Miriam E. Tucker

STOCKHOLM – Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the annual meeting of the European Association for the Study of Diabetes.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that ratio for men was 2.23.

Among women with diabetes aged 18-39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50-59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Dr. Mani stated that he had no disclosures.

STOCKHOLM – Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the annual meeting of the European Association for the Study of Diabetes.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that ratio for men was 2.23.

Among women with diabetes aged 18-39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50-59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Dr. Mani stated that he had no disclosures.

STOCKHOLM – Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the annual meeting of the European Association for the Study of Diabetes.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that ratio for men was 2.23.

Among women with diabetes aged 18-39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50-59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Dr. Mani stated that he had no disclosures.

STOCKHOLM – Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the annual meeting of the European Association for the Study of Diabetes.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that ratio for men was 2.23.

Among women with diabetes aged 18-39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50-59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Dr. Mani stated that he had no disclosures.

STOCKHOLM – Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the annual meeting of the European Association for the Study of Diabetes.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that ratio for men was 2.23.

Among women with diabetes aged 18-39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50-59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Dr. Mani stated that he had no disclosures.

STOCKHOLM – Both the prevalence and the incidence of pancreatitis were significantly greater among adults with diabetes than in those without, in an analysis of a U.K. database comprising more than 2 million general practice adult patients.

Rates of pancreatitis have been rising in recent years, along with increases in obesity and related conditions, including gallstones and hyperlipidemia. Previous studies have identified a link between type 2 diabetes, antihyperglycemic medications, and pancreatitis, but these have mainly used small population sizes and have not stratified by age and sex, Dr. Hamidreza Mani, an endocrinologist at the University of Leicester (England), said at the annual meeting of the European Association for the Study of Diabetes.

Dr. Mani and his associates used the U.K. General Practice Research Database, one of the largest patient databases in the world, comprising 2.34 million adults. Of those, 75,322 were identified with a history of type 2 diabetes. Among those, 574 (0.76%) also had a history of pancreatitis, compared with just 0.17% of the 2.2 million without diabetes.

This gave a crude hazard ratio of 4.5 for those with diabetes, compared with those without diabetes. After adjustment for age and sex, the odds ratio for a history of pancreatitis in those with diabetes, compared with those without, was 3.1, which was highly statistically significant, he said.

In all, 74,748 diabetes patients who were not found to have prevalent pancreatitis were followed forward for a mean of 3.1 years beyond a specified index date. Controls were followed for a mean of 3.2 years. There were 134 incident cases of diabetes among the diabetic group and 1,975 among the controls, giving crude incidence rates of 58 and 27 per 100,000 population, respectively. After adjustment again for age and sex, the relative risk of acute pancreatitis that was associated with diabetes was 1.47.

Striking age and sex differences were found. By sex overall, the incidence of pancreatitis among women with diabetes, compared with those without, was 1.95, whereas that ratio for men was 2.23.

Among women with diabetes aged 18-39 years, the incidence of pancreatitis was nearly sixfold, compared with those without diabetes, whereas the rate among women with diabetes aged 50-59 years was actually a bit less than among those without (hazard ratio, 0.86).

Among the men, the greatest incidence occurred in the 50- to 59-year age range, with a hazard ratio of 2.9, compared with men without diabetes. In diabetic men older than 80 years of age, the incidence of pancreatitis dropped to just half that of nondiabetic men (HR, 0.53).

The reason for the sex difference is unclear. Hormonal and other physiologic differences may account for some of it, but not for the sixfold increase among young women, he commented.

The overall pancreatitis incidence of 27.4 per 100,000 among patients with diabetes in this database is far greater than the 10 per 100,000 U.K. incidence that was reported in 1998, Dr. Mani noted.

Dr. Mani stated that he had no disclosures.

STOCKHOLM — Screening for prevalent type 2 diabetes in primary care identified people at high modifiable cardiovascular risk, but subsequent intensive multifactorial treatment improved cardiovascular outcomes by only an insignificant 17% over routine care in a large 5-year randomized study.

Nevertheless, “when compared to no screening and no diabetes treatment, screening and either early routine diabetes care or intensive multifactorial treatment are likely to reduce cardiovascular morbidity and mortality by nearly half,” Dr. William H. Herman, who was not involved in the research, commented at the annual meeting of the European Association for the Study of Diabetes.

Indeed, the difference between the intensive intervention and routine treatment groups is not the main point of the ADDITION study, said Dr. Herman, professor of medicine at the University of Michigan, Ann Arbor, who served as the independent commentator on the study. “The reality is that once people were labeled with diabetes they achieved much better risk factor control ... During the time this community-based study was being conducted, there were major national and international initiatives to improve diabetes care, and they clearly had an impact on blood pressure, cholesterol, smoking, and glycemia,” Dr. Herman said in an interview. “It’s the combination of screening, diagnosis, and treatment that seemed to have an impact.”

As part of the Anglo-Danish-Dutch Study of Intensive Treatment In People With Screen Detected Diabetes in Primary Care (ADDITION), 76,308 people aged 40-69 years without known diabetes were screened in 334 primary care practices in Denmark, Great Britain, and the Netherlands beginning in 2000. Those found to have diabetes were invited to enter the ADDITION treatment study at one of five participating centers. The screening results, published previously, showed that individuals with screening-detected type 2 diabetes and included in the ADDITION study had a raised and potentially modifiable risk of coronary heart disease (CHD). Specifically, the median estimated 10-year risk of CHD was 11% in women and 21% in men (Diabetologia 2008;51:1127-34).

Dr. Simon Griffin of the Institute of Metabolic Science, Addenbrooke’s Hospital, Cambridge, England, presented the 5-year ADDITION outcome results for 1,379 randomized to routine care and 1,678 who received intensive multifactorial intervention. At baseline, patients were aged 60 years, had a mean body mass index of 32 kg/m2, and slightly more than half were male. Before diabetes diagnosis, less than half – about 40% – were on antihypertensive medication and only 15% were on statins, despite having a mean blood pressure of approximately 150/86 mm Hg and mean LDL cholesterol levels of 131 mg/dL.

The intensive intervention included structured lifestyle education (dietary modification, increased physical activity, and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing.

Over the 5-year study period, treatment with antihypertensive medication, statins, and aspirin increased dramatically in both groups, although to a slightly greater degree in the intensive treatment group. At 5 years, statin use was 68% for the routine care group and 78% for intensive treatment, daily aspirin was used by 40% and 69%, and glucose-lowering medication by 54% and 64%, respectively, Dr. Griffin reported.

The proportion of patients achieving targets for blood pressure, cholesterol, and glycemia – targets that changed over the study period based on national guidelines – increased in both groups but was slightly greater with intensive treatment. The primary outcome composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, revascularization as a first event, and amputation did not differ significantly between the routine and intensive treatment groups at 8.5% vs. 7.2%, with a hazard ratio of 0.83. All-cause mortality, a secondary outcome, also did not differ significantly, with a hazard ratio of 0.91, Dr. Griffin said.

Dr. Griffin noted that the mortality rate in both groups was low, and even in the routine care group it was lower than that of the general diabetes population in Denmark and only slightly higher than the age-matched Danish general population.

The ADDITION study was funded by unrestricted grants from Novo Nordisk A/S (main industry sponsor), ASTRA Denmark, Pfizer Danmark, GlaxoSmithKline Pharma Denmark, SERVIER Danmark, A/S HemoCue Danmark, and A/S Novo Nordisk Scandinavia AB. Research funds also were contributed by the Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the Aarhus University Research Foundation, Novo Nordisk Foundation, the National Board of Health, the Danish Medical Research Council, the Danish Diabetes Association, the A.P. Møller Foundation for the Advancement of Medical Science, the Bernhard and Marie Kleins Trust, the Centre for Innovation in Nursing Education, the County of Aarhus, and the Danish Council of Nursing.

Dr. Griffin said he has received lecture fees from GSK, Unilever, Eli Lilly, and MSD. His attendance at the 2008 EASD meeting was paid by Eli Lilly. Dr. Herman stated that he had nothing to disclose.

STOCKHOLM — Screening for prevalent type 2 diabetes in primary care identified people at high modifiable cardiovascular risk, but subsequent intensive multifactorial treatment improved cardiovascular outcomes by only an insignificant 17% over routine care in a large 5-year randomized study.

Nevertheless, “when compared to no screening and no diabetes treatment, screening and either early routine diabetes care or intensive multifactorial treatment are likely to reduce cardiovascular morbidity and mortality by nearly half,” Dr. William H. Herman, who was not involved in the research, commented at the annual meeting of the European Association for the Study of Diabetes.

Indeed, the difference between the intensive intervention and routine treatment groups is not the main point of the ADDITION study, said Dr. Herman, professor of medicine at the University of Michigan, Ann Arbor, who served as the independent commentator on the study. “The reality is that once people were labeled with diabetes they achieved much better risk factor control ... During the time this community-based study was being conducted, there were major national and international initiatives to improve diabetes care, and they clearly had an impact on blood pressure, cholesterol, smoking, and glycemia,” Dr. Herman said in an interview. “It’s the combination of screening, diagnosis, and treatment that seemed to have an impact.”

As part of the Anglo-Danish-Dutch Study of Intensive Treatment In People With Screen Detected Diabetes in Primary Care (ADDITION), 76,308 people aged 40-69 years without known diabetes were screened in 334 primary care practices in Denmark, Great Britain, and the Netherlands beginning in 2000. Those found to have diabetes were invited to enter the ADDITION treatment study at one of five participating centers. The screening results, published previously, showed that individuals with screening-detected type 2 diabetes and included in the ADDITION study had a raised and potentially modifiable risk of coronary heart disease (CHD). Specifically, the median estimated 10-year risk of CHD was 11% in women and 21% in men (Diabetologia 2008;51:1127-34).

Dr. Simon Griffin of the Institute of Metabolic Science, Addenbrooke’s Hospital, Cambridge, England, presented the 5-year ADDITION outcome results for 1,379 randomized to routine care and 1,678 who received intensive multifactorial intervention. At baseline, patients were aged 60 years, had a mean body mass index of 32 kg/m2, and slightly more than half were male. Before diabetes diagnosis, less than half – about 40% – were on antihypertensive medication and only 15% were on statins, despite having a mean blood pressure of approximately 150/86 mm Hg and mean LDL cholesterol levels of 131 mg/dL.

The intensive intervention included structured lifestyle education (dietary modification, increased physical activity, and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing.

Over the 5-year study period, treatment with antihypertensive medication, statins, and aspirin increased dramatically in both groups, although to a slightly greater degree in the intensive treatment group. At 5 years, statin use was 68% for the routine care group and 78% for intensive treatment, daily aspirin was used by 40% and 69%, and glucose-lowering medication by 54% and 64%, respectively, Dr. Griffin reported.

The proportion of patients achieving targets for blood pressure, cholesterol, and glycemia – targets that changed over the study period based on national guidelines – increased in both groups but was slightly greater with intensive treatment. The primary outcome composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, revascularization as a first event, and amputation did not differ significantly between the routine and intensive treatment groups at 8.5% vs. 7.2%, with a hazard ratio of 0.83. All-cause mortality, a secondary outcome, also did not differ significantly, with a hazard ratio of 0.91, Dr. Griffin said.

Dr. Griffin noted that the mortality rate in both groups was low, and even in the routine care group it was lower than that of the general diabetes population in Denmark and only slightly higher than the age-matched Danish general population.

The ADDITION study was funded by unrestricted grants from Novo Nordisk A/S (main industry sponsor), ASTRA Denmark, Pfizer Danmark, GlaxoSmithKline Pharma Denmark, SERVIER Danmark, A/S HemoCue Danmark, and A/S Novo Nordisk Scandinavia AB. Research funds also were contributed by the Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the Aarhus University Research Foundation, Novo Nordisk Foundation, the National Board of Health, the Danish Medical Research Council, the Danish Diabetes Association, the A.P. Møller Foundation for the Advancement of Medical Science, the Bernhard and Marie Kleins Trust, the Centre for Innovation in Nursing Education, the County of Aarhus, and the Danish Council of Nursing.

Dr. Griffin said he has received lecture fees from GSK, Unilever, Eli Lilly, and MSD. His attendance at the 2008 EASD meeting was paid by Eli Lilly. Dr. Herman stated that he had nothing to disclose.

STOCKHOLM — Screening for prevalent type 2 diabetes in primary care identified people at high modifiable cardiovascular risk, but subsequent intensive multifactorial treatment improved cardiovascular outcomes by only an insignificant 17% over routine care in a large 5-year randomized study.

Nevertheless, “when compared to no screening and no diabetes treatment, screening and either early routine diabetes care or intensive multifactorial treatment are likely to reduce cardiovascular morbidity and mortality by nearly half,” Dr. William H. Herman, who was not involved in the research, commented at the annual meeting of the European Association for the Study of Diabetes.

Indeed, the difference between the intensive intervention and routine treatment groups is not the main point of the ADDITION study, said Dr. Herman, professor of medicine at the University of Michigan, Ann Arbor, who served as the independent commentator on the study. “The reality is that once people were labeled with diabetes they achieved much better risk factor control ... During the time this community-based study was being conducted, there were major national and international initiatives to improve diabetes care, and they clearly had an impact on blood pressure, cholesterol, smoking, and glycemia,” Dr. Herman said in an interview. “It’s the combination of screening, diagnosis, and treatment that seemed to have an impact.”

As part of the Anglo-Danish-Dutch Study of Intensive Treatment In People With Screen Detected Diabetes in Primary Care (ADDITION), 76,308 people aged 40-69 years without known diabetes were screened in 334 primary care practices in Denmark, Great Britain, and the Netherlands beginning in 2000. Those found to have diabetes were invited to enter the ADDITION treatment study at one of five participating centers. The screening results, published previously, showed that individuals with screening-detected type 2 diabetes and included in the ADDITION study had a raised and potentially modifiable risk of coronary heart disease (CHD). Specifically, the median estimated 10-year risk of CHD was 11% in women and 21% in men (Diabetologia 2008;51:1127-34).

Dr. Simon Griffin of the Institute of Metabolic Science, Addenbrooke’s Hospital, Cambridge, England, presented the 5-year ADDITION outcome results for 1,379 randomized to routine care and 1,678 who received intensive multifactorial intervention. At baseline, patients were aged 60 years, had a mean body mass index of 32 kg/m2, and slightly more than half were male. Before diabetes diagnosis, less than half – about 40% – were on antihypertensive medication and only 15% were on statins, despite having a mean blood pressure of approximately 150/86 mm Hg and mean LDL cholesterol levels of 131 mg/dL.

The intensive intervention included structured lifestyle education (dietary modification, increased physical activity, and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing.

Over the 5-year study period, treatment with antihypertensive medication, statins, and aspirin increased dramatically in both groups, although to a slightly greater degree in the intensive treatment group. At 5 years, statin use was 68% for the routine care group and 78% for intensive treatment, daily aspirin was used by 40% and 69%, and glucose-lowering medication by 54% and 64%, respectively, Dr. Griffin reported.

The proportion of patients achieving targets for blood pressure, cholesterol, and glycemia – targets that changed over the study period based on national guidelines – increased in both groups but was slightly greater with intensive treatment. The primary outcome composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, revascularization as a first event, and amputation did not differ significantly between the routine and intensive treatment groups at 8.5% vs. 7.2%, with a hazard ratio of 0.83. All-cause mortality, a secondary outcome, also did not differ significantly, with a hazard ratio of 0.91, Dr. Griffin said.

Dr. Griffin noted that the mortality rate in both groups was low, and even in the routine care group it was lower than that of the general diabetes population in Denmark and only slightly higher than the age-matched Danish general population.

The ADDITION study was funded by unrestricted grants from Novo Nordisk A/S (main industry sponsor), ASTRA Denmark, Pfizer Danmark, GlaxoSmithKline Pharma Denmark, SERVIER Danmark, A/S HemoCue Danmark, and A/S Novo Nordisk Scandinavia AB. Research funds also were contributed by the Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, the Aarhus University Research Foundation, Novo Nordisk Foundation, the National Board of Health, the Danish Medical Research Council, the Danish Diabetes Association, the A.P. Møller Foundation for the Advancement of Medical Science, the Bernhard and Marie Kleins Trust, the Centre for Innovation in Nursing Education, the County of Aarhus, and the Danish Council of Nursing.

Dr. Griffin said he has received lecture fees from GSK, Unilever, Eli Lilly, and MSD. His attendance at the 2008 EASD meeting was paid by Eli Lilly. Dr. Herman stated that he had nothing to disclose.

SAN ANTONIO – The state of Montana is proof that the success of the landmark Diabetes Prevention Program can be translated to the real world.

The Diabetes Prevention Program, funded by the National Institutes of Health, randomized 3,234 nondiabetic individuals with elevated glucose levels to placebo, metformin (850 mg twice daily), or a lifestyle modification program with the goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. After an average follow-up of 2.8 years, the lifestyle intervention reduced the progression to diabetes by 58% compared with placebo, while metformin lowered the risk by 31% (N. Engl. J. Med. 2002;346:393-403).

In Montana, four existing diabetes prevention programs that were staffed by certified diabetes educators, registered dieticians, cardiac rehabilitation specialists, exercise specialists, and physical therapists were selected to deliver Montana’s lifestyle coaching.

Staff at all sites – another four were added in 2009 – attended a 2-day training in the DPP program that was adapted for group sessions, in contrast to the individual sessions delivered in the original trial, according to Karl K. Vanderwood, M.P.H., of the Montana Diabetes Project.

The weight loss and exercise goals were the same as in the DPP. A total of 16 classes were delivered over 16 weeks, compared with the DPP, where 16 sessions occurred over 16-24 weeks. Participants also had the option of attending twice-weekly physical activity sessions. Between 8 and 30 participants attended the classes, and there was no variation in outcome by group size, said Mr. Vanderwood.

Eligible adults were referred by primary care providers. Participants had to have a body mass index of 25 kg/m2 or greater, along with one or more other risk factors for diabetes or cardiovascular disease such as a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), hypertension, dyslipidemia, or a history of gestational diabetes mellitus. (Unlike the DPP, a strict diagnosis of IGT or IFG was not required.)

Of 1,003 recruited, 801 completed the initial 16-week program. Of those, 563 were followed up again at 10 months. At 16 weeks, there were significant reductions from baseline in weight (99 to 92 kg, a 7% drop), systolic blood pressure (134 to 127 mm Hg, a 5% drop), diastolic blood pressure (82 to 79 mm Hg, a 4% drop), HDL cholesterol (49 to 46 mg/dL, a 6% drop), LDL cholesterol (125 to 115 mg/dL, an 8% drop), and fasting blood glucose (102 to 97 mg/dL, a 5% drop).

Weight reduction often brings an initial drop in HDL cholesterol, which tends to level out with weight maintenance, Mr. Vanderwood noted. Indeed, at the 10-month follow-up, the mean HDL cholesterol had risen to 51 mg/dL, a statistically significant increase from baseline. At 10 months, the improvements in systolic and diastolic blood pressure, LDL cholesterol, and fasting blood glucose remained statistically different from baseline. Mean weight was 90 kg, from 97 kg at baseline among the 563 participants analyzed. This did not achieve statistical significance.

At baseline, 70% of participants had three or more cardiometabolic risk factors, whereas by 10 months more than half had just 0-2 such risk factors, he added.

These outcomes are similar to those seen in the DPP. Since the only evaluation after 10 months has been a mailed survey, there are no conclusive data regarding progression to diabetes. However, that’s not really the aim of this pilot project, which was designed to see whether a DPP-based program could be implemented in the community, Mr. Vanderwood said in a follow-up interview.

“Our focus is on implementing the DPP and using our resources (money) to do so. Our thought is that it is more important to get people ‘inoculated’ with intervention than to expend time and resources following up on them,” he said, adding that the health department may decide to monitor diabetes conversion rates long term.

An important key to success of the program was that it utilized experienced staff at facilities with established referral mechanisms from community providers. “Health care providers welcomed this project into their community. I think they were jumping for joy to have a place to send these folks,” said certified diabetes educator Marcene K. Butcher, R.D., also of the Montana Diabetes Project.

Future plans include a telehealth option contracted with rural sites, the addition of four additional new physical sites, and a possible demonstration project with the state Medicaid program.

A major question has been whether the intensive lifestyle intervention provided in the optimal DPP clinical trial setting could be implemented in the real world. At the meeting, Ms. Butcher and Mr. Vanderwood described how the adapted version of the DPP lifestyle intervention was delivered in the state of Montana via group sessions conducted within established diabetes education programs. They also offered advice on how other parts of the country might follow suit.

Diabetes educators were key. “Diabetes educators are uniquely qualified and uniquely situated to provide diabetes prevention,” said Ms. Butcher, quality diabetes education initiative coordinator with the Montana Department of Public Health and Human Services in Helena.

“Here in Montana we’re providing the evidence that is needed for reimbursement for diabetes educators doing prevention,” she added, referring to an issue that was raised numerous times throughout the AADE meeting.

Mr. Vanderwood, who served as the Montana project’s program manager but is now a PhD student in epidemiology at the University of Pittsburgh, said that the concept initially came from the state’s medical officer, who recognized the burden of diabetes in the state and the importance of prevention. In 2006, he urged the state health department to request available tobacco settlement funding for chronic disease programs, including diabetes prevention.

A subsequent bill that provided funding for asthma, cancer, cardiovascular disease, and diabetes was signed into law in April 2007. The keys to securing funding were the strong evidence base of the DPP, the leadership within the health department, the fact that the proposed program had measurable objectives, and a supportive legislative subcommittee that “understood the importance of diabetes prevention,” Mr. Vanderwood said.

Seeking support through state legislation is one way to obtain funding. Other sources include existing wellness programs or having participants themselves pay. In addition, a new partnership between UnitedHealth Group and the Centers for Disease Control and Prevention is launching diabetes prevention programs that will be delivered to covered employees through Walgreen’s pharmacies and local YMCAs around the country. Hopefully that will spur coverage from other insurers, he commented.

In addition to diabetes prevention programs, other proven options might include work sites, churches, and YMCAs, Ms. Butcher said.

Both Ms. Butcher and Mr. Vanderwood stated that they had no financial disclosures.

SAN ANTONIO – The state of Montana is proof that the success of the landmark Diabetes Prevention Program can be translated to the real world.

The Diabetes Prevention Program, funded by the National Institutes of Health, randomized 3,234 nondiabetic individuals with elevated glucose levels to placebo, metformin (850 mg twice daily), or a lifestyle modification program with the goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. After an average follow-up of 2.8 years, the lifestyle intervention reduced the progression to diabetes by 58% compared with placebo, while metformin lowered the risk by 31% (N. Engl. J. Med. 2002;346:393-403).

In Montana, four existing diabetes prevention programs that were staffed by certified diabetes educators, registered dieticians, cardiac rehabilitation specialists, exercise specialists, and physical therapists were selected to deliver Montana’s lifestyle coaching.

Staff at all sites – another four were added in 2009 – attended a 2-day training in the DPP program that was adapted for group sessions, in contrast to the individual sessions delivered in the original trial, according to Karl K. Vanderwood, M.P.H., of the Montana Diabetes Project.

The weight loss and exercise goals were the same as in the DPP. A total of 16 classes were delivered over 16 weeks, compared with the DPP, where 16 sessions occurred over 16-24 weeks. Participants also had the option of attending twice-weekly physical activity sessions. Between 8 and 30 participants attended the classes, and there was no variation in outcome by group size, said Mr. Vanderwood.

Eligible adults were referred by primary care providers. Participants had to have a body mass index of 25 kg/m2 or greater, along with one or more other risk factors for diabetes or cardiovascular disease such as a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), hypertension, dyslipidemia, or a history of gestational diabetes mellitus. (Unlike the DPP, a strict diagnosis of IGT or IFG was not required.)

Of 1,003 recruited, 801 completed the initial 16-week program. Of those, 563 were followed up again at 10 months. At 16 weeks, there were significant reductions from baseline in weight (99 to 92 kg, a 7% drop), systolic blood pressure (134 to 127 mm Hg, a 5% drop), diastolic blood pressure (82 to 79 mm Hg, a 4% drop), HDL cholesterol (49 to 46 mg/dL, a 6% drop), LDL cholesterol (125 to 115 mg/dL, an 8% drop), and fasting blood glucose (102 to 97 mg/dL, a 5% drop).

Weight reduction often brings an initial drop in HDL cholesterol, which tends to level out with weight maintenance, Mr. Vanderwood noted. Indeed, at the 10-month follow-up, the mean HDL cholesterol had risen to 51 mg/dL, a statistically significant increase from baseline. At 10 months, the improvements in systolic and diastolic blood pressure, LDL cholesterol, and fasting blood glucose remained statistically different from baseline. Mean weight was 90 kg, from 97 kg at baseline among the 563 participants analyzed. This did not achieve statistical significance.

At baseline, 70% of participants had three or more cardiometabolic risk factors, whereas by 10 months more than half had just 0-2 such risk factors, he added.

These outcomes are similar to those seen in the DPP. Since the only evaluation after 10 months has been a mailed survey, there are no conclusive data regarding progression to diabetes. However, that’s not really the aim of this pilot project, which was designed to see whether a DPP-based program could be implemented in the community, Mr. Vanderwood said in a follow-up interview.

“Our focus is on implementing the DPP and using our resources (money) to do so. Our thought is that it is more important to get people ‘inoculated’ with intervention than to expend time and resources following up on them,” he said, adding that the health department may decide to monitor diabetes conversion rates long term.

An important key to success of the program was that it utilized experienced staff at facilities with established referral mechanisms from community providers. “Health care providers welcomed this project into their community. I think they were jumping for joy to have a place to send these folks,” said certified diabetes educator Marcene K. Butcher, R.D., also of the Montana Diabetes Project.

Future plans include a telehealth option contracted with rural sites, the addition of four additional new physical sites, and a possible demonstration project with the state Medicaid program.

A major question has been whether the intensive lifestyle intervention provided in the optimal DPP clinical trial setting could be implemented in the real world. At the meeting, Ms. Butcher and Mr. Vanderwood described how the adapted version of the DPP lifestyle intervention was delivered in the state of Montana via group sessions conducted within established diabetes education programs. They also offered advice on how other parts of the country might follow suit.

Diabetes educators were key. “Diabetes educators are uniquely qualified and uniquely situated to provide diabetes prevention,” said Ms. Butcher, quality diabetes education initiative coordinator with the Montana Department of Public Health and Human Services in Helena.

“Here in Montana we’re providing the evidence that is needed for reimbursement for diabetes educators doing prevention,” she added, referring to an issue that was raised numerous times throughout the AADE meeting.

Mr. Vanderwood, who served as the Montana project’s program manager but is now a PhD student in epidemiology at the University of Pittsburgh, said that the concept initially came from the state’s medical officer, who recognized the burden of diabetes in the state and the importance of prevention. In 2006, he urged the state health department to request available tobacco settlement funding for chronic disease programs, including diabetes prevention.

A subsequent bill that provided funding for asthma, cancer, cardiovascular disease, and diabetes was signed into law in April 2007. The keys to securing funding were the strong evidence base of the DPP, the leadership within the health department, the fact that the proposed program had measurable objectives, and a supportive legislative subcommittee that “understood the importance of diabetes prevention,” Mr. Vanderwood said.

Seeking support through state legislation is one way to obtain funding. Other sources include existing wellness programs or having participants themselves pay. In addition, a new partnership between UnitedHealth Group and the Centers for Disease Control and Prevention is launching diabetes prevention programs that will be delivered to covered employees through Walgreen’s pharmacies and local YMCAs around the country. Hopefully that will spur coverage from other insurers, he commented.

In addition to diabetes prevention programs, other proven options might include work sites, churches, and YMCAs, Ms. Butcher said.

Both Ms. Butcher and Mr. Vanderwood stated that they had no financial disclosures.

SAN ANTONIO – The state of Montana is proof that the success of the landmark Diabetes Prevention Program can be translated to the real world.

The Diabetes Prevention Program, funded by the National Institutes of Health, randomized 3,234 nondiabetic individuals with elevated glucose levels to placebo, metformin (850 mg twice daily), or a lifestyle modification program with the goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. After an average follow-up of 2.8 years, the lifestyle intervention reduced the progression to diabetes by 58% compared with placebo, while metformin lowered the risk by 31% (N. Engl. J. Med. 2002;346:393-403).

In Montana, four existing diabetes prevention programs that were staffed by certified diabetes educators, registered dieticians, cardiac rehabilitation specialists, exercise specialists, and physical therapists were selected to deliver Montana’s lifestyle coaching.

Staff at all sites – another four were added in 2009 – attended a 2-day training in the DPP program that was adapted for group sessions, in contrast to the individual sessions delivered in the original trial, according to Karl K. Vanderwood, M.P.H., of the Montana Diabetes Project.

The weight loss and exercise goals were the same as in the DPP. A total of 16 classes were delivered over 16 weeks, compared with the DPP, where 16 sessions occurred over 16-24 weeks. Participants also had the option of attending twice-weekly physical activity sessions. Between 8 and 30 participants attended the classes, and there was no variation in outcome by group size, said Mr. Vanderwood.

Eligible adults were referred by primary care providers. Participants had to have a body mass index of 25 kg/m2 or greater, along with one or more other risk factors for diabetes or cardiovascular disease such as a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), hypertension, dyslipidemia, or a history of gestational diabetes mellitus. (Unlike the DPP, a strict diagnosis of IGT or IFG was not required.)

Of 1,003 recruited, 801 completed the initial 16-week program. Of those, 563 were followed up again at 10 months. At 16 weeks, there were significant reductions from baseline in weight (99 to 92 kg, a 7% drop), systolic blood pressure (134 to 127 mm Hg, a 5% drop), diastolic blood pressure (82 to 79 mm Hg, a 4% drop), HDL cholesterol (49 to 46 mg/dL, a 6% drop), LDL cholesterol (125 to 115 mg/dL, an 8% drop), and fasting blood glucose (102 to 97 mg/dL, a 5% drop).

Weight reduction often brings an initial drop in HDL cholesterol, which tends to level out with weight maintenance, Mr. Vanderwood noted. Indeed, at the 10-month follow-up, the mean HDL cholesterol had risen to 51 mg/dL, a statistically significant increase from baseline. At 10 months, the improvements in systolic and diastolic blood pressure, LDL cholesterol, and fasting blood glucose remained statistically different from baseline. Mean weight was 90 kg, from 97 kg at baseline among the 563 participants analyzed. This did not achieve statistical significance.

At baseline, 70% of participants had three or more cardiometabolic risk factors, whereas by 10 months more than half had just 0-2 such risk factors, he added.

These outcomes are similar to those seen in the DPP. Since the only evaluation after 10 months has been a mailed survey, there are no conclusive data regarding progression to diabetes. However, that’s not really the aim of this pilot project, which was designed to see whether a DPP-based program could be implemented in the community, Mr. Vanderwood said in a follow-up interview.

“Our focus is on implementing the DPP and using our resources (money) to do so. Our thought is that it is more important to get people ‘inoculated’ with intervention than to expend time and resources following up on them,” he said, adding that the health department may decide to monitor diabetes conversion rates long term.

An important key to success of the program was that it utilized experienced staff at facilities with established referral mechanisms from community providers. “Health care providers welcomed this project into their community. I think they were jumping for joy to have a place to send these folks,” said certified diabetes educator Marcene K. Butcher, R.D., also of the Montana Diabetes Project.

Future plans include a telehealth option contracted with rural sites, the addition of four additional new physical sites, and a possible demonstration project with the state Medicaid program.

A major question has been whether the intensive lifestyle intervention provided in the optimal DPP clinical trial setting could be implemented in the real world. At the meeting, Ms. Butcher and Mr. Vanderwood described how the adapted version of the DPP lifestyle intervention was delivered in the state of Montana via group sessions conducted within established diabetes education programs. They also offered advice on how other parts of the country might follow suit.

Diabetes educators were key. “Diabetes educators are uniquely qualified and uniquely situated to provide diabetes prevention,” said Ms. Butcher, quality diabetes education initiative coordinator with the Montana Department of Public Health and Human Services in Helena.

“Here in Montana we’re providing the evidence that is needed for reimbursement for diabetes educators doing prevention,” she added, referring to an issue that was raised numerous times throughout the AADE meeting.

Mr. Vanderwood, who served as the Montana project’s program manager but is now a PhD student in epidemiology at the University of Pittsburgh, said that the concept initially came from the state’s medical officer, who recognized the burden of diabetes in the state and the importance of prevention. In 2006, he urged the state health department to request available tobacco settlement funding for chronic disease programs, including diabetes prevention.

A subsequent bill that provided funding for asthma, cancer, cardiovascular disease, and diabetes was signed into law in April 2007. The keys to securing funding were the strong evidence base of the DPP, the leadership within the health department, the fact that the proposed program had measurable objectives, and a supportive legislative subcommittee that “understood the importance of diabetes prevention,” Mr. Vanderwood said.

Seeking support through state legislation is one way to obtain funding. Other sources include existing wellness programs or having participants themselves pay. In addition, a new partnership between UnitedHealth Group and the Centers for Disease Control and Prevention is launching diabetes prevention programs that will be delivered to covered employees through Walgreen’s pharmacies and local YMCAs around the country. Hopefully that will spur coverage from other insurers, he commented.

In addition to diabetes prevention programs, other proven options might include work sites, churches, and YMCAs, Ms. Butcher said.

Both Ms. Butcher and Mr. Vanderwood stated that they had no financial disclosures.

SAN ANTONIO – The state of Montana is proof that the success of the landmark Diabetes Prevention Program can be translated to the real world.

The Diabetes Prevention Program, funded by the National Institutes of Health, randomized 3,234 nondiabetic individuals with elevated glucose levels to placebo, metformin (850 mg twice daily), or a lifestyle modification program with the goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. After an average follow-up of 2.8 years, the lifestyle intervention reduced the progression to diabetes by 58% compared with placebo, while metformin lowered the risk by 31% (N. Engl. J. Med. 2002;346:393-403).

In Montana, four existing diabetes prevention programs that were staffed by certified diabetes educators, registered dieticians, cardiac rehabilitation specialists, exercise specialists, and physical therapists were selected to deliver Montana’s lifestyle coaching.

Staff at all sites – another four were added in 2009 – attended a 2-day training in the DPP program that was adapted for group sessions, in contrast to the individual sessions delivered in the original trial, according to Karl K. Vanderwood, M.P.H., of the Montana Diabetes Project.

The weight loss and exercise goals were the same as in the DPP. A total of 16 classes were delivered over 16 weeks, compared with the DPP, where 16 sessions occurred over 16-24 weeks. Participants also had the option of attending twice-weekly physical activity sessions. Between 8 and 30 participants attended the classes, and there was no variation in outcome by group size, said Mr. Vanderwood.

Eligible adults were referred by primary care providers. Participants had to have a body mass index of 25 kg/m2 or greater, along with one or more other risk factors for diabetes or cardiovascular disease such as a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), hypertension, dyslipidemia, or a history of gestational diabetes mellitus. (Unlike the DPP, a strict diagnosis of IGT or IFG was not required.)

Of 1,003 recruited, 801 completed the initial 16-week program. Of those, 563 were followed up again at 10 months. At 16 weeks, there were significant reductions from baseline in weight (99 to 92 kg, a 7% drop), systolic blood pressure (134 to 127 mm Hg, a 5% drop), diastolic blood pressure (82 to 79 mm Hg, a 4% drop), HDL cholesterol (49 to 46 mg/dL, a 6% drop), LDL cholesterol (125 to 115 mg/dL, an 8% drop), and fasting blood glucose (102 to 97 mg/dL, a 5% drop).

Weight reduction often brings an initial drop in HDL cholesterol, which tends to level out with weight maintenance, Mr. Vanderwood noted. Indeed, at the 10-month follow-up, the mean HDL cholesterol had risen to 51 mg/dL, a statistically significant increase from baseline. At 10 months, the improvements in systolic and diastolic blood pressure, LDL cholesterol, and fasting blood glucose remained statistically different from baseline. Mean weight was 90 kg, from 97 kg at baseline among the 563 participants analyzed. This did not achieve statistical significance.

At baseline, 70% of participants had three or more cardiometabolic risk factors, whereas by 10 months more than half had just 0-2 such risk factors, he added.

These outcomes are similar to those seen in the DPP. Since the only evaluation after 10 months has been a mailed survey, there are no conclusive data regarding progression to diabetes. However, that’s not really the aim of this pilot project, which was designed to see whether a DPP-based program could be implemented in the community, Mr. Vanderwood said in a follow-up interview.

“Our focus is on implementing the DPP and using our resources (money) to do so. Our thought is that it is more important to get people ‘inoculated’ with intervention than to expend time and resources following up on them,” he said, adding that the health department may decide to monitor diabetes conversion rates long term.

An important key to success of the program was that it utilized experienced staff at facilities with established referral mechanisms from community providers. “Health care providers welcomed this project into their community. I think they were jumping for joy to have a place to send these folks,” said certified diabetes educator Marcene K. Butcher, R.D., also of the Montana Diabetes Project.

Future plans include a telehealth option contracted with rural sites, the addition of four additional new physical sites, and a possible demonstration project with the state Medicaid program.

A major question has been whether the intensive lifestyle intervention provided in the optimal DPP clinical trial setting could be implemented in the real world. At the meeting, Ms. Butcher and Mr. Vanderwood described how the adapted version of the DPP lifestyle intervention was delivered in the state of Montana via group sessions conducted within established diabetes education programs. They also offered advice on how other parts of the country might follow suit.

Diabetes educators were key. “Diabetes educators are uniquely qualified and uniquely situated to provide diabetes prevention,” said Ms. Butcher, quality diabetes education initiative coordinator with the Montana Department of Public Health and Human Services in Helena.

“Here in Montana we’re providing the evidence that is needed for reimbursement for diabetes educators doing prevention,” she added, referring to an issue that was raised numerous times throughout the AADE meeting.

Mr. Vanderwood, who served as the Montana project’s program manager but is now a PhD student in epidemiology at the University of Pittsburgh, said that the concept initially came from the state’s medical officer, who recognized the burden of diabetes in the state and the importance of prevention. In 2006, he urged the state health department to request available tobacco settlement funding for chronic disease programs, including diabetes prevention.

A subsequent bill that provided funding for asthma, cancer, cardiovascular disease, and diabetes was signed into law in April 2007. The keys to securing funding were the strong evidence base of the DPP, the leadership within the health department, the fact that the proposed program had measurable objectives, and a supportive legislative subcommittee that “understood the importance of diabetes prevention,” Mr. Vanderwood said.

Seeking support through state legislation is one way to obtain funding. Other sources include existing wellness programs or having participants themselves pay. In addition, a new partnership between UnitedHealth Group and the Centers for Disease Control and Prevention is launching diabetes prevention programs that will be delivered to covered employees through Walgreen’s pharmacies and local YMCAs around the country. Hopefully that will spur coverage from other insurers, he commented.

In addition to diabetes prevention programs, other proven options might include work sites, churches, and YMCAs, Ms. Butcher said.

Both Ms. Butcher and Mr. Vanderwood stated that they had no financial disclosures.

SAN ANTONIO – The state of Montana is proof that the success of the landmark Diabetes Prevention Program can be translated to the real world.

The Diabetes Prevention Program, funded by the National Institutes of Health, randomized 3,234 nondiabetic individuals with elevated glucose levels to placebo, metformin (850 mg twice daily), or a lifestyle modification program with the goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. After an average follow-up of 2.8 years, the lifestyle intervention reduced the progression to diabetes by 58% compared with placebo, while metformin lowered the risk by 31% (N. Engl. J. Med. 2002;346:393-403).

In Montana, four existing diabetes prevention programs that were staffed by certified diabetes educators, registered dieticians, cardiac rehabilitation specialists, exercise specialists, and physical therapists were selected to deliver Montana’s lifestyle coaching.

Staff at all sites – another four were added in 2009 – attended a 2-day training in the DPP program that was adapted for group sessions, in contrast to the individual sessions delivered in the original trial, according to Karl K. Vanderwood, M.P.H., of the Montana Diabetes Project.

The weight loss and exercise goals were the same as in the DPP. A total of 16 classes were delivered over 16 weeks, compared with the DPP, where 16 sessions occurred over 16-24 weeks. Participants also had the option of attending twice-weekly physical activity sessions. Between 8 and 30 participants attended the classes, and there was no variation in outcome by group size, said Mr. Vanderwood.

Eligible adults were referred by primary care providers. Participants had to have a body mass index of 25 kg/m2 or greater, along with one or more other risk factors for diabetes or cardiovascular disease such as a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), hypertension, dyslipidemia, or a history of gestational diabetes mellitus. (Unlike the DPP, a strict diagnosis of IGT or IFG was not required.)

Of 1,003 recruited, 801 completed the initial 16-week program. Of those, 563 were followed up again at 10 months. At 16 weeks, there were significant reductions from baseline in weight (99 to 92 kg, a 7% drop), systolic blood pressure (134 to 127 mm Hg, a 5% drop), diastolic blood pressure (82 to 79 mm Hg, a 4% drop), HDL cholesterol (49 to 46 mg/dL, a 6% drop), LDL cholesterol (125 to 115 mg/dL, an 8% drop), and fasting blood glucose (102 to 97 mg/dL, a 5% drop).

Weight reduction often brings an initial drop in HDL cholesterol, which tends to level out with weight maintenance, Mr. Vanderwood noted. Indeed, at the 10-month follow-up, the mean HDL cholesterol had risen to 51 mg/dL, a statistically significant increase from baseline. At 10 months, the improvements in systolic and diastolic blood pressure, LDL cholesterol, and fasting blood glucose remained statistically different from baseline. Mean weight was 90 kg, from 97 kg at baseline among the 563 participants analyzed. This did not achieve statistical significance.

At baseline, 70% of participants had three or more cardiometabolic risk factors, whereas by 10 months more than half had just 0-2 such risk factors, he added.

These outcomes are similar to those seen in the DPP. Since the only evaluation after 10 months has been a mailed survey, there are no conclusive data regarding progression to diabetes. However, that’s not really the aim of this pilot project, which was designed to see whether a DPP-based program could be implemented in the community, Mr. Vanderwood said in a follow-up interview.

“Our focus is on implementing the DPP and using our resources (money) to do so. Our thought is that it is more important to get people ‘inoculated’ with intervention than to expend time and resources following up on them,” he said, adding that the health department may decide to monitor diabetes conversion rates long term.

An important key to success of the program was that it utilized experienced staff at facilities with established referral mechanisms from community providers. “Health care providers welcomed this project into their community. I think they were jumping for joy to have a place to send these folks,” said certified diabetes educator Marcene K. Butcher, R.D., also of the Montana Diabetes Project.

Future plans include a telehealth option contracted with rural sites, the addition of four additional new physical sites, and a possible demonstration project with the state Medicaid program.

A major question has been whether the intensive lifestyle intervention provided in the optimal DPP clinical trial setting could be implemented in the real world. At the meeting, Ms. Butcher and Mr. Vanderwood described how the adapted version of the DPP lifestyle intervention was delivered in the state of Montana via group sessions conducted within established diabetes education programs. They also offered advice on how other parts of the country might follow suit.

Diabetes educators were key. “Diabetes educators are uniquely qualified and uniquely situated to provide diabetes prevention,” said Ms. Butcher, quality diabetes education initiative coordinator with the Montana Department of Public Health and Human Services in Helena.

“Here in Montana we’re providing the evidence that is needed for reimbursement for diabetes educators doing prevention,” she added, referring to an issue that was raised numerous times throughout the AADE meeting.

Mr. Vanderwood, who served as the Montana project’s program manager but is now a PhD student in epidemiology at the University of Pittsburgh, said that the concept initially came from the state’s medical officer, who recognized the burden of diabetes in the state and the importance of prevention. In 2006, he urged the state health department to request available tobacco settlement funding for chronic disease programs, including diabetes prevention.

A subsequent bill that provided funding for asthma, cancer, cardiovascular disease, and diabetes was signed into law in April 2007. The keys to securing funding were the strong evidence base of the DPP, the leadership within the health department, the fact that the proposed program had measurable objectives, and a supportive legislative subcommittee that “understood the importance of diabetes prevention,” Mr. Vanderwood said.

Seeking support through state legislation is one way to obtain funding. Other sources include existing wellness programs or having participants themselves pay. In addition, a new partnership between UnitedHealth Group and the Centers for Disease Control and Prevention is launching diabetes prevention programs that will be delivered to covered employees through Walgreen’s pharmacies and local YMCAs around the country. Hopefully that will spur coverage from other insurers, he commented.

In addition to diabetes prevention programs, other proven options might include work sites, churches, and YMCAs, Ms. Butcher said.

Both Ms. Butcher and Mr. Vanderwood stated that they had no financial disclosures.

SAN ANTONIO – The state of Montana is proof that the success of the landmark Diabetes Prevention Program can be translated to the real world.

The Diabetes Prevention Program, funded by the National Institutes of Health, randomized 3,234 nondiabetic individuals with elevated glucose levels to placebo, metformin (850 mg twice daily), or a lifestyle modification program with the goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. After an average follow-up of 2.8 years, the lifestyle intervention reduced the progression to diabetes by 58% compared with placebo, while metformin lowered the risk by 31% (N. Engl. J. Med. 2002;346:393-403).

In Montana, four existing diabetes prevention programs that were staffed by certified diabetes educators, registered dieticians, cardiac rehabilitation specialists, exercise specialists, and physical therapists were selected to deliver Montana’s lifestyle coaching.

Staff at all sites – another four were added in 2009 – attended a 2-day training in the DPP program that was adapted for group sessions, in contrast to the individual sessions delivered in the original trial, according to Karl K. Vanderwood, M.P.H., of the Montana Diabetes Project.

The weight loss and exercise goals were the same as in the DPP. A total of 16 classes were delivered over 16 weeks, compared with the DPP, where 16 sessions occurred over 16-24 weeks. Participants also had the option of attending twice-weekly physical activity sessions. Between 8 and 30 participants attended the classes, and there was no variation in outcome by group size, said Mr. Vanderwood.

Eligible adults were referred by primary care providers. Participants had to have a body mass index of 25 kg/m2 or greater, along with one or more other risk factors for diabetes or cardiovascular disease such as a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), hypertension, dyslipidemia, or a history of gestational diabetes mellitus. (Unlike the DPP, a strict diagnosis of IGT or IFG was not required.)

Of 1,003 recruited, 801 completed the initial 16-week program. Of those, 563 were followed up again at 10 months. At 16 weeks, there were significant reductions from baseline in weight (99 to 92 kg, a 7% drop), systolic blood pressure (134 to 127 mm Hg, a 5% drop), diastolic blood pressure (82 to 79 mm Hg, a 4% drop), HDL cholesterol (49 to 46 mg/dL, a 6% drop), LDL cholesterol (125 to 115 mg/dL, an 8% drop), and fasting blood glucose (102 to 97 mg/dL, a 5% drop).

Weight reduction often brings an initial drop in HDL cholesterol, which tends to level out with weight maintenance, Mr. Vanderwood noted. Indeed, at the 10-month follow-up, the mean HDL cholesterol had risen to 51 mg/dL, a statistically significant increase from baseline. At 10 months, the improvements in systolic and diastolic blood pressure, LDL cholesterol, and fasting blood glucose remained statistically different from baseline. Mean weight was 90 kg, from 97 kg at baseline among the 563 participants analyzed. This did not achieve statistical significance.

At baseline, 70% of participants had three or more cardiometabolic risk factors, whereas by 10 months more than half had just 0-2 such risk factors, he added.

These outcomes are similar to those seen in the DPP. Since the only evaluation after 10 months has been a mailed survey, there are no conclusive data regarding progression to diabetes. However, that’s not really the aim of this pilot project, which was designed to see whether a DPP-based program could be implemented in the community, Mr. Vanderwood said in a follow-up interview.

“Our focus is on implementing the DPP and using our resources (money) to do so. Our thought is that it is more important to get people ‘inoculated’ with intervention than to expend time and resources following up on them,” he said, adding that the health department may decide to monitor diabetes conversion rates long term.

An important key to success of the program was that it utilized experienced staff at facilities with established referral mechanisms from community providers. “Health care providers welcomed this project into their community. I think they were jumping for joy to have a place to send these folks,” said certified diabetes educator Marcene K. Butcher, R.D., also of the Montana Diabetes Project.

Future plans include a telehealth option contracted with rural sites, the addition of four additional new physical sites, and a possible demonstration project with the state Medicaid program.

A major question has been whether the intensive lifestyle intervention provided in the optimal DPP clinical trial setting could be implemented in the real world. At the meeting, Ms. Butcher and Mr. Vanderwood described how the adapted version of the DPP lifestyle intervention was delivered in the state of Montana via group sessions conducted within established diabetes education programs. They also offered advice on how other parts of the country might follow suit.

Diabetes educators were key. “Diabetes educators are uniquely qualified and uniquely situated to provide diabetes prevention,” said Ms. Butcher, quality diabetes education initiative coordinator with the Montana Department of Public Health and Human Services in Helena.

“Here in Montana we’re providing the evidence that is needed for reimbursement for diabetes educators doing prevention,” she added, referring to an issue that was raised numerous times throughout the AADE meeting.

Mr. Vanderwood, who served as the Montana project’s program manager but is now a PhD student in epidemiology at the University of Pittsburgh, said that the concept initially came from the state’s medical officer, who recognized the burden of diabetes in the state and the importance of prevention. In 2006, he urged the state health department to request available tobacco settlement funding for chronic disease programs, including diabetes prevention.

A subsequent bill that provided funding for asthma, cancer, cardiovascular disease, and diabetes was signed into law in April 2007. The keys to securing funding were the strong evidence base of the DPP, the leadership within the health department, the fact that the proposed program had measurable objectives, and a supportive legislative subcommittee that “understood the importance of diabetes prevention,” Mr. Vanderwood said.

Seeking support through state legislation is one way to obtain funding. Other sources include existing wellness programs or having participants themselves pay. In addition, a new partnership between UnitedHealth Group and the Centers for Disease Control and Prevention is launching diabetes prevention programs that will be delivered to covered employees through Walgreen’s pharmacies and local YMCAs around the country. Hopefully that will spur coverage from other insurers, he commented.

In addition to diabetes prevention programs, other proven options might include work sites, churches, and YMCAs, Ms. Butcher said.

Both Ms. Butcher and Mr. Vanderwood stated that they had no financial disclosures.

Major Finding: One or more hypoglycemic events occurred in 26 of 40 patients despite hemoglobin A_1c values above 8%. Of 102 hypoglycemic episodes, 95 were not recognized by fingerstick testing or by symptoms.

Data Source: Study using blinded continuous glucose monitoring for 72 or more hours in 40 community-dwelling diabetes patients seen at a tertiary diabetes center.

Disclosures: The American Diabetes Association funded the study. Dr. Munshi stated that she had no conflicts of interest.

ORLANDO — Hypoglycemic episodes were common despite high hemoglobin A_1c levels among 40 elderly community-living adults with diabetes who underwent continuous glucose monitoring.

“Raising A_1c goals may not be adequate to prevent hypoglycemia in this vulnerable population,” Dr. Medha N. Munshi said.

Guidelines from the American Diabetes Association and the American Geriatric Society advise that the usual recommended hemoglobin A_1c target of less than 6.5%-7.0% might be relaxed for elderly adults who have a history of severe hypoglycemia, limited life expectancy, advanced diabetes complications, or extensive comorbidity (Diabetes Care 2010;33[suppl 1]).

In practice, this has been interpreted as a goal of less than 8%. The ADA guideline was based on level “C” evidence, and no study has ever clearly demonstrated that raising the HbA_1c target actually reduces the risk of hypoglycemia, said Dr. Munshi, director of the Joslin Diabetes Center geriatric programs at Beth Israel Deaconess Medical Center, Boston.

The current study used blinded continuous glucose monitoring (CGM) for 72 hours or longer in 40 community-dwelling diabetes patients who were seen at the Joslin Diabetes Center. To be included, they had to be older than 69 years and have a hemoglobin A_1c level greater than 8%.

The study group was 60% female and 80% white. Mean age was 75 years and mean HbA_1c was 9.3%. The patients took a mean of eight medications per day, with more than half (55%) on insulin alone, and another 38% on insulin plus one or more oral agents. Two-thirds had type 2 diabetes and the rest had type 1. Nearly a quarter were living alone, said Dr. Munshi, also with Harvard Medical School, Boston.

Patients performed four fingerstick glucose measurements per day and kept daily diaries of hypoglycemic symptoms, diet, and physical activity. One or more hypoglycemic events, defined as a glucose value less than 70 mg/dL, occurred in 26 of the 40 patients. Nearly three-fourths of the events involved glucose levels of 50-59 mg/dL, and in just under half the glucose dropped below 50 mg/dL.

The 26 patients experiencing hypoglycemia did not differ from the 14 without such events in patient characteristics including age, diabetes duration, HbA_1c, or insulin treatment. There were also no differences between those who did and did not have hypoglycemia in the comorbidities cognitive dysfunction, depression, falls in the past 6 months, number of medications, hypertension, or vision/hearing problems.

Of the 26 with hypoglycemia, 12 had HbA_1c levels above 9%. “Even a high A_1c doesn't preclude lows. Hemoglobin A_1c measures the mean. There are wide fluctuations in this population,” Dr. Munshi noted.

There was a total of 102 hypoglycemic episodes, with a mean duration of 3 hours per patient. Nocturnal episodes lasted for a mean of 2.5 hours. “The duration of episodes was quite concerning,” she said.

Surprisingly, more than half (58%) of the 102 hypoglycemic episodes occurred among the 16 patients with type 2 diabetes, with a mean duration of nocturnal hypoglycemia nearly twice that of the hypoglycemia in the type 1 patients (2.9 vs. 1.6 hours). “Even the type 2 patients had wide glycemic excursions,” Dr. Munshi commented.

Also of concern, the majority of episodes (95 of the 102) were not recognized by fingerstick testing or by the patients' symptoms. Moreover, there were no significant relationships between severity of hypoglycemia and age, type of diabetes, duration, HbA_1c, treatment, or living alone.

In a follow-up interview, Dr. Munshi cited a previous study she and her colleagues published last year, showing that simplification of complex insulin regimens by using C-peptide to assess whether patients could eliminate or reduce the amount of insulin taken, so that oral agents could be used instead, reduced hypoglycemic episodes without deterioration of glycemic control (Am. J. Med. 2009;122:395-7).

“I believe that elderly patients with other comorbidities are unable to follow complex insulin regimens appropriately and end up having wide fluctuations in their glucose values. If a treatment regimen is designed with consideration for an elderly patient's self-care abilities, risk of hypoglycemia can be reduced,” she said in the interview.

And when available, CGM can be extremely helpful for elderly patients. “I think CGM can be a great tool for pattern recognition and assessment of risk of hypoglycemia in elderly patients who are on complex insulin regimens without consideration of glycemic control,” Dr. Munshi said.

Major Finding: One or more hypoglycemic events occurred in 26 of 40 patients despite hemoglobin A_1c values above 8%. Of 102 hypoglycemic episodes, 95 were not recognized by fingerstick testing or by symptoms.

Data Source: Study using blinded continuous glucose monitoring for 72 or more hours in 40 community-dwelling diabetes patients seen at a tertiary diabetes center.

Disclosures: The American Diabetes Association funded the study. Dr. Munshi stated that she had no conflicts of interest.

ORLANDO — Hypoglycemic episodes were common despite high hemoglobin A_1c levels among 40 elderly community-living adults with diabetes who underwent continuous glucose monitoring.

“Raising A_1c goals may not be adequate to prevent hypoglycemia in this vulnerable population,” Dr. Medha N. Munshi said.

Guidelines from the American Diabetes Association and the American Geriatric Society advise that the usual recommended hemoglobin A_1c target of less than 6.5%-7.0% might be relaxed for elderly adults who have a history of severe hypoglycemia, limited life expectancy, advanced diabetes complications, or extensive comorbidity (Diabetes Care 2010;33[suppl 1]).

In practice, this has been interpreted as a goal of less than 8%. The ADA guideline was based on level “C” evidence, and no study has ever clearly demonstrated that raising the HbA_1c target actually reduces the risk of hypoglycemia, said Dr. Munshi, director of the Joslin Diabetes Center geriatric programs at Beth Israel Deaconess Medical Center, Boston.

The current study used blinded continuous glucose monitoring (CGM) for 72 hours or longer in 40 community-dwelling diabetes patients who were seen at the Joslin Diabetes Center. To be included, they had to be older than 69 years and have a hemoglobin A_1c level greater than 8%.

The study group was 60% female and 80% white. Mean age was 75 years and mean HbA_1c was 9.3%. The patients took a mean of eight medications per day, with more than half (55%) on insulin alone, and another 38% on insulin plus one or more oral agents. Two-thirds had type 2 diabetes and the rest had type 1. Nearly a quarter were living alone, said Dr. Munshi, also with Harvard Medical School, Boston.

Patients performed four fingerstick glucose measurements per day and kept daily diaries of hypoglycemic symptoms, diet, and physical activity. One or more hypoglycemic events, defined as a glucose value less than 70 mg/dL, occurred in 26 of the 40 patients. Nearly three-fourths of the events involved glucose levels of 50-59 mg/dL, and in just under half the glucose dropped below 50 mg/dL.

The 26 patients experiencing hypoglycemia did not differ from the 14 without such events in patient characteristics including age, diabetes duration, HbA_1c, or insulin treatment. There were also no differences between those who did and did not have hypoglycemia in the comorbidities cognitive dysfunction, depression, falls in the past 6 months, number of medications, hypertension, or vision/hearing problems.

Of the 26 with hypoglycemia, 12 had HbA_1c levels above 9%. “Even a high A_1c doesn't preclude lows. Hemoglobin A_1c measures the mean. There are wide fluctuations in this population,” Dr. Munshi noted.

There was a total of 102 hypoglycemic episodes, with a mean duration of 3 hours per patient. Nocturnal episodes lasted for a mean of 2.5 hours. “The duration of episodes was quite concerning,” she said.

Surprisingly, more than half (58%) of the 102 hypoglycemic episodes occurred among the 16 patients with type 2 diabetes, with a mean duration of nocturnal hypoglycemia nearly twice that of the hypoglycemia in the type 1 patients (2.9 vs. 1.6 hours). “Even the type 2 patients had wide glycemic excursions,” Dr. Munshi commented.

Also of concern, the majority of episodes (95 of the 102) were not recognized by fingerstick testing or by the patients' symptoms. Moreover, there were no significant relationships between severity of hypoglycemia and age, type of diabetes, duration, HbA_1c, treatment, or living alone.

In a follow-up interview, Dr. Munshi cited a previous study she and her colleagues published last year, showing that simplification of complex insulin regimens by using C-peptide to assess whether patients could eliminate or reduce the amount of insulin taken, so that oral agents could be used instead, reduced hypoglycemic episodes without deterioration of glycemic control (Am. J. Med. 2009;122:395-7).

“I believe that elderly patients with other comorbidities are unable to follow complex insulin regimens appropriately and end up having wide fluctuations in their glucose values. If a treatment regimen is designed with consideration for an elderly patient's self-care abilities, risk of hypoglycemia can be reduced,” she said in the interview.

And when available, CGM can be extremely helpful for elderly patients. “I think CGM can be a great tool for pattern recognition and assessment of risk of hypoglycemia in elderly patients who are on complex insulin regimens without consideration of glycemic control,” Dr. Munshi said.

Major Finding: One or more hypoglycemic events occurred in 26 of 40 patients despite hemoglobin A_1c values above 8%. Of 102 hypoglycemic episodes, 95 were not recognized by fingerstick testing or by symptoms.

Data Source: Study using blinded continuous glucose monitoring for 72 or more hours in 40 community-dwelling diabetes patients seen at a tertiary diabetes center.

Disclosures: The American Diabetes Association funded the study. Dr. Munshi stated that she had no conflicts of interest.

ORLANDO — Hypoglycemic episodes were common despite high hemoglobin A_1c levels among 40 elderly community-living adults with diabetes who underwent continuous glucose monitoring.

“Raising A_1c goals may not be adequate to prevent hypoglycemia in this vulnerable population,” Dr. Medha N. Munshi said.

Guidelines from the American Diabetes Association and the American Geriatric Society advise that the usual recommended hemoglobin A_1c target of less than 6.5%-7.0% might be relaxed for elderly adults who have a history of severe hypoglycemia, limited life expectancy, advanced diabetes complications, or extensive comorbidity (Diabetes Care 2010;33[suppl 1]).

In practice, this has been interpreted as a goal of less than 8%. The ADA guideline was based on level “C” evidence, and no study has ever clearly demonstrated that raising the HbA_1c target actually reduces the risk of hypoglycemia, said Dr. Munshi, director of the Joslin Diabetes Center geriatric programs at Beth Israel Deaconess Medical Center, Boston.

The current study used blinded continuous glucose monitoring (CGM) for 72 hours or longer in 40 community-dwelling diabetes patients who were seen at the Joslin Diabetes Center. To be included, they had to be older than 69 years and have a hemoglobin A_1c level greater than 8%.

The study group was 60% female and 80% white. Mean age was 75 years and mean HbA_1c was 9.3%. The patients took a mean of eight medications per day, with more than half (55%) on insulin alone, and another 38% on insulin plus one or more oral agents. Two-thirds had type 2 diabetes and the rest had type 1. Nearly a quarter were living alone, said Dr. Munshi, also with Harvard Medical School, Boston.

Patients performed four fingerstick glucose measurements per day and kept daily diaries of hypoglycemic symptoms, diet, and physical activity. One or more hypoglycemic events, defined as a glucose value less than 70 mg/dL, occurred in 26 of the 40 patients. Nearly three-fourths of the events involved glucose levels of 50-59 mg/dL, and in just under half the glucose dropped below 50 mg/dL.

The 26 patients experiencing hypoglycemia did not differ from the 14 without such events in patient characteristics including age, diabetes duration, HbA_1c, or insulin treatment. There were also no differences between those who did and did not have hypoglycemia in the comorbidities cognitive dysfunction, depression, falls in the past 6 months, number of medications, hypertension, or vision/hearing problems.

Of the 26 with hypoglycemia, 12 had HbA_1c levels above 9%. “Even a high A_1c doesn't preclude lows. Hemoglobin A_1c measures the mean. There are wide fluctuations in this population,” Dr. Munshi noted.

There was a total of 102 hypoglycemic episodes, with a mean duration of 3 hours per patient. Nocturnal episodes lasted for a mean of 2.5 hours. “The duration of episodes was quite concerning,” she said.

Surprisingly, more than half (58%) of the 102 hypoglycemic episodes occurred among the 16 patients with type 2 diabetes, with a mean duration of nocturnal hypoglycemia nearly twice that of the hypoglycemia in the type 1 patients (2.9 vs. 1.6 hours). “Even the type 2 patients had wide glycemic excursions,” Dr. Munshi commented.

Also of concern, the majority of episodes (95 of the 102) were not recognized by fingerstick testing or by the patients' symptoms. Moreover, there were no significant relationships between severity of hypoglycemia and age, type of diabetes, duration, HbA_1c, treatment, or living alone.

In a follow-up interview, Dr. Munshi cited a previous study she and her colleagues published last year, showing that simplification of complex insulin regimens by using C-peptide to assess whether patients could eliminate or reduce the amount of insulin taken, so that oral agents could be used instead, reduced hypoglycemic episodes without deterioration of glycemic control (Am. J. Med. 2009;122:395-7).

“I believe that elderly patients with other comorbidities are unable to follow complex insulin regimens appropriately and end up having wide fluctuations in their glucose values. If a treatment regimen is designed with consideration for an elderly patient's self-care abilities, risk of hypoglycemia can be reduced,” she said in the interview.

And when available, CGM can be extremely helpful for elderly patients. “I think CGM can be a great tool for pattern recognition and assessment of risk of hypoglycemia in elderly patients who are on complex insulin regimens without consideration of glycemic control,” Dr. Munshi said.

Dapagliflozin significantly reduced hemoglobin A_1c levels compared with placebo in a phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 534 patients with type 2 diabetes inadequately controlled with metformin alone.

The study was funded by dapagliflozin codevelopers Bristol-Myers Squibb (BMS) and AstraZeneca (AZ). The drug is a selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), which is located in the proximal tubule of the kidney nephron and functions to reabsorb most of the glucose filtered by the glomerulus. By binding to SGLT2 and inhibiting renal glucose reabsorption, dapagliflozin promotes urinary glucose excretion and reduces blood glucose levels independently of beta-cell function or insulin sensitivity, Dr. Clifford J. Bailey reported at the meeting. The findings were published simultaneously (Lancet 2010;375:2223-33).

In all, 546 patients were randomized to 2.5-mg, 5.0-mg, or 10.0-mg once-daily doses of dapagliflozin or placebo for 24 weeks, in addition to their usual metformin doses. Among the 534 who completed the trial, reductions in HbA_1c were significantly greater in the dapagliflozin groups, with mean reductions from baseline of 0.67, 0.70, and 0.84 percentage points with the 2.5-, 5.0-, and 10.0-mg doses, respectively, compared with 0.30 for placebo.

More patients in the dapagliflozin groups achieved an HbA_1c value of less than 7.0% at week 24 than did those in the placebo group, with the difference reaching statistical significance for the 5.0- and 10.0-mg doses (37.5% and 40.6%, respectively, vs. 25.9% for placebo). Differences in plasma fasting glucose concentrations were notable by week 1 in the dapagliflozin groups, and by week 24 were significant for all three doses (reductions of 18-23 mg/dL compared with 6 mg/dL with placebo).

Weight loss was also greater with dapagliflozin, compared with those assigned to placebo. At week 24, the 2.5-, 5.0-, and 10.0-mg groups had lost 2.2, 3.0, and 2.9 kg, respectively, compared with 0.9 kg for placebo patients. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, said Dr. Bailey, of Aston University, Birmingham, England.

Urinary glucose excretion increased in all of the dapagliflozin groups, whereas creatinine remained constant, Dr. Bailey noted.

There were no deaths during the study, and overall adverse events leading to discontinuation were less frequent with dapagliflozin than placebo. There were no major hypoglycemic events.

Signs, symptoms, and other reports suggestive of urinary tract infections were not increased with dapagliflozin, but reports of those suggesting genital infections were: These were reported by 8%-13% in the dapagliflozin groups, compared with 5% in the placebo group. The increased rate occurred in both men and women. All were of mild or moderate intensity and resolved with treatment, and none led to study discontinuation.

Genital infections are not uncommon in patients with diabetes and can be appropriately managed with better appreciation of those at higher risk, Dr. Bailey pointed out.

Serious adverse events were not associated with any particular group. No clinically meaningful changes in serum electrolytes occurred in any of the groups, and abnormalities in serum sodium and serum potassium were rare and transient. No alterations were seen in measures of renal function, including serum creatinine. No apparent changes occurred in fasting lipid profiles with dapagliflozin other than greater mean HDL cholesterol and lower triglycerides compared with placebo, he noted.

Aside from BMS and AZ, Dr. Bailey also has consulted for Merck Sharp & Dohme, Novo Nordisk, GlaxoSmithKline, and Takeda and has received research grants from Sanofi-Aventis. Three other study authors are employees of BMS, while BMS was the only disclosure for the fifth investigator.

Dapagliflozin significantly reduced hemoglobin A_1c levels compared with placebo in a phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 534 patients with type 2 diabetes inadequately controlled with metformin alone.

The study was funded by dapagliflozin codevelopers Bristol-Myers Squibb (BMS) and AstraZeneca (AZ). The drug is a selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), which is located in the proximal tubule of the kidney nephron and functions to reabsorb most of the glucose filtered by the glomerulus. By binding to SGLT2 and inhibiting renal glucose reabsorption, dapagliflozin promotes urinary glucose excretion and reduces blood glucose levels independently of beta-cell function or insulin sensitivity, Dr. Clifford J. Bailey reported at the meeting. The findings were published simultaneously (Lancet 2010;375:2223-33).

In all, 546 patients were randomized to 2.5-mg, 5.0-mg, or 10.0-mg once-daily doses of dapagliflozin or placebo for 24 weeks, in addition to their usual metformin doses. Among the 534 who completed the trial, reductions in HbA_1c were significantly greater in the dapagliflozin groups, with mean reductions from baseline of 0.67, 0.70, and 0.84 percentage points with the 2.5-, 5.0-, and 10.0-mg doses, respectively, compared with 0.30 for placebo.

More patients in the dapagliflozin groups achieved an HbA_1c value of less than 7.0% at week 24 than did those in the placebo group, with the difference reaching statistical significance for the 5.0- and 10.0-mg doses (37.5% and 40.6%, respectively, vs. 25.9% for placebo). Differences in plasma fasting glucose concentrations were notable by week 1 in the dapagliflozin groups, and by week 24 were significant for all three doses (reductions of 18-23 mg/dL compared with 6 mg/dL with placebo).

Weight loss was also greater with dapagliflozin, compared with those assigned to placebo. At week 24, the 2.5-, 5.0-, and 10.0-mg groups had lost 2.2, 3.0, and 2.9 kg, respectively, compared with 0.9 kg for placebo patients. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, said Dr. Bailey, of Aston University, Birmingham, England.

Urinary glucose excretion increased in all of the dapagliflozin groups, whereas creatinine remained constant, Dr. Bailey noted.

There were no deaths during the study, and overall adverse events leading to discontinuation were less frequent with dapagliflozin than placebo. There were no major hypoglycemic events.

Signs, symptoms, and other reports suggestive of urinary tract infections were not increased with dapagliflozin, but reports of those suggesting genital infections were: These were reported by 8%-13% in the dapagliflozin groups, compared with 5% in the placebo group. The increased rate occurred in both men and women. All were of mild or moderate intensity and resolved with treatment, and none led to study discontinuation.

Genital infections are not uncommon in patients with diabetes and can be appropriately managed with better appreciation of those at higher risk, Dr. Bailey pointed out.

Serious adverse events were not associated with any particular group. No clinically meaningful changes in serum electrolytes occurred in any of the groups, and abnormalities in serum sodium and serum potassium were rare and transient. No alterations were seen in measures of renal function, including serum creatinine. No apparent changes occurred in fasting lipid profiles with dapagliflozin other than greater mean HDL cholesterol and lower triglycerides compared with placebo, he noted.

Aside from BMS and AZ, Dr. Bailey also has consulted for Merck Sharp & Dohme, Novo Nordisk, GlaxoSmithKline, and Takeda and has received research grants from Sanofi-Aventis. Three other study authors are employees of BMS, while BMS was the only disclosure for the fifth investigator.

Dapagliflozin significantly reduced hemoglobin A_1c levels compared with placebo in a phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 534 patients with type 2 diabetes inadequately controlled with metformin alone.

The study was funded by dapagliflozin codevelopers Bristol-Myers Squibb (BMS) and AstraZeneca (AZ). The drug is a selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), which is located in the proximal tubule of the kidney nephron and functions to reabsorb most of the glucose filtered by the glomerulus. By binding to SGLT2 and inhibiting renal glucose reabsorption, dapagliflozin promotes urinary glucose excretion and reduces blood glucose levels independently of beta-cell function or insulin sensitivity, Dr. Clifford J. Bailey reported at the meeting. The findings were published simultaneously (Lancet 2010;375:2223-33).

In all, 546 patients were randomized to 2.5-mg, 5.0-mg, or 10.0-mg once-daily doses of dapagliflozin or placebo for 24 weeks, in addition to their usual metformin doses. Among the 534 who completed the trial, reductions in HbA_1c were significantly greater in the dapagliflozin groups, with mean reductions from baseline of 0.67, 0.70, and 0.84 percentage points with the 2.5-, 5.0-, and 10.0-mg doses, respectively, compared with 0.30 for placebo.

More patients in the dapagliflozin groups achieved an HbA_1c value of less than 7.0% at week 24 than did those in the placebo group, with the difference reaching statistical significance for the 5.0- and 10.0-mg doses (37.5% and 40.6%, respectively, vs. 25.9% for placebo). Differences in plasma fasting glucose concentrations were notable by week 1 in the dapagliflozin groups, and by week 24 were significant for all three doses (reductions of 18-23 mg/dL compared with 6 mg/dL with placebo).

Weight loss was also greater with dapagliflozin, compared with those assigned to placebo. At week 24, the 2.5-, 5.0-, and 10.0-mg groups had lost 2.2, 3.0, and 2.9 kg, respectively, compared with 0.9 kg for placebo patients. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, said Dr. Bailey, of Aston University, Birmingham, England.

Urinary glucose excretion increased in all of the dapagliflozin groups, whereas creatinine remained constant, Dr. Bailey noted.

There were no deaths during the study, and overall adverse events leading to discontinuation were less frequent with dapagliflozin than placebo. There were no major hypoglycemic events.

Signs, symptoms, and other reports suggestive of urinary tract infections were not increased with dapagliflozin, but reports of those suggesting genital infections were: These were reported by 8%-13% in the dapagliflozin groups, compared with 5% in the placebo group. The increased rate occurred in both men and women. All were of mild or moderate intensity and resolved with treatment, and none led to study discontinuation.

Genital infections are not uncommon in patients with diabetes and can be appropriately managed with better appreciation of those at higher risk, Dr. Bailey pointed out.

Serious adverse events were not associated with any particular group. No clinically meaningful changes in serum electrolytes occurred in any of the groups, and abnormalities in serum sodium and serum potassium were rare and transient. No alterations were seen in measures of renal function, including serum creatinine. No apparent changes occurred in fasting lipid profiles with dapagliflozin other than greater mean HDL cholesterol and lower triglycerides compared with placebo, he noted.

Aside from BMS and AZ, Dr. Bailey also has consulted for Merck Sharp & Dohme, Novo Nordisk, GlaxoSmithKline, and Takeda and has received research grants from Sanofi-Aventis. Three other study authors are employees of BMS, while BMS was the only disclosure for the fifth investigator.

Major Finding: At 6 months, mean reduction in HbA_1c was similar between patients taking VIAject and those taking regular human insulin before meals but hypoglycemic event rates were significantly reduced with VIAject (0.33 vs. 0.66 events per month) and weight gain was significantly less with VIAject (0.46 vs. 1.35 kg).

Data Source: Open-label, multicenter, randomized phase III trial of 471 patients with type 2 diabetes.

Disclosures: The study was funded by Biodel Corp., for which Dr. Rodbard serves on the advisory board. She also has consultant, speaker, and/or research grant support relationships with a number of other companies that make diabetes-related products.

ORLANDO — An investigational rapid-acting human insulin formulation provided glucose control similar to that of regular human insulin, but it yielded a twofold reduction in hypoglycemia and significantly less weight gain in a 6-month, multicenter, open-label study of 471 patients with type 2 diabetes.

The formulation, called VIAject, is absorbed more rapidly after subcutaneous injection than either insulin lispro or regular human insulin.

Findings from Biodel Corp.'s phase III study of VIAject were presented at the scientific sessions by Dr. Helena Rodbard, an endocrinologist in private practice in Rockville, Md., and a past president of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

The subjects had a mean age of 56 years, slightly more than half were male, and the mean body mass index was 33 kg/m

At baseline, they had a mean hemoglobin A_1c value of 8%. They were randomized to preprandial VIAject or human regular insulin in combination with previously prescribed insulin glargine, metformin, and/or thiazolidinedione therapy.

Because of the difference in action time, regular human insulin was injected 30-40 minutes before meals, while VIAject was given immediately before patients had meals.

At 6 months, the mean reduction in HbA_1c was similar in the two groups: The VIAject group dropped by 0.56 percentage points, the regular human insulin group by 0.70 points.

But nonsevere hypoglycemic event rates were significantly reduced in the patients taking VIAject, at just 0.33 events per month, compared with 0.66 events per month with regular human insulin, Dr. Rodbard reported.

Patients who were taking VIAject also gained significantly less weight, an average of 0.46 kg vs. 1.35 kg in patients who were taking regular human insulin.

Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups, Dr. Rodbard reported.

Injection site pain or irritation was greater with VIAject, but this declined during the course of the study. Moreover, the proposed U-100 pH-neutral commercial formulation of VIAject is associated with less injection site discomfort than is the U-25 pH 4 version used in this study, she pointed out.

Biodel is seeking Food and Drug Administration clearance to market VIAject based on two pivotal 6-month, phase III clinical trials in patients with type 1 and type 2 diabetes, as well as on results from long-term, 18-month safety extension trials for patients who completed the two pivotal phase III clinical trials.

The Prescription Drug User Fee Act action date for Biodel's new drug application is expected to be Oct. 30, 2010, the company said in a statement.

Major Finding: At 6 months, mean reduction in HbA_1c was similar between patients taking VIAject and those taking regular human insulin before meals but hypoglycemic event rates were significantly reduced with VIAject (0.33 vs. 0.66 events per month) and weight gain was significantly less with VIAject (0.46 vs. 1.35 kg).

Data Source: Open-label, multicenter, randomized phase III trial of 471 patients with type 2 diabetes.

Disclosures: The study was funded by Biodel Corp., for which Dr. Rodbard serves on the advisory board. She also has consultant, speaker, and/or research grant support relationships with a number of other companies that make diabetes-related products.

ORLANDO — An investigational rapid-acting human insulin formulation provided glucose control similar to that of regular human insulin, but it yielded a twofold reduction in hypoglycemia and significantly less weight gain in a 6-month, multicenter, open-label study of 471 patients with type 2 diabetes.

The formulation, called VIAject, is absorbed more rapidly after subcutaneous injection than either insulin lispro or regular human insulin.

Findings from Biodel Corp.'s phase III study of VIAject were presented at the scientific sessions by Dr. Helena Rodbard, an endocrinologist in private practice in Rockville, Md., and a past president of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

The subjects had a mean age of 56 years, slightly more than half were male, and the mean body mass index was 33 kg/m

At baseline, they had a mean hemoglobin A_1c value of 8%. They were randomized to preprandial VIAject or human regular insulin in combination with previously prescribed insulin glargine, metformin, and/or thiazolidinedione therapy.

Because of the difference in action time, regular human insulin was injected 30-40 minutes before meals, while VIAject was given immediately before patients had meals.

At 6 months, the mean reduction in HbA_1c was similar in the two groups: The VIAject group dropped by 0.56 percentage points, the regular human insulin group by 0.70 points.

But nonsevere hypoglycemic event rates were significantly reduced in the patients taking VIAject, at just 0.33 events per month, compared with 0.66 events per month with regular human insulin, Dr. Rodbard reported.

Patients who were taking VIAject also gained significantly less weight, an average of 0.46 kg vs. 1.35 kg in patients who were taking regular human insulin.

Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups, Dr. Rodbard reported.

Injection site pain or irritation was greater with VIAject, but this declined during the course of the study. Moreover, the proposed U-100 pH-neutral commercial formulation of VIAject is associated with less injection site discomfort than is the U-25 pH 4 version used in this study, she pointed out.

Biodel is seeking Food and Drug Administration clearance to market VIAject based on two pivotal 6-month, phase III clinical trials in patients with type 1 and type 2 diabetes, as well as on results from long-term, 18-month safety extension trials for patients who completed the two pivotal phase III clinical trials.

The Prescription Drug User Fee Act action date for Biodel's new drug application is expected to be Oct. 30, 2010, the company said in a statement.

Major Finding: At 6 months, mean reduction in HbA_1c was similar between patients taking VIAject and those taking regular human insulin before meals but hypoglycemic event rates were significantly reduced with VIAject (0.33 vs. 0.66 events per month) and weight gain was significantly less with VIAject (0.46 vs. 1.35 kg).

Data Source: Open-label, multicenter, randomized phase III trial of 471 patients with type 2 diabetes.

Disclosures: The study was funded by Biodel Corp., for which Dr. Rodbard serves on the advisory board. She also has consultant, speaker, and/or research grant support relationships with a number of other companies that make diabetes-related products.

ORLANDO — An investigational rapid-acting human insulin formulation provided glucose control similar to that of regular human insulin, but it yielded a twofold reduction in hypoglycemia and significantly less weight gain in a 6-month, multicenter, open-label study of 471 patients with type 2 diabetes.

The formulation, called VIAject, is absorbed more rapidly after subcutaneous injection than either insulin lispro or regular human insulin.

Findings from Biodel Corp.'s phase III study of VIAject were presented at the scientific sessions by Dr. Helena Rodbard, an endocrinologist in private practice in Rockville, Md., and a past president of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

The subjects had a mean age of 56 years, slightly more than half were male, and the mean body mass index was 33 kg/m

At baseline, they had a mean hemoglobin A_1c value of 8%. They were randomized to preprandial VIAject or human regular insulin in combination with previously prescribed insulin glargine, metformin, and/or thiazolidinedione therapy.

Because of the difference in action time, regular human insulin was injected 30-40 minutes before meals, while VIAject was given immediately before patients had meals.

At 6 months, the mean reduction in HbA_1c was similar in the two groups: The VIAject group dropped by 0.56 percentage points, the regular human insulin group by 0.70 points.

But nonsevere hypoglycemic event rates were significantly reduced in the patients taking VIAject, at just 0.33 events per month, compared with 0.66 events per month with regular human insulin, Dr. Rodbard reported.

Patients who were taking VIAject also gained significantly less weight, an average of 0.46 kg vs. 1.35 kg in patients who were taking regular human insulin.

Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups, Dr. Rodbard reported.

Injection site pain or irritation was greater with VIAject, but this declined during the course of the study. Moreover, the proposed U-100 pH-neutral commercial formulation of VIAject is associated with less injection site discomfort than is the U-25 pH 4 version used in this study, she pointed out.

Biodel is seeking Food and Drug Administration clearance to market VIAject based on two pivotal 6-month, phase III clinical trials in patients with type 1 and type 2 diabetes, as well as on results from long-term, 18-month safety extension trials for patients who completed the two pivotal phase III clinical trials.

The Prescription Drug User Fee Act action date for Biodel's new drug application is expected to be Oct. 30, 2010, the company said in a statement.

SAN ANTONIO — Data continue to show that diabetes education saves money.

Last year, the findings of an analysis of 3 years' worth of data from a large national claims database showed that patients with diabetes who receive diabetes education incur lower costs than do those who have not received the education (Diabetes Educ. 2009;35:752-60).

Now, preliminary findings from a new analysis of the same database show that the cost reduction comes primarily from a drop in hospital admissions, and that ongoing diabetes education beyond the initial sessions received at diagnosis are necessary to produce the cost savings.

The findings were presented by actuarial consultant Ian Duncan, president of Solucia Consulting. His firm conducted the analysis for the AADE using data from Solucia's claims database of about 20 million individuals, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 who were on Medicare.

“We all know how much you do for patients, how much you improve their lifestyle and help them cope with their condition. But the kinds of people we work with—the insurance payers (Medicaid agencies, Medicare, and health plans)—are interested in whether the investment for the services you provide brings a return to them in terms of the costs and the claims that the patients incur,” said Mr. Duncan, also of the department of health administration at Georgetown University in Washington.

In 2007, the adjusted cost per member per month of plan members with diabetes who were commercially insured was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively. Those differences were significant for both groups.

The follow-up, risk-adjusted analysis of patients who were continuously enrolled in 2005-2008 showed a significant difference in costs for the commercially insured patients ($985 for the 3,094 who received diabetes education vs. $1,043 for the 31,075 who did not), but there were no differences in the Medicare group, which included just 898 patients who received diabetes education and 23,342 who did not (nearly $1,400 for both).

However, when the frequency of diabetes education was factored in, it became clear that enrollees who received two or more sessions of diabetes education incurred lower costs than did those who received just one or no sessions.

In the commercially insured group in 2008, costs per patient per month were $845 for those receiving at least two education sessions, $863 for those who had just one session, and $907 for those with no diabetes education. In the Medicare group, the costs for those with zero and one session were nearly identical ($1,343 and $1,337, respectively), whereas the patients who did receive diabetes education that was covered by Medicare cost $1,267.50 per month. Neither quite reached statistical significance.

“This year's data show that follow-up diabetes education is what really produces the outstanding results,” Mr. Duncan commented, to audience applause.

These differences were seen even though more diabetes education was associated with higher medication compliance and thus greater pharmacy costs. In 2008, costs for glucose-lowering drugs were nearly identical for those with commercial insurance who received no education sessions or just one ($76 and $78, respectively) but were significantly higher for those who had at least two sessions ($99). Similarly, those figures in the Medicare group were $69 and $70, compared with $81, respectively.

Reductions in hospital admissions in the group receiving diabetes education more than made up for the higher pharmacy cost. In 2008, there were just 180 per 1,000 admissions for diabetes patients with commercial insurance who received two or more diabetes education sessions, compared with 212 per 1,000 for those with one session and 221 per 1,000 for no sessions. The difference was not as striking in Medicare, where those figures were 709, 665, and 735 per 1,000, respectively.

This study is ongoing, with additional analyses of laboratory and clinical values as well as measures of behavior change, he said.

Disclosures: Other than the AADE funding for this study, Mr. Duncan stated that he had no further disclosures.

SAN ANTONIO — Data continue to show that diabetes education saves money.

Last year, the findings of an analysis of 3 years' worth of data from a large national claims database showed that patients with diabetes who receive diabetes education incur lower costs than do those who have not received the education (Diabetes Educ. 2009;35:752-60).

Now, preliminary findings from a new analysis of the same database show that the cost reduction comes primarily from a drop in hospital admissions, and that ongoing diabetes education beyond the initial sessions received at diagnosis are necessary to produce the cost savings.

The findings were presented by actuarial consultant Ian Duncan, president of Solucia Consulting. His firm conducted the analysis for the AADE using data from Solucia's claims database of about 20 million individuals, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 who were on Medicare.

“We all know how much you do for patients, how much you improve their lifestyle and help them cope with their condition. But the kinds of people we work with—the insurance payers (Medicaid agencies, Medicare, and health plans)—are interested in whether the investment for the services you provide brings a return to them in terms of the costs and the claims that the patients incur,” said Mr. Duncan, also of the department of health administration at Georgetown University in Washington.

In 2007, the adjusted cost per member per month of plan members with diabetes who were commercially insured was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively. Those differences were significant for both groups.

The follow-up, risk-adjusted analysis of patients who were continuously enrolled in 2005-2008 showed a significant difference in costs for the commercially insured patients ($985 for the 3,094 who received diabetes education vs. $1,043 for the 31,075 who did not), but there were no differences in the Medicare group, which included just 898 patients who received diabetes education and 23,342 who did not (nearly $1,400 for both).

However, when the frequency of diabetes education was factored in, it became clear that enrollees who received two or more sessions of diabetes education incurred lower costs than did those who received just one or no sessions.

In the commercially insured group in 2008, costs per patient per month were $845 for those receiving at least two education sessions, $863 for those who had just one session, and $907 for those with no diabetes education. In the Medicare group, the costs for those with zero and one session were nearly identical ($1,343 and $1,337, respectively), whereas the patients who did receive diabetes education that was covered by Medicare cost $1,267.50 per month. Neither quite reached statistical significance.

“This year's data show that follow-up diabetes education is what really produces the outstanding results,” Mr. Duncan commented, to audience applause.

These differences were seen even though more diabetes education was associated with higher medication compliance and thus greater pharmacy costs. In 2008, costs for glucose-lowering drugs were nearly identical for those with commercial insurance who received no education sessions or just one ($76 and $78, respectively) but were significantly higher for those who had at least two sessions ($99). Similarly, those figures in the Medicare group were $69 and $70, compared with $81, respectively.

Reductions in hospital admissions in the group receiving diabetes education more than made up for the higher pharmacy cost. In 2008, there were just 180 per 1,000 admissions for diabetes patients with commercial insurance who received two or more diabetes education sessions, compared with 212 per 1,000 for those with one session and 221 per 1,000 for no sessions. The difference was not as striking in Medicare, where those figures were 709, 665, and 735 per 1,000, respectively.

This study is ongoing, with additional analyses of laboratory and clinical values as well as measures of behavior change, he said.

Disclosures: Other than the AADE funding for this study, Mr. Duncan stated that he had no further disclosures.

SAN ANTONIO — Data continue to show that diabetes education saves money.

Last year, the findings of an analysis of 3 years' worth of data from a large national claims database showed that patients with diabetes who receive diabetes education incur lower costs than do those who have not received the education (Diabetes Educ. 2009;35:752-60).

Now, preliminary findings from a new analysis of the same database show that the cost reduction comes primarily from a drop in hospital admissions, and that ongoing diabetes education beyond the initial sessions received at diagnosis are necessary to produce the cost savings.

The findings were presented by actuarial consultant Ian Duncan, president of Solucia Consulting. His firm conducted the analysis for the AADE using data from Solucia's claims database of about 20 million individuals, including both Medicare and commercially insured members. In 2007, the database contained 166,931 individuals with diabetes who had commercial insurance and 56,345 who were on Medicare.

“We all know how much you do for patients, how much you improve their lifestyle and help them cope with their condition. But the kinds of people we work with—the insurance payers (Medicaid agencies, Medicare, and health plans)—are interested in whether the investment for the services you provide brings a return to them in terms of the costs and the claims that the patients incur,” said Mr. Duncan, also of the department of health administration at Georgetown University in Washington.

In 2007, the adjusted cost per member per month of plan members with diabetes who were commercially insured was $923 among those who received diabetes education, compared with $1,072 among those who did not. For Medicare enrollees, those figures were $1,241 and $1,322, respectively. Those differences were significant for both groups.

The follow-up, risk-adjusted analysis of patients who were continuously enrolled in 2005-2008 showed a significant difference in costs for the commercially insured patients ($985 for the 3,094 who received diabetes education vs. $1,043 for the 31,075 who did not), but there were no differences in the Medicare group, which included just 898 patients who received diabetes education and 23,342 who did not (nearly $1,400 for both).

However, when the frequency of diabetes education was factored in, it became clear that enrollees who received two or more sessions of diabetes education incurred lower costs than did those who received just one or no sessions.

In the commercially insured group in 2008, costs per patient per month were $845 for those receiving at least two education sessions, $863 for those who had just one session, and $907 for those with no diabetes education. In the Medicare group, the costs for those with zero and one session were nearly identical ($1,343 and $1,337, respectively), whereas the patients who did receive diabetes education that was covered by Medicare cost $1,267.50 per month. Neither quite reached statistical significance.

“This year's data show that follow-up diabetes education is what really produces the outstanding results,” Mr. Duncan commented, to audience applause.

These differences were seen even though more diabetes education was associated with higher medication compliance and thus greater pharmacy costs. In 2008, costs for glucose-lowering drugs were nearly identical for those with commercial insurance who received no education sessions or just one ($76 and $78, respectively) but were significantly higher for those who had at least two sessions ($99). Similarly, those figures in the Medicare group were $69 and $70, compared with $81, respectively.

Reductions in hospital admissions in the group receiving diabetes education more than made up for the higher pharmacy cost. In 2008, there were just 180 per 1,000 admissions for diabetes patients with commercial insurance who received two or more diabetes education sessions, compared with 212 per 1,000 for those with one session and 221 per 1,000 for no sessions. The difference was not as striking in Medicare, where those figures were 709, 665, and 735 per 1,000, respectively.

This study is ongoing, with additional analyses of laboratory and clinical values as well as measures of behavior change, he said.

Disclosures: Other than the AADE funding for this study, Mr. Duncan stated that he had no further disclosures.

Major Finding: At 12 months, the likelihood of an oral medication adherence rate above 80% was 4.77 times greater among the intervention group than among controls, a significant difference despite wide confidence intervals.

Data Source: A randomized controlled study of 265 patients with type 2 diabetes conducted with pharmacists at four Safeway pharmacies in Washington state.

Disclosures: The study was funded by a grant from the American Association of Diabetes Educators' Education and Research Foundation.

SAN ANTONIO — A personalized phone call from a retail chain store pharmacist to patients who missed diabetes prescription refills significantly improved medication adherence at 1 year in a study of 265 patients with type 2 diabetes.

“Because adults with diabetes visit pharmacies more often than they visit any other health professional [setting], it is believed there is an untapped opportunity for pharmacists to provide self-management education and support for medications,” said certified diabetes educator Peggy S. Odegard, Pharm.D.

The randomized, controlled Medication Adherence Program (MAP) study was conducted at four pharmacies inside Safeway grocery stores in Washington state. When a prescription refill for an oral glucose-lowering medication was missed by 6 days, a pharmacist would call the patients to ask why they had missed the refill and whether they would like to refill it now. Depending on the response, the pharmacist would offer individualized advice and education. A follow-up phone call was made at 1 week to 1 month after the intervention to further assess the patients' needs and address any problems.

The subjects had all been using the pharmacy consistently for a year or longer. The 145 controls, who were not called when refills were missed, were slightly younger, with a mean age of 61 years, compared with 65 years for the 120 who received the phone call intervention. The groups' other baseline characteristics were similar, including sex (a little more than half were women), the number of different medications they were taking, and the proportion who were on insulin (23% in both groups).

Among 119 patients who reported problems with taking their medications, 27% cited “difficulty with taking medication,” 26% said they simply “forgot to order refills,” and 8% “forgot to pick up refills.” Of those with “difficulty taking medication,” the most common difficulty listed was “remembering dose.”

Adherence was assessed by the change in “medication possession ratio” (MPR), or the number of days of medication supplied in a prescription fill divided by the number of days until the prescription was refilled. For example, a 30-day supply that is filled and then refilled in 30 days would yield an MPR of 1.0. But if a patient receives a 30-day prescription but doesn't refill it for 60 days, the MPR would be 0.5, or half the adherence rate expected, explained Dr. Odegard, of the University of Washington, Seattle, in an interview.

At baseline, MPR for diabetes medications did not differ between the two groups (0.86 for the intervention group and 0.84 for controls). However, the proportion of patients with an MPR greater than 0.8 was slightly higher in the intervention group than in the controls (74.4% vs. 65.2%), meaning that it would be harder to prove that the intervention worked because the patients in that group already were somewhat more adherent, Dr. Odegard pointed out.

Over 12 months, the pharmacists conducted an average of 3.4 phone call interventions (or occasionally in-person interventions) per patient, and were reimbursed $10 per intervention. Interventions lasted an average of 12.6 minutes each. In addition to diabetes education (including advice on prevention of medication side effects) and adherence support (including integration of medication dosing with daily activities), pharmacists helped to optimize the patients' regimen with the prescriber and/or helped with economic adjustment (for example, a change to generic).

At 12 months, the MPR was significantly improved in the intervention group (up to 0.90 from 0.86), whereas in the control group the MPR declined slightly (from 0.84 to 0.82), a significant difference. Moreover, the likelihood of an oral medication adherence rate greater than 80% (MPR 0.80 or higher) was 4.77 times greater among the intervention group than in the controls. This difference was significant despite wide confidence intervals, said Dr. Odegard.

A regression model that included demographic variables, regimen complexity, and prior oral medication adherence measures explained 70% of the change in MPR scores at 12 months. Significant predictors of a change in MPR were a low MPR during the prior period, less resistance to taking medication, and less time needed with the pharmacist.

Dr. Odegard and her associates are hoping to integrate this type of program into local pharmacy chains. Several remaining challenges include the fact that patients don't always pick up their own medications, some might use both community and mail order pharmacies, and some might have multiple physicians for their diabetes care.

During the question-and-answer period, Dr. Odegard remarked that such programs could provide a significant revenue stream to pharmacies. She and her colleagues are currently conducting a cost analysis. Indeed, Safeway has been very supportive. “If a company like Safeway can take the lead on helping drive corporate policy change in helping pharmacists to do this kind of thing, if it really makes a difference, it will be huge. … We're really hoping that reimbursement can go to pharmacies or other health care providers who perform these services,” she said.

Major Finding: At 12 months, the likelihood of an oral medication adherence rate above 80% was 4.77 times greater among the intervention group than among controls, a significant difference despite wide confidence intervals.

Data Source: A randomized controlled study of 265 patients with type 2 diabetes conducted with pharmacists at four Safeway pharmacies in Washington state.

Disclosures: The study was funded by a grant from the American Association of Diabetes Educators' Education and Research Foundation.

SAN ANTONIO — A personalized phone call from a retail chain store pharmacist to patients who missed diabetes prescription refills significantly improved medication adherence at 1 year in a study of 265 patients with type 2 diabetes.

“Because adults with diabetes visit pharmacies more often than they visit any other health professional [setting], it is believed there is an untapped opportunity for pharmacists to provide self-management education and support for medications,” said certified diabetes educator Peggy S. Odegard, Pharm.D.

The randomized, controlled Medication Adherence Program (MAP) study was conducted at four pharmacies inside Safeway grocery stores in Washington state. When a prescription refill for an oral glucose-lowering medication was missed by 6 days, a pharmacist would call the patients to ask why they had missed the refill and whether they would like to refill it now. Depending on the response, the pharmacist would offer individualized advice and education. A follow-up phone call was made at 1 week to 1 month after the intervention to further assess the patients' needs and address any problems.

The subjects had all been using the pharmacy consistently for a year or longer. The 145 controls, who were not called when refills were missed, were slightly younger, with a mean age of 61 years, compared with 65 years for the 120 who received the phone call intervention. The groups' other baseline characteristics were similar, including sex (a little more than half were women), the number of different medications they were taking, and the proportion who were on insulin (23% in both groups).

Among 119 patients who reported problems with taking their medications, 27% cited “difficulty with taking medication,” 26% said they simply “forgot to order refills,” and 8% “forgot to pick up refills.” Of those with “difficulty taking medication,” the most common difficulty listed was “remembering dose.”

Adherence was assessed by the change in “medication possession ratio” (MPR), or the number of days of medication supplied in a prescription fill divided by the number of days until the prescription was refilled. For example, a 30-day supply that is filled and then refilled in 30 days would yield an MPR of 1.0. But if a patient receives a 30-day prescription but doesn't refill it for 60 days, the MPR would be 0.5, or half the adherence rate expected, explained Dr. Odegard, of the University of Washington, Seattle, in an interview.

At baseline, MPR for diabetes medications did not differ between the two groups (0.86 for the intervention group and 0.84 for controls). However, the proportion of patients with an MPR greater than 0.8 was slightly higher in the intervention group than in the controls (74.4% vs. 65.2%), meaning that it would be harder to prove that the intervention worked because the patients in that group already were somewhat more adherent, Dr. Odegard pointed out.

Over 12 months, the pharmacists conducted an average of 3.4 phone call interventions (or occasionally in-person interventions) per patient, and were reimbursed $10 per intervention. Interventions lasted an average of 12.6 minutes each. In addition to diabetes education (including advice on prevention of medication side effects) and adherence support (including integration of medication dosing with daily activities), pharmacists helped to optimize the patients' regimen with the prescriber and/or helped with economic adjustment (for example, a change to generic).

At 12 months, the MPR was significantly improved in the intervention group (up to 0.90 from 0.86), whereas in the control group the MPR declined slightly (from 0.84 to 0.82), a significant difference. Moreover, the likelihood of an oral medication adherence rate greater than 80% (MPR 0.80 or higher) was 4.77 times greater among the intervention group than in the controls. This difference was significant despite wide confidence intervals, said Dr. Odegard.

A regression model that included demographic variables, regimen complexity, and prior oral medication adherence measures explained 70% of the change in MPR scores at 12 months. Significant predictors of a change in MPR were a low MPR during the prior period, less resistance to taking medication, and less time needed with the pharmacist.

Dr. Odegard and her associates are hoping to integrate this type of program into local pharmacy chains. Several remaining challenges include the fact that patients don't always pick up their own medications, some might use both community and mail order pharmacies, and some might have multiple physicians for their diabetes care.

During the question-and-answer period, Dr. Odegard remarked that such programs could provide a significant revenue stream to pharmacies. She and her colleagues are currently conducting a cost analysis. Indeed, Safeway has been very supportive. “If a company like Safeway can take the lead on helping drive corporate policy change in helping pharmacists to do this kind of thing, if it really makes a difference, it will be huge. … We're really hoping that reimbursement can go to pharmacies or other health care providers who perform these services,” she said.

Major Finding: At 12 months, the likelihood of an oral medication adherence rate above 80% was 4.77 times greater among the intervention group than among controls, a significant difference despite wide confidence intervals.

Data Source: A randomized controlled study of 265 patients with type 2 diabetes conducted with pharmacists at four Safeway pharmacies in Washington state.

Disclosures: The study was funded by a grant from the American Association of Diabetes Educators' Education and Research Foundation.

SAN ANTONIO — A personalized phone call from a retail chain store pharmacist to patients who missed diabetes prescription refills significantly improved medication adherence at 1 year in a study of 265 patients with type 2 diabetes.

“Because adults with diabetes visit pharmacies more often than they visit any other health professional [setting], it is believed there is an untapped opportunity for pharmacists to provide self-management education and support for medications,” said certified diabetes educator Peggy S. Odegard, Pharm.D.

The randomized, controlled Medication Adherence Program (MAP) study was conducted at four pharmacies inside Safeway grocery stores in Washington state. When a prescription refill for an oral glucose-lowering medication was missed by 6 days, a pharmacist would call the patients to ask why they had missed the refill and whether they would like to refill it now. Depending on the response, the pharmacist would offer individualized advice and education. A follow-up phone call was made at 1 week to 1 month after the intervention to further assess the patients' needs and address any problems.

The subjects had all been using the pharmacy consistently for a year or longer. The 145 controls, who were not called when refills were missed, were slightly younger, with a mean age of 61 years, compared with 65 years for the 120 who received the phone call intervention. The groups' other baseline characteristics were similar, including sex (a little more than half were women), the number of different medications they were taking, and the proportion who were on insulin (23% in both groups).

Among 119 patients who reported problems with taking their medications, 27% cited “difficulty with taking medication,” 26% said they simply “forgot to order refills,” and 8% “forgot to pick up refills.” Of those with “difficulty taking medication,” the most common difficulty listed was “remembering dose.”

Adherence was assessed by the change in “medication possession ratio” (MPR), or the number of days of medication supplied in a prescription fill divided by the number of days until the prescription was refilled. For example, a 30-day supply that is filled and then refilled in 30 days would yield an MPR of 1.0. But if a patient receives a 30-day prescription but doesn't refill it for 60 days, the MPR would be 0.5, or half the adherence rate expected, explained Dr. Odegard, of the University of Washington, Seattle, in an interview.

At baseline, MPR for diabetes medications did not differ between the two groups (0.86 for the intervention group and 0.84 for controls). However, the proportion of patients with an MPR greater than 0.8 was slightly higher in the intervention group than in the controls (74.4% vs. 65.2%), meaning that it would be harder to prove that the intervention worked because the patients in that group already were somewhat more adherent, Dr. Odegard pointed out.

Over 12 months, the pharmacists conducted an average of 3.4 phone call interventions (or occasionally in-person interventions) per patient, and were reimbursed $10 per intervention. Interventions lasted an average of 12.6 minutes each. In addition to diabetes education (including advice on prevention of medication side effects) and adherence support (including integration of medication dosing with daily activities), pharmacists helped to optimize the patients' regimen with the prescriber and/or helped with economic adjustment (for example, a change to generic).

At 12 months, the MPR was significantly improved in the intervention group (up to 0.90 from 0.86), whereas in the control group the MPR declined slightly (from 0.84 to 0.82), a significant difference. Moreover, the likelihood of an oral medication adherence rate greater than 80% (MPR 0.80 or higher) was 4.77 times greater among the intervention group than in the controls. This difference was significant despite wide confidence intervals, said Dr. Odegard.

A regression model that included demographic variables, regimen complexity, and prior oral medication adherence measures explained 70% of the change in MPR scores at 12 months. Significant predictors of a change in MPR were a low MPR during the prior period, less resistance to taking medication, and less time needed with the pharmacist.

Dr. Odegard and her associates are hoping to integrate this type of program into local pharmacy chains. Several remaining challenges include the fact that patients don't always pick up their own medications, some might use both community and mail order pharmacies, and some might have multiple physicians for their diabetes care.

During the question-and-answer period, Dr. Odegard remarked that such programs could provide a significant revenue stream to pharmacies. She and her colleagues are currently conducting a cost analysis. Indeed, Safeway has been very supportive. “If a company like Safeway can take the lead on helping drive corporate policy change in helping pharmacists to do this kind of thing, if it really makes a difference, it will be huge. … We're really hoping that reimbursement can go to pharmacies or other health care providers who perform these services,” she said.