ADA Annual Scientific Sessions 2015

Boston – A purified food supplement designed to alter gut bacterial composition improved both metformin tolerance and fasting glucose levels among people with type 2 diabetes, according to results from a small randomized study presented at the annual scientific sessions of the American Diabetes Association.

Research into how diabetes affects and is affected by the gut microbiome is still in its infancy. However, compared with nondiabetics, people with type 2 diabetes have been shown to have microbiomes richer in certain types of bacteria than others, and these altered bacterial profiles may be linked to changes in insulin sensitivity, glucose regulation, and methane production.

Mark L Heiman, Ph.D., of MicroBiome Therapeutics in New Orleans, designed the intervention, a powder comprising three purified food ingredients: inulin from agave, beta-glucan from oatmeal, and polyphenols derived from blueberry skins. These were hypothesized to alter gut microbial composition by stimulating blooms of microbes that can generate short-chain fatty acids, displacing some bacteria-producing lactic acid; increase viscosity in the colon (allowing for sequestering of bile acids); and combat oxidative stress and methane production.

Though first investigated as a monotherapy for use in people with prediabetes, the so-called gut microbiome modulator NM504 was found incidentally to improve metformin tolerance in people with newly diagnosed type 2 diabetes (Benef. Microbes 2014;5:29-32), and researchers hypothesized that metformin likely interacts with microbiota in the colon, resulting in an abundance of lactate-producing bacteria. Lactic acid production in the colon, exacerbated by starch or sugar consumption, is a known contributor to adverse GI side effects in people taking metformin.

Dr. Heiman presented results from a randomized, placebo-controlled, single-center crossover study in 10 people with type 2 diabetes (8 female) with difficulty tolerating metformin due to GI symptoms or who had discontinued previous therapy because of these symptoms (J. Diabetes Sci. Technol. 2015;9:808-14).

Subjects were randomly assigned metformin (500 mg twice daily in the first week titrated to three times daily in the second week) alongside the experimental product or placebo. They were asked to record their glucose and adverse GI symptoms (including stool consistency, urgency to evacuate, bloating sensation, and flatulence) every day; metformin tolerance was measured by these symptoms using a scoring system previously validated in patients with irritable bowel syndrome.

After 2 weeks of treatment and a washout period of 2 weeks with no treatment, subjects’ initial treatment assignments were reversed for an additional 2 weeks, and outcomes were recorded.

The combination of metformin and NM504 resulted in improved tolerance score of metformin, compared with placebo (6.78 ± 0.65 [mean ± standard error of the mean] vs. 4.45 ± 0.69, P = .0006). Mean fasting glucose levels were significantly lower with the metformin/NM504 combination (121.3 ± 7.8 mg/dL) than with metformin-placebo (151.9 ± 7.8 mg/dL), (P < .02).

It is unclear whether the improved glucose was a result of improved availability of metformin or an independent effect of the intervention. Last year Dr. Heiman presented results from a previous study of 28 adults with prediabetes randomized to NM504 monotherapy or placebo who saw significantly lower blood sugar levels at 120 and 180 minutes after a glucose challenge, compared with patients taking placebo. This was presented at the International Congress of Endocrinology’s annual meeting (ICE-Endo) 2014 meeting in Chicago; Dr. Heiman noted that the results are awaiting review and perhaps publication.

Dr. Heiman commented that the glucose-regulating effect seen in the metformin study “appeared somewhat durable, even after the 2-week washout period” among subjects switching from intervention to placebo; however, further studies would be needed to determine its effect on insulin sensitivity. Fecal microbial composition was not investigated before and after treatment.

Dr. Daniel Hsia of Pennington Biomedical Research Center, in Baton Rouge, La., a study coauthor, said in an interview that although larger trials would be needed to validate the results and better understand the activity of the intervention in the gut, the findings were “promising” for a proof-of-concept study.

“At this point, we’re not going to start using this in every single diabetes patient on metformin, but it’s very encouraging that you could potentially make it more accessible. Metformin is a very good agent with one of the longest histories. It’s cheap, it can be used in combination with a lot of other medications, but a certain percentage of people will have to stop metformin altogether due to side effects.” Metformin is also approved for children with type 2 diabetes as young as 10 years, he pointed out. “The fact that [NM504] is food and you could add this to the regimen makes it very appealing” for use in adolescent patients, he said.

Dr. Heiman, a former obesity researcher at Eli Lilly, said that interventions to manipulate gut microbiota were worthy of deeper investigation. “In the past we were content to say ‘you’ve got bacteria to help you digest food’ – but little was known about what they do, whether they convert sugars to short-chain fatty acids, whether they might send out signals that may, for example, make you crave sugar. The exciting things is learning what all the signals are, and how they communicate with the body,” he said.

MicroBiome Therapeutics, owner of a patent on the investigational product, sponsored the study. Dr Heiman is an employee of MicroBiome Therapeutics, and another coauthor disclosed funding from the company. Dr. Hsia and three other coauthors reported no conflicts of interest.

Boston – A purified food supplement designed to alter gut bacterial composition improved both metformin tolerance and fasting glucose levels among people with type 2 diabetes, according to results from a small randomized study presented at the annual scientific sessions of the American Diabetes Association.

Research into how diabetes affects and is affected by the gut microbiome is still in its infancy. However, compared with nondiabetics, people with type 2 diabetes have been shown to have microbiomes richer in certain types of bacteria than others, and these altered bacterial profiles may be linked to changes in insulin sensitivity, glucose regulation, and methane production.

Mark L Heiman, Ph.D., of MicroBiome Therapeutics in New Orleans, designed the intervention, a powder comprising three purified food ingredients: inulin from agave, beta-glucan from oatmeal, and polyphenols derived from blueberry skins. These were hypothesized to alter gut microbial composition by stimulating blooms of microbes that can generate short-chain fatty acids, displacing some bacteria-producing lactic acid; increase viscosity in the colon (allowing for sequestering of bile acids); and combat oxidative stress and methane production.

Though first investigated as a monotherapy for use in people with prediabetes, the so-called gut microbiome modulator NM504 was found incidentally to improve metformin tolerance in people with newly diagnosed type 2 diabetes (Benef. Microbes 2014;5:29-32), and researchers hypothesized that metformin likely interacts with microbiota in the colon, resulting in an abundance of lactate-producing bacteria. Lactic acid production in the colon, exacerbated by starch or sugar consumption, is a known contributor to adverse GI side effects in people taking metformin.

Dr. Heiman presented results from a randomized, placebo-controlled, single-center crossover study in 10 people with type 2 diabetes (8 female) with difficulty tolerating metformin due to GI symptoms or who had discontinued previous therapy because of these symptoms (J. Diabetes Sci. Technol. 2015;9:808-14).

Subjects were randomly assigned metformin (500 mg twice daily in the first week titrated to three times daily in the second week) alongside the experimental product or placebo. They were asked to record their glucose and adverse GI symptoms (including stool consistency, urgency to evacuate, bloating sensation, and flatulence) every day; metformin tolerance was measured by these symptoms using a scoring system previously validated in patients with irritable bowel syndrome.

After 2 weeks of treatment and a washout period of 2 weeks with no treatment, subjects’ initial treatment assignments were reversed for an additional 2 weeks, and outcomes were recorded.

The combination of metformin and NM504 resulted in improved tolerance score of metformin, compared with placebo (6.78 ± 0.65 [mean ± standard error of the mean] vs. 4.45 ± 0.69, P = .0006). Mean fasting glucose levels were significantly lower with the metformin/NM504 combination (121.3 ± 7.8 mg/dL) than with metformin-placebo (151.9 ± 7.8 mg/dL), (P < .02).

It is unclear whether the improved glucose was a result of improved availability of metformin or an independent effect of the intervention. Last year Dr. Heiman presented results from a previous study of 28 adults with prediabetes randomized to NM504 monotherapy or placebo who saw significantly lower blood sugar levels at 120 and 180 minutes after a glucose challenge, compared with patients taking placebo. This was presented at the International Congress of Endocrinology’s annual meeting (ICE-Endo) 2014 meeting in Chicago; Dr. Heiman noted that the results are awaiting review and perhaps publication.

Dr. Heiman commented that the glucose-regulating effect seen in the metformin study “appeared somewhat durable, even after the 2-week washout period” among subjects switching from intervention to placebo; however, further studies would be needed to determine its effect on insulin sensitivity. Fecal microbial composition was not investigated before and after treatment.

Dr. Daniel Hsia of Pennington Biomedical Research Center, in Baton Rouge, La., a study coauthor, said in an interview that although larger trials would be needed to validate the results and better understand the activity of the intervention in the gut, the findings were “promising” for a proof-of-concept study.

“At this point, we’re not going to start using this in every single diabetes patient on metformin, but it’s very encouraging that you could potentially make it more accessible. Metformin is a very good agent with one of the longest histories. It’s cheap, it can be used in combination with a lot of other medications, but a certain percentage of people will have to stop metformin altogether due to side effects.” Metformin is also approved for children with type 2 diabetes as young as 10 years, he pointed out. “The fact that [NM504] is food and you could add this to the regimen makes it very appealing” for use in adolescent patients, he said.

Dr. Heiman, a former obesity researcher at Eli Lilly, said that interventions to manipulate gut microbiota were worthy of deeper investigation. “In the past we were content to say ‘you’ve got bacteria to help you digest food’ – but little was known about what they do, whether they convert sugars to short-chain fatty acids, whether they might send out signals that may, for example, make you crave sugar. The exciting things is learning what all the signals are, and how they communicate with the body,” he said.

MicroBiome Therapeutics, owner of a patent on the investigational product, sponsored the study. Dr Heiman is an employee of MicroBiome Therapeutics, and another coauthor disclosed funding from the company. Dr. Hsia and three other coauthors reported no conflicts of interest.

Boston – A purified food supplement designed to alter gut bacterial composition improved both metformin tolerance and fasting glucose levels among people with type 2 diabetes, according to results from a small randomized study presented at the annual scientific sessions of the American Diabetes Association.

Research into how diabetes affects and is affected by the gut microbiome is still in its infancy. However, compared with nondiabetics, people with type 2 diabetes have been shown to have microbiomes richer in certain types of bacteria than others, and these altered bacterial profiles may be linked to changes in insulin sensitivity, glucose regulation, and methane production.

Mark L Heiman, Ph.D., of MicroBiome Therapeutics in New Orleans, designed the intervention, a powder comprising three purified food ingredients: inulin from agave, beta-glucan from oatmeal, and polyphenols derived from blueberry skins. These were hypothesized to alter gut microbial composition by stimulating blooms of microbes that can generate short-chain fatty acids, displacing some bacteria-producing lactic acid; increase viscosity in the colon (allowing for sequestering of bile acids); and combat oxidative stress and methane production.

Though first investigated as a monotherapy for use in people with prediabetes, the so-called gut microbiome modulator NM504 was found incidentally to improve metformin tolerance in people with newly diagnosed type 2 diabetes (Benef. Microbes 2014;5:29-32), and researchers hypothesized that metformin likely interacts with microbiota in the colon, resulting in an abundance of lactate-producing bacteria. Lactic acid production in the colon, exacerbated by starch or sugar consumption, is a known contributor to adverse GI side effects in people taking metformin.

Dr. Heiman presented results from a randomized, placebo-controlled, single-center crossover study in 10 people with type 2 diabetes (8 female) with difficulty tolerating metformin due to GI symptoms or who had discontinued previous therapy because of these symptoms (J. Diabetes Sci. Technol. 2015;9:808-14).

Subjects were randomly assigned metformin (500 mg twice daily in the first week titrated to three times daily in the second week) alongside the experimental product or placebo. They were asked to record their glucose and adverse GI symptoms (including stool consistency, urgency to evacuate, bloating sensation, and flatulence) every day; metformin tolerance was measured by these symptoms using a scoring system previously validated in patients with irritable bowel syndrome.

After 2 weeks of treatment and a washout period of 2 weeks with no treatment, subjects’ initial treatment assignments were reversed for an additional 2 weeks, and outcomes were recorded.

The combination of metformin and NM504 resulted in improved tolerance score of metformin, compared with placebo (6.78 ± 0.65 [mean ± standard error of the mean] vs. 4.45 ± 0.69, P = .0006). Mean fasting glucose levels were significantly lower with the metformin/NM504 combination (121.3 ± 7.8 mg/dL) than with metformin-placebo (151.9 ± 7.8 mg/dL), (P < .02).

It is unclear whether the improved glucose was a result of improved availability of metformin or an independent effect of the intervention. Last year Dr. Heiman presented results from a previous study of 28 adults with prediabetes randomized to NM504 monotherapy or placebo who saw significantly lower blood sugar levels at 120 and 180 minutes after a glucose challenge, compared with patients taking placebo. This was presented at the International Congress of Endocrinology’s annual meeting (ICE-Endo) 2014 meeting in Chicago; Dr. Heiman noted that the results are awaiting review and perhaps publication.

Dr. Heiman commented that the glucose-regulating effect seen in the metformin study “appeared somewhat durable, even after the 2-week washout period” among subjects switching from intervention to placebo; however, further studies would be needed to determine its effect on insulin sensitivity. Fecal microbial composition was not investigated before and after treatment.

Dr. Daniel Hsia of Pennington Biomedical Research Center, in Baton Rouge, La., a study coauthor, said in an interview that although larger trials would be needed to validate the results and better understand the activity of the intervention in the gut, the findings were “promising” for a proof-of-concept study.

“At this point, we’re not going to start using this in every single diabetes patient on metformin, but it’s very encouraging that you could potentially make it more accessible. Metformin is a very good agent with one of the longest histories. It’s cheap, it can be used in combination with a lot of other medications, but a certain percentage of people will have to stop metformin altogether due to side effects.” Metformin is also approved for children with type 2 diabetes as young as 10 years, he pointed out. “The fact that [NM504] is food and you could add this to the regimen makes it very appealing” for use in adolescent patients, he said.

Dr. Heiman, a former obesity researcher at Eli Lilly, said that interventions to manipulate gut microbiota were worthy of deeper investigation. “In the past we were content to say ‘you’ve got bacteria to help you digest food’ – but little was known about what they do, whether they convert sugars to short-chain fatty acids, whether they might send out signals that may, for example, make you crave sugar. The exciting things is learning what all the signals are, and how they communicate with the body,” he said.

MicroBiome Therapeutics, owner of a patent on the investigational product, sponsored the study. Dr Heiman is an employee of MicroBiome Therapeutics, and another coauthor disclosed funding from the company. Dr. Hsia and three other coauthors reported no conflicts of interest.

BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.

Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.

©Tashatuvango/Thinkstockphotos.com

A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.

Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.

Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).

Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.

“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”

The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.

Ms. Talavera reported having no conflicts of interest to disclose.

BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.

Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.

©Tashatuvango/Thinkstockphotos.com

A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.

Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.

Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).

Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.

“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”

The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.

Ms. Talavera reported having no conflicts of interest to disclose.

BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.

Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.

©Tashatuvango/Thinkstockphotos.com

A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.

Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.

Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).

Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.

“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”

The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.

Ms. Talavera reported having no conflicts of interest to disclose.

BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.

Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.

©Tashatuvango/Thinkstockphotos.com

A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.

Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.

Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).

Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.

“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”

The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.

Ms. Talavera reported having no conflicts of interest to disclose.

sworcester@frontlinemedcom.com

BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.

Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.

©Tashatuvango/Thinkstockphotos.com

A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.

Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.

Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).

Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.

“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”

The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.

Ms. Talavera reported having no conflicts of interest to disclose.

sworcester@frontlinemedcom.com

BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.

Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.

©Tashatuvango/Thinkstockphotos.com

A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.

Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.

Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).

Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.

“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”

The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.

Ms. Talavera reported having no conflicts of interest to disclose.

sworcester@frontlinemedcom.com

BOSTON – Liraglutide in combination with metformin reduced epicardial adipose tissue by nearly half within 6 months of treatment in people with type 2 diabetes, an effect independent of either body weight loss or glycemic control, according to a new study.

Epicardial adipose tissue (EAT) is the fat depot around the heart. While EAT has many cardioprotective properties, increased or excess EAT – seen more frequently in people with type 2 diabetes – has been linked to coronary artery disease, metabolic syndrome, diabetes, insulin resistance, and liver disease, according to a review by Gianluca Iacobellis, M.D., Ph.D., professor of clinical medicine in the division of endocrinology, diabetes and metabolism at the University of Miami (Nat. Rev. Endocrinol. 2015;11: 363-71).

More than a decade ago, Dr. Iacobellis proposed and validated ultrasound measurement of EAT thickness as marker of visceral fat and a therapeutic target (J. Clin. Endocrinol. Metab. 2003;88: 5163-8).

At the annual scientific sessions of the American Diabetes Association, Dr. Iacobellis presented preliminary findings from a case-control study in 35 patients with type 2 diabetes with body mass indexes greater than 27 kg/m² and hemoglobin A_1c levels no greater than 8% on metformin monotherapy.

Patients were randomized to remain on metformin or metformin plus the glucagon-like peptide-1 (GLP-1) analogue liraglutide subcutaneously up to 1.8 mg once daily for 6 months. EAT thickness was measured by ultrasound at baseline, 3 months, and 6 months, along with HbA_1c and BMI measures. In the liraglutide group (20 patients), EAT decreased significantly from 10.2 mm to 6.9 mm and 5.8 mm (P < 0.001) after 3 months and 6 months, respectively, for a 42% reduction at 6 months. The metformin-only group (15 patients) saw no reduction in EAT.

The EAT reduction seen in the intervention group was much greater than, and independent of, reductions in body weight or HbA_1c. Average BMI fell from 33 kg/m² at baseline to 31.8 kg/m² and 31.7 kg/m² at 3 months and 6 months, respectively, while HbA_1c declined 18% among patients on liraglutide.

The findings have important clinical and research implications, Dr. Iacobellis said in an interview. “Emerging evidence is pointing out that EAT as measured with reliable, safe, and cheap ultrasound can be a therapeutic target for medications directly or indirectly targeting the adipose tissue,” he said. And EAT can be measured in clinical settings, he added.

Moreover, there is a strong likelihood that further studies will show cardiovascular benefit associated with reductions in EAT, Dr. Iacobellis predicted.

“There is a direct cross-talk between the cardiac fat and the heart,” he said. “If you target the fat, if you’re able to modulate or to reduce the adipose tissue of the heart, you can directly modulate the myocardium and improve cardiovascular performance.”

Dr. Iacobellis’ study on liraglutide is ongoing, and the investigators are examining the effects of other classes of drugs, including the sodium-glucose cotransporter-2 (SLGT-2) inhibitors, on EAT in people with type 2 diabetes. Dr. Iacobellis said he did not know whether to consider the EAT reduction a likely class effect of GLP-1 analogue medications. It is biologically plausible, he added, because human adipose tissues express GLP-1 receptors.

Other studies are showing that exenatide may have some beneficial cardiovascular effect in patients with coronary artery disease, he said. “However, liraglutide seems to be the most effective in targeting the adipose tissue. There may be a class effect, but one drug could have a more prominent effect compared to others.”

It is possible that liraglutide’s metabolic and weight-loss benefits are in some way mediated by its effect on EAT and other visceral fat depots, Dr. Iacobellis observed, although further research will be needed to show that.

“We know that people lose weight on liraglutide, and we know they have an improvement in glucose control. But what we don’t know is whether the metabolic improvement is actually driven by an effect of the medication on the organ-specific fat depot,” he said.

Novo Nordisk and the University of Miami sponsored the study. Neither Dr. Iacobellis nor his coauthors disclosed conflicts of interest.

BOSTON – Liraglutide in combination with metformin reduced epicardial adipose tissue by nearly half within 6 months of treatment in people with type 2 diabetes, an effect independent of either body weight loss or glycemic control, according to a new study.

Epicardial adipose tissue (EAT) is the fat depot around the heart. While EAT has many cardioprotective properties, increased or excess EAT – seen more frequently in people with type 2 diabetes – has been linked to coronary artery disease, metabolic syndrome, diabetes, insulin resistance, and liver disease, according to a review by Gianluca Iacobellis, M.D., Ph.D., professor of clinical medicine in the division of endocrinology, diabetes and metabolism at the University of Miami (Nat. Rev. Endocrinol. 2015;11: 363-71).

More than a decade ago, Dr. Iacobellis proposed and validated ultrasound measurement of EAT thickness as marker of visceral fat and a therapeutic target (J. Clin. Endocrinol. Metab. 2003;88: 5163-8).

At the annual scientific sessions of the American Diabetes Association, Dr. Iacobellis presented preliminary findings from a case-control study in 35 patients with type 2 diabetes with body mass indexes greater than 27 kg/m² and hemoglobin A_1c levels no greater than 8% on metformin monotherapy.

Patients were randomized to remain on metformin or metformin plus the glucagon-like peptide-1 (GLP-1) analogue liraglutide subcutaneously up to 1.8 mg once daily for 6 months. EAT thickness was measured by ultrasound at baseline, 3 months, and 6 months, along with HbA_1c and BMI measures. In the liraglutide group (20 patients), EAT decreased significantly from 10.2 mm to 6.9 mm and 5.8 mm (P < 0.001) after 3 months and 6 months, respectively, for a 42% reduction at 6 months. The metformin-only group (15 patients) saw no reduction in EAT.

The EAT reduction seen in the intervention group was much greater than, and independent of, reductions in body weight or HbA_1c. Average BMI fell from 33 kg/m² at baseline to 31.8 kg/m² and 31.7 kg/m² at 3 months and 6 months, respectively, while HbA_1c declined 18% among patients on liraglutide.

The findings have important clinical and research implications, Dr. Iacobellis said in an interview. “Emerging evidence is pointing out that EAT as measured with reliable, safe, and cheap ultrasound can be a therapeutic target for medications directly or indirectly targeting the adipose tissue,” he said. And EAT can be measured in clinical settings, he added.

Moreover, there is a strong likelihood that further studies will show cardiovascular benefit associated with reductions in EAT, Dr. Iacobellis predicted.

“There is a direct cross-talk between the cardiac fat and the heart,” he said. “If you target the fat, if you’re able to modulate or to reduce the adipose tissue of the heart, you can directly modulate the myocardium and improve cardiovascular performance.”

Dr. Iacobellis’ study on liraglutide is ongoing, and the investigators are examining the effects of other classes of drugs, including the sodium-glucose cotransporter-2 (SLGT-2) inhibitors, on EAT in people with type 2 diabetes. Dr. Iacobellis said he did not know whether to consider the EAT reduction a likely class effect of GLP-1 analogue medications. It is biologically plausible, he added, because human adipose tissues express GLP-1 receptors.

Other studies are showing that exenatide may have some beneficial cardiovascular effect in patients with coronary artery disease, he said. “However, liraglutide seems to be the most effective in targeting the adipose tissue. There may be a class effect, but one drug could have a more prominent effect compared to others.”

It is possible that liraglutide’s metabolic and weight-loss benefits are in some way mediated by its effect on EAT and other visceral fat depots, Dr. Iacobellis observed, although further research will be needed to show that.

“We know that people lose weight on liraglutide, and we know they have an improvement in glucose control. But what we don’t know is whether the metabolic improvement is actually driven by an effect of the medication on the organ-specific fat depot,” he said.

Novo Nordisk and the University of Miami sponsored the study. Neither Dr. Iacobellis nor his coauthors disclosed conflicts of interest.

BOSTON – Liraglutide in combination with metformin reduced epicardial adipose tissue by nearly half within 6 months of treatment in people with type 2 diabetes, an effect independent of either body weight loss or glycemic control, according to a new study.

Epicardial adipose tissue (EAT) is the fat depot around the heart. While EAT has many cardioprotective properties, increased or excess EAT – seen more frequently in people with type 2 diabetes – has been linked to coronary artery disease, metabolic syndrome, diabetes, insulin resistance, and liver disease, according to a review by Gianluca Iacobellis, M.D., Ph.D., professor of clinical medicine in the division of endocrinology, diabetes and metabolism at the University of Miami (Nat. Rev. Endocrinol. 2015;11: 363-71).

More than a decade ago, Dr. Iacobellis proposed and validated ultrasound measurement of EAT thickness as marker of visceral fat and a therapeutic target (J. Clin. Endocrinol. Metab. 2003;88: 5163-8).

At the annual scientific sessions of the American Diabetes Association, Dr. Iacobellis presented preliminary findings from a case-control study in 35 patients with type 2 diabetes with body mass indexes greater than 27 kg/m² and hemoglobin A_1c levels no greater than 8% on metformin monotherapy.

Patients were randomized to remain on metformin or metformin plus the glucagon-like peptide-1 (GLP-1) analogue liraglutide subcutaneously up to 1.8 mg once daily for 6 months. EAT thickness was measured by ultrasound at baseline, 3 months, and 6 months, along with HbA_1c and BMI measures. In the liraglutide group (20 patients), EAT decreased significantly from 10.2 mm to 6.9 mm and 5.8 mm (P < 0.001) after 3 months and 6 months, respectively, for a 42% reduction at 6 months. The metformin-only group (15 patients) saw no reduction in EAT.

The EAT reduction seen in the intervention group was much greater than, and independent of, reductions in body weight or HbA_1c. Average BMI fell from 33 kg/m² at baseline to 31.8 kg/m² and 31.7 kg/m² at 3 months and 6 months, respectively, while HbA_1c declined 18% among patients on liraglutide.

The findings have important clinical and research implications, Dr. Iacobellis said in an interview. “Emerging evidence is pointing out that EAT as measured with reliable, safe, and cheap ultrasound can be a therapeutic target for medications directly or indirectly targeting the adipose tissue,” he said. And EAT can be measured in clinical settings, he added.

Moreover, there is a strong likelihood that further studies will show cardiovascular benefit associated with reductions in EAT, Dr. Iacobellis predicted.

“There is a direct cross-talk between the cardiac fat and the heart,” he said. “If you target the fat, if you’re able to modulate or to reduce the adipose tissue of the heart, you can directly modulate the myocardium and improve cardiovascular performance.”

Dr. Iacobellis’ study on liraglutide is ongoing, and the investigators are examining the effects of other classes of drugs, including the sodium-glucose cotransporter-2 (SLGT-2) inhibitors, on EAT in people with type 2 diabetes. Dr. Iacobellis said he did not know whether to consider the EAT reduction a likely class effect of GLP-1 analogue medications. It is biologically plausible, he added, because human adipose tissues express GLP-1 receptors.

Other studies are showing that exenatide may have some beneficial cardiovascular effect in patients with coronary artery disease, he said. “However, liraglutide seems to be the most effective in targeting the adipose tissue. There may be a class effect, but one drug could have a more prominent effect compared to others.”

It is possible that liraglutide’s metabolic and weight-loss benefits are in some way mediated by its effect on EAT and other visceral fat depots, Dr. Iacobellis observed, although further research will be needed to show that.

“We know that people lose weight on liraglutide, and we know they have an improvement in glucose control. But what we don’t know is whether the metabolic improvement is actually driven by an effect of the medication on the organ-specific fat depot,” he said.

Novo Nordisk and the University of Miami sponsored the study. Neither Dr. Iacobellis nor his coauthors disclosed conflicts of interest.

BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A_1c in a cluster-randomized controlled trial.

Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA_1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA_1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.

Among those with an HbA_1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.

Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA_1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.

The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.

CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.

All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.

The intervention group subjects continued to see significant HbA_1c improvement over 12 months, even after adjusting for differences in baseline HbA_1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA_1c in that group eventually started to increase.

“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.

The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA_1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.

Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.

The current study bolsters those findings.

“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA_1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.

She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.

Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.

Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.

In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.

Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.

Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA_1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA_1c between 7% and 9% experienced significant reductions in HbA_1c at 6 months, and the levels were maintained at 12 months.

Those at highest risk – with pre-education HbA_1c greater than 9% – also experienced significant reductions in HbA_1c at 6 months, with maintenance of the improvements at 12 months.

Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.

“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.

This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.

“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.

Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.

This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”

Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.

“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.

Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.

The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).

A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.

“Yet those referrals are critical,” Dr. Siminerio said in the release.

“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.

The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.

sworcester@frontlinemedcom.com

BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A_1c in a cluster-randomized controlled trial.

Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA_1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA_1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.

Among those with an HbA_1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.

Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA_1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.

The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.

CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.

All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.

The intervention group subjects continued to see significant HbA_1c improvement over 12 months, even after adjusting for differences in baseline HbA_1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA_1c in that group eventually started to increase.

“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.

The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA_1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.

Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.

The current study bolsters those findings.

“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA_1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.

She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.

Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.

Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.

In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.

Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.

Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA_1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA_1c between 7% and 9% experienced significant reductions in HbA_1c at 6 months, and the levels were maintained at 12 months.

Those at highest risk – with pre-education HbA_1c greater than 9% – also experienced significant reductions in HbA_1c at 6 months, with maintenance of the improvements at 12 months.

Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.

“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.

This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.

“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.

Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.

This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”

Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.

“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.

Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.

The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).

A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.

“Yet those referrals are critical,” Dr. Siminerio said in the release.

“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.

The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.

sworcester@frontlinemedcom.com

BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A_1c in a cluster-randomized controlled trial.

Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA_1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA_1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.

Among those with an HbA_1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.

Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA_1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.

The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.

CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.

All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.

The intervention group subjects continued to see significant HbA_1c improvement over 12 months, even after adjusting for differences in baseline HbA_1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA_1c in that group eventually started to increase.

“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.

The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA_1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.

Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.

The current study bolsters those findings.

“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA_1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.

She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.

Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.

Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.

In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.

Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.

Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA_1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA_1c between 7% and 9% experienced significant reductions in HbA_1c at 6 months, and the levels were maintained at 12 months.

Those at highest risk – with pre-education HbA_1c greater than 9% – also experienced significant reductions in HbA_1c at 6 months, with maintenance of the improvements at 12 months.

Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.

“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.

This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.

“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.

Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.

This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”

Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.

“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.

Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.

The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).

A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.

“Yet those referrals are critical,” Dr. Siminerio said in the release.

“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.

The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.

sworcester@frontlinemedcom.com

BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.

For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.

©Jami Garrison/Thinkstock.com

“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.

Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.

For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.

The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.

To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m² reduction in body mass index after a median of 16 sessions in 12 months.

Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.

Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.

Dr. Zhang reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.

For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.

©Jami Garrison/Thinkstock.com

“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.

Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.

For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.

The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.

To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m² reduction in body mass index after a median of 16 sessions in 12 months.

Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.

Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.

Dr. Zhang reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.

For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.

©Jami Garrison/Thinkstock.com

“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.

Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.

For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.

The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.

To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m² reduction in body mass index after a median of 16 sessions in 12 months.

Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.

Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.

Dr. Zhang reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON– Alefacept, an immunosuppressive biologic drug approved to treat psoriasis but later withdrawn by its manufacturer, appears to stem the progression of new-onset type 1 diabetes more than a year after therapy is stopped.

In type 1 diabetes, pancreatic beta cells are destroyed by autoreactive effector T cells, which alefacept targets as one of its mechanisms of action.

“What we think is happening – the most likely conservative hypothesis – is that we’ve rescued beta cells that were traumatized but not killed,” resulting in some restoration of beta-cell function and endogenous insulin secretion, said Dr. Gerald Nepom, director of Benaroya Research Institute at Virginia Mason in Seattle.

At the 75th annual sessions of the American Diabetes association, Dr. Mario Ehlers, another researcher involved with the study, presented 24-month results from T1DAL (Targeting of memory T cells with alefacept in new onset type 1 diabetes).

The study randomized 49 people aged 12-35 years who had been diagnosed with type 1 diabetes within the previous 100 days to treatment with weekly injections of alefacept (n = 33) or placebo (n = 16). Active treatment occurred over two 12-week periods, with the last treatment administered 36 weeks into the study.

In 2013, the T1DAL investigators published their results from 12 months (about 4 months after treatment was stopped). They found that alefacept did not bring about statistically significant differences over placebo in insulin production 2 hours after a meal (measured as mean C-peptide secretion area under curve), but at 4 hours, the differences reached statistical significance (Lancet 2013;1:284-94). In addition, insulin use and hypoglycemic events were found to be significantly reduced in the treatment arm.

New results from 24 months’ follow-up of the T1DAL cohort showed a more impressive effect.

At 15 months after cessation of therapy, the 2-hour postprandial mean C-peptide AUC was significantly greater in the treatment group (P = .002) than the placebo group, as was the 4-hour measure (P = .015). Insulin requirements remained significantly lower (P = .002) and rates of major hypoglycemic events were reduced by about half (P < .001) among subjects who had received alefacept.

Dr. Nepom stressed that while these results were “spectacular” for patients who responded, only about one-third of the treatment arm showed higher C peptide at 24 months than at baseline. “So while there was sustained and significant benefit, it was not in everybody,” he said.

“There’s a responder and a nonresponder situation here, and we’re continuing to evaluate all kinds of biologic biomarkers to try and understand the differences between patients who improved in the second year and those who didn’t.”

Investigators will continue following up the T1DAL patients who responded for as long as patients consent, without further medication, to see how durable the effect is, Dr. Nepom said.

An optimal clinical treatment protocol with alefacept needs to be investigated in a separate trial, he said. Currently, the focus is on adding an immunomodulatory drug after induction treatment with alefacept in the hope that this prolongs the “honeymoon period” seen in the T1DAL responders, and/or extends the benefit to more than just a third of patients.

“Durable clinical responses are likely to require therapies that address more than a single immunological pathway, such as a sequential combination of treatments that first interrupt ongoing disease and secondly restore normal function,” Dr. Nepom said.

Like T1DAL, the new trial will be conducted under the Immune Tolerance Network, a publicly funded research consortium headed by Dr. Nepom that makes all its trial data available to the public. The results from T1DAL will be also published this year in the Journal of Clinical Investigation.

Alefacept (Amevive, Astellas Pharma) was approved by the U.S. Food and Drug Administration in 2003 to treat moderate to severe chronic plaque psoriasis in adults. In 2011, its manufacturer withdrew it from the market, citing business reasons. “We are actively working with interested parties to fix that situation,” Dr. Nepom said.

The Immune Tolerance Network is also investigating whether tocilizumab (Actemra, Genentech), an antibody that targets the interleukin-6 receptor, can slow disease progression and help maintain insulin production in people with new-onset T1D.

The Immune Tolerance Network is funded by the National Institute of Allergy and Infectious Diseases. Dr. Nepom disclosed financial support from Genentech, GlaxoSmithKline, and Pfizer, and research support from Astellas and Bayer. A T1DAL coauthor and former lead investigator, Mark Rigby, recently joined Janssen pharmaceuticals as an employee. Dr. Ehlers disclosed no conflicts of interest.

BOSTON– Alefacept, an immunosuppressive biologic drug approved to treat psoriasis but later withdrawn by its manufacturer, appears to stem the progression of new-onset type 1 diabetes more than a year after therapy is stopped.

In type 1 diabetes, pancreatic beta cells are destroyed by autoreactive effector T cells, which alefacept targets as one of its mechanisms of action.

“What we think is happening – the most likely conservative hypothesis – is that we’ve rescued beta cells that were traumatized but not killed,” resulting in some restoration of beta-cell function and endogenous insulin secretion, said Dr. Gerald Nepom, director of Benaroya Research Institute at Virginia Mason in Seattle.

At the 75th annual sessions of the American Diabetes association, Dr. Mario Ehlers, another researcher involved with the study, presented 24-month results from T1DAL (Targeting of memory T cells with alefacept in new onset type 1 diabetes).

The study randomized 49 people aged 12-35 years who had been diagnosed with type 1 diabetes within the previous 100 days to treatment with weekly injections of alefacept (n = 33) or placebo (n = 16). Active treatment occurred over two 12-week periods, with the last treatment administered 36 weeks into the study.

In 2013, the T1DAL investigators published their results from 12 months (about 4 months after treatment was stopped). They found that alefacept did not bring about statistically significant differences over placebo in insulin production 2 hours after a meal (measured as mean C-peptide secretion area under curve), but at 4 hours, the differences reached statistical significance (Lancet 2013;1:284-94). In addition, insulin use and hypoglycemic events were found to be significantly reduced in the treatment arm.

New results from 24 months’ follow-up of the T1DAL cohort showed a more impressive effect.

At 15 months after cessation of therapy, the 2-hour postprandial mean C-peptide AUC was significantly greater in the treatment group (P = .002) than the placebo group, as was the 4-hour measure (P = .015). Insulin requirements remained significantly lower (P = .002) and rates of major hypoglycemic events were reduced by about half (P < .001) among subjects who had received alefacept.

Dr. Nepom stressed that while these results were “spectacular” for patients who responded, only about one-third of the treatment arm showed higher C peptide at 24 months than at baseline. “So while there was sustained and significant benefit, it was not in everybody,” he said.

“There’s a responder and a nonresponder situation here, and we’re continuing to evaluate all kinds of biologic biomarkers to try and understand the differences between patients who improved in the second year and those who didn’t.”

Investigators will continue following up the T1DAL patients who responded for as long as patients consent, without further medication, to see how durable the effect is, Dr. Nepom said.

An optimal clinical treatment protocol with alefacept needs to be investigated in a separate trial, he said. Currently, the focus is on adding an immunomodulatory drug after induction treatment with alefacept in the hope that this prolongs the “honeymoon period” seen in the T1DAL responders, and/or extends the benefit to more than just a third of patients.

“Durable clinical responses are likely to require therapies that address more than a single immunological pathway, such as a sequential combination of treatments that first interrupt ongoing disease and secondly restore normal function,” Dr. Nepom said.

Like T1DAL, the new trial will be conducted under the Immune Tolerance Network, a publicly funded research consortium headed by Dr. Nepom that makes all its trial data available to the public. The results from T1DAL will be also published this year in the Journal of Clinical Investigation.

Alefacept (Amevive, Astellas Pharma) was approved by the U.S. Food and Drug Administration in 2003 to treat moderate to severe chronic plaque psoriasis in adults. In 2011, its manufacturer withdrew it from the market, citing business reasons. “We are actively working with interested parties to fix that situation,” Dr. Nepom said.

The Immune Tolerance Network is also investigating whether tocilizumab (Actemra, Genentech), an antibody that targets the interleukin-6 receptor, can slow disease progression and help maintain insulin production in people with new-onset T1D.

The Immune Tolerance Network is funded by the National Institute of Allergy and Infectious Diseases. Dr. Nepom disclosed financial support from Genentech, GlaxoSmithKline, and Pfizer, and research support from Astellas and Bayer. A T1DAL coauthor and former lead investigator, Mark Rigby, recently joined Janssen pharmaceuticals as an employee. Dr. Ehlers disclosed no conflicts of interest.

BOSTON– Alefacept, an immunosuppressive biologic drug approved to treat psoriasis but later withdrawn by its manufacturer, appears to stem the progression of new-onset type 1 diabetes more than a year after therapy is stopped.

In type 1 diabetes, pancreatic beta cells are destroyed by autoreactive effector T cells, which alefacept targets as one of its mechanisms of action.

“What we think is happening – the most likely conservative hypothesis – is that we’ve rescued beta cells that were traumatized but not killed,” resulting in some restoration of beta-cell function and endogenous insulin secretion, said Dr. Gerald Nepom, director of Benaroya Research Institute at Virginia Mason in Seattle.

At the 75th annual sessions of the American Diabetes association, Dr. Mario Ehlers, another researcher involved with the study, presented 24-month results from T1DAL (Targeting of memory T cells with alefacept in new onset type 1 diabetes).

The study randomized 49 people aged 12-35 years who had been diagnosed with type 1 diabetes within the previous 100 days to treatment with weekly injections of alefacept (n = 33) or placebo (n = 16). Active treatment occurred over two 12-week periods, with the last treatment administered 36 weeks into the study.

In 2013, the T1DAL investigators published their results from 12 months (about 4 months after treatment was stopped). They found that alefacept did not bring about statistically significant differences over placebo in insulin production 2 hours after a meal (measured as mean C-peptide secretion area under curve), but at 4 hours, the differences reached statistical significance (Lancet 2013;1:284-94). In addition, insulin use and hypoglycemic events were found to be significantly reduced in the treatment arm.

New results from 24 months’ follow-up of the T1DAL cohort showed a more impressive effect.

At 15 months after cessation of therapy, the 2-hour postprandial mean C-peptide AUC was significantly greater in the treatment group (P = .002) than the placebo group, as was the 4-hour measure (P = .015). Insulin requirements remained significantly lower (P = .002) and rates of major hypoglycemic events were reduced by about half (P < .001) among subjects who had received alefacept.

Dr. Nepom stressed that while these results were “spectacular” for patients who responded, only about one-third of the treatment arm showed higher C peptide at 24 months than at baseline. “So while there was sustained and significant benefit, it was not in everybody,” he said.

“There’s a responder and a nonresponder situation here, and we’re continuing to evaluate all kinds of biologic biomarkers to try and understand the differences between patients who improved in the second year and those who didn’t.”

Investigators will continue following up the T1DAL patients who responded for as long as patients consent, without further medication, to see how durable the effect is, Dr. Nepom said.

An optimal clinical treatment protocol with alefacept needs to be investigated in a separate trial, he said. Currently, the focus is on adding an immunomodulatory drug after induction treatment with alefacept in the hope that this prolongs the “honeymoon period” seen in the T1DAL responders, and/or extends the benefit to more than just a third of patients.

“Durable clinical responses are likely to require therapies that address more than a single immunological pathway, such as a sequential combination of treatments that first interrupt ongoing disease and secondly restore normal function,” Dr. Nepom said.

Like T1DAL, the new trial will be conducted under the Immune Tolerance Network, a publicly funded research consortium headed by Dr. Nepom that makes all its trial data available to the public. The results from T1DAL will be also published this year in the Journal of Clinical Investigation.

Alefacept (Amevive, Astellas Pharma) was approved by the U.S. Food and Drug Administration in 2003 to treat moderate to severe chronic plaque psoriasis in adults. In 2011, its manufacturer withdrew it from the market, citing business reasons. “We are actively working with interested parties to fix that situation,” Dr. Nepom said.

The Immune Tolerance Network is also investigating whether tocilizumab (Actemra, Genentech), an antibody that targets the interleukin-6 receptor, can slow disease progression and help maintain insulin production in people with new-onset T1D.

The Immune Tolerance Network is funded by the National Institute of Allergy and Infectious Diseases. Dr. Nepom disclosed financial support from Genentech, GlaxoSmithKline, and Pfizer, and research support from Astellas and Bayer. A T1DAL coauthor and former lead investigator, Mark Rigby, recently joined Janssen pharmaceuticals as an employee. Dr. Ehlers disclosed no conflicts of interest.

BOSTON – Rural African-American women with poorly controlled type 2 diabetes saw significant improvements in glycemic control when their disease-related distress levels dropped.

The findings, from a randomized, controlled trial of 150 women, add to a growing body of evidence that diabetes-related emotional distress – which can include concerns related to disease management, a fear of becoming sicker, and a sense of being isolated or overwhelmed as a result of the disease – bears on clinical outcomes in type 2 diabetes, particularly HbA_1c.

©Tashatuvango/Thinkstockphotos.com

A validated diabetes distress score was introduced a decade ago for use in clinical research (Diabetes Care 2005;28:626-31), and last year investigators in San Francisco showed that people with lower stress related to their diabetic care regimens had significantly lower HbA_1c and better medication adherence (Diabetes Care 2014;37:617-24).

At the annual scientific sessions of the American Diabetes Association, Doyle Cummings, Pharm.D., of East Carolina University in Greenville, N.C., presented data from the EMPOWER study, a prospective, randomized clinical trial among rural African-American women in North Carolina. Dr. Cummings reported a similar association between distress and HbA_1c.

The EMPOWER study randomized 150 mostly low-income African-American women with uncontrolled type 2 diabetes (mean age 55, mean 10.9 years with diabetes, and mean HbA_1c of 9.1) to an in-person or phone-delivered lifestyle intervention delivered by community health workers or mailed written advice. The in-person or phone-delivered intervention involved 16 sessions of training in nutrition, physical activity, and self-monitoring, emphasizing small and incremental changes.

The investigators looked at weight and HbA_1c at 12 months, compared with baseline in both groups, and found modest improvements for both measures in the active intervention group as predicted and significantly greater reductions in the subgroup on oral medications only.

Distress levels at baseline and 12 months were among the study’s secondary outcomes, along with measures of medication adherence, self-efficacy, and self-care behaviors.

Dr. Cummings told the conference that the investigators were surprised to find “no substantial difference in the decline in distress levels between treatment groups. The folks in the intervention and control groups had fairly similar reductions in mean distress scores at 12 months,” he said, with two-thirds of subjects reporting some degree of decline.

The investigators combined data from the two groups to examine distress levels and other outcomes. “And we found that HbA_1c dropped much more substantially in those in whom distress was lowered, compared to those with whom distress was unchanged or increased,” Dr. Cummings said. “Medication adherence, self-care behaviors, and diabetes empowerment and self-efficacy were all substantially improved in the group with lower levels of distress at the end of the trial.”

But even after controlling for these other covariables, distress level remained a significant correlate of change in HbA_1c (P = .04).

“Why does this happen? The truth is, we don’t know,” Dr. Cummings said.

Changes in HbA_1c may be related to factors such as self-care behaviors and adherence, he acknowledged, “but quite frankly there could be other mechanisms less explored that may help to explain this relationship. So clearly we need additional research. What this does show is that lowering distress seems to be a valuable strategy in folks like this with elevated HbA_1c levels.”

Dr. Cummings spoke about some of the daily challenges facing the women in the study. “We’re surprised at the number of these women caring for children, grandchildren, and other members of their families, often while working, and yet not finding time to care for themselves. It is clearly an important cultural phenomenon that we need to understand better.”

Also at the conference, Dr. Cummings and colleagues presented a separate, striking set of findings on distress and cardiovascular outcomes using data from a different source: the national Reasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study.

Dr. Cummings and colleagues compared the relationship between baseline depressive symptoms and/or distress and incident stroke, acute coronary heart disease (CHD), and CV death in more than 4,000 black and white adults 45 and older with diabetes, and nearly 18,000 subjects without diabetes, followed up for more than 5 years.

Subjects with diabetes were more likely to have either depressive symptoms or distress (26.7% vs. 23.2%, P < .001) or both (10.1% vs. 6.2%, P < .001), compared with those without diabetes.

In models adjusted for sociodemographics, medical conditions, health behaviors, and physiologic measures, either distress or depressive symptoms at baseline was associated with increased risk for stroke (adjusted hazard ratio 1.54; 95% confidence interval, 1.04-2.27) and cardiovascular (CV) death (aHR, 1.61; 95% CI, 1.14-2.29) among subjects with diabetes. None of these associations were significant for people without diabetes.

The presence of both depressive symptoms and distress at baseline was associated with an increased risk for acute CHD (aHR 1.58; 95% CI, 1-2.50) and CV death (aHR 2.27; 95% CI, 1.40-3.67) but not stroke (aHR 1.54; 95% CI, 0.84-2.82) in people with diabetes. However, this relationship was not observed in those without diabetes.

“Folks who reported diabetes plus stress and depressive symptoms had more than a twofold increase in CV death relative to those with diabetes with no behavioral comorbidity, even after adjusting for a wide range of demographic and CV risk factors,” Dr. Cummings told the conference.

“Comorbidity in patients with diabetes remains a challenging problem that is associated with increased risks,” he added.

The EMPOWER study was funded by the Bristol Myers Squibb Foundation. The REGARDS study was funded by the National Institutes of Health.

Dr. Cummings declared an advisory relationship with Sanofi-Aventis not bearing on either set of findings.

BOSTON – Rural African-American women with poorly controlled type 2 diabetes saw significant improvements in glycemic control when their disease-related distress levels dropped.

The findings, from a randomized, controlled trial of 150 women, add to a growing body of evidence that diabetes-related emotional distress – which can include concerns related to disease management, a fear of becoming sicker, and a sense of being isolated or overwhelmed as a result of the disease – bears on clinical outcomes in type 2 diabetes, particularly HbA_1c.

©Tashatuvango/Thinkstockphotos.com

A validated diabetes distress score was introduced a decade ago for use in clinical research (Diabetes Care 2005;28:626-31), and last year investigators in San Francisco showed that people with lower stress related to their diabetic care regimens had significantly lower HbA_1c and better medication adherence (Diabetes Care 2014;37:617-24).

At the annual scientific sessions of the American Diabetes Association, Doyle Cummings, Pharm.D., of East Carolina University in Greenville, N.C., presented data from the EMPOWER study, a prospective, randomized clinical trial among rural African-American women in North Carolina. Dr. Cummings reported a similar association between distress and HbA_1c.

The EMPOWER study randomized 150 mostly low-income African-American women with uncontrolled type 2 diabetes (mean age 55, mean 10.9 years with diabetes, and mean HbA_1c of 9.1) to an in-person or phone-delivered lifestyle intervention delivered by community health workers or mailed written advice. The in-person or phone-delivered intervention involved 16 sessions of training in nutrition, physical activity, and self-monitoring, emphasizing small and incremental changes.

The investigators looked at weight and HbA_1c at 12 months, compared with baseline in both groups, and found modest improvements for both measures in the active intervention group as predicted and significantly greater reductions in the subgroup on oral medications only.

Distress levels at baseline and 12 months were among the study’s secondary outcomes, along with measures of medication adherence, self-efficacy, and self-care behaviors.

Dr. Cummings told the conference that the investigators were surprised to find “no substantial difference in the decline in distress levels between treatment groups. The folks in the intervention and control groups had fairly similar reductions in mean distress scores at 12 months,” he said, with two-thirds of subjects reporting some degree of decline.

The investigators combined data from the two groups to examine distress levels and other outcomes. “And we found that HbA_1c dropped much more substantially in those in whom distress was lowered, compared to those with whom distress was unchanged or increased,” Dr. Cummings said. “Medication adherence, self-care behaviors, and diabetes empowerment and self-efficacy were all substantially improved in the group with lower levels of distress at the end of the trial.”

But even after controlling for these other covariables, distress level remained a significant correlate of change in HbA_1c (P = .04).

“Why does this happen? The truth is, we don’t know,” Dr. Cummings said.

Changes in HbA_1c may be related to factors such as self-care behaviors and adherence, he acknowledged, “but quite frankly there could be other mechanisms less explored that may help to explain this relationship. So clearly we need additional research. What this does show is that lowering distress seems to be a valuable strategy in folks like this with elevated HbA_1c levels.”

Dr. Cummings spoke about some of the daily challenges facing the women in the study. “We’re surprised at the number of these women caring for children, grandchildren, and other members of their families, often while working, and yet not finding time to care for themselves. It is clearly an important cultural phenomenon that we need to understand better.”

Also at the conference, Dr. Cummings and colleagues presented a separate, striking set of findings on distress and cardiovascular outcomes using data from a different source: the national Reasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study.

Dr. Cummings and colleagues compared the relationship between baseline depressive symptoms and/or distress and incident stroke, acute coronary heart disease (CHD), and CV death in more than 4,000 black and white adults 45 and older with diabetes, and nearly 18,000 subjects without diabetes, followed up for more than 5 years.

Subjects with diabetes were more likely to have either depressive symptoms or distress (26.7% vs. 23.2%, P < .001) or both (10.1% vs. 6.2%, P < .001), compared with those without diabetes.

In models adjusted for sociodemographics, medical conditions, health behaviors, and physiologic measures, either distress or depressive symptoms at baseline was associated with increased risk for stroke (adjusted hazard ratio 1.54; 95% confidence interval, 1.04-2.27) and cardiovascular (CV) death (aHR, 1.61; 95% CI, 1.14-2.29) among subjects with diabetes. None of these associations were significant for people without diabetes.

The presence of both depressive symptoms and distress at baseline was associated with an increased risk for acute CHD (aHR 1.58; 95% CI, 1-2.50) and CV death (aHR 2.27; 95% CI, 1.40-3.67) but not stroke (aHR 1.54; 95% CI, 0.84-2.82) in people with diabetes. However, this relationship was not observed in those without diabetes.

“Folks who reported diabetes plus stress and depressive symptoms had more than a twofold increase in CV death relative to those with diabetes with no behavioral comorbidity, even after adjusting for a wide range of demographic and CV risk factors,” Dr. Cummings told the conference.

“Comorbidity in patients with diabetes remains a challenging problem that is associated with increased risks,” he added.

The EMPOWER study was funded by the Bristol Myers Squibb Foundation. The REGARDS study was funded by the National Institutes of Health.

Dr. Cummings declared an advisory relationship with Sanofi-Aventis not bearing on either set of findings.

BOSTON – Rural African-American women with poorly controlled type 2 diabetes saw significant improvements in glycemic control when their disease-related distress levels dropped.

The findings, from a randomized, controlled trial of 150 women, add to a growing body of evidence that diabetes-related emotional distress – which can include concerns related to disease management, a fear of becoming sicker, and a sense of being isolated or overwhelmed as a result of the disease – bears on clinical outcomes in type 2 diabetes, particularly HbA_1c.

©Tashatuvango/Thinkstockphotos.com

A validated diabetes distress score was introduced a decade ago for use in clinical research (Diabetes Care 2005;28:626-31), and last year investigators in San Francisco showed that people with lower stress related to their diabetic care regimens had significantly lower HbA_1c and better medication adherence (Diabetes Care 2014;37:617-24).

At the annual scientific sessions of the American Diabetes Association, Doyle Cummings, Pharm.D., of East Carolina University in Greenville, N.C., presented data from the EMPOWER study, a prospective, randomized clinical trial among rural African-American women in North Carolina. Dr. Cummings reported a similar association between distress and HbA_1c.

The EMPOWER study randomized 150 mostly low-income African-American women with uncontrolled type 2 diabetes (mean age 55, mean 10.9 years with diabetes, and mean HbA_1c of 9.1) to an in-person or phone-delivered lifestyle intervention delivered by community health workers or mailed written advice. The in-person or phone-delivered intervention involved 16 sessions of training in nutrition, physical activity, and self-monitoring, emphasizing small and incremental changes.

The investigators looked at weight and HbA_1c at 12 months, compared with baseline in both groups, and found modest improvements for both measures in the active intervention group as predicted and significantly greater reductions in the subgroup on oral medications only.

Distress levels at baseline and 12 months were among the study’s secondary outcomes, along with measures of medication adherence, self-efficacy, and self-care behaviors.

Dr. Cummings told the conference that the investigators were surprised to find “no substantial difference in the decline in distress levels between treatment groups. The folks in the intervention and control groups had fairly similar reductions in mean distress scores at 12 months,” he said, with two-thirds of subjects reporting some degree of decline.

The investigators combined data from the two groups to examine distress levels and other outcomes. “And we found that HbA_1c dropped much more substantially in those in whom distress was lowered, compared to those with whom distress was unchanged or increased,” Dr. Cummings said. “Medication adherence, self-care behaviors, and diabetes empowerment and self-efficacy were all substantially improved in the group with lower levels of distress at the end of the trial.”

But even after controlling for these other covariables, distress level remained a significant correlate of change in HbA_1c (P = .04).

“Why does this happen? The truth is, we don’t know,” Dr. Cummings said.

Changes in HbA_1c may be related to factors such as self-care behaviors and adherence, he acknowledged, “but quite frankly there could be other mechanisms less explored that may help to explain this relationship. So clearly we need additional research. What this does show is that lowering distress seems to be a valuable strategy in folks like this with elevated HbA_1c levels.”

Dr. Cummings spoke about some of the daily challenges facing the women in the study. “We’re surprised at the number of these women caring for children, grandchildren, and other members of their families, often while working, and yet not finding time to care for themselves. It is clearly an important cultural phenomenon that we need to understand better.”

Also at the conference, Dr. Cummings and colleagues presented a separate, striking set of findings on distress and cardiovascular outcomes using data from a different source: the national Reasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study.

Dr. Cummings and colleagues compared the relationship between baseline depressive symptoms and/or distress and incident stroke, acute coronary heart disease (CHD), and CV death in more than 4,000 black and white adults 45 and older with diabetes, and nearly 18,000 subjects without diabetes, followed up for more than 5 years.

Subjects with diabetes were more likely to have either depressive symptoms or distress (26.7% vs. 23.2%, P < .001) or both (10.1% vs. 6.2%, P < .001), compared with those without diabetes.

In models adjusted for sociodemographics, medical conditions, health behaviors, and physiologic measures, either distress or depressive symptoms at baseline was associated with increased risk for stroke (adjusted hazard ratio 1.54; 95% confidence interval, 1.04-2.27) and cardiovascular (CV) death (aHR, 1.61; 95% CI, 1.14-2.29) among subjects with diabetes. None of these associations were significant for people without diabetes.

The presence of both depressive symptoms and distress at baseline was associated with an increased risk for acute CHD (aHR 1.58; 95% CI, 1-2.50) and CV death (aHR 2.27; 95% CI, 1.40-3.67) but not stroke (aHR 1.54; 95% CI, 0.84-2.82) in people with diabetes. However, this relationship was not observed in those without diabetes.

“Folks who reported diabetes plus stress and depressive symptoms had more than a twofold increase in CV death relative to those with diabetes with no behavioral comorbidity, even after adjusting for a wide range of demographic and CV risk factors,” Dr. Cummings told the conference.

“Comorbidity in patients with diabetes remains a challenging problem that is associated with increased risks,” he added.

The EMPOWER study was funded by the Bristol Myers Squibb Foundation. The REGARDS study was funded by the National Institutes of Health.

Dr. Cummings declared an advisory relationship with Sanofi-Aventis not bearing on either set of findings.

BOSTON – Diabetes leads to a loss of 2.3-6.8 life-years and costs between $14,768 and $159,081 over a lifetime, depending on age, sex, race, and body mass index, according to National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS) data.

The average number of life-years lost was greater for women than for men, and was greater for blacks than for whites (average of 5.2 for black women vs. 5.0 years for white women, and 4.8 for black men vs. 4.6 for white men). Life-years lost increased with BMI category for most of the age-sex-race combinations evaluated, Man Yee (Mallory) Leung, Ph.D., reported at the annual scientific sessions of the American Diabetes Association. The lifetime costs were higher for men than for women ($93,957 vs. $81,521), and an inverted U-shape was noted across BMI categories for most of the age/sex/race groups, with peaks at the Class II obesity category, said Dr. Leung of Washington University, St. Louis.

Dr. Leung and her colleagues used data from the 2009-2012 NHIS (the most recently available data), and linked to the Medical Expenditure Panel Survey for their analysis. The NHIS Linked Mortality Public-Use Files were used to predict mortality risk.

The sample was divided into groups with different combinations of race, sex, age, and BMI categories, and life expectancies and lifetime health care expenditures for diabetic patients and nondiabetic patients were simulated, she explained, noting that all estimates were adjusted for complex sampling design in the NHIS and MEPS.

The findings underscore the huge economic burden of diabetes on society, and further define the associated life years lost as a result of the disease, she said.

This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as by grants to one of the authors from the Foundation for Barnes-Jewish Hospital and the Breast Cancer Research Foundation. Dr. Leung reported having no conflicts of interest.

sworcester@frontlinemedcom.com

BOSTON – Diabetes leads to a loss of 2.3-6.8 life-years and costs between $14,768 and $159,081 over a lifetime, depending on age, sex, race, and body mass index, according to National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS) data.

The average number of life-years lost was greater for women than for men, and was greater for blacks than for whites (average of 5.2 for black women vs. 5.0 years for white women, and 4.8 for black men vs. 4.6 for white men). Life-years lost increased with BMI category for most of the age-sex-race combinations evaluated, Man Yee (Mallory) Leung, Ph.D., reported at the annual scientific sessions of the American Diabetes Association. The lifetime costs were higher for men than for women ($93,957 vs. $81,521), and an inverted U-shape was noted across BMI categories for most of the age/sex/race groups, with peaks at the Class II obesity category, said Dr. Leung of Washington University, St. Louis.

Dr. Leung and her colleagues used data from the 2009-2012 NHIS (the most recently available data), and linked to the Medical Expenditure Panel Survey for their analysis. The NHIS Linked Mortality Public-Use Files were used to predict mortality risk.

The sample was divided into groups with different combinations of race, sex, age, and BMI categories, and life expectancies and lifetime health care expenditures for diabetic patients and nondiabetic patients were simulated, she explained, noting that all estimates were adjusted for complex sampling design in the NHIS and MEPS.

The findings underscore the huge economic burden of diabetes on society, and further define the associated life years lost as a result of the disease, she said.

This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as by grants to one of the authors from the Foundation for Barnes-Jewish Hospital and the Breast Cancer Research Foundation. Dr. Leung reported having no conflicts of interest.

sworcester@frontlinemedcom.com

BOSTON – Diabetes leads to a loss of 2.3-6.8 life-years and costs between $14,768 and $159,081 over a lifetime, depending on age, sex, race, and body mass index, according to National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS) data.

The average number of life-years lost was greater for women than for men, and was greater for blacks than for whites (average of 5.2 for black women vs. 5.0 years for white women, and 4.8 for black men vs. 4.6 for white men). Life-years lost increased with BMI category for most of the age-sex-race combinations evaluated, Man Yee (Mallory) Leung, Ph.D., reported at the annual scientific sessions of the American Diabetes Association. The lifetime costs were higher for men than for women ($93,957 vs. $81,521), and an inverted U-shape was noted across BMI categories for most of the age/sex/race groups, with peaks at the Class II obesity category, said Dr. Leung of Washington University, St. Louis.

Dr. Leung and her colleagues used data from the 2009-2012 NHIS (the most recently available data), and linked to the Medical Expenditure Panel Survey for their analysis. The NHIS Linked Mortality Public-Use Files were used to predict mortality risk.

The sample was divided into groups with different combinations of race, sex, age, and BMI categories, and life expectancies and lifetime health care expenditures for diabetic patients and nondiabetic patients were simulated, she explained, noting that all estimates were adjusted for complex sampling design in the NHIS and MEPS.

The findings underscore the huge economic burden of diabetes on society, and further define the associated life years lost as a result of the disease, she said.

This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as by grants to one of the authors from the Foundation for Barnes-Jewish Hospital and the Breast Cancer Research Foundation. Dr. Leung reported having no conflicts of interest.

sworcester@frontlinemedcom.com

BOSTON – Women at risk for gestational diabetes held off excess weight gain better when coached on healthy eating alone compared with those coached about physical activity, or on diet and exercise together.

The findings, presented at the annual scientific sessions of the American Diabetes Association, come from a pilot study in 150 obese pregnant women recruited from nine European countries randomized to one of the three lifestyle interventions.

The pilot study is the precursor to a larger ongoing randomized trial called DALI (Vitamin D & Lifestyle Intervention for Gestational Diabetes Mellitus Prevention). Dr. David Simmons of the University of Western Sydney, Australia, who presented the pilot study’s findings at the meeting, said he and his coinvestigators found it puzzling that a combined diet-and-exercise intervention would be less effective than a diet-alone intervention.

The women, all recruited at or before week 19 of their pregnancies (most entered around week 14), were well matched across the study arms for body mass index (mean 34.1-34.8) and fasting glucose and insulin sensitivity measurements at baseline. A glucose tolerance test was used to exclude women with GDM at baseline, though some of the women in the cohort had previous GDM. Also excluded were women unable to comply with the recommendations because of physical or psychiatric disability.

The researchers created five sets of recommendations for physical activity (for example: sitting less, building strength, taking more steps) and another seven for eating (including increasing intake of protein, vegetables, and fiber, and reducing intake of carbohydrates and fat) that were emphasized and detailed by lifestyle coaches during the intervention. The intervention was delivered over five in-person, one-on-one coaching sessions 30-45 minutes long, with follow-up phone calls in between. The sessions lasted through week 30.

Women in the combined group received all 12 of the diet and exercise messages. The problem may have been an overload of guidance in that arm of the study, Dr. Simmons said.

“We thought it was a no-brainer that the more you put in, the more you’d get out,” he said. But possibly, “having 12 messages kind of swamped people, and it was just too much for them to focus on.”

Women randomized to physical activity counseling alone (n = 50) saw 2.6 kilograms more weight gain at 24-28 weeks of pregnancy than did women randomized to nutrition counseling alone (n = 50), Dr. Simmons reported. The difference narrowed to 1.6 kilos by 35-37 weeks but remained significant.

Fasting glucose measurements were significantly higher in the exercise group at 35-37 weeks compared with the nutrition group. The combined intervention was not significantly better than was exercise alone for either the fasting glucose or weight measures. Though the study was not powered to detect significant differences in GDM risk, women in the physical activity group saw a higher incidence of GDM, 42%, compared to 31% for the combined intervention and 28% for the diet-only group.

The findings suggest “that healthy eating was the more efficacious strategy in dealing with excess weight gain,” which is a risk factor for GDM, said Dr. Simmons. “What we see now certainly justifies the use of early healthy eating interventions in obese pregnant women.”

He added that the larger trial, which will randomize 440 women with the same characteristics to one of the three lifestyle interventions or no intervention, will seek to confirm the findings and will be powered to pick up significant differences in GDM risk.

A separate trial under DALI, recruiting another 440 obese pregnant women, will look at vitamin D supplementation alone and alongside lifestyle inventions, and placebo.

The DALI studies are funded by the European Commission. Dr. Simmons declared no conflict of interest.

BOSTON – Women at risk for gestational diabetes held off excess weight gain better when coached on healthy eating alone compared with those coached about physical activity, or on diet and exercise together.

The findings, presented at the annual scientific sessions of the American Diabetes Association, come from a pilot study in 150 obese pregnant women recruited from nine European countries randomized to one of the three lifestyle interventions.

The pilot study is the precursor to a larger ongoing randomized trial called DALI (Vitamin D & Lifestyle Intervention for Gestational Diabetes Mellitus Prevention). Dr. David Simmons of the University of Western Sydney, Australia, who presented the pilot study’s findings at the meeting, said he and his coinvestigators found it puzzling that a combined diet-and-exercise intervention would be less effective than a diet-alone intervention.

The women, all recruited at or before week 19 of their pregnancies (most entered around week 14), were well matched across the study arms for body mass index (mean 34.1-34.8) and fasting glucose and insulin sensitivity measurements at baseline. A glucose tolerance test was used to exclude women with GDM at baseline, though some of the women in the cohort had previous GDM. Also excluded were women unable to comply with the recommendations because of physical or psychiatric disability.

The researchers created five sets of recommendations for physical activity (for example: sitting less, building strength, taking more steps) and another seven for eating (including increasing intake of protein, vegetables, and fiber, and reducing intake of carbohydrates and fat) that were emphasized and detailed by lifestyle coaches during the intervention. The intervention was delivered over five in-person, one-on-one coaching sessions 30-45 minutes long, with follow-up phone calls in between. The sessions lasted through week 30.

Women in the combined group received all 12 of the diet and exercise messages. The problem may have been an overload of guidance in that arm of the study, Dr. Simmons said.

“We thought it was a no-brainer that the more you put in, the more you’d get out,” he said. But possibly, “having 12 messages kind of swamped people, and it was just too much for them to focus on.”

Women randomized to physical activity counseling alone (n = 50) saw 2.6 kilograms more weight gain at 24-28 weeks of pregnancy than did women randomized to nutrition counseling alone (n = 50), Dr. Simmons reported. The difference narrowed to 1.6 kilos by 35-37 weeks but remained significant.

Fasting glucose measurements were significantly higher in the exercise group at 35-37 weeks compared with the nutrition group. The combined intervention was not significantly better than was exercise alone for either the fasting glucose or weight measures. Though the study was not powered to detect significant differences in GDM risk, women in the physical activity group saw a higher incidence of GDM, 42%, compared to 31% for the combined intervention and 28% for the diet-only group.

The findings suggest “that healthy eating was the more efficacious strategy in dealing with excess weight gain,” which is a risk factor for GDM, said Dr. Simmons. “What we see now certainly justifies the use of early healthy eating interventions in obese pregnant women.”

He added that the larger trial, which will randomize 440 women with the same characteristics to one of the three lifestyle interventions or no intervention, will seek to confirm the findings and will be powered to pick up significant differences in GDM risk.

A separate trial under DALI, recruiting another 440 obese pregnant women, will look at vitamin D supplementation alone and alongside lifestyle inventions, and placebo.

The DALI studies are funded by the European Commission. Dr. Simmons declared no conflict of interest.

BOSTON – Women at risk for gestational diabetes held off excess weight gain better when coached on healthy eating alone compared with those coached about physical activity, or on diet and exercise together.

The findings, presented at the annual scientific sessions of the American Diabetes Association, come from a pilot study in 150 obese pregnant women recruited from nine European countries randomized to one of the three lifestyle interventions.

The pilot study is the precursor to a larger ongoing randomized trial called DALI (Vitamin D & Lifestyle Intervention for Gestational Diabetes Mellitus Prevention). Dr. David Simmons of the University of Western Sydney, Australia, who presented the pilot study’s findings at the meeting, said he and his coinvestigators found it puzzling that a combined diet-and-exercise intervention would be less effective than a diet-alone intervention.

The women, all recruited at or before week 19 of their pregnancies (most entered around week 14), were well matched across the study arms for body mass index (mean 34.1-34.8) and fasting glucose and insulin sensitivity measurements at baseline. A glucose tolerance test was used to exclude women with GDM at baseline, though some of the women in the cohort had previous GDM. Also excluded were women unable to comply with the recommendations because of physical or psychiatric disability.

The researchers created five sets of recommendations for physical activity (for example: sitting less, building strength, taking more steps) and another seven for eating (including increasing intake of protein, vegetables, and fiber, and reducing intake of carbohydrates and fat) that were emphasized and detailed by lifestyle coaches during the intervention. The intervention was delivered over five in-person, one-on-one coaching sessions 30-45 minutes long, with follow-up phone calls in between. The sessions lasted through week 30.

Women in the combined group received all 12 of the diet and exercise messages. The problem may have been an overload of guidance in that arm of the study, Dr. Simmons said.

“We thought it was a no-brainer that the more you put in, the more you’d get out,” he said. But possibly, “having 12 messages kind of swamped people, and it was just too much for them to focus on.”

Women randomized to physical activity counseling alone (n = 50) saw 2.6 kilograms more weight gain at 24-28 weeks of pregnancy than did women randomized to nutrition counseling alone (n = 50), Dr. Simmons reported. The difference narrowed to 1.6 kilos by 35-37 weeks but remained significant.

Fasting glucose measurements were significantly higher in the exercise group at 35-37 weeks compared with the nutrition group. The combined intervention was not significantly better than was exercise alone for either the fasting glucose or weight measures. Though the study was not powered to detect significant differences in GDM risk, women in the physical activity group saw a higher incidence of GDM, 42%, compared to 31% for the combined intervention and 28% for the diet-only group.

The findings suggest “that healthy eating was the more efficacious strategy in dealing with excess weight gain,” which is a risk factor for GDM, said Dr. Simmons. “What we see now certainly justifies the use of early healthy eating interventions in obese pregnant women.”

He added that the larger trial, which will randomize 440 women with the same characteristics to one of the three lifestyle interventions or no intervention, will seek to confirm the findings and will be powered to pick up significant differences in GDM risk.

A separate trial under DALI, recruiting another 440 obese pregnant women, will look at vitamin D supplementation alone and alongside lifestyle inventions, and placebo.

The DALI studies are funded by the European Commission. Dr. Simmons declared no conflict of interest.