6% male. Both genders had a mean age of 14.5 years, and mean diabetes duration of 6.3 years for the females and 5.9 years for the males. Mean body mass indices were 22.8 kg/m

Each adolescent was asked to complete an extensive questionnaire covering topics such as self-management and health behaviors, treatment goals, family dynamics, well-being and quality of life, diabetes burden, and weight perception/dieting. Also included was the question: “How often do you miss insulin to control your weight?” Possible responses were “never,” “once a month,” “once a week,” or “every day.”

The majority—91.7% of the females and 93.0% of the males—checked “once a month.” “Never” was a distant second, reported by 5.1% of females and 4.2% of males, followed by “once a week” (2.5% female/1.9% male) and “every day” (0.7% female/0.9% male).

“This was not just in general, but specifically to avoid weight gain. Clearly, people are connecting the two aspects,” Dr. Skovlund commented.

The nearly equal proportion of males and females is striking. “A lot of the insulin omission literature has focused on this being a female phenomenon. … But we have certainly also seen it in boys,” he said.

Not surprisingly, those who reported omitting insulin doses either daily or weekly (“high omitters”) had poorer metabolic control, and averaged a significant difference of half a percentage point in hemoglobin A_1c values, compared with the “low omitters,” those who omitted never or monthly (8.99% female/8.61% male vs. 8.24% female/8.08% male). Insulin omission remained significantly correlated with HbA_1c after controlling for age and diabetes duration, but not gender.

Insulin omission also was highly correlated with other weight-loss behaviors, such as fasting, vomiting, and use of diet pills/laxatives, as well as reduced well-being. Insulin omission was reported both by patients on multiple daily injections as well as those on insulin pumps (who made up about 20% of the overall group).

The findings are not all that surprising to pediatric endocrinologist Dr. Francine R. Kaufman, who heads the Los Angeles center: “Kids miss doses all the time. … The question is why.”

Her adolescent patient population with type 1 diabetes tends to be well educated and aware that insulin omission can control weight via glycosuria. In fact, in the United States the practice of omitting insulin by young people with type 1 diabetes in order to control weight has been dubbed “Diabulemia” and is currently a hot topic in the lay press, she noted in an interview.

But the thought process may not always be so straightforward. Rather, teens might rationalize to themselves that perhaps they didn't eat as much as they did, or that they don't need as much insulin as they actually do. “A lot of it is not totally willful, but kind of miscalculating the dose,” she remarked.

ST. LOUIS — Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

What's more, data suggest that the vast majority of obstructive sleep apnea (OSA) cases among people with and without diabetes are undiagnosed. “There is a large population of untreated OSA sufferers,” she said.

Because sleep apnea is so common among people with diabetes—concomitant with obesity and hypertension—the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA, and those found to have the condition are referred for treatment and follow-up.

In a study published by the Whittier's Dr. Daniel Einhorn and his associates, 72.4% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (35.8%) had an AHI of at least 15 events per hour, a more severe apnea level associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities such as body mass index (BMI), alcohol use, and cigarette smoking (Endocrine Practice 2007;13:355–62).

The proportion of those with an AHI at or above 15 events per hour was much higher among men than women (49% vs. 21%). Other significant risk factors included age 62 years and older, a BMI of 30 kg/m

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension), in 50% of those with congestive heart failure, and in 50% of those with atrial fibrillation. It is also found in 77% of the morbidly obese population.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas. The resulting higher cortisol levels are related to insulin resistance, which predisposes to impaired glucose tolerance and other cardiovascular risk factors, said Ms. LaRue, formerly with the Whittier Institute.

A study in which the results of overnight polysomnography and oral glucose tolerance testing were compared in 30 obese (but not diabetic) patients with OSA and in 27 equally obese individuals without OSA demonstrated that those who had OSA were more insulin resistant, independent of the degree and distribution of adiposity. The authors hypothesized that the worsening in insulin sensitivity in the OSA patients could reflect the hypoxic state and would account for the increased vascular risk (Clin. Endocrinol. 2003;59:374–9).

Treatment of OSA with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those who were given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the investigators said (Circulation 2003;107:68–73).

Insulin sensitivity was significantly improved at 2 days and at 3 months of CPAP therapy among 40 patients with an AHI greater than 20, more so among those with BMIs less than 30 kg/m

Another study of 25 patients with type 2 diabetes and sleep-disordered breathing demonstrated that an average of 83 days' treatment with CPAP significantly reduced postprandial glucose values, by about 60 mg/dL after each meal. Hemoglobin A_1c (HbA_1c) levels also dropped significantly among those with a baseline level greater than 7% (from 9.2% to 8.6%). Reduction in HbA_1c was significantly correlated with days of CPAP use among those who wore the device for more than 4 hours per day (Arch. Intern. Med. 2005;165:447–52).

Ms. LaRue noted, “When sleep apnea is treated appropriately, look at the benefits that can happen. … It's another tool to help our patients live healthier with their diabetes.

ST. LOUIS — Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

What's more, data suggest that the vast majority of obstructive sleep apnea (OSA) cases among people with and without diabetes are undiagnosed. “There is a large population of untreated OSA sufferers,” she said.

Because sleep apnea is so common among people with diabetes—concomitant with obesity and hypertension—the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA, and those found to have the condition are referred for treatment and follow-up.

In a study published by the Whittier's Dr. Daniel Einhorn and his associates, 72.4% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (35.8%) had an AHI of at least 15 events per hour, a more severe apnea level associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities such as body mass index (BMI), alcohol use, and cigarette smoking (Endocrine Practice 2007;13:355–62).

The proportion of those with an AHI at or above 15 events per hour was much higher among men than women (49% vs. 21%). Other significant risk factors included age 62 years and older, a BMI of 30 kg/m

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension), in 50% of those with congestive heart failure, and in 50% of those with atrial fibrillation. It is also found in 77% of the morbidly obese population.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas. The resulting higher cortisol levels are related to insulin resistance, which predisposes to impaired glucose tolerance and other cardiovascular risk factors, said Ms. LaRue, formerly with the Whittier Institute.

A study in which the results of overnight polysomnography and oral glucose tolerance testing were compared in 30 obese (but not diabetic) patients with OSA and in 27 equally obese individuals without OSA demonstrated that those who had OSA were more insulin resistant, independent of the degree and distribution of adiposity. The authors hypothesized that the worsening in insulin sensitivity in the OSA patients could reflect the hypoxic state and would account for the increased vascular risk (Clin. Endocrinol. 2003;59:374–9).

Treatment of OSA with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those who were given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the investigators said (Circulation 2003;107:68–73).

Insulin sensitivity was significantly improved at 2 days and at 3 months of CPAP therapy among 40 patients with an AHI greater than 20, more so among those with BMIs less than 30 kg/m

Another study of 25 patients with type 2 diabetes and sleep-disordered breathing demonstrated that an average of 83 days' treatment with CPAP significantly reduced postprandial glucose values, by about 60 mg/dL after each meal. Hemoglobin A_1c (HbA_1c) levels also dropped significantly among those with a baseline level greater than 7% (from 9.2% to 8.6%). Reduction in HbA_1c was significantly correlated with days of CPAP use among those who wore the device for more than 4 hours per day (Arch. Intern. Med. 2005;165:447–52).

Ms. LaRue noted, “When sleep apnea is treated appropriately, look at the benefits that can happen. … It's another tool to help our patients live healthier with their diabetes.

ST. LOUIS — Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

What's more, data suggest that the vast majority of obstructive sleep apnea (OSA) cases among people with and without diabetes are undiagnosed. “There is a large population of untreated OSA sufferers,” she said.

Because sleep apnea is so common among people with diabetes—concomitant with obesity and hypertension—the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA, and those found to have the condition are referred for treatment and follow-up.

In a study published by the Whittier's Dr. Daniel Einhorn and his associates, 72.4% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (35.8%) had an AHI of at least 15 events per hour, a more severe apnea level associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities such as body mass index (BMI), alcohol use, and cigarette smoking (Endocrine Practice 2007;13:355–62).

The proportion of those with an AHI at or above 15 events per hour was much higher among men than women (49% vs. 21%). Other significant risk factors included age 62 years and older, a BMI of 30 kg/m

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension), in 50% of those with congestive heart failure, and in 50% of those with atrial fibrillation. It is also found in 77% of the morbidly obese population.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas. The resulting higher cortisol levels are related to insulin resistance, which predisposes to impaired glucose tolerance and other cardiovascular risk factors, said Ms. LaRue, formerly with the Whittier Institute.

A study in which the results of overnight polysomnography and oral glucose tolerance testing were compared in 30 obese (but not diabetic) patients with OSA and in 27 equally obese individuals without OSA demonstrated that those who had OSA were more insulin resistant, independent of the degree and distribution of adiposity. The authors hypothesized that the worsening in insulin sensitivity in the OSA patients could reflect the hypoxic state and would account for the increased vascular risk (Clin. Endocrinol. 2003;59:374–9).

Treatment of OSA with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those who were given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the investigators said (Circulation 2003;107:68–73).

Insulin sensitivity was significantly improved at 2 days and at 3 months of CPAP therapy among 40 patients with an AHI greater than 20, more so among those with BMIs less than 30 kg/m

Another study of 25 patients with type 2 diabetes and sleep-disordered breathing demonstrated that an average of 83 days' treatment with CPAP significantly reduced postprandial glucose values, by about 60 mg/dL after each meal. Hemoglobin A_1c (HbA_1c) levels also dropped significantly among those with a baseline level greater than 7% (from 9.2% to 8.6%). Reduction in HbA_1c was significantly correlated with days of CPAP use among those who wore the device for more than 4 hours per day (Arch. Intern. Med. 2005;165:447–52).

Ms. LaRue noted, “When sleep apnea is treated appropriately, look at the benefits that can happen. … It's another tool to help our patients live healthier with their diabetes.

WASHINGTON — There's good and bad news from the 2006 National Survey on Drug Use and Health: Overall drug use among adolescents has declined since 2002, but prescription drug misuse among young adults has skyrocketed.

In the federally funded annual survey of approximately 67,500 Americans, the proportion of adolescents aged 12–17 years who acknowledged drug use in the past month dropped from 11.6% in 2002 to 9.8% in 2006, similar to the 9.9% level in 2005. Current marijuana use in that age group declined even more significantly in those 4 years, from 8.2% to 6.7%.

“Illicit drug use among youth [aged] 12–17 is at a 5-year low. That's definitely cause for celebration. Tobacco use continues to decline and perceptions about risk for marijuana use continue to increase, and that's a great combination,” said Terry L. Cline, Ph.D., administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), at a press briefing.

But nonmedical use of prescription drugs among young adults aged 18–25 years increased from 5.4% in 2002 to 6.4% in 2006, largely because of a rise in the nonmedical use of pain relievers. “The survey also tells us there is much work left to be done. Many of these painkillers being abused are unused medications that should have been properly disposed [of],” Dr. Cline said.

SAMHSA currently is involved in a national point-of-purchase public education campaign to release information about the proper disposal of unused medications. The information soon will be available at more than 6,300 pharmacies across the country, he said.

Underage drinking is another area of concern, as the level among 12- to 20-year-olds remains unchanged since 2002, at 28.3% in 2006. The Surgeon General's recently released Call to Action to Reduce and Prevent Underage Drinking is part of an interagency effort to target the problem, Dr. Cline noted.

John P. Walters, director of the White House Office of National Drug Control Policy (ONDCP), presented additional findings from the survey. Of note, he said, is that a huge difference in marijuana use was found between youth aged 12–17 years who reported that their parents strongly disapprove of marijuana use, at 4.6%, versus those who did not perceive strong parental disapproval, 26.5%, a fivefold difference.

Among young adults aged 18–24, the drop in marijuana use from 17.3% in 2002 to 16.3% in 2006 was “vastly overshadowed” by the increase in prescription drug use, 75% of which are pain relievers. That usage is now much greater than that of cocaine and heroin and is even reaching the initiation rate for marijuana. Most people who abuse prescription drugs get them from family and friends, Mr. Walters said.

“You have to help people understand that when they're done with prescription painkillers in particular, [they need to] throw them away. … We have to start remembering that OxyContin and Vicodin in the medicine cabinet today, if not protected, are as dangerous as cocaine and heroin,” said Mr. Walters, whose job title is known informally as “the nation's drug czar.”

A somewhat surprising finding is the striking rise in drug use rates among Baby Boomers aged 50–54, which shot up by over the 4-year survey period, from 3.4% to 6.0%. “What we have here is something we've never seen before: Increasing rates of illicit drug use among older Americans. This was typically a problem of youth. But today, we have older Americans bringing those levels of substance abuse with them [as they age]. … Once you become involved with these substances, it is very difficult to become clean and sober,” Mr. Walters noted.

Dr. Cline said SAMHSA is collaborating with various entities to address the issues brought out by the survey. Among those efforts are a partnership with the ONDCP to provide resources to more than 700 communities to prevent drug abuse and provision of grants to 34 states, 3 territories, and 5 tribal organizations to promote science-based prevention strategies at the community level. In addition, SAMHSA has just launched a new initiative called ACTION (Adopting Changes to Improve Outcomes Now), aiming to improve access to addiction treatment services and to keep clients engaged in treatment. “We need to make certain that addiction is treated with the same sense of urgency as other medical conditions,” he said.

WASHINGTON — There's good and bad news from the 2006 National Survey on Drug Use and Health: Overall drug use among adolescents has declined since 2002, but prescription drug misuse among young adults has skyrocketed.

In the federally funded annual survey of approximately 67,500 Americans, the proportion of adolescents aged 12–17 years who acknowledged drug use in the past month dropped from 11.6% in 2002 to 9.8% in 2006, similar to the 9.9% level in 2005. Current marijuana use in that age group declined even more significantly in those 4 years, from 8.2% to 6.7%.

“Illicit drug use among youth [aged] 12–17 is at a 5-year low. That's definitely cause for celebration. Tobacco use continues to decline and perceptions about risk for marijuana use continue to increase, and that's a great combination,” said Terry L. Cline, Ph.D., administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), at a press briefing.

But nonmedical use of prescription drugs among young adults aged 18–25 years increased from 5.4% in 2002 to 6.4% in 2006, largely because of a rise in the nonmedical use of pain relievers. “The survey also tells us there is much work left to be done. Many of these painkillers being abused are unused medications that should have been properly disposed [of],” Dr. Cline said.

SAMHSA currently is involved in a national point-of-purchase public education campaign to release information about the proper disposal of unused medications. The information soon will be available at more than 6,300 pharmacies across the country, he said.

Underage drinking is another area of concern, as the level among 12- to 20-year-olds remains unchanged since 2002, at 28.3% in 2006. The Surgeon General's recently released Call to Action to Reduce and Prevent Underage Drinking is part of an interagency effort to target the problem, Dr. Cline noted.

John P. Walters, director of the White House Office of National Drug Control Policy (ONDCP), presented additional findings from the survey. Of note, he said, is that a huge difference in marijuana use was found between youth aged 12–17 years who reported that their parents strongly disapprove of marijuana use, at 4.6%, versus those who did not perceive strong parental disapproval, 26.5%, a fivefold difference.

Among young adults aged 18–24, the drop in marijuana use from 17.3% in 2002 to 16.3% in 2006 was “vastly overshadowed” by the increase in prescription drug use, 75% of which are pain relievers. That usage is now much greater than that of cocaine and heroin and is even reaching the initiation rate for marijuana. Most people who abuse prescription drugs get them from family and friends, Mr. Walters said.

“You have to help people understand that when they're done with prescription painkillers in particular, [they need to] throw them away. … We have to start remembering that OxyContin and Vicodin in the medicine cabinet today, if not protected, are as dangerous as cocaine and heroin,” said Mr. Walters, whose job title is known informally as “the nation's drug czar.”

A somewhat surprising finding is the striking rise in drug use rates among Baby Boomers aged 50–54, which shot up by over the 4-year survey period, from 3.4% to 6.0%. “What we have here is something we've never seen before: Increasing rates of illicit drug use among older Americans. This was typically a problem of youth. But today, we have older Americans bringing those levels of substance abuse with them [as they age]. … Once you become involved with these substances, it is very difficult to become clean and sober,” Mr. Walters noted.

Dr. Cline said SAMHSA is collaborating with various entities to address the issues brought out by the survey. Among those efforts are a partnership with the ONDCP to provide resources to more than 700 communities to prevent drug abuse and provision of grants to 34 states, 3 territories, and 5 tribal organizations to promote science-based prevention strategies at the community level. In addition, SAMHSA has just launched a new initiative called ACTION (Adopting Changes to Improve Outcomes Now), aiming to improve access to addiction treatment services and to keep clients engaged in treatment. “We need to make certain that addiction is treated with the same sense of urgency as other medical conditions,” he said.

WASHINGTON — There's good and bad news from the 2006 National Survey on Drug Use and Health: Overall drug use among adolescents has declined since 2002, but prescription drug misuse among young adults has skyrocketed.

In the federally funded annual survey of approximately 67,500 Americans, the proportion of adolescents aged 12–17 years who acknowledged drug use in the past month dropped from 11.6% in 2002 to 9.8% in 2006, similar to the 9.9% level in 2005. Current marijuana use in that age group declined even more significantly in those 4 years, from 8.2% to 6.7%.

“Illicit drug use among youth [aged] 12–17 is at a 5-year low. That's definitely cause for celebration. Tobacco use continues to decline and perceptions about risk for marijuana use continue to increase, and that's a great combination,” said Terry L. Cline, Ph.D., administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), at a press briefing.

But nonmedical use of prescription drugs among young adults aged 18–25 years increased from 5.4% in 2002 to 6.4% in 2006, largely because of a rise in the nonmedical use of pain relievers. “The survey also tells us there is much work left to be done. Many of these painkillers being abused are unused medications that should have been properly disposed [of],” Dr. Cline said.

SAMHSA currently is involved in a national point-of-purchase public education campaign to release information about the proper disposal of unused medications. The information soon will be available at more than 6,300 pharmacies across the country, he said.

Underage drinking is another area of concern, as the level among 12- to 20-year-olds remains unchanged since 2002, at 28.3% in 2006. The Surgeon General's recently released Call to Action to Reduce and Prevent Underage Drinking is part of an interagency effort to target the problem, Dr. Cline noted.

John P. Walters, director of the White House Office of National Drug Control Policy (ONDCP), presented additional findings from the survey. Of note, he said, is that a huge difference in marijuana use was found between youth aged 12–17 years who reported that their parents strongly disapprove of marijuana use, at 4.6%, versus those who did not perceive strong parental disapproval, 26.5%, a fivefold difference.

Among young adults aged 18–24, the drop in marijuana use from 17.3% in 2002 to 16.3% in 2006 was “vastly overshadowed” by the increase in prescription drug use, 75% of which are pain relievers. That usage is now much greater than that of cocaine and heroin and is even reaching the initiation rate for marijuana. Most people who abuse prescription drugs get them from family and friends, Mr. Walters said.

“You have to help people understand that when they're done with prescription painkillers in particular, [they need to] throw them away. … We have to start remembering that OxyContin and Vicodin in the medicine cabinet today, if not protected, are as dangerous as cocaine and heroin,” said Mr. Walters, whose job title is known informally as “the nation's drug czar.”

A somewhat surprising finding is the striking rise in drug use rates among Baby Boomers aged 50–54, which shot up by over the 4-year survey period, from 3.4% to 6.0%. “What we have here is something we've never seen before: Increasing rates of illicit drug use among older Americans. This was typically a problem of youth. But today, we have older Americans bringing those levels of substance abuse with them [as they age]. … Once you become involved with these substances, it is very difficult to become clean and sober,” Mr. Walters noted.

Dr. Cline said SAMHSA is collaborating with various entities to address the issues brought out by the survey. Among those efforts are a partnership with the ONDCP to provide resources to more than 700 communities to prevent drug abuse and provision of grants to 34 states, 3 territories, and 5 tribal organizations to promote science-based prevention strategies at the community level. In addition, SAMHSA has just launched a new initiative called ACTION (Adopting Changes to Improve Outcomes Now), aiming to improve access to addiction treatment services and to keep clients engaged in treatment. “We need to make certain that addiction is treated with the same sense of urgency as other medical conditions,” he said.

www.richardsurwit.com.

ST. LOUIS — Convincing your diabetic patients to stop consuming caffeine could significantly reduce their postprandial glucose levels and possibly improve their overall metabolic control, Richard S. Surwit, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

It has long been known that caffeine increases blood pressure, heart rate, and levels of stress (also known as “counterregulatory”) hormones, which in turn are associated with reduced insulin sensitivity. In two placebo-controlled studies designed to look specifically at the impact of oral caffeine on carbohydrate metabolism in regular coffee drinkers with type 2 diabetes, Dr. Surwit and his associates at Duke University, Durham, N.C., have shown that although caffeine does not appear to affect fasting blood glucose levels, it has a major impact on both 2-hour postprandial glucose values and insulin levels. The lead author of both studies was James D. Lane, Ph.D., professor of medical psychology at Duke.

Indeed, the magnitude of the effect is in the range of glucose-lowering medications that are taken before meals, such as nateglinide and acarbose, said Dr. Surwit, professor and chief of the division of medical psychology, and vice chairman of the department of psychiatry and behavioral sciences at Duke.

“If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free. … You can't get that effect without spending a few dollars a day for a pill. Here, you're getting it without adding anything to their regimen, just taking something away,” Dr. Surwit remarked.

In the first study, 14 habitual coffee drinkers with type 2 diabetes were given gelatin capsules of either 125 mg of anhydrous caffeine plus dextrose filler or the filler alone on 2 days within a 2-week period. After fasting blood was drawn, they ingested 250 mg of caffeine or placebo in two capsules with water, and another fasting blood sample was taken an hour later. The patients then consumed a liquid meal containing 75 g of carbohydrates (Boost), and additional blood samples were taken at 1 and 2 hours after the meal (Diabetes Care 2004;27:2047–8).

Caffeine did not affect the fasting levels of plasma glucose or insulin, compared with placebo. After the liquid meal, however, glucose levels were 21% higher and insulin levels were 48% higher when the patients had consumed caffeine before the meal, compared with when they hadn't.

The second study was designed to overcome the first study's limitation of using caffeine-containing capsules rather than real coffee or tea, both of which contain numerous organic compounds that might independently affect glucose tolerance positively or negatively. This time, another group of 20 patients with type 2 diabetes who were also regular coffee drinkers were given decaffeinated coffee with or without 250 mg of anhydrous caffeine dissolved into it, roughly equivalent to a 16-ounce mug of regular brewed coffee. This method allowed for precise control of caffeine content and equivalence of other chemical compounds present in coffee—such as magnesium and roasted quinides—that might influence blood sugar levels, said Dr. Surwit, who is also codirector of Dukes' Behavioral Endocrinology Clinic.

Again, there was a significant postprandial effect: The mean glucose value following caffeine consumption was 28% higher than it was without caffeine, and the mean insulin values were 19% higher than they were without caffeine (Endocr. Pract. 2007;13:239–43).

The magnitude of the effect was not related to age, body weight, body mass index, hemoglobin A_1c, fasting plasma glucose, or the usual amount of caffeine consumed. The only correlation was with duration of diabetes: The difference between caffeine and placebo grew by 0.17 mmol/L every 2 hours for each year of diabetes history among the patients. The authors speculated that this could be because patients with a longer duration of diabetes would have less available insulin reserve, which would result in a reduced capacity to overcome the insulin resistance caused by the caffeine.

These findings do not conflict with highly publicized studies suggesting that coffee drinking might reduce the incidence of type 2 diabetes (JAMA 2005;294:97–104), because those data are correlational and not causal—people who drink more coffee might eat less, for example, Dr. Surwit pointed out.

It has not been shown whether or not cutting caffeine can result in a significant improvement in overall metabolic control, but increasingly, data suggest that postprandial glucose values may influence HbA_1c to a greater extent than do fasting levels. Dr. Surwit's group hopes to do that study next.

Getting patients to quit drinking caffeine may be tricky, but it's not impossible. “The idea that people need caffeine to stay alert and be productive and be active is nonsense,” said Dr. Surwit. Patients will experience headaches and irritability for a few days, after which those symptoms go away. “It doesn't take more than 3 or 4 days to get people completely off caffeine.”

'If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free.' DR. SURWIT

www.richardsurwit.com.

ST. LOUIS — Convincing your diabetic patients to stop consuming caffeine could significantly reduce their postprandial glucose levels and possibly improve their overall metabolic control, Richard S. Surwit, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

It has long been known that caffeine increases blood pressure, heart rate, and levels of stress (also known as “counterregulatory”) hormones, which in turn are associated with reduced insulin sensitivity. In two placebo-controlled studies designed to look specifically at the impact of oral caffeine on carbohydrate metabolism in regular coffee drinkers with type 2 diabetes, Dr. Surwit and his associates at Duke University, Durham, N.C., have shown that although caffeine does not appear to affect fasting blood glucose levels, it has a major impact on both 2-hour postprandial glucose values and insulin levels. The lead author of both studies was James D. Lane, Ph.D., professor of medical psychology at Duke.

Indeed, the magnitude of the effect is in the range of glucose-lowering medications that are taken before meals, such as nateglinide and acarbose, said Dr. Surwit, professor and chief of the division of medical psychology, and vice chairman of the department of psychiatry and behavioral sciences at Duke.

“If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free. … You can't get that effect without spending a few dollars a day for a pill. Here, you're getting it without adding anything to their regimen, just taking something away,” Dr. Surwit remarked.

In the first study, 14 habitual coffee drinkers with type 2 diabetes were given gelatin capsules of either 125 mg of anhydrous caffeine plus dextrose filler or the filler alone on 2 days within a 2-week period. After fasting blood was drawn, they ingested 250 mg of caffeine or placebo in two capsules with water, and another fasting blood sample was taken an hour later. The patients then consumed a liquid meal containing 75 g of carbohydrates (Boost), and additional blood samples were taken at 1 and 2 hours after the meal (Diabetes Care 2004;27:2047–8).

Caffeine did not affect the fasting levels of plasma glucose or insulin, compared with placebo. After the liquid meal, however, glucose levels were 21% higher and insulin levels were 48% higher when the patients had consumed caffeine before the meal, compared with when they hadn't.

The second study was designed to overcome the first study's limitation of using caffeine-containing capsules rather than real coffee or tea, both of which contain numerous organic compounds that might independently affect glucose tolerance positively or negatively. This time, another group of 20 patients with type 2 diabetes who were also regular coffee drinkers were given decaffeinated coffee with or without 250 mg of anhydrous caffeine dissolved into it, roughly equivalent to a 16-ounce mug of regular brewed coffee. This method allowed for precise control of caffeine content and equivalence of other chemical compounds present in coffee—such as magnesium and roasted quinides—that might influence blood sugar levels, said Dr. Surwit, who is also codirector of Dukes' Behavioral Endocrinology Clinic.

Again, there was a significant postprandial effect: The mean glucose value following caffeine consumption was 28% higher than it was without caffeine, and the mean insulin values were 19% higher than they were without caffeine (Endocr. Pract. 2007;13:239–43).

The magnitude of the effect was not related to age, body weight, body mass index, hemoglobin A_1c, fasting plasma glucose, or the usual amount of caffeine consumed. The only correlation was with duration of diabetes: The difference between caffeine and placebo grew by 0.17 mmol/L every 2 hours for each year of diabetes history among the patients. The authors speculated that this could be because patients with a longer duration of diabetes would have less available insulin reserve, which would result in a reduced capacity to overcome the insulin resistance caused by the caffeine.

These findings do not conflict with highly publicized studies suggesting that coffee drinking might reduce the incidence of type 2 diabetes (JAMA 2005;294:97–104), because those data are correlational and not causal—people who drink more coffee might eat less, for example, Dr. Surwit pointed out.

It has not been shown whether or not cutting caffeine can result in a significant improvement in overall metabolic control, but increasingly, data suggest that postprandial glucose values may influence HbA_1c to a greater extent than do fasting levels. Dr. Surwit's group hopes to do that study next.

Getting patients to quit drinking caffeine may be tricky, but it's not impossible. “The idea that people need caffeine to stay alert and be productive and be active is nonsense,” said Dr. Surwit. Patients will experience headaches and irritability for a few days, after which those symptoms go away. “It doesn't take more than 3 or 4 days to get people completely off caffeine.”

'If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free.' DR. SURWIT

www.richardsurwit.com.

ST. LOUIS — Convincing your diabetic patients to stop consuming caffeine could significantly reduce their postprandial glucose levels and possibly improve their overall metabolic control, Richard S. Surwit, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

It has long been known that caffeine increases blood pressure, heart rate, and levels of stress (also known as “counterregulatory”) hormones, which in turn are associated with reduced insulin sensitivity. In two placebo-controlled studies designed to look specifically at the impact of oral caffeine on carbohydrate metabolism in regular coffee drinkers with type 2 diabetes, Dr. Surwit and his associates at Duke University, Durham, N.C., have shown that although caffeine does not appear to affect fasting blood glucose levels, it has a major impact on both 2-hour postprandial glucose values and insulin levels. The lead author of both studies was James D. Lane, Ph.D., professor of medical psychology at Duke.

Indeed, the magnitude of the effect is in the range of glucose-lowering medications that are taken before meals, such as nateglinide and acarbose, said Dr. Surwit, professor and chief of the division of medical psychology, and vice chairman of the department of psychiatry and behavioral sciences at Duke.

“If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free. … You can't get that effect without spending a few dollars a day for a pill. Here, you're getting it without adding anything to their regimen, just taking something away,” Dr. Surwit remarked.

In the first study, 14 habitual coffee drinkers with type 2 diabetes were given gelatin capsules of either 125 mg of anhydrous caffeine plus dextrose filler or the filler alone on 2 days within a 2-week period. After fasting blood was drawn, they ingested 250 mg of caffeine or placebo in two capsules with water, and another fasting blood sample was taken an hour later. The patients then consumed a liquid meal containing 75 g of carbohydrates (Boost), and additional blood samples were taken at 1 and 2 hours after the meal (Diabetes Care 2004;27:2047–8).

Caffeine did not affect the fasting levels of plasma glucose or insulin, compared with placebo. After the liquid meal, however, glucose levels were 21% higher and insulin levels were 48% higher when the patients had consumed caffeine before the meal, compared with when they hadn't.

The second study was designed to overcome the first study's limitation of using caffeine-containing capsules rather than real coffee or tea, both of which contain numerous organic compounds that might independently affect glucose tolerance positively or negatively. This time, another group of 20 patients with type 2 diabetes who were also regular coffee drinkers were given decaffeinated coffee with or without 250 mg of anhydrous caffeine dissolved into it, roughly equivalent to a 16-ounce mug of regular brewed coffee. This method allowed for precise control of caffeine content and equivalence of other chemical compounds present in coffee—such as magnesium and roasted quinides—that might influence blood sugar levels, said Dr. Surwit, who is also codirector of Dukes' Behavioral Endocrinology Clinic.

Again, there was a significant postprandial effect: The mean glucose value following caffeine consumption was 28% higher than it was without caffeine, and the mean insulin values were 19% higher than they were without caffeine (Endocr. Pract. 2007;13:239–43).

The magnitude of the effect was not related to age, body weight, body mass index, hemoglobin A_1c, fasting plasma glucose, or the usual amount of caffeine consumed. The only correlation was with duration of diabetes: The difference between caffeine and placebo grew by 0.17 mmol/L every 2 hours for each year of diabetes history among the patients. The authors speculated that this could be because patients with a longer duration of diabetes would have less available insulin reserve, which would result in a reduced capacity to overcome the insulin resistance caused by the caffeine.

These findings do not conflict with highly publicized studies suggesting that coffee drinking might reduce the incidence of type 2 diabetes (JAMA 2005;294:97–104), because those data are correlational and not causal—people who drink more coffee might eat less, for example, Dr. Surwit pointed out.

It has not been shown whether or not cutting caffeine can result in a significant improvement in overall metabolic control, but increasingly, data suggest that postprandial glucose values may influence HbA_1c to a greater extent than do fasting levels. Dr. Surwit's group hopes to do that study next.

Getting patients to quit drinking caffeine may be tricky, but it's not impossible. “The idea that people need caffeine to stay alert and be productive and be active is nonsense,” said Dr. Surwit. Patients will experience headaches and irritability for a few days, after which those symptoms go away. “It doesn't take more than 3 or 4 days to get people completely off caffeine.”

'If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free.' DR. SURWIT

ST. LOUIS — Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

What's more, data suggest that the majority of obstructive sleep apnea (OSA) cases among people with and without diabetes are undiagnosed, she said.

Because sleep apnea is so common in people with diabetes—concomitant with obesity and hypertension—the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA, and those found to have the condition are referred for treatment and follow-up.

In a study published by the Whittier's Dr. Daniel Einhorn and his associates, 72.4% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (35.8%) had an AHI of at least 15 events per hour, a more severe apnea level associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities such as body mass index (BMI), alcohol use, and cigarette smoking (Endocrine Practice 2007;13:355–62).

The proportion of those with an AHI at or above 15 events per hour was much higher among men than women (49% vs. 21%). Other significant risk factors included age 62 years and older, a BMI of 30 kg/m

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension), in 50% of those with congestive heart failure, and in 50% of those with atrial fibrillation. It is found in 77% of the morbidly obese population.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas. The resulting higher cortisol levels are related to insulin resistance, which predisposes to impaired glucose tolerance and other cardiovascular risk factors, said Ms. LaRue, formerly with the Whittier Institute.

A study in which the results of overnight polysomnography and oral glucose tolerance testing were compared in 30 obese (but not diabetic) patients with OSA and in 27 equally obese individuals without OSA showed that those who had OSA were more insulin resistant, independent of the degree and distribution of adiposity. The authors hypothesized that the worsening in insulin sensitivity in the OSA patients could reflect the hypoxic state and would account for the increased vascular risk (Clin. Endocrinol. 2003;59:374–9).

Treatment of OSA with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those who were given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the authors wrote (Circulation 2003;107:68–73).

Insulin sensitivity was significantly improved at 2 days and at 3 months of CPAP therapy among 40 patients with an AHI greater than 20, more so among those with BMIs less than 30 kg/m

Another study of 25 patients with type 2 diabetes and sleep-disordered breathing demonstrated that an average of 83 days' treatment with CPAP significantly reduced postprandial glucose values, by about 60 mg/dL after each meal. Hemoglobin A_1c (HbA_1c) levels also dropped significantly among those with a baseline level greater than 7% (from 9.2% to 8.6%). Reduction in HbA_1c was significantly correlated with days of CPAP use among those who wore the device for more than 4 hours per day (Arch. Intern. Med. 2005;165:447–52).

“When sleep apnea is treated appropriately, look at the benefits. … It's another tool to help patients live [more healthily] with diabetes,” Ms. LaRue noted.

ST. LOUIS — Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

What's more, data suggest that the majority of obstructive sleep apnea (OSA) cases among people with and without diabetes are undiagnosed, she said.

Because sleep apnea is so common in people with diabetes—concomitant with obesity and hypertension—the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA, and those found to have the condition are referred for treatment and follow-up.

In a study published by the Whittier's Dr. Daniel Einhorn and his associates, 72.4% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (35.8%) had an AHI of at least 15 events per hour, a more severe apnea level associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities such as body mass index (BMI), alcohol use, and cigarette smoking (Endocrine Practice 2007;13:355–62).

The proportion of those with an AHI at or above 15 events per hour was much higher among men than women (49% vs. 21%). Other significant risk factors included age 62 years and older, a BMI of 30 kg/m

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension), in 50% of those with congestive heart failure, and in 50% of those with atrial fibrillation. It is found in 77% of the morbidly obese population.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas. The resulting higher cortisol levels are related to insulin resistance, which predisposes to impaired glucose tolerance and other cardiovascular risk factors, said Ms. LaRue, formerly with the Whittier Institute.

A study in which the results of overnight polysomnography and oral glucose tolerance testing were compared in 30 obese (but not diabetic) patients with OSA and in 27 equally obese individuals without OSA showed that those who had OSA were more insulin resistant, independent of the degree and distribution of adiposity. The authors hypothesized that the worsening in insulin sensitivity in the OSA patients could reflect the hypoxic state and would account for the increased vascular risk (Clin. Endocrinol. 2003;59:374–9).

Treatment of OSA with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those who were given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the authors wrote (Circulation 2003;107:68–73).

Insulin sensitivity was significantly improved at 2 days and at 3 months of CPAP therapy among 40 patients with an AHI greater than 20, more so among those with BMIs less than 30 kg/m

Another study of 25 patients with type 2 diabetes and sleep-disordered breathing demonstrated that an average of 83 days' treatment with CPAP significantly reduced postprandial glucose values, by about 60 mg/dL after each meal. Hemoglobin A_1c (HbA_1c) levels also dropped significantly among those with a baseline level greater than 7% (from 9.2% to 8.6%). Reduction in HbA_1c was significantly correlated with days of CPAP use among those who wore the device for more than 4 hours per day (Arch. Intern. Med. 2005;165:447–52).

“When sleep apnea is treated appropriately, look at the benefits. … It's another tool to help patients live [more healthily] with diabetes,” Ms. LaRue noted.

ST. LOUIS — Sleep apnea assessment and treatment should be considered an integral part of diabetes management, Susan M. LaRue, R.D., said at the annual meeting of the American Association of Diabetes Educators.

“Sleep apnea is highly prevalent in people with diabetes, people with hypertension and obesity, all of which we see in huge numbers in our patient population,” said Ms. LaRue, a certified diabetes educator with Amylin Pharmaceuticals.

What's more, data suggest that the majority of obstructive sleep apnea (OSA) cases among people with and without diabetes are undiagnosed, she said.

Because sleep apnea is so common in people with diabetes—concomitant with obesity and hypertension—the Scripps' Whittier Institute for Diabetes, La Jolla, Calif., has instituted a “best practice” in which every patient is screened for OSA, and those found to have the condition are referred for treatment and follow-up.

In a study published by the Whittier's Dr. Daniel Einhorn and his associates, 72.4% of 279 adults with type 2 diabetes were found to have some degree of sleep apnea, defined as an apnea-hypopnea index (AHI) of five events or more per hour. Over a third of the patients (35.8%) had an AHI of at least 15 events per hour, a more severe apnea level associated with a doubling of the risk for the development of hypertension after adjustment for comorbidities such as body mass index (BMI), alcohol use, and cigarette smoking (Endocrine Practice 2007;13:355–62).

The proportion of those with an AHI at or above 15 events per hour was much higher among men than women (49% vs. 21%). Other significant risk factors included age 62 years and older, a BMI of 30 kg/m

That study and the symposium in which Ms. LaRue spoke were both sponsored by the ResMed Corp., which manufactures continuous positive airway pressure (CPAP) devices for treatment of OSA.

Diabetes is among several cardiovascular-related conditions that are strongly associated with OSA. Data suggest that OSA is present in about 80% of individuals with drug-resistant hypertension (35% of all hypertension), in 50% of those with congestive heart failure, and in 50% of those with atrial fibrillation. It is found in 77% of the morbidly obese population.

The mechanism for the association is not known, but theories focus on the increased sympathetic nervous activity resulting from repeated apneas. The resulting higher cortisol levels are related to insulin resistance, which predisposes to impaired glucose tolerance and other cardiovascular risk factors, said Ms. LaRue, formerly with the Whittier Institute.

A study in which the results of overnight polysomnography and oral glucose tolerance testing were compared in 30 obese (but not diabetic) patients with OSA and in 27 equally obese individuals without OSA showed that those who had OSA were more insulin resistant, independent of the degree and distribution of adiposity. The authors hypothesized that the worsening in insulin sensitivity in the OSA patients could reflect the hypoxic state and would account for the increased vascular risk (Clin. Endocrinol. 2003;59:374–9).

Treatment of OSA with CPAP not only reduces apneic episodes and improves sleep quality, but also appears to improve the cardiovascular and metabolic abnormalities. In a German study of 60 patients with moderate to severe OSA, those who were given “therapeutic” levels of CPAP for an average of 9 weeks had a 95% reduction in apneas and hypopneas and a decrease in mean arterial blood pressure of 9.9 mm Hg.

That level of decline would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%, the authors wrote (Circulation 2003;107:68–73).

Insulin sensitivity was significantly improved at 2 days and at 3 months of CPAP therapy among 40 patients with an AHI greater than 20, more so among those with BMIs less than 30 kg/m

Another study of 25 patients with type 2 diabetes and sleep-disordered breathing demonstrated that an average of 83 days' treatment with CPAP significantly reduced postprandial glucose values, by about 60 mg/dL after each meal. Hemoglobin A_1c (HbA_1c) levels also dropped significantly among those with a baseline level greater than 7% (from 9.2% to 8.6%). Reduction in HbA_1c was significantly correlated with days of CPAP use among those who wore the device for more than 4 hours per day (Arch. Intern. Med. 2005;165:447–52).

“When sleep apnea is treated appropriately, look at the benefits. … It's another tool to help patients live [more healthily] with diabetes,” Ms. LaRue noted.

CHICAGO — Nocturnal administration of very-low-dose glucagon appears to prevent hypoglycemia in patients with type 1 diabetes, Dr. Steven V. Edelman reported at the annual scientific sessions of the American Diabetes Association.

Hypoglycemia limits the ability to achieve intensive glucose control among patients with type 1 diabetes. “As we try to intensify control in our patients and as the level of recommended [hemoglobin] A_1c keeps getting lower and lower, we face the risk of severe and sometimes fatal hypoglycemia, especially at night. … Once a patient has had a severe low blood sugar, they're quite afraid to intensify their control,” noted Dr. Edelman, professor of medicine at the University of California, San Diego.

And it happens often. In a recent study of 60 patients with type 1 diabetes using continuous glucose monitoring for an average of 12 days, patients experienced 2.1 episodes per day of hypoglycemia (below 70 mg/dL for more than 10 minutes), lasting approximately 1.1 hours each, for a total of 2.3 hours/day. Of those, 60% occurred overnight (Diabetes Care 2005;28:2361–6).

A San Francisco-based company called DiObex Inc. (www.diobex.com

“The concept behind VLDG is to infuse just enough overnight to prevent insulin-induced hypoglycemia, but not enough to cause hyperglycemia and deteriorate overall glycemic control,” Dr. Edelman said.

He presented findings from a single-center pharmacology study in which six patients with type 1 diabetes treated with insulin pumps underwent 10 separate overnight (10:00 p.m. to 7:00 a.m.) infusions of different doses and durations of VLDG, and also underwent control infusions. The doses were 2, 4, or 8 ng/kg per minute, and the durations were 6, 9, or 12 hours. The patients, four women and two men, had a mean age of 46.2 years and a diabetes duration of 27.8 years. They were in good control, with a mean hemoglobin A_1c of 6.52%.

During the control infusions, mean endogenous glucagon levels in the patients ranged from 25 to 50 pg/mL, compared with the normal range of 40–130 pg/mL. During the VLDG infusions, the mean level rose to 80–120 pg/mL with the dose of 8 ng/kg per minute.

The mean amount of time spent in the hypoglycemic range (below 70 mg/dL) ranged from 4% to 16% with the different infusion doses, compared with 30% with the control infusions. Median time spent in hypoglycemia was less than 1% with the infusion doses of 2 and 4 ng/mL per minute and 0% with infusions of 8 ng/mL per minute, versus 14% with the control infusions, Dr. Edelman reported.

Fasting glucose levels at 7:00 a.m. did not exceed 130 mg/dL with the infusion of 2 ng/mL per minute, and only exceeded it with the longest (12-hour) infusion of 4 ng/mL per minute. However, fasting glucose exceeded 130 mg/dL even with the shortest (6-hour) infusion of the 8 ng/mL per minute; most of the patients had a level of around 130 mg/dL, except for the higher dose, he noted. Overall, the patients on VLDG did not have markedly elevated fasting glucoses, compared with the control group. Similarly, median peak glucose levels were around 150 mg/dL in all except during the 12-hour infusion of 8 ng/mL per minute, where it exceeded 250 mg/dL.

No drug-related adverse event of any kind was reported, Dr. Edelman said.

The company plans to proceed next year with a larger trial of longer duration in patients undergoing intensification of insulin therapy. They will receive a single nightly injection of an extended-release formulation, in the home setting.

In a follow-up interview, coauthor Dr. Bernice Welles, vice president of development at DiObex, said VLDG could be considered as long-term therapy. “Since the inability to mount a glucagon response in the face of hypoglycemia that develops after several years of diabetes appears to persist for life, it is not unreasonable to think of our product as chronic replacement therapy. The doses that we expect to bring to market will keep patients in a physiological range of glucagon levels.”

Children might particularly benefit, she noted. “There is a very large unmet medical need here. We hear many stories of parents who can't sleep at night for fear of hypoglycemia in their young children.”

CHICAGO — Nocturnal administration of very-low-dose glucagon appears to prevent hypoglycemia in patients with type 1 diabetes, Dr. Steven V. Edelman reported at the annual scientific sessions of the American Diabetes Association.

Hypoglycemia limits the ability to achieve intensive glucose control among patients with type 1 diabetes. “As we try to intensify control in our patients and as the level of recommended [hemoglobin] A_1c keeps getting lower and lower, we face the risk of severe and sometimes fatal hypoglycemia, especially at night. … Once a patient has had a severe low blood sugar, they're quite afraid to intensify their control,” noted Dr. Edelman, professor of medicine at the University of California, San Diego.

And it happens often. In a recent study of 60 patients with type 1 diabetes using continuous glucose monitoring for an average of 12 days, patients experienced 2.1 episodes per day of hypoglycemia (below 70 mg/dL for more than 10 minutes), lasting approximately 1.1 hours each, for a total of 2.3 hours/day. Of those, 60% occurred overnight (Diabetes Care 2005;28:2361–6).

A San Francisco-based company called DiObex Inc. (www.diobex.com

“The concept behind VLDG is to infuse just enough overnight to prevent insulin-induced hypoglycemia, but not enough to cause hyperglycemia and deteriorate overall glycemic control,” Dr. Edelman said.

He presented findings from a single-center pharmacology study in which six patients with type 1 diabetes treated with insulin pumps underwent 10 separate overnight (10:00 p.m. to 7:00 a.m.) infusions of different doses and durations of VLDG, and also underwent control infusions. The doses were 2, 4, or 8 ng/kg per minute, and the durations were 6, 9, or 12 hours. The patients, four women and two men, had a mean age of 46.2 years and a diabetes duration of 27.8 years. They were in good control, with a mean hemoglobin A_1c of 6.52%.

During the control infusions, mean endogenous glucagon levels in the patients ranged from 25 to 50 pg/mL, compared with the normal range of 40–130 pg/mL. During the VLDG infusions, the mean level rose to 80–120 pg/mL with the dose of 8 ng/kg per minute.

The mean amount of time spent in the hypoglycemic range (below 70 mg/dL) ranged from 4% to 16% with the different infusion doses, compared with 30% with the control infusions. Median time spent in hypoglycemia was less than 1% with the infusion doses of 2 and 4 ng/mL per minute and 0% with infusions of 8 ng/mL per minute, versus 14% with the control infusions, Dr. Edelman reported.

Fasting glucose levels at 7:00 a.m. did not exceed 130 mg/dL with the infusion of 2 ng/mL per minute, and only exceeded it with the longest (12-hour) infusion of 4 ng/mL per minute. However, fasting glucose exceeded 130 mg/dL even with the shortest (6-hour) infusion of the 8 ng/mL per minute; most of the patients had a level of around 130 mg/dL, except for the higher dose, he noted. Overall, the patients on VLDG did not have markedly elevated fasting glucoses, compared with the control group. Similarly, median peak glucose levels were around 150 mg/dL in all except during the 12-hour infusion of 8 ng/mL per minute, where it exceeded 250 mg/dL.

No drug-related adverse event of any kind was reported, Dr. Edelman said.

The company plans to proceed next year with a larger trial of longer duration in patients undergoing intensification of insulin therapy. They will receive a single nightly injection of an extended-release formulation, in the home setting.

In a follow-up interview, coauthor Dr. Bernice Welles, vice president of development at DiObex, said VLDG could be considered as long-term therapy. “Since the inability to mount a glucagon response in the face of hypoglycemia that develops after several years of diabetes appears to persist for life, it is not unreasonable to think of our product as chronic replacement therapy. The doses that we expect to bring to market will keep patients in a physiological range of glucagon levels.”

Children might particularly benefit, she noted. “There is a very large unmet medical need here. We hear many stories of parents who can't sleep at night for fear of hypoglycemia in their young children.”

CHICAGO — Nocturnal administration of very-low-dose glucagon appears to prevent hypoglycemia in patients with type 1 diabetes, Dr. Steven V. Edelman reported at the annual scientific sessions of the American Diabetes Association.

Hypoglycemia limits the ability to achieve intensive glucose control among patients with type 1 diabetes. “As we try to intensify control in our patients and as the level of recommended [hemoglobin] A_1c keeps getting lower and lower, we face the risk of severe and sometimes fatal hypoglycemia, especially at night. … Once a patient has had a severe low blood sugar, they're quite afraid to intensify their control,” noted Dr. Edelman, professor of medicine at the University of California, San Diego.

And it happens often. In a recent study of 60 patients with type 1 diabetes using continuous glucose monitoring for an average of 12 days, patients experienced 2.1 episodes per day of hypoglycemia (below 70 mg/dL for more than 10 minutes), lasting approximately 1.1 hours each, for a total of 2.3 hours/day. Of those, 60% occurred overnight (Diabetes Care 2005;28:2361–6).

A San Francisco-based company called DiObex Inc. (www.diobex.com

“The concept behind VLDG is to infuse just enough overnight to prevent insulin-induced hypoglycemia, but not enough to cause hyperglycemia and deteriorate overall glycemic control,” Dr. Edelman said.

He presented findings from a single-center pharmacology study in which six patients with type 1 diabetes treated with insulin pumps underwent 10 separate overnight (10:00 p.m. to 7:00 a.m.) infusions of different doses and durations of VLDG, and also underwent control infusions. The doses were 2, 4, or 8 ng/kg per minute, and the durations were 6, 9, or 12 hours. The patients, four women and two men, had a mean age of 46.2 years and a diabetes duration of 27.8 years. They were in good control, with a mean hemoglobin A_1c of 6.52%.

During the control infusions, mean endogenous glucagon levels in the patients ranged from 25 to 50 pg/mL, compared with the normal range of 40–130 pg/mL. During the VLDG infusions, the mean level rose to 80–120 pg/mL with the dose of 8 ng/kg per minute.

The mean amount of time spent in the hypoglycemic range (below 70 mg/dL) ranged from 4% to 16% with the different infusion doses, compared with 30% with the control infusions. Median time spent in hypoglycemia was less than 1% with the infusion doses of 2 and 4 ng/mL per minute and 0% with infusions of 8 ng/mL per minute, versus 14% with the control infusions, Dr. Edelman reported.

Fasting glucose levels at 7:00 a.m. did not exceed 130 mg/dL with the infusion of 2 ng/mL per minute, and only exceeded it with the longest (12-hour) infusion of 4 ng/mL per minute. However, fasting glucose exceeded 130 mg/dL even with the shortest (6-hour) infusion of the 8 ng/mL per minute; most of the patients had a level of around 130 mg/dL, except for the higher dose, he noted. Overall, the patients on VLDG did not have markedly elevated fasting glucoses, compared with the control group. Similarly, median peak glucose levels were around 150 mg/dL in all except during the 12-hour infusion of 8 ng/mL per minute, where it exceeded 250 mg/dL.

No drug-related adverse event of any kind was reported, Dr. Edelman said.

The company plans to proceed next year with a larger trial of longer duration in patients undergoing intensification of insulin therapy. They will receive a single nightly injection of an extended-release formulation, in the home setting.

In a follow-up interview, coauthor Dr. Bernice Welles, vice president of development at DiObex, said VLDG could be considered as long-term therapy. “Since the inability to mount a glucagon response in the face of hypoglycemia that develops after several years of diabetes appears to persist for life, it is not unreasonable to think of our product as chronic replacement therapy. The doses that we expect to bring to market will keep patients in a physiological range of glucagon levels.”

Children might particularly benefit, she noted. “There is a very large unmet medical need here. We hear many stories of parents who can't sleep at night for fear of hypoglycemia in their young children.”

ST. LOUIS — Obtaining insurance coverage for continuous glucose monitoring may be something of a battle right now, but in many cases it's a winnable one, Jean R. Halford, R.D., said at the annual meeting of the American Association of Diabetes Educators.

The continuous glucose monitoring (CGM) device that provides data directly to patients is very recent technology. Medtronic Inc.'s Guardian system was approved in limited release by the Food and Drug Administration in July 2005. In early 2006, two CGM systems—Medtronic's integrated system (the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System) and DexCom Inc.'s STS system—were approved. In March 2007, Medtronic's second-generation Paradigm RT system with the MiniLink transmitter was licensed, and in May 2007, DexCom received approval for its new 7-day sensor (the Seven System). Abbott Laboratories' investigational Freestyle Navigator CGM system is expected to receive approval very soon.

As with all new expensive technology, insurers are not rushing to cover CGM. Medtronic's Guardian costs $1,399, whereas the Paradigm is $999 minus the cost of the pump, which is typically covered. The 3-day sensors cost $35 each. The Seven System is $800, plus $240 for a box of four 7-day sensors.

Because of these high costs, many health care professionals are holding back on recommending CGM to patients because they know it probably won't be covered. “I believe it is our role as educators to make our patients aware of all the devices and technologies that are out there. … We shouldn't preclude who we talk to based on whether they have insurance coverage,” said Ms. Halford, a licensed dietician and certified diabetes educator at the Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho. The center, which is the largest diabetes practice in the state, currently has 175 patients using continuous glucose monitoring.

Reimbursement may become easier in 2008, when the Centers for Medicare and Medicaid Services is expected to issue new Healthcare Common Procedural Coding System level II codes specifically for CGM. But in the meantime, the “junk codes” E1399 and A9999 (miscellaneous durable medical equipment) might work. Alternatively, Ms. Halford suggested, it's worth trying the CGM code S1030, which was developed for the previous device, the GlucoWatch. That device is no longer on the market, but the code's description— “continuous noninvasive glucose monitoring device, purchase”—doesn't specify any brand.

There are also two CPT codes (95250 and 95251) that were initially implemented for use with the Medtronic Continuous Glucose Monitoring System, which is worn by patients for 3 days, after which the physician downloads the glucose values. That device, first approved in 1999, does not provide results directly to patients. With the new systems, the same CPT codes can be used for CGM initiation and education, and for physician interpretation and report, respectively. Make sure those codes are in your contract, Ms. Halford advised.

But of course reimbursement isn't a guarantee even with a code, and—even if a patient's insurance does approve CGM—there is likely to be a huge out-of-pocket deductible for what is thus far a uniformly “out of network” expense. Until long-term data are available, insurance companies are likely to view CGM as investigational. “They think of it as a fancy traditional point-in-time glucose monitor. … They cannot comprehend the utilization for better control and peace of mind for the patient,” she noted.

So educating insurers is part of Ms. Halford's “coordinated battle plan”: First, identify the key individuals at each CGM manufacturer and develop a working relationship with them. Once they recognize that you are a “champion” of the technology, they will provide needed resources. Next, identify and meet the insurance company's case managers and develop a relationship with them. These individuals can be extremely helpful, Ms. Halford noted, as they are often in close contact with the company's medical director.

If possible, try to schedule a meeting with the insurance company's medical director and case manager, as well as the CGM manufacturers' managed care directors. “If we're persistent, we can make these contacts. You just have to want to make it happen,” she remarked.

Initially at least, it makes sense to go after the “obvious” patients who would benefit from CGM, such as women with type 1 diabetes who are pregnant or planning a pregnancy, patients with gastroparesis, those on dialysis who are unable to get on the kidney transplant list unless their glucose control improves, or those with hypoglycemic unawareness, which is the one condition that the insurance companies “are really tuned into,” she noted.

It's important to submit every prior authorization every time, so that insurance companies can see that there is a demand for continuous monitoring. With each letter, find out exactly what information they want and provide it. Create a file for each insurance company, including fax and telephone numbers, and key contacts.

There are two possible approaches for reimbursement. Patients can submit claims themselves for reimbursement without prior authorization. They will need a letter of medical necessity from the physician, along with individual invoices showing payments. It's a good idea to submit the invoice for the starter kit separately from the sensors, to improve the chances of staying “under the radar” in terms of any monetary caps (typically $500–$600) on device coverage that the insurer may have, she advised.

The other approach is for the physician's office to submit the request for prior authorization. Be prepared to write several letters. The initial letter of medical necessity should be kept relatively short. Include the patient's name, date of birth, insurance identification number, the medical necessity for the device, and information about the device, including utility, cost, and potential cost savings.

If the initial request is denied, the first letter of appeal—sent to a specific appeals person along with the case number of the denial—should go further in making the case. Provide information about hospitalizations for hypoglycemia or ketoacidosis, emergency visits, glucagon administration, lost time/injuries at work, previous complications related to low or high blood sugar, and any physician notes regarding labs, procedures, current care plan, and frequency of testing. It's also a good idea to provide journal abstracts highlighting the patient's specific needs. But don't send the entire article, because insurers will often point to the one sentence at the end saying that “more research is needed,” Ms. Halford advised.

The third letter goes to the company's medical director. Include all the previous identifying information, but it's not necessary at this point to include lab work and medical information, because there will already be a file on the patient. Here, the goal is to address the patient's “right for appropriate and adequate medical care” and the insurer's “obligation” to meet those rights. Be sure to address any previous argument the company made against coverage.

It may also help to request a letter from the manufacturer's managed care director, who can review the clinical merits of CGM, clarify any misunderstandings regarding the therapy, address technology criteria set out by individual insurance companies and how CGM meets them, and assist with developing medical policy for CGM.

Although there are as yet no long-term outcomes data on CGM, there is certainly plenty of literature on the relationship between good blood glucose control and prevention of complications, including the landmark Diabetes Control and Complications Trial. Articles on the cost savings to insurance companies when hemoglobin A_1c levels are improved may also help. “Provide the insurance companies with a comprehensive list of reference materials,” Ms. Halford recommended.

It might help to “piggyback” the CGM with other covered technologies, such as the insulin pump or the fingerstick method for self-monitoring of blood glucose. In all, 19 states (Alaska, Colorado, Connecticut, Florida, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Oregon, South Carolina, Vermont, Virginia, Wisconsin, and Wyoming) and the District of Columbia have now mandated coverage for self-monitoring. One major insurer (CareFirst BlueCross BlueShield) has begun covering CGM technologies in Maryland, Virginia, and the District of Columbia because of its interpretation of Maryland's statute requiring coverage of all “glucose monitoring technologies and supplies.”

“If you're fortunate to live in one of those states, you want to check and see if there's a little opening you can wiggle your toe into and pry the door open,” she said.

Another avenue to try is calling the state health insurance commission to discuss why the patient is being billed for out-of-network costs when “in-network” relationships don't exist because they have not yet been negotiated between manufacturers and distributors.

And one more possibility: Use the Americans with Disabilities Act for patients who risk losing their jobs secondary to poor blood glucose control. Insurance companies can't be forced to cover CGM, but if they cover things like hearing aids and special glasses, then they must “equitably” provide coverage for CGM. At least that argument is worth a try, Ms. Halford said.

ST. LOUIS — Obtaining insurance coverage for continuous glucose monitoring may be something of a battle right now, but in many cases it's a winnable one, Jean R. Halford, R.D., said at the annual meeting of the American Association of Diabetes Educators.

The continuous glucose monitoring (CGM) device that provides data directly to patients is very recent technology. Medtronic Inc.'s Guardian system was approved in limited release by the Food and Drug Administration in July 2005. In early 2006, two CGM systems—Medtronic's integrated system (the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System) and DexCom Inc.'s STS system—were approved. In March 2007, Medtronic's second-generation Paradigm RT system with the MiniLink transmitter was licensed, and in May 2007, DexCom received approval for its new 7-day sensor (the Seven System). Abbott Laboratories' investigational Freestyle Navigator CGM system is expected to receive approval very soon.

As with all new expensive technology, insurers are not rushing to cover CGM. Medtronic's Guardian costs $1,399, whereas the Paradigm is $999 minus the cost of the pump, which is typically covered. The 3-day sensors cost $35 each. The Seven System is $800, plus $240 for a box of four 7-day sensors.

Because of these high costs, many health care professionals are holding back on recommending CGM to patients because they know it probably won't be covered. “I believe it is our role as educators to make our patients aware of all the devices and technologies that are out there. … We shouldn't preclude who we talk to based on whether they have insurance coverage,” said Ms. Halford, a licensed dietician and certified diabetes educator at the Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho. The center, which is the largest diabetes practice in the state, currently has 175 patients using continuous glucose monitoring.

Reimbursement may become easier in 2008, when the Centers for Medicare and Medicaid Services is expected to issue new Healthcare Common Procedural Coding System level II codes specifically for CGM. But in the meantime, the “junk codes” E1399 and A9999 (miscellaneous durable medical equipment) might work. Alternatively, Ms. Halford suggested, it's worth trying the CGM code S1030, which was developed for the previous device, the GlucoWatch. That device is no longer on the market, but the code's description— “continuous noninvasive glucose monitoring device, purchase”—doesn't specify any brand.

There are also two CPT codes (95250 and 95251) that were initially implemented for use with the Medtronic Continuous Glucose Monitoring System, which is worn by patients for 3 days, after which the physician downloads the glucose values. That device, first approved in 1999, does not provide results directly to patients. With the new systems, the same CPT codes can be used for CGM initiation and education, and for physician interpretation and report, respectively. Make sure those codes are in your contract, Ms. Halford advised.

But of course reimbursement isn't a guarantee even with a code, and—even if a patient's insurance does approve CGM—there is likely to be a huge out-of-pocket deductible for what is thus far a uniformly “out of network” expense. Until long-term data are available, insurance companies are likely to view CGM as investigational. “They think of it as a fancy traditional point-in-time glucose monitor. … They cannot comprehend the utilization for better control and peace of mind for the patient,” she noted.

So educating insurers is part of Ms. Halford's “coordinated battle plan”: First, identify the key individuals at each CGM manufacturer and develop a working relationship with them. Once they recognize that you are a “champion” of the technology, they will provide needed resources. Next, identify and meet the insurance company's case managers and develop a relationship with them. These individuals can be extremely helpful, Ms. Halford noted, as they are often in close contact with the company's medical director.

If possible, try to schedule a meeting with the insurance company's medical director and case manager, as well as the CGM manufacturers' managed care directors. “If we're persistent, we can make these contacts. You just have to want to make it happen,” she remarked.

Initially at least, it makes sense to go after the “obvious” patients who would benefit from CGM, such as women with type 1 diabetes who are pregnant or planning a pregnancy, patients with gastroparesis, those on dialysis who are unable to get on the kidney transplant list unless their glucose control improves, or those with hypoglycemic unawareness, which is the one condition that the insurance companies “are really tuned into,” she noted.

It's important to submit every prior authorization every time, so that insurance companies can see that there is a demand for continuous monitoring. With each letter, find out exactly what information they want and provide it. Create a file for each insurance company, including fax and telephone numbers, and key contacts.

There are two possible approaches for reimbursement. Patients can submit claims themselves for reimbursement without prior authorization. They will need a letter of medical necessity from the physician, along with individual invoices showing payments. It's a good idea to submit the invoice for the starter kit separately from the sensors, to improve the chances of staying “under the radar” in terms of any monetary caps (typically $500–$600) on device coverage that the insurer may have, she advised.

The other approach is for the physician's office to submit the request for prior authorization. Be prepared to write several letters. The initial letter of medical necessity should be kept relatively short. Include the patient's name, date of birth, insurance identification number, the medical necessity for the device, and information about the device, including utility, cost, and potential cost savings.

If the initial request is denied, the first letter of appeal—sent to a specific appeals person along with the case number of the denial—should go further in making the case. Provide information about hospitalizations for hypoglycemia or ketoacidosis, emergency visits, glucagon administration, lost time/injuries at work, previous complications related to low or high blood sugar, and any physician notes regarding labs, procedures, current care plan, and frequency of testing. It's also a good idea to provide journal abstracts highlighting the patient's specific needs. But don't send the entire article, because insurers will often point to the one sentence at the end saying that “more research is needed,” Ms. Halford advised.

The third letter goes to the company's medical director. Include all the previous identifying information, but it's not necessary at this point to include lab work and medical information, because there will already be a file on the patient. Here, the goal is to address the patient's “right for appropriate and adequate medical care” and the insurer's “obligation” to meet those rights. Be sure to address any previous argument the company made against coverage.

It may also help to request a letter from the manufacturer's managed care director, who can review the clinical merits of CGM, clarify any misunderstandings regarding the therapy, address technology criteria set out by individual insurance companies and how CGM meets them, and assist with developing medical policy for CGM.

Although there are as yet no long-term outcomes data on CGM, there is certainly plenty of literature on the relationship between good blood glucose control and prevention of complications, including the landmark Diabetes Control and Complications Trial. Articles on the cost savings to insurance companies when hemoglobin A_1c levels are improved may also help. “Provide the insurance companies with a comprehensive list of reference materials,” Ms. Halford recommended.

It might help to “piggyback” the CGM with other covered technologies, such as the insulin pump or the fingerstick method for self-monitoring of blood glucose. In all, 19 states (Alaska, Colorado, Connecticut, Florida, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Oregon, South Carolina, Vermont, Virginia, Wisconsin, and Wyoming) and the District of Columbia have now mandated coverage for self-monitoring. One major insurer (CareFirst BlueCross BlueShield) has begun covering CGM technologies in Maryland, Virginia, and the District of Columbia because of its interpretation of Maryland's statute requiring coverage of all “glucose monitoring technologies and supplies.”

“If you're fortunate to live in one of those states, you want to check and see if there's a little opening you can wiggle your toe into and pry the door open,” she said.

Another avenue to try is calling the state health insurance commission to discuss why the patient is being billed for out-of-network costs when “in-network” relationships don't exist because they have not yet been negotiated between manufacturers and distributors.

And one more possibility: Use the Americans with Disabilities Act for patients who risk losing their jobs secondary to poor blood glucose control. Insurance companies can't be forced to cover CGM, but if they cover things like hearing aids and special glasses, then they must “equitably” provide coverage for CGM. At least that argument is worth a try, Ms. Halford said.

ST. LOUIS — Obtaining insurance coverage for continuous glucose monitoring may be something of a battle right now, but in many cases it's a winnable one, Jean R. Halford, R.D., said at the annual meeting of the American Association of Diabetes Educators.

The continuous glucose monitoring (CGM) device that provides data directly to patients is very recent technology. Medtronic Inc.'s Guardian system was approved in limited release by the Food and Drug Administration in July 2005. In early 2006, two CGM systems—Medtronic's integrated system (the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System) and DexCom Inc.'s STS system—were approved. In March 2007, Medtronic's second-generation Paradigm RT system with the MiniLink transmitter was licensed, and in May 2007, DexCom received approval for its new 7-day sensor (the Seven System). Abbott Laboratories' investigational Freestyle Navigator CGM system is expected to receive approval very soon.

As with all new expensive technology, insurers are not rushing to cover CGM. Medtronic's Guardian costs $1,399, whereas the Paradigm is $999 minus the cost of the pump, which is typically covered. The 3-day sensors cost $35 each. The Seven System is $800, plus $240 for a box of four 7-day sensors.

Because of these high costs, many health care professionals are holding back on recommending CGM to patients because they know it probably won't be covered. “I believe it is our role as educators to make our patients aware of all the devices and technologies that are out there. … We shouldn't preclude who we talk to based on whether they have insurance coverage,” said Ms. Halford, a licensed dietician and certified diabetes educator at the Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho. The center, which is the largest diabetes practice in the state, currently has 175 patients using continuous glucose monitoring.

Reimbursement may become easier in 2008, when the Centers for Medicare and Medicaid Services is expected to issue new Healthcare Common Procedural Coding System level II codes specifically for CGM. But in the meantime, the “junk codes” E1399 and A9999 (miscellaneous durable medical equipment) might work. Alternatively, Ms. Halford suggested, it's worth trying the CGM code S1030, which was developed for the previous device, the GlucoWatch. That device is no longer on the market, but the code's description— “continuous noninvasive glucose monitoring device, purchase”—doesn't specify any brand.

There are also two CPT codes (95250 and 95251) that were initially implemented for use with the Medtronic Continuous Glucose Monitoring System, which is worn by patients for 3 days, after which the physician downloads the glucose values. That device, first approved in 1999, does not provide results directly to patients. With the new systems, the same CPT codes can be used for CGM initiation and education, and for physician interpretation and report, respectively. Make sure those codes are in your contract, Ms. Halford advised.

But of course reimbursement isn't a guarantee even with a code, and—even if a patient's insurance does approve CGM—there is likely to be a huge out-of-pocket deductible for what is thus far a uniformly “out of network” expense. Until long-term data are available, insurance companies are likely to view CGM as investigational. “They think of it as a fancy traditional point-in-time glucose monitor. … They cannot comprehend the utilization for better control and peace of mind for the patient,” she noted.

So educating insurers is part of Ms. Halford's “coordinated battle plan”: First, identify the key individuals at each CGM manufacturer and develop a working relationship with them. Once they recognize that you are a “champion” of the technology, they will provide needed resources. Next, identify and meet the insurance company's case managers and develop a relationship with them. These individuals can be extremely helpful, Ms. Halford noted, as they are often in close contact with the company's medical director.

If possible, try to schedule a meeting with the insurance company's medical director and case manager, as well as the CGM manufacturers' managed care directors. “If we're persistent, we can make these contacts. You just have to want to make it happen,” she remarked.

Initially at least, it makes sense to go after the “obvious” patients who would benefit from CGM, such as women with type 1 diabetes who are pregnant or planning a pregnancy, patients with gastroparesis, those on dialysis who are unable to get on the kidney transplant list unless their glucose control improves, or those with hypoglycemic unawareness, which is the one condition that the insurance companies “are really tuned into,” she noted.

It's important to submit every prior authorization every time, so that insurance companies can see that there is a demand for continuous monitoring. With each letter, find out exactly what information they want and provide it. Create a file for each insurance company, including fax and telephone numbers, and key contacts.

There are two possible approaches for reimbursement. Patients can submit claims themselves for reimbursement without prior authorization. They will need a letter of medical necessity from the physician, along with individual invoices showing payments. It's a good idea to submit the invoice for the starter kit separately from the sensors, to improve the chances of staying “under the radar” in terms of any monetary caps (typically $500–$600) on device coverage that the insurer may have, she advised.

The other approach is for the physician's office to submit the request for prior authorization. Be prepared to write several letters. The initial letter of medical necessity should be kept relatively short. Include the patient's name, date of birth, insurance identification number, the medical necessity for the device, and information about the device, including utility, cost, and potential cost savings.

If the initial request is denied, the first letter of appeal—sent to a specific appeals person along with the case number of the denial—should go further in making the case. Provide information about hospitalizations for hypoglycemia or ketoacidosis, emergency visits, glucagon administration, lost time/injuries at work, previous complications related to low or high blood sugar, and any physician notes regarding labs, procedures, current care plan, and frequency of testing. It's also a good idea to provide journal abstracts highlighting the patient's specific needs. But don't send the entire article, because insurers will often point to the one sentence at the end saying that “more research is needed,” Ms. Halford advised.

The third letter goes to the company's medical director. Include all the previous identifying information, but it's not necessary at this point to include lab work and medical information, because there will already be a file on the patient. Here, the goal is to address the patient's “right for appropriate and adequate medical care” and the insurer's “obligation” to meet those rights. Be sure to address any previous argument the company made against coverage.

It may also help to request a letter from the manufacturer's managed care director, who can review the clinical merits of CGM, clarify any misunderstandings regarding the therapy, address technology criteria set out by individual insurance companies and how CGM meets them, and assist with developing medical policy for CGM.

Although there are as yet no long-term outcomes data on CGM, there is certainly plenty of literature on the relationship between good blood glucose control and prevention of complications, including the landmark Diabetes Control and Complications Trial. Articles on the cost savings to insurance companies when hemoglobin A_1c levels are improved may also help. “Provide the insurance companies with a comprehensive list of reference materials,” Ms. Halford recommended.

It might help to “piggyback” the CGM with other covered technologies, such as the insulin pump or the fingerstick method for self-monitoring of blood glucose. In all, 19 states (Alaska, Colorado, Connecticut, Florida, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Oregon, South Carolina, Vermont, Virginia, Wisconsin, and Wyoming) and the District of Columbia have now mandated coverage for self-monitoring. One major insurer (CareFirst BlueCross BlueShield) has begun covering CGM technologies in Maryland, Virginia, and the District of Columbia because of its interpretation of Maryland's statute requiring coverage of all “glucose monitoring technologies and supplies.”

“If you're fortunate to live in one of those states, you want to check and see if there's a little opening you can wiggle your toe into and pry the door open,” she said.

Another avenue to try is calling the state health insurance commission to discuss why the patient is being billed for out-of-network costs when “in-network” relationships don't exist because they have not yet been negotiated between manufacturers and distributors.

And one more possibility: Use the Americans with Disabilities Act for patients who risk losing their jobs secondary to poor blood glucose control. Insurance companies can't be forced to cover CGM, but if they cover things like hearing aids and special glasses, then they must “equitably” provide coverage for CGM. At least that argument is worth a try, Ms. Halford said.

Dr. Griffin P. Rodgers plans to push forward his agenda of “vigorous, multi-pronged research efforts” in the areas of diabetes, obesity, and endocrinology, even if his budget pushes back a bit.

On April 1, Dr. Rodgers was named the new director of the National Institute of Diabetes and Digestive and Kidney Diseases, overseeing a budget of $1.8 billion and a staff 650 scientists and administrators. The Bush administration's proposed fiscal 2008 budget would essentially “flatline” that amount for the fourth year in a row. At press time, the U.S. House of Representatives had voted to provide a modest $26-million budget increase for the institute, and the Senate was not expected to take a vote until after its August recess.

Regardless of the final budget allocation, Dr. Rodgers aims to maximize it. “I think federally funded research really plays an indispensable role in [improving the] understanding, prevention, and treatment of disease. And with the budget provided to us, we are actively pursuing a wide range of promising research avenues,” he said in an interview.

Dr. Rodgers outlined five “core principles” that guide his vision for basic, translational, and clinical research in the areas of diabetes, obesity, and other endocrine diseases:

▸ Maintain a vigorous, investigator-initiated research portfolio. “The innovativeness and problem-solving capability of individual investigators are crucial for research progress,” he noted.

Among the diabetes-related priorities are those that will increase understanding of the mechanisms of genes associated with both type 1 and type 2 diabetes, and how the pathways involved might lead to treatment, prevention, or cure. The application of new technologies, such as proteomics and metabolomics, to the study of diabetes and its complications also ranks high on the priority list.

In obesity, NIDDK intends to fund investigator-driven research that illuminates the regulation of appetite and energy expenditure via hormone signaling, as well as the behavioral and environmental factors contributing to the problem.

▸ Support pivotal clinical studies and trials. Translation of results from two major groundbreaking NIDDK-funded studies—the Diabetes Control and Complications Trial (DCCT) and the Diabetes Prevention Program (DPP)—will remain an institute priority. These ongoing efforts include the DCCT follow-up study, the EDIC (Epidemiology of Diabetes Interventions and Complications) trial, and the DPP Outcomes Study.

Two new studies, both focusing on young people, could have major implications for public health policy and clinical management, respectively.

The HEALTHY trial is a multistate initiative based in 42 middle schools, aimed at determining if changes in food services and physical education classes, along with activities that encourage healthy behaviors, can lower risk factors for type 2 diabetes. Results from that study are expected in 2009.

The other study, called TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth), is investigating the best treatments for type 2 diabetes in children. It is still accepting patients. (See box.) Other clinical studies are looking at behavioral approaches to reducing obesity in adults in the general population, and in minority groups in particular.

Strategies to maximize research dollars include the funding of ancillary studies to supplement ongoing large clinical trials, as well as supporting a central repository for biologic materials, derived from those trials, that can be accessed by the broader research community. “We look at these as ways of really extending the investments we've already made in clinical trials. The goal is to derive the maximum benefit from our prior investments,” Dr. Rodgers said.

▸ Preserve a stable pool of talented new investigators. Over the past several years, applications from new investigators for regular research (RO1) grants have received a two-percentage-point advantage in funding consideration, compared with applications from established investigators. And more recently, new investigator applications that just miss the general funding line—commonly called the “payline”—have received second-chance individual consideration via an approach called “special emphasis funding.” New investigators may also receive short-term support, called R56 awards, that assist them in collecting preliminary data in order to subsequently submit a revised, stronger application for a longer-term regular research grant in the next cycle.

Unfortunately, “we've had to make across-the-board cuts in the size of grants to preserve a payline that has been declining somewhat over the years,” Dr. Rodgers said. Another goal is to “preserve a cadre of new investigators so we really don't lose a generation of investigators during this period of some resource allocation challenges.”

▸ Foster exceptional research, training, and mentoring opportunities. Maintaining a pipeline of NIDDK-focused investigators is critically important, Dr. Rodgers said. To that end, competitive institutional research training awards will be given to pediatric endocrinologists involved in diabetes research.

He noted that significant support will also continue at the graduate student and postdoctoral levels. “These programs will help ensure that there will be a cadre of well-trained PhD scientists and physician-scientists specializing in endocrinology and diabetes research,” Dr. Rodgers said.

▸ Ensure knowledge dissemination. Efforts such as the 10-year-old National Diabetes Education Program (cosponsored with the Centers for Disease Control and Prevention), the National Kidney Disease Education Program, and the Weight-Control Information Network are essential to the institute's mission. “People talk about bench-to-bedside research, but there are data that currently exist that, if they were implemented in practice, would really provide striking benefits to patients on a large scale. A lot of this is a knowledge gap, and that's what we're trying to work with in these education dissemination efforts,” said Dr. Rodgers.

A hematologist by training, Dr. Rodgers has worked at the National Institutes of Health since 1982. He is widely recognized for the development of the first effective therapy for sickle cell anemia, and has performed basic research focused on the understanding of the molecular bases of how drugs induce gamma-globin gene expression. “My own personal work in the area of hematology has provided me with a level of comfort, both in the basic and translational and clinical arenas, that sort of guide the way I think about areas of research that the institute is more generally involved in,” he said in the interview.

Resources for NIDDK Initiatives

▸

www.niddkrepository.org

▸

www.obesityresearch.nih.gov

▸

www.todaystudy.org

▸

www.nih.gov/news/pr/aug2006/niddk-28.htm

▸

www.ndep.nih.gov

▸

www.nkdep.nih.gov

▸

http://win.niddk.nih.gov

Dr. Griffin P. Rodgers plans to push forward his agenda of “vigorous, multi-pronged research efforts” in the areas of diabetes, obesity, and endocrinology, even if his budget pushes back a bit.

On April 1, Dr. Rodgers was named the new director of the National Institute of Diabetes and Digestive and Kidney Diseases, overseeing a budget of $1.8 billion and a staff 650 scientists and administrators. The Bush administration's proposed fiscal 2008 budget would essentially “flatline” that amount for the fourth year in a row. At press time, the U.S. House of Representatives had voted to provide a modest $26-million budget increase for the institute, and the Senate was not expected to take a vote until after its August recess.

Regardless of the final budget allocation, Dr. Rodgers aims to maximize it. “I think federally funded research really plays an indispensable role in [improving the] understanding, prevention, and treatment of disease. And with the budget provided to us, we are actively pursuing a wide range of promising research avenues,” he said in an interview.

Dr. Rodgers outlined five “core principles” that guide his vision for basic, translational, and clinical research in the areas of diabetes, obesity, and other endocrine diseases:

▸ Maintain a vigorous, investigator-initiated research portfolio. “The innovativeness and problem-solving capability of individual investigators are crucial for research progress,” he noted.

Among the diabetes-related priorities are those that will increase understanding of the mechanisms of genes associated with both type 1 and type 2 diabetes, and how the pathways involved might lead to treatment, prevention, or cure. The application of new technologies, such as proteomics and metabolomics, to the study of diabetes and its complications also ranks high on the priority list.

In obesity, NIDDK intends to fund investigator-driven research that illuminates the regulation of appetite and energy expenditure via hormone signaling, as well as the behavioral and environmental factors contributing to the problem.

▸ Support pivotal clinical studies and trials. Translation of results from two major groundbreaking NIDDK-funded studies—the Diabetes Control and Complications Trial (DCCT) and the Diabetes Prevention Program (DPP)—will remain an institute priority. These ongoing efforts include the DCCT follow-up study, the EDIC (Epidemiology of Diabetes Interventions and Complications) trial, and the DPP Outcomes Study.

Two new studies, both focusing on young people, could have major implications for public health policy and clinical management, respectively.

The HEALTHY trial is a multistate initiative based in 42 middle schools, aimed at determining if changes in food services and physical education classes, along with activities that encourage healthy behaviors, can lower risk factors for type 2 diabetes. Results from that study are expected in 2009.

The other study, called TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth), is investigating the best treatments for type 2 diabetes in children. It is still accepting patients. (See box.) Other clinical studies are looking at behavioral approaches to reducing obesity in adults in the general population, and in minority groups in particular.

Strategies to maximize research dollars include the funding of ancillary studies to supplement ongoing large clinical trials, as well as supporting a central repository for biologic materials, derived from those trials, that can be accessed by the broader research community. “We look at these as ways of really extending the investments we've already made in clinical trials. The goal is to derive the maximum benefit from our prior investments,” Dr. Rodgers said.

▸ Preserve a stable pool of talented new investigators. Over the past several years, applications from new investigators for regular research (RO1) grants have received a two-percentage-point advantage in funding consideration, compared with applications from established investigators. And more recently, new investigator applications that just miss the general funding line—commonly called the “payline”—have received second-chance individual consideration via an approach called “special emphasis funding.” New investigators may also receive short-term support, called R56 awards, that assist them in collecting preliminary data in order to subsequently submit a revised, stronger application for a longer-term regular research grant in the next cycle.

Unfortunately, “we've had to make across-the-board cuts in the size of grants to preserve a payline that has been declining somewhat over the years,” Dr. Rodgers said. Another goal is to “preserve a cadre of new investigators so we really don't lose a generation of investigators during this period of some resource allocation challenges.”

▸ Foster exceptional research, training, and mentoring opportunities. Maintaining a pipeline of NIDDK-focused investigators is critically important, Dr. Rodgers said. To that end, competitive institutional research training awards will be given to pediatric endocrinologists involved in diabetes research.

He noted that significant support will also continue at the graduate student and postdoctoral levels. “These programs will help ensure that there will be a cadre of well-trained PhD scientists and physician-scientists specializing in endocrinology and diabetes research,” Dr. Rodgers said.

▸ Ensure knowledge dissemination. Efforts such as the 10-year-old National Diabetes Education Program (cosponsored with the Centers for Disease Control and Prevention), the National Kidney Disease Education Program, and the Weight-Control Information Network are essential to the institute's mission. “People talk about bench-to-bedside research, but there are data that currently exist that, if they were implemented in practice, would really provide striking benefits to patients on a large scale. A lot of this is a knowledge gap, and that's what we're trying to work with in these education dissemination efforts,” said Dr. Rodgers.

A hematologist by training, Dr. Rodgers has worked at the National Institutes of Health since 1982. He is widely recognized for the development of the first effective therapy for sickle cell anemia, and has performed basic research focused on the understanding of the molecular bases of how drugs induce gamma-globin gene expression. “My own personal work in the area of hematology has provided me with a level of comfort, both in the basic and translational and clinical arenas, that sort of guide the way I think about areas of research that the institute is more generally involved in,” he said in the interview.

Resources for NIDDK Initiatives

▸

www.niddkrepository.org

▸

www.obesityresearch.nih.gov

▸

www.todaystudy.org

▸

www.nih.gov/news/pr/aug2006/niddk-28.htm

▸

www.ndep.nih.gov

▸

www.nkdep.nih.gov

▸

http://win.niddk.nih.gov

Dr. Griffin P. Rodgers plans to push forward his agenda of “vigorous, multi-pronged research efforts” in the areas of diabetes, obesity, and endocrinology, even if his budget pushes back a bit.

On April 1, Dr. Rodgers was named the new director of the National Institute of Diabetes and Digestive and Kidney Diseases, overseeing a budget of $1.8 billion and a staff 650 scientists and administrators. The Bush administration's proposed fiscal 2008 budget would essentially “flatline” that amount for the fourth year in a row. At press time, the U.S. House of Representatives had voted to provide a modest $26-million budget increase for the institute, and the Senate was not expected to take a vote until after its August recess.

Regardless of the final budget allocation, Dr. Rodgers aims to maximize it. “I think federally funded research really plays an indispensable role in [improving the] understanding, prevention, and treatment of disease. And with the budget provided to us, we are actively pursuing a wide range of promising research avenues,” he said in an interview.

Dr. Rodgers outlined five “core principles” that guide his vision for basic, translational, and clinical research in the areas of diabetes, obesity, and other endocrine diseases:

▸ Maintain a vigorous, investigator-initiated research portfolio. “The innovativeness and problem-solving capability of individual investigators are crucial for research progress,” he noted.

Among the diabetes-related priorities are those that will increase understanding of the mechanisms of genes associated with both type 1 and type 2 diabetes, and how the pathways involved might lead to treatment, prevention, or cure. The application of new technologies, such as proteomics and metabolomics, to the study of diabetes and its complications also ranks high on the priority list.

In obesity, NIDDK intends to fund investigator-driven research that illuminates the regulation of appetite and energy expenditure via hormone signaling, as well as the behavioral and environmental factors contributing to the problem.

▸ Support pivotal clinical studies and trials. Translation of results from two major groundbreaking NIDDK-funded studies—the Diabetes Control and Complications Trial (DCCT) and the Diabetes Prevention Program (DPP)—will remain an institute priority. These ongoing efforts include the DCCT follow-up study, the EDIC (Epidemiology of Diabetes Interventions and Complications) trial, and the DPP Outcomes Study.

Two new studies, both focusing on young people, could have major implications for public health policy and clinical management, respectively.

The HEALTHY trial is a multistate initiative based in 42 middle schools, aimed at determining if changes in food services and physical education classes, along with activities that encourage healthy behaviors, can lower risk factors for type 2 diabetes. Results from that study are expected in 2009.

The other study, called TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth), is investigating the best treatments for type 2 diabetes in children. It is still accepting patients. (See box.) Other clinical studies are looking at behavioral approaches to reducing obesity in adults in the general population, and in minority groups in particular.

Strategies to maximize research dollars include the funding of ancillary studies to supplement ongoing large clinical trials, as well as supporting a central repository for biologic materials, derived from those trials, that can be accessed by the broader research community. “We look at these as ways of really extending the investments we've already made in clinical trials. The goal is to derive the maximum benefit from our prior investments,” Dr. Rodgers said.

▸ Preserve a stable pool of talented new investigators. Over the past several years, applications from new investigators for regular research (RO1) grants have received a two-percentage-point advantage in funding consideration, compared with applications from established investigators. And more recently, new investigator applications that just miss the general funding line—commonly called the “payline”—have received second-chance individual consideration via an approach called “special emphasis funding.” New investigators may also receive short-term support, called R56 awards, that assist them in collecting preliminary data in order to subsequently submit a revised, stronger application for a longer-term regular research grant in the next cycle.

Unfortunately, “we've had to make across-the-board cuts in the size of grants to preserve a payline that has been declining somewhat over the years,” Dr. Rodgers said. Another goal is to “preserve a cadre of new investigators so we really don't lose a generation of investigators during this period of some resource allocation challenges.”

▸ Foster exceptional research, training, and mentoring opportunities. Maintaining a pipeline of NIDDK-focused investigators is critically important, Dr. Rodgers said. To that end, competitive institutional research training awards will be given to pediatric endocrinologists involved in diabetes research.

He noted that significant support will also continue at the graduate student and postdoctoral levels. “These programs will help ensure that there will be a cadre of well-trained PhD scientists and physician-scientists specializing in endocrinology and diabetes research,” Dr. Rodgers said.

▸ Ensure knowledge dissemination. Efforts such as the 10-year-old National Diabetes Education Program (cosponsored with the Centers for Disease Control and Prevention), the National Kidney Disease Education Program, and the Weight-Control Information Network are essential to the institute's mission. “People talk about bench-to-bedside research, but there are data that currently exist that, if they were implemented in practice, would really provide striking benefits to patients on a large scale. A lot of this is a knowledge gap, and that's what we're trying to work with in these education dissemination efforts,” said Dr. Rodgers.

A hematologist by training, Dr. Rodgers has worked at the National Institutes of Health since 1982. He is widely recognized for the development of the first effective therapy for sickle cell anemia, and has performed basic research focused on the understanding of the molecular bases of how drugs induce gamma-globin gene expression. “My own personal work in the area of hematology has provided me with a level of comfort, both in the basic and translational and clinical arenas, that sort of guide the way I think about areas of research that the institute is more generally involved in,” he said in the interview.

Resources for NIDDK Initiatives

▸

www.niddkrepository.org

▸

www.obesityresearch.nih.gov

▸

www.todaystudy.org

▸

www.nih.gov/news/pr/aug2006/niddk-28.htm

▸

www.ndep.nih.gov

▸

www.nkdep.nih.gov

▸

http://win.niddk.nih.gov

ST. LOUIS — The latest results of a large national survey of diabetes educators identifies areas in which the profession might be able to optimize its delivery of patient care while improving its financial viability at the same time.

Launched in 2005, the aim of the American Association of Diabetes Educators' (AADE) National Practice Survey is to lay the groundwork for creating evidence-based practices, Mary M. Austin and Malinda Peeples explained in a joint presentation at the association's annual meeting.

The challenge is to define core elements of successful diabetes education programs and to standardize those in a way that will still allow providers to use their creativity and customize their programs, said Ms. Peeples, a certified diabetes educator and immediate past president of the AADE.

Earlier National Practice Survey (NPS) results have been published (Diabetes Educ. 2007;33:424–33), but the 2007 data, which are currently being analyzed by a health economist, are significant because they are the first to illustrate trends, noted Ms. Austin, who also is a certified diabetes educator and past president of the AADE.

The survey consisted of 33 questions on program structure, 7 questions on process (interventions, program services, and activity), and 8 questions pertaining to outcomes. A diabetes education program was defined as “any structured, organized delivery of diabetes education occurring in any practice setting.”

In 2007, the survey was mailed to 10,865 AADE members. The 30% return rate was a significant increase from the 21% of 9,322 members who responded in 2005. Educators from every state in the union responded, with the greatest numbers from Texas, California, New York, Illinois, Ohio, and Florida. Ms. Peeples acknowledged that a limitation of the survey was that it was sent only to AADE members.

Most (92%) of the 2007 respondents reported they are currently “providing, supervising, or coordinating” diabetes patient education. A total of 73% described their role as “diabetes educator,” and 28% described it as “diabetes program manager/director/coordinator.”

From 2005 to 2007, there was an increase in the number of programs serving multiple locations (38% to 43%, respectively), with a corresponding decrease in the proportion serving a single location (62% to 57%). In 2007, 26% of the programs were serving 2 locations, and an almost equal proportion (24%) were serving more than 10 locations. These findings are not surprising because there have been reimbursement initiatives that encourage programs to serve multiple sites, Ms. Peeples said.

Also not surprising was that hospital outpatient settings were the most common venues for delivery of diabetes education (33%), followed by hospital inpatient settings (15%), and physician's offices (12%). But beyond those, there was a range of venues, including health system ambulatory clinics (5%), community education centers (4%), offices run by self-employed/independent educators (3%), and work site health clinics (2%). At least some respondents worked in each of the 17 types of settings listed in the survey, and 9% listed their setting as “other.”

Equally diverse was the list of disciplines from which diabetes educators emerge. Registered nurses topped the list at 51%, a significant increase from 45% in 2005. Registered dieticians were second, at 33%, also significantly up from 30% in 2005. Pharmacists dropped a bit, from 4% in 2005 to 3% in 2007. Those numbers closely reflect the entire AADE membership, Ms. Peeples said.

But also on the list in small proportions were professionals such as exercise physiologists, social workers, psychologists, and physicians (primary care and endocrinologists). A majority (79%) had earned a CDE credential, whereas only a small percentage (3%) had a board certification in advanced diabetes management (BC-ADM). Sixty-two percent worked full-time (a slight drop from the 66% in 2005) and 37% part-time (up from 34%).

The programs were divided almost equally among urban, suburban, and rural settings. “This is important when you hear about how rural areas are underserved. … We're already there. We just need to understand better how we can maximize the efforts of educators in some of those areas,” Ms. Peeples said.

Of concern was the fact that most of the programs reported just 4–20 patient visits a week. “We need to get more data on staff/patient ratios. Some educators may be seeing as few as four patients a week. If that's the case, then there's a real challenge to financial viability,” she remarked.

The results highlighted an area for improvement in the proportion of visits for newly diagnosed patients, which remained at about 45% throughout the 3 years since the last survey.

Because only half of all patients with diabetes in the United States are currently meeting recommended diabetes management goals, Ms. Peebles noted, “Do educators not have an opportunity to really begin to impact and improve diabetes care by seeing patients on an ongoing basis, not just when they're newly diagnosed? There may be limits in terms of reimbursement, but these data allow us to talk about these issues.” Results also showed that payment sources for diabetes education included 29% from Medicare, 18% from managed care (HMO, PPO, or IPA), 16% from private (indemnity) insurance, and 9% from Medicaid. Of great concern was the finding that only about 10% of the 484 program managers reported that their programs were operating at a profit, which was down from 14% in 2005. At the same time, 44% of programs were operating at a loss, which is not much different from the 42% that were in 2005. Also worrisome was that 15% of program managers in 2007 (as opposed to 16% in 2005) said they didn't know whether their programs were making a profit, operating at cost, or losing money. “To us, that's pretty alarming,” Ms. Peeples remarked.

The survey also attempted to correlate profitability with the number of patient visits. The data were not easy to interpret. In general it seemed that the small proportion of programs (just 0.3%, or 17) that had more than 5,000 patient visits a year were the most likely to be making a profit, but even then only 18% were doing so. Of programs with 2,001–5,000 patient visits a year, 10% were making a profit; 48% were operating at a loss, Ms. Austin reported.

“We're trying to [determine] whether it's size or number of visits that makes a difference in terms of profitability. Right now we're having a difficult time figuring it all out, but it looks like nobody is really operating at full profit with no loss. Everyone's operating at some loss, but once you get over 5,000 [patients a year], you're losing less than everyone else.”

Another worrisome trend elicited from this year's survey was a slight downturn in the amount of clinical data collected and reported since 2005, with 12% of programs not collecting any outcome measures. “It wasn't significant, but it's something we need to keep an eye on. We don't know … whether it's a staffing issue, time, or something else,” Ms. Austin said.

A question added for the first time in 2007 concerned use of the chronic care model, which has been adopted by the AADE. In response to the question, “Are you interacting with providers who are using a chronic care model?” 37% said yes, 32% said no, and 31% answered I don't know. However, when asked if they were familiar with the McColl Institute chronic care model that has been endorsed by AADE, only 23% said yes. More information is available at www.improvingchroniccare.com

ST. LOUIS — The latest results of a large national survey of diabetes educators identifies areas in which the profession might be able to optimize its delivery of patient care while improving its financial viability at the same time.

Launched in 2005, the aim of the American Association of Diabetes Educators' (AADE) National Practice Survey is to lay the groundwork for creating evidence-based practices, Mary M. Austin and Malinda Peeples explained in a joint presentation at the association's annual meeting.

The challenge is to define core elements of successful diabetes education programs and to standardize those in a way that will still allow providers to use their creativity and customize their programs, said Ms. Peeples, a certified diabetes educator and immediate past president of the AADE.

Earlier National Practice Survey (NPS) results have been published (Diabetes Educ. 2007;33:424–33), but the 2007 data, which are currently being analyzed by a health economist, are significant because they are the first to illustrate trends, noted Ms. Austin, who also is a certified diabetes educator and past president of the AADE.

The survey consisted of 33 questions on program structure, 7 questions on process (interventions, program services, and activity), and 8 questions pertaining to outcomes. A diabetes education program was defined as “any structured, organized delivery of diabetes education occurring in any practice setting.”

In 2007, the survey was mailed to 10,865 AADE members. The 30% return rate was a significant increase from the 21% of 9,322 members who responded in 2005. Educators from every state in the union responded, with the greatest numbers from Texas, California, New York, Illinois, Ohio, and Florida. Ms. Peeples acknowledged that a limitation of the survey was that it was sent only to AADE members.

Most (92%) of the 2007 respondents reported they are currently “providing, supervising, or coordinating” diabetes patient education. A total of 73% described their role as “diabetes educator,” and 28% described it as “diabetes program manager/director/coordinator.”

From 2005 to 2007, there was an increase in the number of programs serving multiple locations (38% to 43%, respectively), with a corresponding decrease in the proportion serving a single location (62% to 57%). In 2007, 26% of the programs were serving 2 locations, and an almost equal proportion (24%) were serving more than 10 locations. These findings are not surprising because there have been reimbursement initiatives that encourage programs to serve multiple sites, Ms. Peeples said.

Also not surprising was that hospital outpatient settings were the most common venues for delivery of diabetes education (33%), followed by hospital inpatient settings (15%), and physician's offices (12%). But beyond those, there was a range of venues, including health system ambulatory clinics (5%), community education centers (4%), offices run by self-employed/independent educators (3%), and work site health clinics (2%). At least some respondents worked in each of the 17 types of settings listed in the survey, and 9% listed their setting as “other.”

Equally diverse was the list of disciplines from which diabetes educators emerge. Registered nurses topped the list at 51%, a significant increase from 45% in 2005. Registered dieticians were second, at 33%, also significantly up from 30% in 2005. Pharmacists dropped a bit, from 4% in 2005 to 3% in 2007. Those numbers closely reflect the entire AADE membership, Ms. Peeples said.

But also on the list in small proportions were professionals such as exercise physiologists, social workers, psychologists, and physicians (primary care and endocrinologists). A majority (79%) had earned a CDE credential, whereas only a small percentage (3%) had a board certification in advanced diabetes management (BC-ADM). Sixty-two percent worked full-time (a slight drop from the 66% in 2005) and 37% part-time (up from 34%).

The programs were divided almost equally among urban, suburban, and rural settings. “This is important when you hear about how rural areas are underserved. … We're already there. We just need to understand better how we can maximize the efforts of educators in some of those areas,” Ms. Peeples said.

Of concern was the fact that most of the programs reported just 4–20 patient visits a week. “We need to get more data on staff/patient ratios. Some educators may be seeing as few as four patients a week. If that's the case, then there's a real challenge to financial viability,” she remarked.

The results highlighted an area for improvement in the proportion of visits for newly diagnosed patients, which remained at about 45% throughout the 3 years since the last survey.

Because only half of all patients with diabetes in the United States are currently meeting recommended diabetes management goals, Ms. Peebles noted, “Do educators not have an opportunity to really begin to impact and improve diabetes care by seeing patients on an ongoing basis, not just when they're newly diagnosed? There may be limits in terms of reimbursement, but these data allow us to talk about these issues.” Results also showed that payment sources for diabetes education included 29% from Medicare, 18% from managed care (HMO, PPO, or IPA), 16% from private (indemnity) insurance, and 9% from Medicaid. Of great concern was the finding that only about 10% of the 484 program managers reported that their programs were operating at a profit, which was down from 14% in 2005. At the same time, 44% of programs were operating at a loss, which is not much different from the 42% that were in 2005. Also worrisome was that 15% of program managers in 2007 (as opposed to 16% in 2005) said they didn't know whether their programs were making a profit, operating at cost, or losing money. “To us, that's pretty alarming,” Ms. Peeples remarked.

The survey also attempted to correlate profitability with the number of patient visits. The data were not easy to interpret. In general it seemed that the small proportion of programs (just 0.3%, or 17) that had more than 5,000 patient visits a year were the most likely to be making a profit, but even then only 18% were doing so. Of programs with 2,001–5,000 patient visits a year, 10% were making a profit; 48% were operating at a loss, Ms. Austin reported.

“We're trying to [determine] whether it's size or number of visits that makes a difference in terms of profitability. Right now we're having a difficult time figuring it all out, but it looks like nobody is really operating at full profit with no loss. Everyone's operating at some loss, but once you get over 5,000 [patients a year], you're losing less than everyone else.”

Another worrisome trend elicited from this year's survey was a slight downturn in the amount of clinical data collected and reported since 2005, with 12% of programs not collecting any outcome measures. “It wasn't significant, but it's something we need to keep an eye on. We don't know … whether it's a staffing issue, time, or something else,” Ms. Austin said.

A question added for the first time in 2007 concerned use of the chronic care model, which has been adopted by the AADE. In response to the question, “Are you interacting with providers who are using a chronic care model?” 37% said yes, 32% said no, and 31% answered I don't know. However, when asked if they were familiar with the McColl Institute chronic care model that has been endorsed by AADE, only 23% said yes. More information is available at www.improvingchroniccare.com

ST. LOUIS — The latest results of a large national survey of diabetes educators identifies areas in which the profession might be able to optimize its delivery of patient care while improving its financial viability at the same time.

Launched in 2005, the aim of the American Association of Diabetes Educators' (AADE) National Practice Survey is to lay the groundwork for creating evidence-based practices, Mary M. Austin and Malinda Peeples explained in a joint presentation at the association's annual meeting.

The challenge is to define core elements of successful diabetes education programs and to standardize those in a way that will still allow providers to use their creativity and customize their programs, said Ms. Peeples, a certified diabetes educator and immediate past president of the AADE.

Earlier National Practice Survey (NPS) results have been published (Diabetes Educ. 2007;33:424–33), but the 2007 data, which are currently being analyzed by a health economist, are significant because they are the first to illustrate trends, noted Ms. Austin, who also is a certified diabetes educator and past president of the AADE.

The survey consisted of 33 questions on program structure, 7 questions on process (interventions, program services, and activity), and 8 questions pertaining to outcomes. A diabetes education program was defined as “any structured, organized delivery of diabetes education occurring in any practice setting.”

In 2007, the survey was mailed to 10,865 AADE members. The 30% return rate was a significant increase from the 21% of 9,322 members who responded in 2005. Educators from every state in the union responded, with the greatest numbers from Texas, California, New York, Illinois, Ohio, and Florida. Ms. Peeples acknowledged that a limitation of the survey was that it was sent only to AADE members.

Most (92%) of the 2007 respondents reported they are currently “providing, supervising, or coordinating” diabetes patient education. A total of 73% described their role as “diabetes educator,” and 28% described it as “diabetes program manager/director/coordinator.”

From 2005 to 2007, there was an increase in the number of programs serving multiple locations (38% to 43%, respectively), with a corresponding decrease in the proportion serving a single location (62% to 57%). In 2007, 26% of the programs were serving 2 locations, and an almost equal proportion (24%) were serving more than 10 locations. These findings are not surprising because there have been reimbursement initiatives that encourage programs to serve multiple sites, Ms. Peeples said.

Also not surprising was that hospital outpatient settings were the most common venues for delivery of diabetes education (33%), followed by hospital inpatient settings (15%), and physician's offices (12%). But beyond those, there was a range of venues, including health system ambulatory clinics (5%), community education centers (4%), offices run by self-employed/independent educators (3%), and work site health clinics (2%). At least some respondents worked in each of the 17 types of settings listed in the survey, and 9% listed their setting as “other.”

Equally diverse was the list of disciplines from which diabetes educators emerge. Registered nurses topped the list at 51%, a significant increase from 45% in 2005. Registered dieticians were second, at 33%, also significantly up from 30% in 2005. Pharmacists dropped a bit, from 4% in 2005 to 3% in 2007. Those numbers closely reflect the entire AADE membership, Ms. Peeples said.

But also on the list in small proportions were professionals such as exercise physiologists, social workers, psychologists, and physicians (primary care and endocrinologists). A majority (79%) had earned a CDE credential, whereas only a small percentage (3%) had a board certification in advanced diabetes management (BC-ADM). Sixty-two percent worked full-time (a slight drop from the 66% in 2005) and 37% part-time (up from 34%).

The programs were divided almost equally among urban, suburban, and rural settings. “This is important when you hear about how rural areas are underserved. … We're already there. We just need to understand better how we can maximize the efforts of educators in some of those areas,” Ms. Peeples said.

Of concern was the fact that most of the programs reported just 4–20 patient visits a week. “We need to get more data on staff/patient ratios. Some educators may be seeing as few as four patients a week. If that's the case, then there's a real challenge to financial viability,” she remarked.

The results highlighted an area for improvement in the proportion of visits for newly diagnosed patients, which remained at about 45% throughout the 3 years since the last survey.

Because only half of all patients with diabetes in the United States are currently meeting recommended diabetes management goals, Ms. Peebles noted, “Do educators not have an opportunity to really begin to impact and improve diabetes care by seeing patients on an ongoing basis, not just when they're newly diagnosed? There may be limits in terms of reimbursement, but these data allow us to talk about these issues.” Results also showed that payment sources for diabetes education included 29% from Medicare, 18% from managed care (HMO, PPO, or IPA), 16% from private (indemnity) insurance, and 9% from Medicaid. Of great concern was the finding that only about 10% of the 484 program managers reported that their programs were operating at a profit, which was down from 14% in 2005. At the same time, 44% of programs were operating at a loss, which is not much different from the 42% that were in 2005. Also worrisome was that 15% of program managers in 2007 (as opposed to 16% in 2005) said they didn't know whether their programs were making a profit, operating at cost, or losing money. “To us, that's pretty alarming,” Ms. Peeples remarked.

The survey also attempted to correlate profitability with the number of patient visits. The data were not easy to interpret. In general it seemed that the small proportion of programs (just 0.3%, or 17) that had more than 5,000 patient visits a year were the most likely to be making a profit, but even then only 18% were doing so. Of programs with 2,001–5,000 patient visits a year, 10% were making a profit; 48% were operating at a loss, Ms. Austin reported.

“We're trying to [determine] whether it's size or number of visits that makes a difference in terms of profitability. Right now we're having a difficult time figuring it all out, but it looks like nobody is really operating at full profit with no loss. Everyone's operating at some loss, but once you get over 5,000 [patients a year], you're losing less than everyone else.”

Another worrisome trend elicited from this year's survey was a slight downturn in the amount of clinical data collected and reported since 2005, with 12% of programs not collecting any outcome measures. “It wasn't significant, but it's something we need to keep an eye on. We don't know … whether it's a staffing issue, time, or something else,” Ms. Austin said.

A question added for the first time in 2007 concerned use of the chronic care model, which has been adopted by the AADE. In response to the question, “Are you interacting with providers who are using a chronic care model?” 37% said yes, 32% said no, and 31% answered I don't know. However, when asked if they were familiar with the McColl Institute chronic care model that has been endorsed by AADE, only 23% said yes. More information is available at www.improvingchroniccare.com