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American Diabetes Association (ADA): Annual Scientific Sessions
Counting carbs comes up short in type 1 diabetes
CHICAGO – Despite being a cornerstone of contemporary diabetes management, carbohydrate counting had no significant effect on glycemic control in type 1 diabetes in a meta-analysis and systematic review involving 667 adults and children.
Pooled results from six randomized controlled trials showed an overall change in hemoglobin A1c levels of just –0.3% points with a variety of carbohydrate counting methods, compared with other dietary interventions (P = .185), Ms. Kirstine Bell reported at the annual scientific sessions of the American Diabetes Association.
Overall, four of the six studies favored carbohydrate counting and all six showed a trend toward decreased risk of hypoglycemia, suggesting a stabilization of blood glucose levels.
Four of the six studies that measured quality of life showed an improvement, but only one reached statistical significance. In addition, there were no changes in insulin dose, weight, or fasting plasma glucose level with the strategy.
"We need additional evidence to support our clinical practice, particularly in children and adolescents" where carbohydrate counting is widely used, said Ms. Bell, a dietician, diabetes educator, and Ph.D. candidate at the University of Sydney, Australia.
She suggested that clinicians and patients need realistic expectations of the improvements in glycemic control achievable with carbohydrate counting. Evidence continues to grow – including a study presented during the same session – on the effect fat and protein can have on prandial insulin requirements. A prescribed meal plan also has been shown to lower HbA1c irrespective of whether it includes carbohydrate counting.
The increase in popularity of flexible insulin therapy and more flexible eating choices means there’s a risk that carbohydrate counting may lead to unhealthy eating and food beliefs, Ms. Bell said. Patients may exceed nutritional recommendations for fats and proteins in an effort to avoid carbohydrates or rely too heavily on packaged foods because the labels make carbohydrate counting easier.
Ultimately, the efficacy of carbohydrate counting is limited by the skills of the patient, she observed. Greater accuracy and precision in carbohydrate counting is associated with lower HbA1c, however, the literature shows a wide variation in counting skills. Skills and compliance were not measured in the studies, and subgroup analyses of different methods of carbohydrate counting were not possible due to the lack of studies, she said.
Session moderator Dr. Anastassios Pittas, codirector of the Diabetes Center at Tufts Medical Center in Boston, applauded the investigators for looking at the evidence behind something clinicians routinely use and take for granted, but joined an audience member in pointing out that there was a lot of heterogeneity in the results, which can influence the strength of the conclusion.
"We have to somehow change the amount of insulin we deliver each meal every day, depending on the circumstances, and I think carb counting is a method that makes the most sense," he said in an interview. "To change my practice I will need to see evidence against the practice, not evidence in favor of what I’m already doing, and the evidence has to be pretty clear."
Data were presented during the same session on one such potential new tool, called the food insulin index. Ironically, it was this research that Ms. Bell also authored that prompted her to conduct the meta-analysis in the first place, she said in an interview. If carb counting was to serve as the control, it was necessary to know how effective it truly was.
What she found after screening 294 potentially relevant studies, was only six quality randomized controlled trials of at least 3 months’ duration. Study quality averaged 7.7 on a 13-point scale, with 13 indicating the least risk of bias.
Five trials were in adults (n = 563) and one in children, aged 8-13 years (n = 104), and all were in the outpatient clinical setting. Controls received usual care, general dietary advice or low glycemic index dietary advice, while a variety of carbohydrate counting methods was used including 10- and 15-gram carbohydrate exchanges.
The results of the meta-analysis chip away at a cornerstone of current practice and are likely to spark debate, particularly when presented by a lowly Ph.D. candidate, albeit in two sessions at the meeting including the presidential oral session.
"I expected people to be quite defensive of their current practice, but at the same time, it highlights the need for more evidence" and "the need to be more aware of the limitation in practice," she told this news agency. "It’s been common to say patients aren’t compliant, or aren’t doing it accurately, or they need to work on their skills, but not necessarily to acknowledge that there may be other factors in play here that aren’t related to their actual ability to count carbohydrates, but to the method itself."
Ms. Bell reported no relevant disclosures.
CHICAGO – Despite being a cornerstone of contemporary diabetes management, carbohydrate counting had no significant effect on glycemic control in type 1 diabetes in a meta-analysis and systematic review involving 667 adults and children.
Pooled results from six randomized controlled trials showed an overall change in hemoglobin A1c levels of just –0.3% points with a variety of carbohydrate counting methods, compared with other dietary interventions (P = .185), Ms. Kirstine Bell reported at the annual scientific sessions of the American Diabetes Association.
Overall, four of the six studies favored carbohydrate counting and all six showed a trend toward decreased risk of hypoglycemia, suggesting a stabilization of blood glucose levels.
Four of the six studies that measured quality of life showed an improvement, but only one reached statistical significance. In addition, there were no changes in insulin dose, weight, or fasting plasma glucose level with the strategy.
"We need additional evidence to support our clinical practice, particularly in children and adolescents" where carbohydrate counting is widely used, said Ms. Bell, a dietician, diabetes educator, and Ph.D. candidate at the University of Sydney, Australia.
She suggested that clinicians and patients need realistic expectations of the improvements in glycemic control achievable with carbohydrate counting. Evidence continues to grow – including a study presented during the same session – on the effect fat and protein can have on prandial insulin requirements. A prescribed meal plan also has been shown to lower HbA1c irrespective of whether it includes carbohydrate counting.
The increase in popularity of flexible insulin therapy and more flexible eating choices means there’s a risk that carbohydrate counting may lead to unhealthy eating and food beliefs, Ms. Bell said. Patients may exceed nutritional recommendations for fats and proteins in an effort to avoid carbohydrates or rely too heavily on packaged foods because the labels make carbohydrate counting easier.
Ultimately, the efficacy of carbohydrate counting is limited by the skills of the patient, she observed. Greater accuracy and precision in carbohydrate counting is associated with lower HbA1c, however, the literature shows a wide variation in counting skills. Skills and compliance were not measured in the studies, and subgroup analyses of different methods of carbohydrate counting were not possible due to the lack of studies, she said.
Session moderator Dr. Anastassios Pittas, codirector of the Diabetes Center at Tufts Medical Center in Boston, applauded the investigators for looking at the evidence behind something clinicians routinely use and take for granted, but joined an audience member in pointing out that there was a lot of heterogeneity in the results, which can influence the strength of the conclusion.
"We have to somehow change the amount of insulin we deliver each meal every day, depending on the circumstances, and I think carb counting is a method that makes the most sense," he said in an interview. "To change my practice I will need to see evidence against the practice, not evidence in favor of what I’m already doing, and the evidence has to be pretty clear."
Data were presented during the same session on one such potential new tool, called the food insulin index. Ironically, it was this research that Ms. Bell also authored that prompted her to conduct the meta-analysis in the first place, she said in an interview. If carb counting was to serve as the control, it was necessary to know how effective it truly was.
What she found after screening 294 potentially relevant studies, was only six quality randomized controlled trials of at least 3 months’ duration. Study quality averaged 7.7 on a 13-point scale, with 13 indicating the least risk of bias.
Five trials were in adults (n = 563) and one in children, aged 8-13 years (n = 104), and all were in the outpatient clinical setting. Controls received usual care, general dietary advice or low glycemic index dietary advice, while a variety of carbohydrate counting methods was used including 10- and 15-gram carbohydrate exchanges.
The results of the meta-analysis chip away at a cornerstone of current practice and are likely to spark debate, particularly when presented by a lowly Ph.D. candidate, albeit in two sessions at the meeting including the presidential oral session.
"I expected people to be quite defensive of their current practice, but at the same time, it highlights the need for more evidence" and "the need to be more aware of the limitation in practice," she told this news agency. "It’s been common to say patients aren’t compliant, or aren’t doing it accurately, or they need to work on their skills, but not necessarily to acknowledge that there may be other factors in play here that aren’t related to their actual ability to count carbohydrates, but to the method itself."
Ms. Bell reported no relevant disclosures.
CHICAGO – Despite being a cornerstone of contemporary diabetes management, carbohydrate counting had no significant effect on glycemic control in type 1 diabetes in a meta-analysis and systematic review involving 667 adults and children.
Pooled results from six randomized controlled trials showed an overall change in hemoglobin A1c levels of just –0.3% points with a variety of carbohydrate counting methods, compared with other dietary interventions (P = .185), Ms. Kirstine Bell reported at the annual scientific sessions of the American Diabetes Association.
Overall, four of the six studies favored carbohydrate counting and all six showed a trend toward decreased risk of hypoglycemia, suggesting a stabilization of blood glucose levels.
Four of the six studies that measured quality of life showed an improvement, but only one reached statistical significance. In addition, there were no changes in insulin dose, weight, or fasting plasma glucose level with the strategy.
"We need additional evidence to support our clinical practice, particularly in children and adolescents" where carbohydrate counting is widely used, said Ms. Bell, a dietician, diabetes educator, and Ph.D. candidate at the University of Sydney, Australia.
She suggested that clinicians and patients need realistic expectations of the improvements in glycemic control achievable with carbohydrate counting. Evidence continues to grow – including a study presented during the same session – on the effect fat and protein can have on prandial insulin requirements. A prescribed meal plan also has been shown to lower HbA1c irrespective of whether it includes carbohydrate counting.
The increase in popularity of flexible insulin therapy and more flexible eating choices means there’s a risk that carbohydrate counting may lead to unhealthy eating and food beliefs, Ms. Bell said. Patients may exceed nutritional recommendations for fats and proteins in an effort to avoid carbohydrates or rely too heavily on packaged foods because the labels make carbohydrate counting easier.
Ultimately, the efficacy of carbohydrate counting is limited by the skills of the patient, she observed. Greater accuracy and precision in carbohydrate counting is associated with lower HbA1c, however, the literature shows a wide variation in counting skills. Skills and compliance were not measured in the studies, and subgroup analyses of different methods of carbohydrate counting were not possible due to the lack of studies, she said.
Session moderator Dr. Anastassios Pittas, codirector of the Diabetes Center at Tufts Medical Center in Boston, applauded the investigators for looking at the evidence behind something clinicians routinely use and take for granted, but joined an audience member in pointing out that there was a lot of heterogeneity in the results, which can influence the strength of the conclusion.
"We have to somehow change the amount of insulin we deliver each meal every day, depending on the circumstances, and I think carb counting is a method that makes the most sense," he said in an interview. "To change my practice I will need to see evidence against the practice, not evidence in favor of what I’m already doing, and the evidence has to be pretty clear."
Data were presented during the same session on one such potential new tool, called the food insulin index. Ironically, it was this research that Ms. Bell also authored that prompted her to conduct the meta-analysis in the first place, she said in an interview. If carb counting was to serve as the control, it was necessary to know how effective it truly was.
What she found after screening 294 potentially relevant studies, was only six quality randomized controlled trials of at least 3 months’ duration. Study quality averaged 7.7 on a 13-point scale, with 13 indicating the least risk of bias.
Five trials were in adults (n = 563) and one in children, aged 8-13 years (n = 104), and all were in the outpatient clinical setting. Controls received usual care, general dietary advice or low glycemic index dietary advice, while a variety of carbohydrate counting methods was used including 10- and 15-gram carbohydrate exchanges.
The results of the meta-analysis chip away at a cornerstone of current practice and are likely to spark debate, particularly when presented by a lowly Ph.D. candidate, albeit in two sessions at the meeting including the presidential oral session.
"I expected people to be quite defensive of their current practice, but at the same time, it highlights the need for more evidence" and "the need to be more aware of the limitation in practice," she told this news agency. "It’s been common to say patients aren’t compliant, or aren’t doing it accurately, or they need to work on their skills, but not necessarily to acknowledge that there may be other factors in play here that aren’t related to their actual ability to count carbohydrates, but to the method itself."
Ms. Bell reported no relevant disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Major finding: The overall change in hemoglobin A1c levels with a variety of carbohydrate counting methods was 0.3% points, compared with other dietary interventions (P = .185).
Data source: Meta-analysis of six randomized controlled trials involving 563 adults and 104 children with type 1 diabetes.
Disclosures: Ms. Bell reported having no financial disclosures.
PCP-based conference calls sustained weight loss in pre-diabetics
CHICAGO – A proven weight-loss intervention can be delivered through primary care practices by telephone and improve weight loss in patients at risk for developing diabetes.
Moreover, group conference calls were even more effective than individual calls at keeping the weight off at 2 years, according to new results from the $3.2-million SHINE (Support, Health Information, Nutrition and Exercise) study.
"A telephone DPP [Diabetes Prevention Program] intervention is not only feasible, but effective," co-principal investigator Paula Trief, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The multicenter DPP research study demonstrated that a modest amount of weight loss through dietary changes and increased physical activity could sharply reduce the risk of developing diabetes, with several trials subsequently looking at how to deliver the DPP in the real world in a less costly but still effective manner. At the same time, the U.S. Preventive Services Task Force recommended that primary care providers offer, or refer patients to, weight loss interventions, in part because of their long-term relationship with patients.
The SHINE study put these two components together to determine whether primary care provider staff could be trained to deliver the DPP, and whether it could be adapted for telephone delivery to increase reach, explained Dr. Trief, professor of psychiatry and behavioral science, State University of New York (SUNY) Upstate Medical University in Syracuse.
Staff, mostly licensed practical nurses and dieticians, from five diverse primary care practices in upstate New York underwent 2 days of training, plus supervision to competence on individual goal setting, feedback, and problem solving for two DPP-based interventions.
A total of 257 patients with metabolic syndrome, but no diabetes, and a body mass index of at least 30 kg/m2 were randomly assigned to participate in the DPP lifestyle balance program as a group (n= 128) or individually (n= 129). Up to 8 patients were enrolled for each group conference call.
In year 1, an educator presented the 16-session DPP core curriculum during weekly phone calls for 5 weeks, then monthly thereafter. Coaches made monthly calls to improve adherence to the weight-loss strategies. In year 2, the educator made monthly calls and used topics from the after-core DPP curriculum, and the coach was available for up to 6 visits. Data are not yet available from year 3, the maintenance phase, in which quarterly contact was encouraged but not arranged by the investigators.
At baseline, the patients mean BMI was 39.3 kg/m2, mean weight 237 pounds (107.6 kg), mean waist circumference 46.6 inches (118.6 cm) and mean fasting glucose 99.6 mg/dL. Their average age was 51.7 years.
Their average fasting glucose was 99.6 mg/dL, blood pressure was 129 mm Hg/75.6 mm Hg, triglycerides were 145.7 mg/dL, high-density lipoprotein cholesterol was 42.4 mg/dL, and low-density lipoprotein cholesterol was 108.3 mg/dL.
At 1 year, patients in the solo and group intervention arms lost an average of 4.6 kg and 6.0 kg, respectively, according to data reported at last year’s AAD meeting by co-principal investigator Dr. Ruth Weinstock, MD, Ph.D., chief of endocrinology, diabetes and metabolism at SUNY and director of the Joslin Diabetes Center. Waist circumference was reduced by an average of -5.0 cm and -4.5 cm, respectively.
At 2 years, solo participants had improved weight loss, but also regained weight, while group participants had further weight loss, Dr. Trief said.
At 2 years, the average weight loss nearly tripled from 2.2 kg in the solo arm to 6.2 kg in the group intervention arm, while the average percent weight loss jumped from –1.8% to –5.6% in the group arm (both P = .01).
In all, 29% of the solo arm met their goal of losing at least 5% of their weight vs. 52.2% in the group arm (P = .01). Waist circumference reductions were statistically similar in the solo and group arms (–2.4 cm vs. –3.1 cm).
As for why the group intervention was more effective over time, Dr. Trief said it was conjecture but that: "It could be that these patients received better advice from their peers.
"When the educator was providing advice and direction, they were doing it based on a script, but the peers were offering all kinds of suggestions: ‘Oh, I tried this kind of food,’ ‘This is how I increased my activity.’ Again, it’s more real world," she said.
It also may be that patients are more likely to accept the advice of peers, may feel more accountable to peers trying to lose weight than to an educator or coach, may try to complete more topic sessions to "keep up" with their peers, and there’s the emotional support provided by the group, Dr. Trief observed.
Secondary analyses are ongoing that may help understand predictors and mediators of successful weight loss, as well as analyses of secondary outcomes, including changes in glucose, lipid levels, and blood pressure; quality of life; and cost-effectiveness, she said.
SHINE was funded by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Trief reported having no financial disclosures.
CHICAGO – A proven weight-loss intervention can be delivered through primary care practices by telephone and improve weight loss in patients at risk for developing diabetes.
Moreover, group conference calls were even more effective than individual calls at keeping the weight off at 2 years, according to new results from the $3.2-million SHINE (Support, Health Information, Nutrition and Exercise) study.
"A telephone DPP [Diabetes Prevention Program] intervention is not only feasible, but effective," co-principal investigator Paula Trief, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The multicenter DPP research study demonstrated that a modest amount of weight loss through dietary changes and increased physical activity could sharply reduce the risk of developing diabetes, with several trials subsequently looking at how to deliver the DPP in the real world in a less costly but still effective manner. At the same time, the U.S. Preventive Services Task Force recommended that primary care providers offer, or refer patients to, weight loss interventions, in part because of their long-term relationship with patients.
The SHINE study put these two components together to determine whether primary care provider staff could be trained to deliver the DPP, and whether it could be adapted for telephone delivery to increase reach, explained Dr. Trief, professor of psychiatry and behavioral science, State University of New York (SUNY) Upstate Medical University in Syracuse.
Staff, mostly licensed practical nurses and dieticians, from five diverse primary care practices in upstate New York underwent 2 days of training, plus supervision to competence on individual goal setting, feedback, and problem solving for two DPP-based interventions.
A total of 257 patients with metabolic syndrome, but no diabetes, and a body mass index of at least 30 kg/m2 were randomly assigned to participate in the DPP lifestyle balance program as a group (n= 128) or individually (n= 129). Up to 8 patients were enrolled for each group conference call.
In year 1, an educator presented the 16-session DPP core curriculum during weekly phone calls for 5 weeks, then monthly thereafter. Coaches made monthly calls to improve adherence to the weight-loss strategies. In year 2, the educator made monthly calls and used topics from the after-core DPP curriculum, and the coach was available for up to 6 visits. Data are not yet available from year 3, the maintenance phase, in which quarterly contact was encouraged but not arranged by the investigators.
At baseline, the patients mean BMI was 39.3 kg/m2, mean weight 237 pounds (107.6 kg), mean waist circumference 46.6 inches (118.6 cm) and mean fasting glucose 99.6 mg/dL. Their average age was 51.7 years.
Their average fasting glucose was 99.6 mg/dL, blood pressure was 129 mm Hg/75.6 mm Hg, triglycerides were 145.7 mg/dL, high-density lipoprotein cholesterol was 42.4 mg/dL, and low-density lipoprotein cholesterol was 108.3 mg/dL.
At 1 year, patients in the solo and group intervention arms lost an average of 4.6 kg and 6.0 kg, respectively, according to data reported at last year’s AAD meeting by co-principal investigator Dr. Ruth Weinstock, MD, Ph.D., chief of endocrinology, diabetes and metabolism at SUNY and director of the Joslin Diabetes Center. Waist circumference was reduced by an average of -5.0 cm and -4.5 cm, respectively.
At 2 years, solo participants had improved weight loss, but also regained weight, while group participants had further weight loss, Dr. Trief said.
At 2 years, the average weight loss nearly tripled from 2.2 kg in the solo arm to 6.2 kg in the group intervention arm, while the average percent weight loss jumped from –1.8% to –5.6% in the group arm (both P = .01).
In all, 29% of the solo arm met their goal of losing at least 5% of their weight vs. 52.2% in the group arm (P = .01). Waist circumference reductions were statistically similar in the solo and group arms (–2.4 cm vs. –3.1 cm).
As for why the group intervention was more effective over time, Dr. Trief said it was conjecture but that: "It could be that these patients received better advice from their peers.
"When the educator was providing advice and direction, they were doing it based on a script, but the peers were offering all kinds of suggestions: ‘Oh, I tried this kind of food,’ ‘This is how I increased my activity.’ Again, it’s more real world," she said.
It also may be that patients are more likely to accept the advice of peers, may feel more accountable to peers trying to lose weight than to an educator or coach, may try to complete more topic sessions to "keep up" with their peers, and there’s the emotional support provided by the group, Dr. Trief observed.
Secondary analyses are ongoing that may help understand predictors and mediators of successful weight loss, as well as analyses of secondary outcomes, including changes in glucose, lipid levels, and blood pressure; quality of life; and cost-effectiveness, she said.
SHINE was funded by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Trief reported having no financial disclosures.
CHICAGO – A proven weight-loss intervention can be delivered through primary care practices by telephone and improve weight loss in patients at risk for developing diabetes.
Moreover, group conference calls were even more effective than individual calls at keeping the weight off at 2 years, according to new results from the $3.2-million SHINE (Support, Health Information, Nutrition and Exercise) study.
"A telephone DPP [Diabetes Prevention Program] intervention is not only feasible, but effective," co-principal investigator Paula Trief, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The multicenter DPP research study demonstrated that a modest amount of weight loss through dietary changes and increased physical activity could sharply reduce the risk of developing diabetes, with several trials subsequently looking at how to deliver the DPP in the real world in a less costly but still effective manner. At the same time, the U.S. Preventive Services Task Force recommended that primary care providers offer, or refer patients to, weight loss interventions, in part because of their long-term relationship with patients.
The SHINE study put these two components together to determine whether primary care provider staff could be trained to deliver the DPP, and whether it could be adapted for telephone delivery to increase reach, explained Dr. Trief, professor of psychiatry and behavioral science, State University of New York (SUNY) Upstate Medical University in Syracuse.
Staff, mostly licensed practical nurses and dieticians, from five diverse primary care practices in upstate New York underwent 2 days of training, plus supervision to competence on individual goal setting, feedback, and problem solving for two DPP-based interventions.
A total of 257 patients with metabolic syndrome, but no diabetes, and a body mass index of at least 30 kg/m2 were randomly assigned to participate in the DPP lifestyle balance program as a group (n= 128) or individually (n= 129). Up to 8 patients were enrolled for each group conference call.
In year 1, an educator presented the 16-session DPP core curriculum during weekly phone calls for 5 weeks, then monthly thereafter. Coaches made monthly calls to improve adherence to the weight-loss strategies. In year 2, the educator made monthly calls and used topics from the after-core DPP curriculum, and the coach was available for up to 6 visits. Data are not yet available from year 3, the maintenance phase, in which quarterly contact was encouraged but not arranged by the investigators.
At baseline, the patients mean BMI was 39.3 kg/m2, mean weight 237 pounds (107.6 kg), mean waist circumference 46.6 inches (118.6 cm) and mean fasting glucose 99.6 mg/dL. Their average age was 51.7 years.
Their average fasting glucose was 99.6 mg/dL, blood pressure was 129 mm Hg/75.6 mm Hg, triglycerides were 145.7 mg/dL, high-density lipoprotein cholesterol was 42.4 mg/dL, and low-density lipoprotein cholesterol was 108.3 mg/dL.
At 1 year, patients in the solo and group intervention arms lost an average of 4.6 kg and 6.0 kg, respectively, according to data reported at last year’s AAD meeting by co-principal investigator Dr. Ruth Weinstock, MD, Ph.D., chief of endocrinology, diabetes and metabolism at SUNY and director of the Joslin Diabetes Center. Waist circumference was reduced by an average of -5.0 cm and -4.5 cm, respectively.
At 2 years, solo participants had improved weight loss, but also regained weight, while group participants had further weight loss, Dr. Trief said.
At 2 years, the average weight loss nearly tripled from 2.2 kg in the solo arm to 6.2 kg in the group intervention arm, while the average percent weight loss jumped from –1.8% to –5.6% in the group arm (both P = .01).
In all, 29% of the solo arm met their goal of losing at least 5% of their weight vs. 52.2% in the group arm (P = .01). Waist circumference reductions were statistically similar in the solo and group arms (–2.4 cm vs. –3.1 cm).
As for why the group intervention was more effective over time, Dr. Trief said it was conjecture but that: "It could be that these patients received better advice from their peers.
"When the educator was providing advice and direction, they were doing it based on a script, but the peers were offering all kinds of suggestions: ‘Oh, I tried this kind of food,’ ‘This is how I increased my activity.’ Again, it’s more real world," she said.
It also may be that patients are more likely to accept the advice of peers, may feel more accountable to peers trying to lose weight than to an educator or coach, may try to complete more topic sessions to "keep up" with their peers, and there’s the emotional support provided by the group, Dr. Trief observed.
Secondary analyses are ongoing that may help understand predictors and mediators of successful weight loss, as well as analyses of secondary outcomes, including changes in glucose, lipid levels, and blood pressure; quality of life; and cost-effectiveness, she said.
SHINE was funded by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Trief reported having no financial disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Major finding: At 2 years, the average weight loss was 2.2 kg among solo participants vs. 6.2 kg among group participants (P = .01).
Data source: Randomized intervention trial in 257 patients with metabolic syndrome without diabetes.
Disclosures: SHINE was funded by the National Institute of Diabetes and Digestive and Kidney Disease. Dr. Trief reported having no financial disclosures.
Islet transplantation found to restore glucose counterregulation
CHIGAGO – Intrahepatic islet transplantation restored glucose counterregulation and improved hypoglycemia symptoms in patients with longstanding type 1 diabetes, results from a small single-center study showed.
The findings support the consideration of the procedure in patients with severe hypoglycemia unawareness, Dr. Michael R. Rickels reported at the annual scientific sessions of the American Diabetes Association.
Currently, islet transplantation is being evaluated as a potential treatment for patients with type 1 diabetes experiencing severe problems with hypoglycemia," Dr. Rickels of the department of medicine at the Hospital of the University of Pennsylvania, Philadelphia, said in an interview. "Difficulty with hypoglycemia increases with longer duration of type 1 diabetes as physiologic defense mechanisms against the development of low blood glucose fail. This study documents absent glucose production by the body during hypoglycemia in patients with longstanding type 1 diabetes that is restored 6 months after undergoing islet transplantation."
In an effort to determine the effect of intrahepatic islet transplantation on glucose counterregulation and hypoglycemia symptoms in patients with longstanding type 1 diabetes Dr. Rickels and his associates evaluated 20 subjects who underwent hyperinsulinemic, hypoglycemic, and euglycemic clamps with infusion of the tracer 6,6-2H2 glucose for measurement of endogenous glucose production. Of the 20 study participants, 12 had longstanding type 1 diabetes (average of 29 years) and underwent intrahepatic islet cell transplantation, and 8 were normal controls. The mean duration of type 1 diabetes in the patients was 29 years, their mean Clarke score was 6.3, and their mean HYPO score was 2,564, indicating hypoglycemia unawareness and severe problems with hypoglycemia.
The patients received a mean of 9,648 islet equivalents/kg by portal vein infusion. As a result 10 of 12 (83%) achieved insulin independence and their hemoglobin A1c levels dropped from a mean of 7.1 to a mean of 5.6 (P less than .001). They also experienced amelioration of hypoglycemia.
For the 12 patients with type 1 diabetes and 6 normal controls, during the final hour of the 4-hour hypoglycemic clamp, the mean level of plasma glucagon was 33 pg/mL in patients prior to islet transplantation, 60 pg/mL in patients after islet transplantation, and about 90 pg/mL in normal controls (P less than .001 for both vs. prior to islet transplantation).
Similar associations were observed for other measurements. The mean level of epinephrine was 116 pg/mL in patients prior to islet transplantation, 253 pg/mL in patients after islet transplantation, and 380 pg/mL in normal controls (P less than .01 for both vs. prior to islet transplantation and normal controls vs. after islet transplantation). The mean level of free fatty acids was 50 mcM in patients prior to islet transplantation, 161 mcM in patients after islet transplantation, and 95 mcM in normal controls (P less than .05 for both vs. prior to islet transplantation). The mean level of endogenous glucose production was 0.6 mg/kg per min in patients prior to islet transplantation, 1.2 mg/kg per min in patients after islet transplantation, and 1.4 mg/kg per min in normal controls (P less than .01 for both vs. prior to islet transplantation).
"These results indicate that present patient selection criteria developed by the Clinical Islet Transplantation Consortium for the protocols in which the current study’s patients participated indeed identify individuals with absent glucose counterregulation, and with the recovery of glucose counterregulation post transplant supports the consideration of islet transplantation as a potential treatment for patients with type 1 diabetes experiencing the most problems with hypoglycemia," said Dr. Rickels, who is also medical director for the hospital’s pancreatic islet cell transplantation program.
He noted certain limitations of the study, including the fact that it was "a small mechanistic study conducted in 12 patients at the University of Pennsylvania, so the results may not be generalizable to the larger population of type 1 diabetes patients who may undergo islet transplantation."
The study was supported by funding from the National Institutes of Health. Dr. Rickels said that he had no relevant financial conflicts to disclose.
CHIGAGO – Intrahepatic islet transplantation restored glucose counterregulation and improved hypoglycemia symptoms in patients with longstanding type 1 diabetes, results from a small single-center study showed.
The findings support the consideration of the procedure in patients with severe hypoglycemia unawareness, Dr. Michael R. Rickels reported at the annual scientific sessions of the American Diabetes Association.
Currently, islet transplantation is being evaluated as a potential treatment for patients with type 1 diabetes experiencing severe problems with hypoglycemia," Dr. Rickels of the department of medicine at the Hospital of the University of Pennsylvania, Philadelphia, said in an interview. "Difficulty with hypoglycemia increases with longer duration of type 1 diabetes as physiologic defense mechanisms against the development of low blood glucose fail. This study documents absent glucose production by the body during hypoglycemia in patients with longstanding type 1 diabetes that is restored 6 months after undergoing islet transplantation."
In an effort to determine the effect of intrahepatic islet transplantation on glucose counterregulation and hypoglycemia symptoms in patients with longstanding type 1 diabetes Dr. Rickels and his associates evaluated 20 subjects who underwent hyperinsulinemic, hypoglycemic, and euglycemic clamps with infusion of the tracer 6,6-2H2 glucose for measurement of endogenous glucose production. Of the 20 study participants, 12 had longstanding type 1 diabetes (average of 29 years) and underwent intrahepatic islet cell transplantation, and 8 were normal controls. The mean duration of type 1 diabetes in the patients was 29 years, their mean Clarke score was 6.3, and their mean HYPO score was 2,564, indicating hypoglycemia unawareness and severe problems with hypoglycemia.
The patients received a mean of 9,648 islet equivalents/kg by portal vein infusion. As a result 10 of 12 (83%) achieved insulin independence and their hemoglobin A1c levels dropped from a mean of 7.1 to a mean of 5.6 (P less than .001). They also experienced amelioration of hypoglycemia.
For the 12 patients with type 1 diabetes and 6 normal controls, during the final hour of the 4-hour hypoglycemic clamp, the mean level of plasma glucagon was 33 pg/mL in patients prior to islet transplantation, 60 pg/mL in patients after islet transplantation, and about 90 pg/mL in normal controls (P less than .001 for both vs. prior to islet transplantation).
Similar associations were observed for other measurements. The mean level of epinephrine was 116 pg/mL in patients prior to islet transplantation, 253 pg/mL in patients after islet transplantation, and 380 pg/mL in normal controls (P less than .01 for both vs. prior to islet transplantation and normal controls vs. after islet transplantation). The mean level of free fatty acids was 50 mcM in patients prior to islet transplantation, 161 mcM in patients after islet transplantation, and 95 mcM in normal controls (P less than .05 for both vs. prior to islet transplantation). The mean level of endogenous glucose production was 0.6 mg/kg per min in patients prior to islet transplantation, 1.2 mg/kg per min in patients after islet transplantation, and 1.4 mg/kg per min in normal controls (P less than .01 for both vs. prior to islet transplantation).
"These results indicate that present patient selection criteria developed by the Clinical Islet Transplantation Consortium for the protocols in which the current study’s patients participated indeed identify individuals with absent glucose counterregulation, and with the recovery of glucose counterregulation post transplant supports the consideration of islet transplantation as a potential treatment for patients with type 1 diabetes experiencing the most problems with hypoglycemia," said Dr. Rickels, who is also medical director for the hospital’s pancreatic islet cell transplantation program.
He noted certain limitations of the study, including the fact that it was "a small mechanistic study conducted in 12 patients at the University of Pennsylvania, so the results may not be generalizable to the larger population of type 1 diabetes patients who may undergo islet transplantation."
The study was supported by funding from the National Institutes of Health. Dr. Rickels said that he had no relevant financial conflicts to disclose.
CHIGAGO – Intrahepatic islet transplantation restored glucose counterregulation and improved hypoglycemia symptoms in patients with longstanding type 1 diabetes, results from a small single-center study showed.
The findings support the consideration of the procedure in patients with severe hypoglycemia unawareness, Dr. Michael R. Rickels reported at the annual scientific sessions of the American Diabetes Association.
Currently, islet transplantation is being evaluated as a potential treatment for patients with type 1 diabetes experiencing severe problems with hypoglycemia," Dr. Rickels of the department of medicine at the Hospital of the University of Pennsylvania, Philadelphia, said in an interview. "Difficulty with hypoglycemia increases with longer duration of type 1 diabetes as physiologic defense mechanisms against the development of low blood glucose fail. This study documents absent glucose production by the body during hypoglycemia in patients with longstanding type 1 diabetes that is restored 6 months after undergoing islet transplantation."
In an effort to determine the effect of intrahepatic islet transplantation on glucose counterregulation and hypoglycemia symptoms in patients with longstanding type 1 diabetes Dr. Rickels and his associates evaluated 20 subjects who underwent hyperinsulinemic, hypoglycemic, and euglycemic clamps with infusion of the tracer 6,6-2H2 glucose for measurement of endogenous glucose production. Of the 20 study participants, 12 had longstanding type 1 diabetes (average of 29 years) and underwent intrahepatic islet cell transplantation, and 8 were normal controls. The mean duration of type 1 diabetes in the patients was 29 years, their mean Clarke score was 6.3, and their mean HYPO score was 2,564, indicating hypoglycemia unawareness and severe problems with hypoglycemia.
The patients received a mean of 9,648 islet equivalents/kg by portal vein infusion. As a result 10 of 12 (83%) achieved insulin independence and their hemoglobin A1c levels dropped from a mean of 7.1 to a mean of 5.6 (P less than .001). They also experienced amelioration of hypoglycemia.
For the 12 patients with type 1 diabetes and 6 normal controls, during the final hour of the 4-hour hypoglycemic clamp, the mean level of plasma glucagon was 33 pg/mL in patients prior to islet transplantation, 60 pg/mL in patients after islet transplantation, and about 90 pg/mL in normal controls (P less than .001 for both vs. prior to islet transplantation).
Similar associations were observed for other measurements. The mean level of epinephrine was 116 pg/mL in patients prior to islet transplantation, 253 pg/mL in patients after islet transplantation, and 380 pg/mL in normal controls (P less than .01 for both vs. prior to islet transplantation and normal controls vs. after islet transplantation). The mean level of free fatty acids was 50 mcM in patients prior to islet transplantation, 161 mcM in patients after islet transplantation, and 95 mcM in normal controls (P less than .05 for both vs. prior to islet transplantation). The mean level of endogenous glucose production was 0.6 mg/kg per min in patients prior to islet transplantation, 1.2 mg/kg per min in patients after islet transplantation, and 1.4 mg/kg per min in normal controls (P less than .01 for both vs. prior to islet transplantation).
"These results indicate that present patient selection criteria developed by the Clinical Islet Transplantation Consortium for the protocols in which the current study’s patients participated indeed identify individuals with absent glucose counterregulation, and with the recovery of glucose counterregulation post transplant supports the consideration of islet transplantation as a potential treatment for patients with type 1 diabetes experiencing the most problems with hypoglycemia," said Dr. Rickels, who is also medical director for the hospital’s pancreatic islet cell transplantation program.
He noted certain limitations of the study, including the fact that it was "a small mechanistic study conducted in 12 patients at the University of Pennsylvania, so the results may not be generalizable to the larger population of type 1 diabetes patients who may undergo islet transplantation."
The study was supported by funding from the National Institutes of Health. Dr. Rickels said that he had no relevant financial conflicts to disclose.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Major finding: After undergoing intrahepatic islet transplantation, 83% of patients with longstanding type 1 diabetes achieved insulin independence and their mean HbA1c levels dropped from 7.1 to 5.6 (P less than .001).
Data source: A single-center study conducted in 12 patients with type 1 diabetes and 8 normal controls to determine the effect of intrahepatic islet transplantation on glucose counterregulation and hypoglycemia symptoms.
Disclosures: The study was supported by funding from the National Institutes of Health. Dr. Rickels said that he had no relevant financial conflicts to disclose.
Insulin delivery system controls glucose overnight
CHICAGO – Use of a first-generation closed-loop insulin delivery system by patients with type 1 diabetes demonstrated the capability of maintaining safe glucose levels overnight, results from a small study demonstrated.
The findings, presented during the annual scientific sessions of the American Diabetes Association, indicate feasibility for continuing refinement of the system, known as the Hypoglycemia-Hyperglycemia Minimizer (HHM), developed by West Chester, Penn.–based Animas Corp., a Johnson & Johnson company. In June of 2011, Animas received Investigational Device Exemption for the use of the system in human clinical feasibility studies. For the current study, the HHM comprised an insulin pump, a continuous glucose monitor, and a control algorithm.
"Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes," Daniel A. Finan, Ph.D., said in an interview prior to the meeting. "Maintaining safe glucose levels during this time frame is crucial in helping not only to achieve better control, but also to provide peace of mind to patients and caregivers."
Dr. Finan, a staff algorithm scientist at Animas Corp, reported results from a feasibility study conducted in 20 adults with type 1 diabetes and designed to investigate the system’s automatic control algorithm, with emphasis on the overnight period of 9 p.m. to 7 a.m. The study was conducted in clinical research centers and involved automatic dosing of insulin based on the continuous glucose monitor values. Concomitant glucose readings were obtained from the YSI 2300 STAT Plus, which were considered the reference measurements.
The mean overnight glucose values based on the HHM continuous glucose monitor and the STAT Plus were 135 and 129 mg/dL, respectively, the median percentage of overnight time spent at glucose values between 70 and 180 mg/dL was 94% and 91%, and the median percentage of overnight time spent at glucose values less than 70 mg/dL was 0% with both methods.
"We are encouraged by the performance of the HHM system in this feasibility study, and particularly by the steady, within-range control it maintained in the patients overnight," Dr. Finan said. "We observed only small amounts of low and high glucose measurements, as determined both by the continuous glucose monitors and the laboratory gold standard" YSI 2300 STAT Plus, he added.
A major limitation of this study was the fact that it was performed at clinical research centers, Dr. Finan said. "The assurance of patient safety with close medical supervision is standard practice for this type of feasibility study, but the clinical research center atmosphere does indeed come with a set of artificialities," Dr. Finan said. "We are working with regulatory agencies to devise a clinical plan that moves the patients from the clinic to more ambulatory conditions."
The study was sponsored by Animas Corp. Dr. Finan is an employee of the company.
American Diabetes Association, Hypoglycemia-Hyperglycemia Minimizer, 2013ADA
CHICAGO – Use of a first-generation closed-loop insulin delivery system by patients with type 1 diabetes demonstrated the capability of maintaining safe glucose levels overnight, results from a small study demonstrated.
The findings, presented during the annual scientific sessions of the American Diabetes Association, indicate feasibility for continuing refinement of the system, known as the Hypoglycemia-Hyperglycemia Minimizer (HHM), developed by West Chester, Penn.–based Animas Corp., a Johnson & Johnson company. In June of 2011, Animas received Investigational Device Exemption for the use of the system in human clinical feasibility studies. For the current study, the HHM comprised an insulin pump, a continuous glucose monitor, and a control algorithm.
"Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes," Daniel A. Finan, Ph.D., said in an interview prior to the meeting. "Maintaining safe glucose levels during this time frame is crucial in helping not only to achieve better control, but also to provide peace of mind to patients and caregivers."
Dr. Finan, a staff algorithm scientist at Animas Corp, reported results from a feasibility study conducted in 20 adults with type 1 diabetes and designed to investigate the system’s automatic control algorithm, with emphasis on the overnight period of 9 p.m. to 7 a.m. The study was conducted in clinical research centers and involved automatic dosing of insulin based on the continuous glucose monitor values. Concomitant glucose readings were obtained from the YSI 2300 STAT Plus, which were considered the reference measurements.
The mean overnight glucose values based on the HHM continuous glucose monitor and the STAT Plus were 135 and 129 mg/dL, respectively, the median percentage of overnight time spent at glucose values between 70 and 180 mg/dL was 94% and 91%, and the median percentage of overnight time spent at glucose values less than 70 mg/dL was 0% with both methods.
"We are encouraged by the performance of the HHM system in this feasibility study, and particularly by the steady, within-range control it maintained in the patients overnight," Dr. Finan said. "We observed only small amounts of low and high glucose measurements, as determined both by the continuous glucose monitors and the laboratory gold standard" YSI 2300 STAT Plus, he added.
A major limitation of this study was the fact that it was performed at clinical research centers, Dr. Finan said. "The assurance of patient safety with close medical supervision is standard practice for this type of feasibility study, but the clinical research center atmosphere does indeed come with a set of artificialities," Dr. Finan said. "We are working with regulatory agencies to devise a clinical plan that moves the patients from the clinic to more ambulatory conditions."
The study was sponsored by Animas Corp. Dr. Finan is an employee of the company.
CHICAGO – Use of a first-generation closed-loop insulin delivery system by patients with type 1 diabetes demonstrated the capability of maintaining safe glucose levels overnight, results from a small study demonstrated.
The findings, presented during the annual scientific sessions of the American Diabetes Association, indicate feasibility for continuing refinement of the system, known as the Hypoglycemia-Hyperglycemia Minimizer (HHM), developed by West Chester, Penn.–based Animas Corp., a Johnson & Johnson company. In June of 2011, Animas received Investigational Device Exemption for the use of the system in human clinical feasibility studies. For the current study, the HHM comprised an insulin pump, a continuous glucose monitor, and a control algorithm.
"Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes," Daniel A. Finan, Ph.D., said in an interview prior to the meeting. "Maintaining safe glucose levels during this time frame is crucial in helping not only to achieve better control, but also to provide peace of mind to patients and caregivers."
Dr. Finan, a staff algorithm scientist at Animas Corp, reported results from a feasibility study conducted in 20 adults with type 1 diabetes and designed to investigate the system’s automatic control algorithm, with emphasis on the overnight period of 9 p.m. to 7 a.m. The study was conducted in clinical research centers and involved automatic dosing of insulin based on the continuous glucose monitor values. Concomitant glucose readings were obtained from the YSI 2300 STAT Plus, which were considered the reference measurements.
The mean overnight glucose values based on the HHM continuous glucose monitor and the STAT Plus were 135 and 129 mg/dL, respectively, the median percentage of overnight time spent at glucose values between 70 and 180 mg/dL was 94% and 91%, and the median percentage of overnight time spent at glucose values less than 70 mg/dL was 0% with both methods.
"We are encouraged by the performance of the HHM system in this feasibility study, and particularly by the steady, within-range control it maintained in the patients overnight," Dr. Finan said. "We observed only small amounts of low and high glucose measurements, as determined both by the continuous glucose monitors and the laboratory gold standard" YSI 2300 STAT Plus, he added.
A major limitation of this study was the fact that it was performed at clinical research centers, Dr. Finan said. "The assurance of patient safety with close medical supervision is standard practice for this type of feasibility study, but the clinical research center atmosphere does indeed come with a set of artificialities," Dr. Finan said. "We are working with regulatory agencies to devise a clinical plan that moves the patients from the clinic to more ambulatory conditions."
The study was sponsored by Animas Corp. Dr. Finan is an employee of the company.
American Diabetes Association, Hypoglycemia-Hyperglycemia Minimizer, 2013ADA
American Diabetes Association, Hypoglycemia-Hyperglycemia Minimizer, 2013ADA
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Major finding: The mean overnight glucose value based on a continuous glucose monitor that was part of a first-generation closed-loop insulin delivery system was 135 mg/dL. The median percentage of overnight time spent at glucose values in the target range of 70-180 mg/dL was 94%.
Data source: A feasibility study of 20 patients with type 1 diabetes designed to investigate the automatic control algorithm of the Hypoglycemia-Hyperglycemia Minimizer, developed by Animas Corp.
Disclosures: Dr. Finan is an employee of Animas Corp., which sponsored the study.
Join us in Chicago for the ADA meeting!
Our team of expert reporters is making its way to Chicago for the American Diabetes Association annual scientific sessions. We’ve got a lot in store for you.
The President's Oral Sessions promise to be highlights of the meeting. The first session, on Friday, will emphasize provocative basic science trials, but one presentation stands out for us: The investigators evaluated whether islet transplantation can restore glucose counterregulation in patients with long-standing type 1 diabetes. Watch upcoming newsletters for our report on the findings from that research.
Tuesday's President's Oral Session will focus on clinical research, with some data that may have an immediate affect on how you practice:
• Should your type 1 diabetes patients count carbs? A meta-analysis sorts through the evidence.
• Should you go straight to triple therapy in a newly diagnosed type 2 diabetes patient? One team of investigators studied just that.
• What more can you learn about diabetes treatment and cancer risk from the ORIGIN trial?
With nearly 2,000 abstracts being presented, we can’t stop there. Look for our live and continuing reports from oral abstract and poster sessions, symposia, and "hot topic" Current Issues sessions.
If you're attending, get the mobile app, wear red on Sunday to Stop Diabetes, sign up for the 5K@ADA fun run, and check out our recommendations on making the most of Chicago while you’re there.
Our team of expert reporters is making its way to Chicago for the American Diabetes Association annual scientific sessions. We’ve got a lot in store for you.
The President's Oral Sessions promise to be highlights of the meeting. The first session, on Friday, will emphasize provocative basic science trials, but one presentation stands out for us: The investigators evaluated whether islet transplantation can restore glucose counterregulation in patients with long-standing type 1 diabetes. Watch upcoming newsletters for our report on the findings from that research.
Tuesday's President's Oral Session will focus on clinical research, with some data that may have an immediate affect on how you practice:
• Should your type 1 diabetes patients count carbs? A meta-analysis sorts through the evidence.
• Should you go straight to triple therapy in a newly diagnosed type 2 diabetes patient? One team of investigators studied just that.
• What more can you learn about diabetes treatment and cancer risk from the ORIGIN trial?
With nearly 2,000 abstracts being presented, we can’t stop there. Look for our live and continuing reports from oral abstract and poster sessions, symposia, and "hot topic" Current Issues sessions.
If you're attending, get the mobile app, wear red on Sunday to Stop Diabetes, sign up for the 5K@ADA fun run, and check out our recommendations on making the most of Chicago while you’re there.
Our team of expert reporters is making its way to Chicago for the American Diabetes Association annual scientific sessions. We’ve got a lot in store for you.
The President's Oral Sessions promise to be highlights of the meeting. The first session, on Friday, will emphasize provocative basic science trials, but one presentation stands out for us: The investigators evaluated whether islet transplantation can restore glucose counterregulation in patients with long-standing type 1 diabetes. Watch upcoming newsletters for our report on the findings from that research.
Tuesday's President's Oral Session will focus on clinical research, with some data that may have an immediate affect on how you practice:
• Should your type 1 diabetes patients count carbs? A meta-analysis sorts through the evidence.
• Should you go straight to triple therapy in a newly diagnosed type 2 diabetes patient? One team of investigators studied just that.
• What more can you learn about diabetes treatment and cancer risk from the ORIGIN trial?
With nearly 2,000 abstracts being presented, we can’t stop there. Look for our live and continuing reports from oral abstract and poster sessions, symposia, and "hot topic" Current Issues sessions.
If you're attending, get the mobile app, wear red on Sunday to Stop Diabetes, sign up for the 5K@ADA fun run, and check out our recommendations on making the most of Chicago while you’re there.