Miriam E. Tucker

Major Finding: Mean HbA_1c decreased from 8.3% to 7.5% with the use of a sensor-augmented pump vs. 8.1% with multiple daily injections.

Data Source: Randomized, controlled trial with 485 patients.

Disclosures: The study was funded by Medtronic MiniMed, maker of an insulin pump and continuous glucose monitor system. Several investigators disclosed that they have earned consulting fees, honoraria, grants, or travel reimbursements from numerous pharmaceutical companies and device manufacturers, including Medtronic, Bayer Healthcare, Lifescan, Novo Nordisk, and Becton Dickson. Those companies also supplied the study with insulin aspart and glucose monitors. Dr. Wolpert disclosed having been a consultant to Abbott, Novo Nordisk, and Insulet.

ORLANDO — Sensor-augmented insulin pump therapy resulted in significant improvements in hemoglobin A_1c levels without increasing hypoglycemia, compared with multiple daily injection therapy, in a 1-year randomized, controlled trial of 485 patients with type 1 diabetes.

Participants in the prospective, multicenter Sensor-Augmented Pump Therapy for A_1c Reduction (STAR)–3 study were seen at 30 sites in the United States and Canada. All patients (aged 7-70 years) had type 1 diabetes treated with multiple daily injections that included a long-acting analogue insulin during the previous 3 months and had an HbA_1c value between 7.4% and 9.5% (mean 8.3% in both groups), Dr. Richard M. Bergenstal reported. The findings were published simultaneously in the New England Journal of Medicine online on June 29 (doi:10.1056/NEJMoa1002853).

All patients received intensive diabetes management training, with the sensor-augmented pump group receiving additional training in the use of the pump. The multiple daily injections (MDI) group wore a continuous glucose monitor that did not display glucose data to the patient. Both groups downloaded their data to an online software system.

For the study's primary end point, change in HbA_1c between the sensor-augmented pump and multiple daily injection groups at 1 year, results were highly significant: The mean HbA_1c decreased from 8.3% to 7.5% in the sensor-augmented pump group and to 8.1% in the MDI group, translating to a fourfold greater reduction with the sensor-augmented pump, said Dr. Bergenstal, executive director of the International Diabetes Center in Minneapolis.

In the 329 adults aged 19 and older, mean HbA_1c was decreased to 7.3%, compared with 7.9% in the MDI group. In the 156 children and adolescents aged 7-18 years, the value was reduced to 7.9% with sensor-augmented pump vs. a slight increase to 8.5% with MDI.

The adult group had achieved that 7.3% value within 3 months and had remained consistent over the entire year; the children and adolescents achieved a mean of 7.5% at 3 months, but the value then drifted upward. However, in the pediatric group the 1-year difference from baseline was still statistically significant, noted Dr. Bergenstal, the ADA's president for medicine and science.

A linear relationship was seen between sensor use and HbA_1c, with reductions of just 0.19 percentage points among those who wore the sensor 21%-40% of the time, compared with a reduction of 1.21 percentage points in those who wore it 81% of the time or more. Results were statistically significant in those who wore the sensor 41% of the time or more, he said.

The proportion of patients who achieved an HbA_1c value of 7% or less at 1 year was 27% with sensor-augmented pump, compared with 10% with MDI, a highly significant difference. In adults, the difference was 34% vs. 12%. In the children and adolescents, the proportions achieving the ADA recommendations of less than 7.5% for those aged 13-19 years and less than 8% for 6- to 12-year-olds were 44% with sensor-augmented pump and 20% with MDI.

Diabetic ketoacidosis was rare in both groups and did not differ between the groups. The amount of time spent in hypoglycemia also did not differ between the two groups. Severe hypoglycemia occurred in 13.31 patients per 100 person-years in the sensor-augmented pump group, compared with 13.48 patients in the MDI group. Among the adults, weight gain was greater with SAP, at 2.4 kg, compared with 1.8 kg with MDI, Dr. Bergenstal said.

In an editorial that accompanied the study report, Dr. Howard Wolpert of the Joslin Diabetes Center, Boston, noted that “continuous glucose monitoring can be viewed as a compass that tells patients where their glucose is heading. However, to reach that goal, patients need to be skilled in diabetes self-management. The expert training and guidance received by patients in clinical trials cannot be readily duplicated in a busy clinical practice,” he said (N. Engl J. Med. 2010 June 29; doi:10.1056/NEJMe1006098).

The benefits of improved glucose control must also be weighed against the demands that the technology places on the patient, he wrote.

“The use of continuous glucose monitoring by patients will almost certainly grow as the next generation of smaller, simpler devices with increased reliability and accuracy becomes available. The development of an infrastructure to support training and follow-up care will also be essential,” Dr. Wolpert concluded.

Major Finding: Mean HbA_1c decreased from 8.3% to 7.5% with the use of a sensor-augmented pump vs. 8.1% with multiple daily injections.

Data Source: Randomized, controlled trial with 485 patients.

Disclosures: The study was funded by Medtronic MiniMed, maker of an insulin pump and continuous glucose monitor system. Several investigators disclosed that they have earned consulting fees, honoraria, grants, or travel reimbursements from numerous pharmaceutical companies and device manufacturers, including Medtronic, Bayer Healthcare, Lifescan, Novo Nordisk, and Becton Dickson. Those companies also supplied the study with insulin aspart and glucose monitors. Dr. Wolpert disclosed having been a consultant to Abbott, Novo Nordisk, and Insulet.

ORLANDO — Sensor-augmented insulin pump therapy resulted in significant improvements in hemoglobin A_1c levels without increasing hypoglycemia, compared with multiple daily injection therapy, in a 1-year randomized, controlled trial of 485 patients with type 1 diabetes.

Participants in the prospective, multicenter Sensor-Augmented Pump Therapy for A_1c Reduction (STAR)–3 study were seen at 30 sites in the United States and Canada. All patients (aged 7-70 years) had type 1 diabetes treated with multiple daily injections that included a long-acting analogue insulin during the previous 3 months and had an HbA_1c value between 7.4% and 9.5% (mean 8.3% in both groups), Dr. Richard M. Bergenstal reported. The findings were published simultaneously in the New England Journal of Medicine online on June 29 (doi:10.1056/NEJMoa1002853).

All patients received intensive diabetes management training, with the sensor-augmented pump group receiving additional training in the use of the pump. The multiple daily injections (MDI) group wore a continuous glucose monitor that did not display glucose data to the patient. Both groups downloaded their data to an online software system.

For the study's primary end point, change in HbA_1c between the sensor-augmented pump and multiple daily injection groups at 1 year, results were highly significant: The mean HbA_1c decreased from 8.3% to 7.5% in the sensor-augmented pump group and to 8.1% in the MDI group, translating to a fourfold greater reduction with the sensor-augmented pump, said Dr. Bergenstal, executive director of the International Diabetes Center in Minneapolis.

In the 329 adults aged 19 and older, mean HbA_1c was decreased to 7.3%, compared with 7.9% in the MDI group. In the 156 children and adolescents aged 7-18 years, the value was reduced to 7.9% with sensor-augmented pump vs. a slight increase to 8.5% with MDI.

The adult group had achieved that 7.3% value within 3 months and had remained consistent over the entire year; the children and adolescents achieved a mean of 7.5% at 3 months, but the value then drifted upward. However, in the pediatric group the 1-year difference from baseline was still statistically significant, noted Dr. Bergenstal, the ADA's president for medicine and science.

A linear relationship was seen between sensor use and HbA_1c, with reductions of just 0.19 percentage points among those who wore the sensor 21%-40% of the time, compared with a reduction of 1.21 percentage points in those who wore it 81% of the time or more. Results were statistically significant in those who wore the sensor 41% of the time or more, he said.

The proportion of patients who achieved an HbA_1c value of 7% or less at 1 year was 27% with sensor-augmented pump, compared with 10% with MDI, a highly significant difference. In adults, the difference was 34% vs. 12%. In the children and adolescents, the proportions achieving the ADA recommendations of less than 7.5% for those aged 13-19 years and less than 8% for 6- to 12-year-olds were 44% with sensor-augmented pump and 20% with MDI.

Diabetic ketoacidosis was rare in both groups and did not differ between the groups. The amount of time spent in hypoglycemia also did not differ between the two groups. Severe hypoglycemia occurred in 13.31 patients per 100 person-years in the sensor-augmented pump group, compared with 13.48 patients in the MDI group. Among the adults, weight gain was greater with SAP, at 2.4 kg, compared with 1.8 kg with MDI, Dr. Bergenstal said.

In an editorial that accompanied the study report, Dr. Howard Wolpert of the Joslin Diabetes Center, Boston, noted that “continuous glucose monitoring can be viewed as a compass that tells patients where their glucose is heading. However, to reach that goal, patients need to be skilled in diabetes self-management. The expert training and guidance received by patients in clinical trials cannot be readily duplicated in a busy clinical practice,” he said (N. Engl J. Med. 2010 June 29; doi:10.1056/NEJMe1006098).

The benefits of improved glucose control must also be weighed against the demands that the technology places on the patient, he wrote.

“The use of continuous glucose monitoring by patients will almost certainly grow as the next generation of smaller, simpler devices with increased reliability and accuracy becomes available. The development of an infrastructure to support training and follow-up care will also be essential,” Dr. Wolpert concluded.

Major Finding: Mean HbA_1c decreased from 8.3% to 7.5% with the use of a sensor-augmented pump vs. 8.1% with multiple daily injections.

Data Source: Randomized, controlled trial with 485 patients.

Disclosures: The study was funded by Medtronic MiniMed, maker of an insulin pump and continuous glucose monitor system. Several investigators disclosed that they have earned consulting fees, honoraria, grants, or travel reimbursements from numerous pharmaceutical companies and device manufacturers, including Medtronic, Bayer Healthcare, Lifescan, Novo Nordisk, and Becton Dickson. Those companies also supplied the study with insulin aspart and glucose monitors. Dr. Wolpert disclosed having been a consultant to Abbott, Novo Nordisk, and Insulet.

ORLANDO — Sensor-augmented insulin pump therapy resulted in significant improvements in hemoglobin A_1c levels without increasing hypoglycemia, compared with multiple daily injection therapy, in a 1-year randomized, controlled trial of 485 patients with type 1 diabetes.

Participants in the prospective, multicenter Sensor-Augmented Pump Therapy for A_1c Reduction (STAR)–3 study were seen at 30 sites in the United States and Canada. All patients (aged 7-70 years) had type 1 diabetes treated with multiple daily injections that included a long-acting analogue insulin during the previous 3 months and had an HbA_1c value between 7.4% and 9.5% (mean 8.3% in both groups), Dr. Richard M. Bergenstal reported. The findings were published simultaneously in the New England Journal of Medicine online on June 29 (doi:10.1056/NEJMoa1002853).

All patients received intensive diabetes management training, with the sensor-augmented pump group receiving additional training in the use of the pump. The multiple daily injections (MDI) group wore a continuous glucose monitor that did not display glucose data to the patient. Both groups downloaded their data to an online software system.

For the study's primary end point, change in HbA_1c between the sensor-augmented pump and multiple daily injection groups at 1 year, results were highly significant: The mean HbA_1c decreased from 8.3% to 7.5% in the sensor-augmented pump group and to 8.1% in the MDI group, translating to a fourfold greater reduction with the sensor-augmented pump, said Dr. Bergenstal, executive director of the International Diabetes Center in Minneapolis.

In the 329 adults aged 19 and older, mean HbA_1c was decreased to 7.3%, compared with 7.9% in the MDI group. In the 156 children and adolescents aged 7-18 years, the value was reduced to 7.9% with sensor-augmented pump vs. a slight increase to 8.5% with MDI.

The adult group had achieved that 7.3% value within 3 months and had remained consistent over the entire year; the children and adolescents achieved a mean of 7.5% at 3 months, but the value then drifted upward. However, in the pediatric group the 1-year difference from baseline was still statistically significant, noted Dr. Bergenstal, the ADA's president for medicine and science.

A linear relationship was seen between sensor use and HbA_1c, with reductions of just 0.19 percentage points among those who wore the sensor 21%-40% of the time, compared with a reduction of 1.21 percentage points in those who wore it 81% of the time or more. Results were statistically significant in those who wore the sensor 41% of the time or more, he said.

The proportion of patients who achieved an HbA_1c value of 7% or less at 1 year was 27% with sensor-augmented pump, compared with 10% with MDI, a highly significant difference. In adults, the difference was 34% vs. 12%. In the children and adolescents, the proportions achieving the ADA recommendations of less than 7.5% for those aged 13-19 years and less than 8% for 6- to 12-year-olds were 44% with sensor-augmented pump and 20% with MDI.

Diabetic ketoacidosis was rare in both groups and did not differ between the groups. The amount of time spent in hypoglycemia also did not differ between the two groups. Severe hypoglycemia occurred in 13.31 patients per 100 person-years in the sensor-augmented pump group, compared with 13.48 patients in the MDI group. Among the adults, weight gain was greater with SAP, at 2.4 kg, compared with 1.8 kg with MDI, Dr. Bergenstal said.

In an editorial that accompanied the study report, Dr. Howard Wolpert of the Joslin Diabetes Center, Boston, noted that “continuous glucose monitoring can be viewed as a compass that tells patients where their glucose is heading. However, to reach that goal, patients need to be skilled in diabetes self-management. The expert training and guidance received by patients in clinical trials cannot be readily duplicated in a busy clinical practice,” he said (N. Engl J. Med. 2010 June 29; doi:10.1056/NEJMe1006098).

The benefits of improved glucose control must also be weighed against the demands that the technology places on the patient, he wrote.

“The use of continuous glucose monitoring by patients will almost certainly grow as the next generation of smaller, simpler devices with increased reliability and accuracy becomes available. The development of an infrastructure to support training and follow-up care will also be essential,” Dr. Wolpert concluded.

ORLANDO — A novel investigational ultra–long-acting insulin analogue produced glycemic control similar to insulin glargine when injected once daily or three times weekly, with better postdinner control.

The analogue, insulin degludec, forms soluble multihexamer depots after subcutaneous injection, resulting in a longer duration of action than any available insulin analogue. Novo Nordisk is developing two formulations, one of degludec alone and the other a 70/30 combination with the short-acting insulin aspart. There is no 70/30 formulation on the market that includes a basal insulin, Dr. Bernard Zinman said in an interview.

Data from two phase II proof-of-concept trials presented at the scientific sessions suggest that insulin degludec provides glucose control comparable to regimens using available basal insulins, with the advantages of fewer injections, better postdinner control, and possibly less hypoglycemia.

Dr. Zinman, professor of medicine and director of the Leadership Sinai Centre for Diabetes at the University of Toronto, reported on a 16-week, open-label, parallel-group, treat-to-target trial in which 245 patients with type 2 diabetes that was inadequately controlled by oral agents were randomized to one of four arms: the 70/30 formulation; a once-daily 55/45 formulation, which has since been discontinued; a three-times-weekly formulation (Monday, Wednesday, and Friday); or insulin glargine. All insulins were injected in the evening and titrated to target a fasting plasma glucose (FPG) of 72-108 mg/dL. All patients also continued taking metformin.

At baseline, the patients had a mean age of 54 years, mean hemoglobin A_1c of 8.7%, mean FPG of 184 mg/dL, and mean body mass index of 29.5 kg/m

After 16 weeks, reduction in HbA_1c from baseline was similar across treatment arms, with drops of 1.3 percentage points with once-daily insulin degludec, 1.5 points with thrice-weekly degludec, and 1.5 points with insulin glargine. Final mean HbA_1c also did not differ between groups, at 7.4% for once-daily degludec, 7.3% for the thrice-weekly version, and 7.2% for insulin glargine. Results for the 55/45 formulation were not reported.

FPG reductions were similar, as were final mean FPG (113, 116, and 115 mg/dL). Mean weekly insulin doses were similar at the end of the trial.

Rates of confirmed hypoglycemia(plasma glucose value of less than 56 mg/dL or requiring assistance) were low and only one severe event was reported (for thrice-weekly degludec). The rate of confirmed hypoglycemia was lower with once-daily degludec than with the thrice-weekly formulation and glargine, but the differences were not statistically significant (0.6, 2.3, 1.1 events per patient-year, respectively).

The proportion of subjects with adverse events did not differ significantly across treatment arms, with no specific patterns or clustering. Most adverse events were mild or moderate in severity, he said.

Dr. Tim Heise, CEO of the Profil Institute for Metabolic Research Ltd., Neuss, Germany, presented the data on the 70/30 degludec-aspart combination (IDegAsp). This 16-week open-label, parallel-group, treat-to-target trial randomized 178 patients who were inadequately controlled on oral agents to receive either once-daily 70/30 IDegAsp, the alternate 55/45 combination, or insulin glargine, all in combination with metformin. (Because the 55/45 combination has been discontinued, reports for that group are not available.)

Both insulins were dosed before dinner and titrated to an FPG target of 72-108 mg/dL. The patients had a mean age of 59 years, HbA_1c of 8.5%, and FPG of 209 mg/dL. After 16 weeks, mean HbA_1c decreased from baseline in both treatment groups, by 1.31 percentage points with IDegAsp and by 1.29 with insulin glargine. HbA_1c values were comparable: 7.0% for IDegAsp and 7.1% for insulin glargine. The proportions achieving HbA_1c values of less than 7.0% without confirmed hypoglycemia were 51% for IDegAsp and 50% with glargine, Dr. Heise reported.

The mean increase in plasma glucose at 2 hours after dinner was significantly lower for degludec than for glargine (2 mg/dL for IDegAsp versus 29 mg/dL with glargine), while FPG was similar between groups (122 and 126 mg/dL, respectively). At the trial's end, mean daily insulin doses were lower for IDegAsp than for insulin glargine.

No severe hypoglycemic events were reported. Rates of confirmed hypoglycemia (PG less than 56 mg/dL) were lower for IDegAsp and glargine than for the 55/45 version (1.2, 0.7, and 2.4 events per patient-year, respectively). One confirmed nocturnal hypoglycemic event was reported for IDegAsp in one patient and three events were reported in three patients on insulin glargine. No other adverse events were reported.

This study was funded by Novo Nordisk, which is now proceeding with phase III trials of insulin degludec.

Dr. Zinman's and Dr. Heise's institution receive research funding from manufacturers of diabetes-related products. Dr. Zinman has financial ties with GlaxoSmithKline, Merck, Amylin Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly and Co., and Medtronic Minimed. Dr. Heise serves on an advisory panel for Novo Nordisk.

At the trial's end, mean daily insulin doses were lower for the analogue than for glargine.

Source DR. HEISE

ORLANDO — A novel investigational ultra–long-acting insulin analogue produced glycemic control similar to insulin glargine when injected once daily or three times weekly, with better postdinner control.

The analogue, insulin degludec, forms soluble multihexamer depots after subcutaneous injection, resulting in a longer duration of action than any available insulin analogue. Novo Nordisk is developing two formulations, one of degludec alone and the other a 70/30 combination with the short-acting insulin aspart. There is no 70/30 formulation on the market that includes a basal insulin, Dr. Bernard Zinman said in an interview.

Data from two phase II proof-of-concept trials presented at the scientific sessions suggest that insulin degludec provides glucose control comparable to regimens using available basal insulins, with the advantages of fewer injections, better postdinner control, and possibly less hypoglycemia.

Dr. Zinman, professor of medicine and director of the Leadership Sinai Centre for Diabetes at the University of Toronto, reported on a 16-week, open-label, parallel-group, treat-to-target trial in which 245 patients with type 2 diabetes that was inadequately controlled by oral agents were randomized to one of four arms: the 70/30 formulation; a once-daily 55/45 formulation, which has since been discontinued; a three-times-weekly formulation (Monday, Wednesday, and Friday); or insulin glargine. All insulins were injected in the evening and titrated to target a fasting plasma glucose (FPG) of 72-108 mg/dL. All patients also continued taking metformin.

At baseline, the patients had a mean age of 54 years, mean hemoglobin A_1c of 8.7%, mean FPG of 184 mg/dL, and mean body mass index of 29.5 kg/m

After 16 weeks, reduction in HbA_1c from baseline was similar across treatment arms, with drops of 1.3 percentage points with once-daily insulin degludec, 1.5 points with thrice-weekly degludec, and 1.5 points with insulin glargine. Final mean HbA_1c also did not differ between groups, at 7.4% for once-daily degludec, 7.3% for the thrice-weekly version, and 7.2% for insulin glargine. Results for the 55/45 formulation were not reported.

FPG reductions were similar, as were final mean FPG (113, 116, and 115 mg/dL). Mean weekly insulin doses were similar at the end of the trial.

Rates of confirmed hypoglycemia(plasma glucose value of less than 56 mg/dL or requiring assistance) were low and only one severe event was reported (for thrice-weekly degludec). The rate of confirmed hypoglycemia was lower with once-daily degludec than with the thrice-weekly formulation and glargine, but the differences were not statistically significant (0.6, 2.3, 1.1 events per patient-year, respectively).

The proportion of subjects with adverse events did not differ significantly across treatment arms, with no specific patterns or clustering. Most adverse events were mild or moderate in severity, he said.

Dr. Tim Heise, CEO of the Profil Institute for Metabolic Research Ltd., Neuss, Germany, presented the data on the 70/30 degludec-aspart combination (IDegAsp). This 16-week open-label, parallel-group, treat-to-target trial randomized 178 patients who were inadequately controlled on oral agents to receive either once-daily 70/30 IDegAsp, the alternate 55/45 combination, or insulin glargine, all in combination with metformin. (Because the 55/45 combination has been discontinued, reports for that group are not available.)

Both insulins were dosed before dinner and titrated to an FPG target of 72-108 mg/dL. The patients had a mean age of 59 years, HbA_1c of 8.5%, and FPG of 209 mg/dL. After 16 weeks, mean HbA_1c decreased from baseline in both treatment groups, by 1.31 percentage points with IDegAsp and by 1.29 with insulin glargine. HbA_1c values were comparable: 7.0% for IDegAsp and 7.1% for insulin glargine. The proportions achieving HbA_1c values of less than 7.0% without confirmed hypoglycemia were 51% for IDegAsp and 50% with glargine, Dr. Heise reported.

The mean increase in plasma glucose at 2 hours after dinner was significantly lower for degludec than for glargine (2 mg/dL for IDegAsp versus 29 mg/dL with glargine), while FPG was similar between groups (122 and 126 mg/dL, respectively). At the trial's end, mean daily insulin doses were lower for IDegAsp than for insulin glargine.

No severe hypoglycemic events were reported. Rates of confirmed hypoglycemia (PG less than 56 mg/dL) were lower for IDegAsp and glargine than for the 55/45 version (1.2, 0.7, and 2.4 events per patient-year, respectively). One confirmed nocturnal hypoglycemic event was reported for IDegAsp in one patient and three events were reported in three patients on insulin glargine. No other adverse events were reported.

This study was funded by Novo Nordisk, which is now proceeding with phase III trials of insulin degludec.

Dr. Zinman's and Dr. Heise's institution receive research funding from manufacturers of diabetes-related products. Dr. Zinman has financial ties with GlaxoSmithKline, Merck, Amylin Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly and Co., and Medtronic Minimed. Dr. Heise serves on an advisory panel for Novo Nordisk.

At the trial's end, mean daily insulin doses were lower for the analogue than for glargine.

Source DR. HEISE

ORLANDO — A novel investigational ultra–long-acting insulin analogue produced glycemic control similar to insulin glargine when injected once daily or three times weekly, with better postdinner control.

The analogue, insulin degludec, forms soluble multihexamer depots after subcutaneous injection, resulting in a longer duration of action than any available insulin analogue. Novo Nordisk is developing two formulations, one of degludec alone and the other a 70/30 combination with the short-acting insulin aspart. There is no 70/30 formulation on the market that includes a basal insulin, Dr. Bernard Zinman said in an interview.

Data from two phase II proof-of-concept trials presented at the scientific sessions suggest that insulin degludec provides glucose control comparable to regimens using available basal insulins, with the advantages of fewer injections, better postdinner control, and possibly less hypoglycemia.

Dr. Zinman, professor of medicine and director of the Leadership Sinai Centre for Diabetes at the University of Toronto, reported on a 16-week, open-label, parallel-group, treat-to-target trial in which 245 patients with type 2 diabetes that was inadequately controlled by oral agents were randomized to one of four arms: the 70/30 formulation; a once-daily 55/45 formulation, which has since been discontinued; a three-times-weekly formulation (Monday, Wednesday, and Friday); or insulin glargine. All insulins were injected in the evening and titrated to target a fasting plasma glucose (FPG) of 72-108 mg/dL. All patients also continued taking metformin.

At baseline, the patients had a mean age of 54 years, mean hemoglobin A_1c of 8.7%, mean FPG of 184 mg/dL, and mean body mass index of 29.5 kg/m

After 16 weeks, reduction in HbA_1c from baseline was similar across treatment arms, with drops of 1.3 percentage points with once-daily insulin degludec, 1.5 points with thrice-weekly degludec, and 1.5 points with insulin glargine. Final mean HbA_1c also did not differ between groups, at 7.4% for once-daily degludec, 7.3% for the thrice-weekly version, and 7.2% for insulin glargine. Results for the 55/45 formulation were not reported.

FPG reductions were similar, as were final mean FPG (113, 116, and 115 mg/dL). Mean weekly insulin doses were similar at the end of the trial.

Rates of confirmed hypoglycemia(plasma glucose value of less than 56 mg/dL or requiring assistance) were low and only one severe event was reported (for thrice-weekly degludec). The rate of confirmed hypoglycemia was lower with once-daily degludec than with the thrice-weekly formulation and glargine, but the differences were not statistically significant (0.6, 2.3, 1.1 events per patient-year, respectively).

The proportion of subjects with adverse events did not differ significantly across treatment arms, with no specific patterns or clustering. Most adverse events were mild or moderate in severity, he said.

Dr. Tim Heise, CEO of the Profil Institute for Metabolic Research Ltd., Neuss, Germany, presented the data on the 70/30 degludec-aspart combination (IDegAsp). This 16-week open-label, parallel-group, treat-to-target trial randomized 178 patients who were inadequately controlled on oral agents to receive either once-daily 70/30 IDegAsp, the alternate 55/45 combination, or insulin glargine, all in combination with metformin. (Because the 55/45 combination has been discontinued, reports for that group are not available.)

Both insulins were dosed before dinner and titrated to an FPG target of 72-108 mg/dL. The patients had a mean age of 59 years, HbA_1c of 8.5%, and FPG of 209 mg/dL. After 16 weeks, mean HbA_1c decreased from baseline in both treatment groups, by 1.31 percentage points with IDegAsp and by 1.29 with insulin glargine. HbA_1c values were comparable: 7.0% for IDegAsp and 7.1% for insulin glargine. The proportions achieving HbA_1c values of less than 7.0% without confirmed hypoglycemia were 51% for IDegAsp and 50% with glargine, Dr. Heise reported.

The mean increase in plasma glucose at 2 hours after dinner was significantly lower for degludec than for glargine (2 mg/dL for IDegAsp versus 29 mg/dL with glargine), while FPG was similar between groups (122 and 126 mg/dL, respectively). At the trial's end, mean daily insulin doses were lower for IDegAsp than for insulin glargine.

No severe hypoglycemic events were reported. Rates of confirmed hypoglycemia (PG less than 56 mg/dL) were lower for IDegAsp and glargine than for the 55/45 version (1.2, 0.7, and 2.4 events per patient-year, respectively). One confirmed nocturnal hypoglycemic event was reported for IDegAsp in one patient and three events were reported in three patients on insulin glargine. No other adverse events were reported.

This study was funded by Novo Nordisk, which is now proceeding with phase III trials of insulin degludec.

Dr. Zinman's and Dr. Heise's institution receive research funding from manufacturers of diabetes-related products. Dr. Zinman has financial ties with GlaxoSmithKline, Merck, Amylin Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly and Co., and Medtronic Minimed. Dr. Heise serves on an advisory panel for Novo Nordisk.

At the trial's end, mean daily insulin doses were lower for the analogue than for glargine.

Source DR. HEISE

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the AES group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of nonobese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS)—not just those who are overweight or obese—should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All of the patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT.

A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and a mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: The 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45). The 2003 Rotterdam criteria (Human Reproduction 2004; 19:41-7) were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in eight of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was found to be greater—although still within the normal range—among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group, as measured by the homeostatic model assessment.

Lipid abnormalities and other parameters of insulin resistance also worsened as weight increased, with both differences in C-reactive protein and high-density lipoprotein levels reaching statistical significance.

Dr. Flannery recommended that physicians use the AES guidelines for performing an OGTT in all girls and women with PCOS, regardless of age or BMI, noting that the most recent guidelines from the American Diabetes Association recommend use of OGTT only in overweight adolescents with additional risk factors.

“If we had applied the ADA guidelines, we would have missed IGT in many of our adolescents,” she said.

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the AES group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of nonobese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS)—not just those who are overweight or obese—should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All of the patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT.

A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and a mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: The 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45). The 2003 Rotterdam criteria (Human Reproduction 2004; 19:41-7) were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in eight of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was found to be greater—although still within the normal range—among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group, as measured by the homeostatic model assessment.

Lipid abnormalities and other parameters of insulin resistance also worsened as weight increased, with both differences in C-reactive protein and high-density lipoprotein levels reaching statistical significance.

Dr. Flannery recommended that physicians use the AES guidelines for performing an OGTT in all girls and women with PCOS, regardless of age or BMI, noting that the most recent guidelines from the American Diabetes Association recommend use of OGTT only in overweight adolescents with additional risk factors.

“If we had applied the ADA guidelines, we would have missed IGT in many of our adolescents,” she said.

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the AES group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of nonobese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS)—not just those who are overweight or obese—should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All of the patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT.

A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and a mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: The 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45). The 2003 Rotterdam criteria (Human Reproduction 2004; 19:41-7) were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in eight of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was found to be greater—although still within the normal range—among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group, as measured by the homeostatic model assessment.

Lipid abnormalities and other parameters of insulin resistance also worsened as weight increased, with both differences in C-reactive protein and high-density lipoprotein levels reaching statistical significance.

Dr. Flannery recommended that physicians use the AES guidelines for performing an OGTT in all girls and women with PCOS, regardless of age or BMI, noting that the most recent guidelines from the American Diabetes Association recommend use of OGTT only in overweight adolescents with additional risk factors.

“If we had applied the ADA guidelines, we would have missed IGT in many of our adolescents,” she said.

Major Finding: A 1-minute, 3-question screening tool predicted individuals in the top 20th percentile of pain scores, with a sensitivity of 67% and a specificity of 72%.

Data Source: Study of 192 women who underwent elective C-sections with spinal morphine.

Disclosures: None was reported.

SAN ANTONIO — A 1-minute, three-question screening tool accurately predicted post–cesarean section pain in a study of 192 women who underwent elective cesarean sections with spinal morphine.

The quick, simple screen was nearly as sensitive and specific in predicting pain after delivery as was a 120-minute battery of tests used in a previous study (Anesthesiology 2006;104:417-25).

“We were looking for a simple, clinically useful way to identify patients at high risk for severe acute pain and subsequent complications who might benefit from earlier intervention,” said Dr. Ashley M. Tonidandel of Wake Forest University, Winston-Salem, N.C.

The three screening questions that were used in the investigation addressed the three strongest independent predictors of postcesarean pain and narcotic usage identified in the study published in Anesthesiology and in another study (Clin. J. Pain 2009;25:455-60).

Those predictors were anticipated pain levelafollowing surgery (on a scale of 0-100), anxiety regarding the upcoming surgery (1-100), and estimated pain medication usage (much less to much more than average).

The study participants had a mean age of 30 years and a mean body mass index of 34 kg/m

At 24 hours following surgery, the mean evoked pain score was 44 (out of 100). The patients used an average of 19 morphine equivalents over 24 hours. More than half of the participants (54%) received a total of 200 mcg of spinal morphine, according to Dr. Tonidandel.

Anxiety, anticipated pain, and expected medication usage were all significantly related to evoked pain and 24-hour morphine equivalents, with high scores on any two of the three items significantly predicting high pain scores.

Overall, the model accounted for 22% of the variance in predicted pain scores, which is “pretty good considering the 22%-28% of variance from the 120-minute battery of questions,” Dr. Tonidandel commented at the meeting.

Using a regression equation, the screening tool predicted individuals in the top 20th percentile of pain scores with a sensitivity of 67% and a specificity of 72%. With the 120-minute screen, those values were 70% and 76%, respectively, she said.

Identifying women at high risk for severe postpartum pain is especially important because previous studies have shown that women who have it are in turn at greater risk for the development of chronic pain (Pain 2008;140:87-94).

In the future, adding genetic information to the model might further increase its accuracy, although “our aim was to simplify,” she said.

Major Finding: A 1-minute, 3-question screening tool predicted individuals in the top 20th percentile of pain scores, with a sensitivity of 67% and a specificity of 72%.

Data Source: Study of 192 women who underwent elective C-sections with spinal morphine.

Disclosures: None was reported.

SAN ANTONIO — A 1-minute, three-question screening tool accurately predicted post–cesarean section pain in a study of 192 women who underwent elective cesarean sections with spinal morphine.

The quick, simple screen was nearly as sensitive and specific in predicting pain after delivery as was a 120-minute battery of tests used in a previous study (Anesthesiology 2006;104:417-25).

“We were looking for a simple, clinically useful way to identify patients at high risk for severe acute pain and subsequent complications who might benefit from earlier intervention,” said Dr. Ashley M. Tonidandel of Wake Forest University, Winston-Salem, N.C.

The three screening questions that were used in the investigation addressed the three strongest independent predictors of postcesarean pain and narcotic usage identified in the study published in Anesthesiology and in another study (Clin. J. Pain 2009;25:455-60).

Those predictors were anticipated pain levelafollowing surgery (on a scale of 0-100), anxiety regarding the upcoming surgery (1-100), and estimated pain medication usage (much less to much more than average).

The study participants had a mean age of 30 years and a mean body mass index of 34 kg/m

At 24 hours following surgery, the mean evoked pain score was 44 (out of 100). The patients used an average of 19 morphine equivalents over 24 hours. More than half of the participants (54%) received a total of 200 mcg of spinal morphine, according to Dr. Tonidandel.

Anxiety, anticipated pain, and expected medication usage were all significantly related to evoked pain and 24-hour morphine equivalents, with high scores on any two of the three items significantly predicting high pain scores.

Overall, the model accounted for 22% of the variance in predicted pain scores, which is “pretty good considering the 22%-28% of variance from the 120-minute battery of questions,” Dr. Tonidandel commented at the meeting.

Using a regression equation, the screening tool predicted individuals in the top 20th percentile of pain scores with a sensitivity of 67% and a specificity of 72%. With the 120-minute screen, those values were 70% and 76%, respectively, she said.

Identifying women at high risk for severe postpartum pain is especially important because previous studies have shown that women who have it are in turn at greater risk for the development of chronic pain (Pain 2008;140:87-94).

In the future, adding genetic information to the model might further increase its accuracy, although “our aim was to simplify,” she said.

Major Finding: A 1-minute, 3-question screening tool predicted individuals in the top 20th percentile of pain scores, with a sensitivity of 67% and a specificity of 72%.

Data Source: Study of 192 women who underwent elective C-sections with spinal morphine.

Disclosures: None was reported.

SAN ANTONIO — A 1-minute, three-question screening tool accurately predicted post–cesarean section pain in a study of 192 women who underwent elective cesarean sections with spinal morphine.

The quick, simple screen was nearly as sensitive and specific in predicting pain after delivery as was a 120-minute battery of tests used in a previous study (Anesthesiology 2006;104:417-25).

“We were looking for a simple, clinically useful way to identify patients at high risk for severe acute pain and subsequent complications who might benefit from earlier intervention,” said Dr. Ashley M. Tonidandel of Wake Forest University, Winston-Salem, N.C.

The three screening questions that were used in the investigation addressed the three strongest independent predictors of postcesarean pain and narcotic usage identified in the study published in Anesthesiology and in another study (Clin. J. Pain 2009;25:455-60).

Those predictors were anticipated pain levelafollowing surgery (on a scale of 0-100), anxiety regarding the upcoming surgery (1-100), and estimated pain medication usage (much less to much more than average).

The study participants had a mean age of 30 years and a mean body mass index of 34 kg/m

At 24 hours following surgery, the mean evoked pain score was 44 (out of 100). The patients used an average of 19 morphine equivalents over 24 hours. More than half of the participants (54%) received a total of 200 mcg of spinal morphine, according to Dr. Tonidandel.

Anxiety, anticipated pain, and expected medication usage were all significantly related to evoked pain and 24-hour morphine equivalents, with high scores on any two of the three items significantly predicting high pain scores.

Overall, the model accounted for 22% of the variance in predicted pain scores, which is “pretty good considering the 22%-28% of variance from the 120-minute battery of questions,” Dr. Tonidandel commented at the meeting.

Using a regression equation, the screening tool predicted individuals in the top 20th percentile of pain scores with a sensitivity of 67% and a specificity of 72%. With the 120-minute screen, those values were 70% and 76%, respectively, she said.

Identifying women at high risk for severe postpartum pain is especially important because previous studies have shown that women who have it are in turn at greater risk for the development of chronic pain (Pain 2008;140:87-94).

In the future, adding genetic information to the model might further increase its accuracy, although “our aim was to simplify,” she said.

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the second group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of non-obese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS)—not just those who are overweight or obese—should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT. A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: the 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45).

(The 2003 Rotterdam criteria [Human Reproduction 2004;19:41-7] were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.)

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in 8 of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was greater—although still within normal range—among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group. Lipid abnormalities also worsened as weight increased.

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the second group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of non-obese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS)—not just those who are overweight or obese—should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT. A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: the 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45).

(The 2003 Rotterdam criteria [Human Reproduction 2004;19:41-7] were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.)

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in 8 of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was greater—although still within normal range—among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group. Lipid abnormalities also worsened as weight increased.

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the second group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.

Data Source: A study of 70 adolescent girls referred to a specialty clinic for menstrual irregularity.

Disclosures: Dr. Flannery stated that she had no financial disclosures.

ORLANDO — More than 10% of non-obese adolescent girls with polycystic ovary syndrome were found to have impaired glucose tolerance in a study of 70 girls who had been referred to a specialty clinic for menstrual irregularity.

The finding suggests that all girls and women with polycystic ovary syndrome (PCOS)—not just those who are overweight or obese—should be evaluated with an oral glucose tolerance test (OGTT), said Dr. Clare A. Flannery of the Yale Multidisciplinary Adolescent PCOS Program and the department of endocrinology–internal medicine at Yale University, New Haven, Conn.

“Without an OGTT, the presence of impaired glucose metabolism is underestimated in lean adolescents with PCOS since their other parameters of insulin resistance may be in normal range. There is a need for a standardized OGTT for every adolescent with PCOS, regardless of weight,” she said.

The study was conducted at the Yale PCOS clinic, where patients referred for menstrual irregularity are seen by an endocrinologist, a gynecologist, and a nutritionist. All patients also receive a transabdominal pelvic ultrasound, androgen panel, fasting lipid testing, and a 75-g OGTT. A group of 80 patients who were enrolled in an ongoing cohort study had a mean age of 15.6 years and mean body mass index (BMI) of 31.4 kg/m

Because there are no established criteria for diagnosing PCOS in adolescence, two of three professional guidelines for diagnosing PCOS in adults were used for the study: the 1990 National Institutes of Health criteria (Blackwell Scientific Publications, 1992:377-84), which includes irregular menses and clinical or biochemical evidence of high androgens with the exclusion of other disorders, and the 2006 Androgen Excess Society (AES) criteria, which allow ultrasound findings of PCOS as a substitute for irregular menses (J. Clin. Endocrinol. Metab. 2006;91:4237-45).

(The 2003 Rotterdam criteria [Human Reproduction 2004;19:41-7] were not used because the definition is less strict and could include adolescents with hypothalamic amenorrhea, she noted.)

Ten adolescents were excluded from analysis because they were either already on metformin or had missing OGTT data. Of the remaining 70, 55 (79%) met the NIH criteria for PCOS diagnosis and 64 (91%) met the AES criteria. One patient who met both criteria was found to have impaired fasting glucose, and another who met both definitions had type 2 diabetes. Impaired glucose tolerance (IGT) was found in 8 of the NIH-defined PCOS patients (14.5%) and 10 of the AES-defined group (16%).

Among the 64 who met the AES PCOS criteria, 40 were obese (BMI of 95th percentile by age or greater). Mean BMI was 36 kg/m

“The nonobese girls were just as likely to have impaired glucose tolerance as their obese counterparts. If we had not indiscriminately applied the OGTT to all our patients, the abnormal glucose metabolism of the nonobese girls may have been missed,” she commented.

In contrast to the OGTT finding, other metabolic characteristics did appear to be driven by obesity rather than PCOS. Fasting glucose was greater—although still within normal range—among the obese patients (86 vs. 82 mg/dL), and there was a trend toward increased insulin resistance among those in the obese group. Lipid abnormalities also worsened as weight increased.

Major Finding: At 26 weeks, HbA_1c in patients treated with long-acting exenatide had dropped 1.5 percentage points, compared with a 1.3-point reduction in those treated with daily insulin glargine.

Data Source: DURATION-3, a phase III, 26-week open-label randomized trial of 456 patients with type 2 diabetes who had suboptimal control despite use of metformin with or without sulfonylureas.

Disclosures: The study was funded by Amylin Pharmaceuticals and Eli Lilly.

A once-weekly formulation of exenatide reduced hemoglobin A_1c level to a greater degree than did once-daily insulin glargine in DURATION-3, a phase III, 26-week open-label randomized trial of 456 patients with type 2 diabetes who had suboptimal control despite use of metformin with or without sulfonylureas.

The overall greater lowering of HbA1_c with exenatide was due to significantly lower postprandial glucose excursions, since fasting plasma glucose was actually lower among the patients randomized to insulin glargine. DURATION-3 (Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea was conducted in 72 sites around the world, funded by Amylin Pharmaceuticals and Eli Lilly and Co. (Lancet 2010;375:2234-43).

Patients randomized to exenatide received a 2-mg dose injected once a week. Those in the insulin glargine group started with 10 IU per day injected at bedtime, and were instructed to adjust insulin doses to achieve target fasting glucose values of 72–99 mg/dL TMetformin doses were kept constant, but patients taking sulfonylureas were advised to reduce that dose. The study design did not allow for blinding, noted Dr. Michaela Diamant, of VU University, Amsterdam, and her associates.

Mean doses of insulin glargine rose from 10 IU to 31 IU per day, and nearly one in four patients reduced their sulfonylurea dose. Metformin doses were about 2,000 mg/day throughout the study.

At 26 weeks, hemoglobin A1_c in the exenatide group had dropped 1.5 percentage points, compared with 1.3 in those receiving glargine, and 60% of the exenatide patients achieved an HbA1_c of less than 7%, compared with 48% for the glargine group, both significant differences. The proportions achieving HbA1_c values less than 6.5% were 35% and 23% respectively.

Mean fasting serum glucose concentrations were reduced in both groups, but to a significantly greater degree with insulin glargine (38 vs. 50 mg/dL), Dr. Diamant and her associates noted.

Whereas exenatide was associated with a progressive decrease in body weight, those taking insulin glargine had progressive increases. At 26 weeks, the exenatide group had lost an average of 2.6 kg, while the glargine group had gained 1.4 kg. In the exenatide group, reductions in body weight occurred in both those who reported nausea (3.5 kg) and those who did not (2.2 kg), they said.

Gastrointestinal events including nausea and diarrhea were among the most frequently reported adverse events in the exenatide group. Nausea was reported by 13% with exenatide vs. 1% with glargine, and diarrhea by 9% and 4%, respectively. All were mild or moderate in intensity. No serious adverse events were reported by more than one patient except for chest pain in two patients. No deaths occurred in either group. Discontinuations owing to adverse events were greater with exenatide (5% vs. 1%), due in part to injection-site reactions (2% vs. 0%).

At 26 weeks, five exenatide and no glargine patients had elevated amylase or lipase concentrations and one patient taking exenatide had edematous pancreatitis, an adverse event that has been reported previously with the currently available twice-daily exenatide. That patient was fully recovered by 2 months.

In an accompanying editorial, Dr. Anoop Misra and Dr. Shashank Joshi pointed out that the nausea, although less common with once-weekly exenatide versus the twice-daily formulation, could still be troublesome in patients who are taking multiple drugs, including metformin, and in those who have diabetic gastroparesis. They also noted that cardiovascular safety data are still needed for this drug, and strict monitoring of pancreatic effects will be necessary.

Both the long-acting and the twice-daily exenatide formulations have been linked to renal dysfunction, and to attenuation of the response among the 6%–9% who develop antibodies to the drug, Dr. Misra and Dr. Joshi said (Lancet 2010;375:2198-9).

Nonetheless, this or other drugs in the glucagon-like peptide-1 receptor analogue class might be suitable for patients with type 2 diabetes who are obese or those in whom hypoglycemia is a clinical concern. “Currently, there is more promise, few disadvantages, and some unknowns about treatment with long-acting exenatide for diabetes,” they concluded.

Dr. Diamant is a consultant and speaker for Eli Lilly, Novo Nordisk, and Merck, Sharpe, and Dohme, and a consultant for Sanofi-Aventis. The VU University has also received research grants from those companies as well Amylin Pharmaceuticals, Novartis, and Takeda. Three of the coauthors are employees of Lilly, and one works for Amylin.

Dr. Misra has received lecture fees and research funding from Sanofi-Aventis, Merck, Novo Nordisk, and Eli Lilly. Dr. Joshi stated that he had no conflicts of interest.

Major Finding: At 26 weeks, HbA_1c in patients treated with long-acting exenatide had dropped 1.5 percentage points, compared with a 1.3-point reduction in those treated with daily insulin glargine.

Data Source: DURATION-3, a phase III, 26-week open-label randomized trial of 456 patients with type 2 diabetes who had suboptimal control despite use of metformin with or without sulfonylureas.

Disclosures: The study was funded by Amylin Pharmaceuticals and Eli Lilly.

A once-weekly formulation of exenatide reduced hemoglobin A_1c level to a greater degree than did once-daily insulin glargine in DURATION-3, a phase III, 26-week open-label randomized trial of 456 patients with type 2 diabetes who had suboptimal control despite use of metformin with or without sulfonylureas.

The overall greater lowering of HbA1_c with exenatide was due to significantly lower postprandial glucose excursions, since fasting plasma glucose was actually lower among the patients randomized to insulin glargine. DURATION-3 (Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea was conducted in 72 sites around the world, funded by Amylin Pharmaceuticals and Eli Lilly and Co. (Lancet 2010;375:2234-43).

Patients randomized to exenatide received a 2-mg dose injected once a week. Those in the insulin glargine group started with 10 IU per day injected at bedtime, and were instructed to adjust insulin doses to achieve target fasting glucose values of 72–99 mg/dL TMetformin doses were kept constant, but patients taking sulfonylureas were advised to reduce that dose. The study design did not allow for blinding, noted Dr. Michaela Diamant, of VU University, Amsterdam, and her associates.

Mean doses of insulin glargine rose from 10 IU to 31 IU per day, and nearly one in four patients reduced their sulfonylurea dose. Metformin doses were about 2,000 mg/day throughout the study.

At 26 weeks, hemoglobin A1_c in the exenatide group had dropped 1.5 percentage points, compared with 1.3 in those receiving glargine, and 60% of the exenatide patients achieved an HbA1_c of less than 7%, compared with 48% for the glargine group, both significant differences. The proportions achieving HbA1_c values less than 6.5% were 35% and 23% respectively.

Mean fasting serum glucose concentrations were reduced in both groups, but to a significantly greater degree with insulin glargine (38 vs. 50 mg/dL), Dr. Diamant and her associates noted.

Whereas exenatide was associated with a progressive decrease in body weight, those taking insulin glargine had progressive increases. At 26 weeks, the exenatide group had lost an average of 2.6 kg, while the glargine group had gained 1.4 kg. In the exenatide group, reductions in body weight occurred in both those who reported nausea (3.5 kg) and those who did not (2.2 kg), they said.

Gastrointestinal events including nausea and diarrhea were among the most frequently reported adverse events in the exenatide group. Nausea was reported by 13% with exenatide vs. 1% with glargine, and diarrhea by 9% and 4%, respectively. All were mild or moderate in intensity. No serious adverse events were reported by more than one patient except for chest pain in two patients. No deaths occurred in either group. Discontinuations owing to adverse events were greater with exenatide (5% vs. 1%), due in part to injection-site reactions (2% vs. 0%).

At 26 weeks, five exenatide and no glargine patients had elevated amylase or lipase concentrations and one patient taking exenatide had edematous pancreatitis, an adverse event that has been reported previously with the currently available twice-daily exenatide. That patient was fully recovered by 2 months.

In an accompanying editorial, Dr. Anoop Misra and Dr. Shashank Joshi pointed out that the nausea, although less common with once-weekly exenatide versus the twice-daily formulation, could still be troublesome in patients who are taking multiple drugs, including metformin, and in those who have diabetic gastroparesis. They also noted that cardiovascular safety data are still needed for this drug, and strict monitoring of pancreatic effects will be necessary.

Both the long-acting and the twice-daily exenatide formulations have been linked to renal dysfunction, and to attenuation of the response among the 6%–9% who develop antibodies to the drug, Dr. Misra and Dr. Joshi said (Lancet 2010;375:2198-9).

Nonetheless, this or other drugs in the glucagon-like peptide-1 receptor analogue class might be suitable for patients with type 2 diabetes who are obese or those in whom hypoglycemia is a clinical concern. “Currently, there is more promise, few disadvantages, and some unknowns about treatment with long-acting exenatide for diabetes,” they concluded.

Dr. Diamant is a consultant and speaker for Eli Lilly, Novo Nordisk, and Merck, Sharpe, and Dohme, and a consultant for Sanofi-Aventis. The VU University has also received research grants from those companies as well Amylin Pharmaceuticals, Novartis, and Takeda. Three of the coauthors are employees of Lilly, and one works for Amylin.

Dr. Misra has received lecture fees and research funding from Sanofi-Aventis, Merck, Novo Nordisk, and Eli Lilly. Dr. Joshi stated that he had no conflicts of interest.

Major Finding: At 26 weeks, HbA_1c in patients treated with long-acting exenatide had dropped 1.5 percentage points, compared with a 1.3-point reduction in those treated with daily insulin glargine.

Data Source: DURATION-3, a phase III, 26-week open-label randomized trial of 456 patients with type 2 diabetes who had suboptimal control despite use of metformin with or without sulfonylureas.

Disclosures: The study was funded by Amylin Pharmaceuticals and Eli Lilly.

A once-weekly formulation of exenatide reduced hemoglobin A_1c level to a greater degree than did once-daily insulin glargine in DURATION-3, a phase III, 26-week open-label randomized trial of 456 patients with type 2 diabetes who had suboptimal control despite use of metformin with or without sulfonylureas.

The overall greater lowering of HbA1_c with exenatide was due to significantly lower postprandial glucose excursions, since fasting plasma glucose was actually lower among the patients randomized to insulin glargine. DURATION-3 (Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea was conducted in 72 sites around the world, funded by Amylin Pharmaceuticals and Eli Lilly and Co. (Lancet 2010;375:2234-43).

Patients randomized to exenatide received a 2-mg dose injected once a week. Those in the insulin glargine group started with 10 IU per day injected at bedtime, and were instructed to adjust insulin doses to achieve target fasting glucose values of 72–99 mg/dL TMetformin doses were kept constant, but patients taking sulfonylureas were advised to reduce that dose. The study design did not allow for blinding, noted Dr. Michaela Diamant, of VU University, Amsterdam, and her associates.

Mean doses of insulin glargine rose from 10 IU to 31 IU per day, and nearly one in four patients reduced their sulfonylurea dose. Metformin doses were about 2,000 mg/day throughout the study.

At 26 weeks, hemoglobin A1_c in the exenatide group had dropped 1.5 percentage points, compared with 1.3 in those receiving glargine, and 60% of the exenatide patients achieved an HbA1_c of less than 7%, compared with 48% for the glargine group, both significant differences. The proportions achieving HbA1_c values less than 6.5% were 35% and 23% respectively.

Mean fasting serum glucose concentrations were reduced in both groups, but to a significantly greater degree with insulin glargine (38 vs. 50 mg/dL), Dr. Diamant and her associates noted.

Whereas exenatide was associated with a progressive decrease in body weight, those taking insulin glargine had progressive increases. At 26 weeks, the exenatide group had lost an average of 2.6 kg, while the glargine group had gained 1.4 kg. In the exenatide group, reductions in body weight occurred in both those who reported nausea (3.5 kg) and those who did not (2.2 kg), they said.

Gastrointestinal events including nausea and diarrhea were among the most frequently reported adverse events in the exenatide group. Nausea was reported by 13% with exenatide vs. 1% with glargine, and diarrhea by 9% and 4%, respectively. All were mild or moderate in intensity. No serious adverse events were reported by more than one patient except for chest pain in two patients. No deaths occurred in either group. Discontinuations owing to adverse events were greater with exenatide (5% vs. 1%), due in part to injection-site reactions (2% vs. 0%).

At 26 weeks, five exenatide and no glargine patients had elevated amylase or lipase concentrations and one patient taking exenatide had edematous pancreatitis, an adverse event that has been reported previously with the currently available twice-daily exenatide. That patient was fully recovered by 2 months.

In an accompanying editorial, Dr. Anoop Misra and Dr. Shashank Joshi pointed out that the nausea, although less common with once-weekly exenatide versus the twice-daily formulation, could still be troublesome in patients who are taking multiple drugs, including metformin, and in those who have diabetic gastroparesis. They also noted that cardiovascular safety data are still needed for this drug, and strict monitoring of pancreatic effects will be necessary.

Both the long-acting and the twice-daily exenatide formulations have been linked to renal dysfunction, and to attenuation of the response among the 6%–9% who develop antibodies to the drug, Dr. Misra and Dr. Joshi said (Lancet 2010;375:2198-9).

Nonetheless, this or other drugs in the glucagon-like peptide-1 receptor analogue class might be suitable for patients with type 2 diabetes who are obese or those in whom hypoglycemia is a clinical concern. “Currently, there is more promise, few disadvantages, and some unknowns about treatment with long-acting exenatide for diabetes,” they concluded.

Dr. Diamant is a consultant and speaker for Eli Lilly, Novo Nordisk, and Merck, Sharpe, and Dohme, and a consultant for Sanofi-Aventis. The VU University has also received research grants from those companies as well Amylin Pharmaceuticals, Novartis, and Takeda. Three of the coauthors are employees of Lilly, and one works for Amylin.

Dr. Misra has received lecture fees and research funding from Sanofi-Aventis, Merck, Novo Nordisk, and Eli Lilly. Dr. Joshi stated that he had no conflicts of interest.

A joint consensus statement from the American Diabetes Association and the American Cancer Society reviews the current state of science regarding the complex relationship between diabetes and cancer.

Epidemiologic evidence suggests that people with diabetes—type 2 in particular—are at increased risk for cancer. The reasons are poorly understood, but may include risk factors common to both disorders, diabetes medications, and possible direct causal links.

The ADA and the ACS convened a consensus development conference in December to examine these links. The writing group independently developed a statement that solely represents the positions of the nine panel members and does not reflect official positions of either sponsoring organization (Diabetes Care 2010;33:1674-85).

The panel, chaired by Dr. Edward Giovannucci of Harvard School of Public Health, Boston, recommended that diabetes patients be strongly advised to undergo appropriate cancer screenings.

The statement was organized around answers to four basic questions:

▸ Is there a meaningful association between diabetes and cancer incidence or prognosis? Cancer and diabetes are diagnosed in the same individual more frequently than would be expected by chance, even after adjustment for age. The association appears to be limited to certain types of cancer, while other cancers appear to be less common among people with diabetes. Type 2 diabetes is associated with an increased risk for cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder, but with a reduced risk of prostate cancer. For some other cancer sites there appears to be no association.

▸ What factors are common to both disorders? The association may be due in part to shared risk factors such as aging, obesity, diet, and physical inactivity. Smoking appears to be an independent risk factor for the development of diabetes and diabetes complications, in addition to cancer. Evidence for the role of alcohol is mixed. Even moderate alcohol consumption increases the risk for certain types of cancer and excess alcohol consumption is also a risk factor for diabetes. But moderate alcohol consumption is linked with a reduced incidence of diabetes.

▸ What are the possible biologic links between diabetes and cancer risk? The document provides detailed summaries of the evidence pertaining to the potential roles of the insulin/insulin-like growth factor receptor axis, hyperglycemia, hyperinsulinemia, and inflammatory cytokines/inflammation.

▸ Do diabetes treatments influence cancer risk or cancer prognosis? The evidence for specific drugs affecting cancer risk is limited, and observed associations may have been confounded by indications for specific drugs, effects on other cancer risk factors, and the complex progressive nature of hyperglycemia and pharmacotherapy in type 2 diabetes. Early evidence suggests that metformin is associated with a lower risk of cancer and that some exogenously administered insulin is associated with an increased cancer risk. Further research is needed to clarify these issues and evaluate if insulin glargine is more strongly associated with cancer risk, compared with other insulins.

The statement also highlights numerous remaining research questions.

Disclosures: The consensus development conference was supported by an unrestricted grant from Amylin Pharmaceuticals Inc., Lilly USA, Merck & Co., Novo Nordisk A/S, and Sanofi-Aventis. Five of the eight study authors reported financial ties with these and other pharmaceutical companies.

Cancer and diabetes are diagnosed in the same individual more frequently than would be expected.

Source Dr. Giovannucci

A joint consensus statement from the American Diabetes Association and the American Cancer Society reviews the current state of science regarding the complex relationship between diabetes and cancer.

Epidemiologic evidence suggests that people with diabetes—type 2 in particular—are at increased risk for cancer. The reasons are poorly understood, but may include risk factors common to both disorders, diabetes medications, and possible direct causal links.

The ADA and the ACS convened a consensus development conference in December to examine these links. The writing group independently developed a statement that solely represents the positions of the nine panel members and does not reflect official positions of either sponsoring organization (Diabetes Care 2010;33:1674-85).

The panel, chaired by Dr. Edward Giovannucci of Harvard School of Public Health, Boston, recommended that diabetes patients be strongly advised to undergo appropriate cancer screenings.

The statement was organized around answers to four basic questions:

▸ Is there a meaningful association between diabetes and cancer incidence or prognosis? Cancer and diabetes are diagnosed in the same individual more frequently than would be expected by chance, even after adjustment for age. The association appears to be limited to certain types of cancer, while other cancers appear to be less common among people with diabetes. Type 2 diabetes is associated with an increased risk for cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder, but with a reduced risk of prostate cancer. For some other cancer sites there appears to be no association.

▸ What factors are common to both disorders? The association may be due in part to shared risk factors such as aging, obesity, diet, and physical inactivity. Smoking appears to be an independent risk factor for the development of diabetes and diabetes complications, in addition to cancer. Evidence for the role of alcohol is mixed. Even moderate alcohol consumption increases the risk for certain types of cancer and excess alcohol consumption is also a risk factor for diabetes. But moderate alcohol consumption is linked with a reduced incidence of diabetes.

▸ What are the possible biologic links between diabetes and cancer risk? The document provides detailed summaries of the evidence pertaining to the potential roles of the insulin/insulin-like growth factor receptor axis, hyperglycemia, hyperinsulinemia, and inflammatory cytokines/inflammation.

▸ Do diabetes treatments influence cancer risk or cancer prognosis? The evidence for specific drugs affecting cancer risk is limited, and observed associations may have been confounded by indications for specific drugs, effects on other cancer risk factors, and the complex progressive nature of hyperglycemia and pharmacotherapy in type 2 diabetes. Early evidence suggests that metformin is associated with a lower risk of cancer and that some exogenously administered insulin is associated with an increased cancer risk. Further research is needed to clarify these issues and evaluate if insulin glargine is more strongly associated with cancer risk, compared with other insulins.

The statement also highlights numerous remaining research questions.

Disclosures: The consensus development conference was supported by an unrestricted grant from Amylin Pharmaceuticals Inc., Lilly USA, Merck & Co., Novo Nordisk A/S, and Sanofi-Aventis. Five of the eight study authors reported financial ties with these and other pharmaceutical companies.

Cancer and diabetes are diagnosed in the same individual more frequently than would be expected.

Source Dr. Giovannucci

A joint consensus statement from the American Diabetes Association and the American Cancer Society reviews the current state of science regarding the complex relationship between diabetes and cancer.

Epidemiologic evidence suggests that people with diabetes—type 2 in particular—are at increased risk for cancer. The reasons are poorly understood, but may include risk factors common to both disorders, diabetes medications, and possible direct causal links.

The ADA and the ACS convened a consensus development conference in December to examine these links. The writing group independently developed a statement that solely represents the positions of the nine panel members and does not reflect official positions of either sponsoring organization (Diabetes Care 2010;33:1674-85).

The panel, chaired by Dr. Edward Giovannucci of Harvard School of Public Health, Boston, recommended that diabetes patients be strongly advised to undergo appropriate cancer screenings.

The statement was organized around answers to four basic questions:

▸ Is there a meaningful association between diabetes and cancer incidence or prognosis? Cancer and diabetes are diagnosed in the same individual more frequently than would be expected by chance, even after adjustment for age. The association appears to be limited to certain types of cancer, while other cancers appear to be less common among people with diabetes. Type 2 diabetes is associated with an increased risk for cancers of the liver, pancreas, endometrium, colon/rectum, breast, and bladder, but with a reduced risk of prostate cancer. For some other cancer sites there appears to be no association.

▸ What factors are common to both disorders? The association may be due in part to shared risk factors such as aging, obesity, diet, and physical inactivity. Smoking appears to be an independent risk factor for the development of diabetes and diabetes complications, in addition to cancer. Evidence for the role of alcohol is mixed. Even moderate alcohol consumption increases the risk for certain types of cancer and excess alcohol consumption is also a risk factor for diabetes. But moderate alcohol consumption is linked with a reduced incidence of diabetes.

▸ What are the possible biologic links between diabetes and cancer risk? The document provides detailed summaries of the evidence pertaining to the potential roles of the insulin/insulin-like growth factor receptor axis, hyperglycemia, hyperinsulinemia, and inflammatory cytokines/inflammation.

▸ Do diabetes treatments influence cancer risk or cancer prognosis? The evidence for specific drugs affecting cancer risk is limited, and observed associations may have been confounded by indications for specific drugs, effects on other cancer risk factors, and the complex progressive nature of hyperglycemia and pharmacotherapy in type 2 diabetes. Early evidence suggests that metformin is associated with a lower risk of cancer and that some exogenously administered insulin is associated with an increased cancer risk. Further research is needed to clarify these issues and evaluate if insulin glargine is more strongly associated with cancer risk, compared with other insulins.

The statement also highlights numerous remaining research questions.

Disclosures: The consensus development conference was supported by an unrestricted grant from Amylin Pharmaceuticals Inc., Lilly USA, Merck & Co., Novo Nordisk A/S, and Sanofi-Aventis. Five of the eight study authors reported financial ties with these and other pharmaceutical companies.

Cancer and diabetes are diagnosed in the same individual more frequently than would be expected.

Source Dr. Giovannucci

ORLANDO — Progress toward an “artificial pancreas” for automatically controlling glucose levels in people with diabetes is happening in incremental steps that will begin with the minimization of hypoglycemic and hyperglycemic excursions.

“The artificial pancreas is not immediately going to be a system that you immediately plug on and walk away from your diabetes …. This is going to be an evolutionary, iterative process,” said Aaron J. Kowalski, assistant vice president for glucose control research at the Juvenile Diabetes Research Foundation.

The foundation is funding much of the research into the development of “closed-loop” insulin delivery systems via its Artificial Pancreas Project.

Current areas of research focus involve systems that would minimize hypoglycemia and hyperglycemia, including a pump shut-off system that predicts impending nocturnal hypoglycemia and suspends delivery for up to 2 hours.

The Medtronic Veo insulin pump that already contains such a mechanism is available in the United Kingdom but not the United States because of regulatory issues, Dr. Kowalski noted during a symposium.

Overnight closed-loop control is already possible with currently available technology, while improved sensors and insulin formulations will ultimately be needed in order to create a fully automated system that is envisioned as including a bihormonal system with glucagon as well as insulin, Dr. Kowalski said.

Dr. Roman Hovorka of the Institute of Metabolic Science and the department of pediatrics at the University of Cambridge, England, presented new data on use of closed-loop overnight glucose control using currently available insulin pumps and sensors along with an algorithm created by his team that utilizes adaptive model-predictive control.

His study involved 17 children and 24 adults with type 1 diabetes.

Over the course of 57 nights with the closed loop, the patients spent an average of 77% of the time in the target glucose range of 71-145 mg/dL, compared with just 47% of 45 nights with insulin pump therapy that did not use a closed-loop system.

Similar benefit was seen in both the adults and the children, Dr. Hovorka said.

Marilyn Ritholz, Ph.D., a psychologist at the Joslin Diabetes Center, Boston, presented new qualitative data on attitudes toward the use of continuous glucose monitors in a focus group of 20 adults with type 1 diabetes who had participated in a JDRF-sponsored trial of the efficacy of CGM.

In semistructured interviews, patients who had more success using CGM tended to use a problem-solving approach and used retrospective data to try to identify patterns, rather than simply relying on the minute-by-minute updates. Support from spouses and other loved ones also was important in achieving good results.

On the other hand, patients who tended to react emotionally to the CGM readings and alarms were less likely to be successful, as were those whose spouses were disinterested or unsupportive.

And, while body image perception did not appear to predict success, certain themes emerged in that area that merit further exploration.

From the patient's perspective, “CGM needs to become a personal accessory and not a medical device,” Dr. Ritholz commented.

Disclosures: Dr. Kowalski and Dr. Ritholz stated that they have no conflicts of interest. Dr. Hovorka is on the advisory panel for Animas, receives research support from MiniMed Medtronic, Abbott Diabetes Care, and Smiths Medical, and is on the speakers bureau for LifeScan, MiniMed Medtronic, Braun, and Novo Nordisk. He also receives license fees from Becton Dickinson.

Dr. Aaron J. Kowalski wears an insulin pump and glucose sensor, two of the three “artificial pancreas” components.

Source Miriam E. Tucker/Elsevier Global Medical News

ORLANDO — Progress toward an “artificial pancreas” for automatically controlling glucose levels in people with diabetes is happening in incremental steps that will begin with the minimization of hypoglycemic and hyperglycemic excursions.

“The artificial pancreas is not immediately going to be a system that you immediately plug on and walk away from your diabetes …. This is going to be an evolutionary, iterative process,” said Aaron J. Kowalski, assistant vice president for glucose control research at the Juvenile Diabetes Research Foundation.

The foundation is funding much of the research into the development of “closed-loop” insulin delivery systems via its Artificial Pancreas Project.

Current areas of research focus involve systems that would minimize hypoglycemia and hyperglycemia, including a pump shut-off system that predicts impending nocturnal hypoglycemia and suspends delivery for up to 2 hours.

The Medtronic Veo insulin pump that already contains such a mechanism is available in the United Kingdom but not the United States because of regulatory issues, Dr. Kowalski noted during a symposium.

Overnight closed-loop control is already possible with currently available technology, while improved sensors and insulin formulations will ultimately be needed in order to create a fully automated system that is envisioned as including a bihormonal system with glucagon as well as insulin, Dr. Kowalski said.

Dr. Roman Hovorka of the Institute of Metabolic Science and the department of pediatrics at the University of Cambridge, England, presented new data on use of closed-loop overnight glucose control using currently available insulin pumps and sensors along with an algorithm created by his team that utilizes adaptive model-predictive control.

His study involved 17 children and 24 adults with type 1 diabetes.

Over the course of 57 nights with the closed loop, the patients spent an average of 77% of the time in the target glucose range of 71-145 mg/dL, compared with just 47% of 45 nights with insulin pump therapy that did not use a closed-loop system.

Similar benefit was seen in both the adults and the children, Dr. Hovorka said.

Marilyn Ritholz, Ph.D., a psychologist at the Joslin Diabetes Center, Boston, presented new qualitative data on attitudes toward the use of continuous glucose monitors in a focus group of 20 adults with type 1 diabetes who had participated in a JDRF-sponsored trial of the efficacy of CGM.

In semistructured interviews, patients who had more success using CGM tended to use a problem-solving approach and used retrospective data to try to identify patterns, rather than simply relying on the minute-by-minute updates. Support from spouses and other loved ones also was important in achieving good results.

On the other hand, patients who tended to react emotionally to the CGM readings and alarms were less likely to be successful, as were those whose spouses were disinterested or unsupportive.

And, while body image perception did not appear to predict success, certain themes emerged in that area that merit further exploration.

From the patient's perspective, “CGM needs to become a personal accessory and not a medical device,” Dr. Ritholz commented.

Disclosures: Dr. Kowalski and Dr. Ritholz stated that they have no conflicts of interest. Dr. Hovorka is on the advisory panel for Animas, receives research support from MiniMed Medtronic, Abbott Diabetes Care, and Smiths Medical, and is on the speakers bureau for LifeScan, MiniMed Medtronic, Braun, and Novo Nordisk. He also receives license fees from Becton Dickinson.

Dr. Aaron J. Kowalski wears an insulin pump and glucose sensor, two of the three “artificial pancreas” components.

Source Miriam E. Tucker/Elsevier Global Medical News

ORLANDO — Progress toward an “artificial pancreas” for automatically controlling glucose levels in people with diabetes is happening in incremental steps that will begin with the minimization of hypoglycemic and hyperglycemic excursions.

“The artificial pancreas is not immediately going to be a system that you immediately plug on and walk away from your diabetes …. This is going to be an evolutionary, iterative process,” said Aaron J. Kowalski, assistant vice president for glucose control research at the Juvenile Diabetes Research Foundation.

The foundation is funding much of the research into the development of “closed-loop” insulin delivery systems via its Artificial Pancreas Project.

Current areas of research focus involve systems that would minimize hypoglycemia and hyperglycemia, including a pump shut-off system that predicts impending nocturnal hypoglycemia and suspends delivery for up to 2 hours.

The Medtronic Veo insulin pump that already contains such a mechanism is available in the United Kingdom but not the United States because of regulatory issues, Dr. Kowalski noted during a symposium.

Overnight closed-loop control is already possible with currently available technology, while improved sensors and insulin formulations will ultimately be needed in order to create a fully automated system that is envisioned as including a bihormonal system with glucagon as well as insulin, Dr. Kowalski said.

Dr. Roman Hovorka of the Institute of Metabolic Science and the department of pediatrics at the University of Cambridge, England, presented new data on use of closed-loop overnight glucose control using currently available insulin pumps and sensors along with an algorithm created by his team that utilizes adaptive model-predictive control.

His study involved 17 children and 24 adults with type 1 diabetes.

Over the course of 57 nights with the closed loop, the patients spent an average of 77% of the time in the target glucose range of 71-145 mg/dL, compared with just 47% of 45 nights with insulin pump therapy that did not use a closed-loop system.

Similar benefit was seen in both the adults and the children, Dr. Hovorka said.

Marilyn Ritholz, Ph.D., a psychologist at the Joslin Diabetes Center, Boston, presented new qualitative data on attitudes toward the use of continuous glucose monitors in a focus group of 20 adults with type 1 diabetes who had participated in a JDRF-sponsored trial of the efficacy of CGM.

In semistructured interviews, patients who had more success using CGM tended to use a problem-solving approach and used retrospective data to try to identify patterns, rather than simply relying on the minute-by-minute updates. Support from spouses and other loved ones also was important in achieving good results.

On the other hand, patients who tended to react emotionally to the CGM readings and alarms were less likely to be successful, as were those whose spouses were disinterested or unsupportive.

And, while body image perception did not appear to predict success, certain themes emerged in that area that merit further exploration.

From the patient's perspective, “CGM needs to become a personal accessory and not a medical device,” Dr. Ritholz commented.

Disclosures: Dr. Kowalski and Dr. Ritholz stated that they have no conflicts of interest. Dr. Hovorka is on the advisory panel for Animas, receives research support from MiniMed Medtronic, Abbott Diabetes Care, and Smiths Medical, and is on the speakers bureau for LifeScan, MiniMed Medtronic, Braun, and Novo Nordisk. He also receives license fees from Becton Dickinson.

Dr. Aaron J. Kowalski wears an insulin pump and glucose sensor, two of the three “artificial pancreas” components.

Source Miriam E. Tucker/Elsevier Global Medical News

Major Finding: Nonalcoholic fatty liver disease in obese children, adolescents, and young adults was twice as high among males as females, with 27% vs. 13% having ALT levels above 40 IU/L. The NAFLD prevalence increased with age in males but decreased with age in females.

Data Source: A prospective, cross-sectional study of 156 obese youth aged 5-20 years.

Disclosures: Dr. Gupta stated that he had no conflicts of interest.

BOSTON — Nonalcoholic fatty liver disease was found in 19% of 156 obese children and young adults aged 5-20 years in a cross-sectional analysis.

In the study, more than half of the males aged 16-20 years had NAFLD, reported Dr. Rish Gupta at the meeting.

The findings suggest that liver function testing (LFT) should be considered in obese children with dyslipidemia and/or insulin resistance, said Dr. Gupta, a pediatric endocrinology fellow at the State University of New York Downstate Medical Center, Brooklyn.

The multiethnic group of 86 females and 70 males all had BMIs greater than the 95th percentile, but did not have diabetes, abnormal thyroid function, or liver disease due to hepatitis or Wilson's disease. Thirty (19%) had levels of ALT greater than 40 IU/L, generally considered the cutoff to indicate NAFLD.

The subjects with elevated ALT did not differ from those with ALT levels at or below 40 IU/L in age (average, 12 years) or BMI (34 kg/m

The prevalence of NAFLD was twice as high in the males as the females, with 27% vs. 13% having ALT levels above 40 IU/L. Males with NAFLD had significantly higher triglycerides than did the females with NAFLD (231 vs. 193 mg/dL), and also had lower HDL (34 vs. 35 mg/dL).

The prevalence of NAFLD rose with age for the entire study group, from 14.5% for 5- to 10-year-olds to 18% for 11- to 15-year-olds, to 31% for 16- to 20-year-olds. However, when broken down by sex, the relation between NAFLD and age went in opposite directions. It actually dropped with age in the females, from 15.1% in the youngest group to 14.7% in the 11- to 15-year group to 7.1% in the older teens/young adults. In contrast, in the males the NAFLD prevalence rose with age from 13.6% to 24.2% to 53%.

The reason for the sex difference in the direction of NAFLD with age may be that puberty in boys is associated with increased insulin resistance, whereas high estrogen levels in females may be protective against NAFLD, Dr. Gupta said.

In an interview, Dr. Gupta advised that all children with a BMI of more than the 95th percentile or with insulin resistance or hypercholesterolemia should undergo LFT. If elevated, the LFT should be repeated in the next 3-6 months. Children with persistently elevated ALT should be further evaluated for viral markers to rule out other known causes of liver disorders.

In addition to lifestyle modification to promote weight loss and improved insulin sensitivity, metformin also can be used to treat NAFLD in children, he said.

Males with NAFLD had higher triglycerides than did the females with NAFLD, and also had lower HDL.

Source DR. GUPTA

Major Finding: Nonalcoholic fatty liver disease in obese children, adolescents, and young adults was twice as high among males as females, with 27% vs. 13% having ALT levels above 40 IU/L. The NAFLD prevalence increased with age in males but decreased with age in females.

Data Source: A prospective, cross-sectional study of 156 obese youth aged 5-20 years.

Disclosures: Dr. Gupta stated that he had no conflicts of interest.

BOSTON — Nonalcoholic fatty liver disease was found in 19% of 156 obese children and young adults aged 5-20 years in a cross-sectional analysis.

In the study, more than half of the males aged 16-20 years had NAFLD, reported Dr. Rish Gupta at the meeting.

The findings suggest that liver function testing (LFT) should be considered in obese children with dyslipidemia and/or insulin resistance, said Dr. Gupta, a pediatric endocrinology fellow at the State University of New York Downstate Medical Center, Brooklyn.

The multiethnic group of 86 females and 70 males all had BMIs greater than the 95th percentile, but did not have diabetes, abnormal thyroid function, or liver disease due to hepatitis or Wilson's disease. Thirty (19%) had levels of ALT greater than 40 IU/L, generally considered the cutoff to indicate NAFLD.

The subjects with elevated ALT did not differ from those with ALT levels at or below 40 IU/L in age (average, 12 years) or BMI (34 kg/m

The prevalence of NAFLD was twice as high in the males as the females, with 27% vs. 13% having ALT levels above 40 IU/L. Males with NAFLD had significantly higher triglycerides than did the females with NAFLD (231 vs. 193 mg/dL), and also had lower HDL (34 vs. 35 mg/dL).

The prevalence of NAFLD rose with age for the entire study group, from 14.5% for 5- to 10-year-olds to 18% for 11- to 15-year-olds, to 31% for 16- to 20-year-olds. However, when broken down by sex, the relation between NAFLD and age went in opposite directions. It actually dropped with age in the females, from 15.1% in the youngest group to 14.7% in the 11- to 15-year group to 7.1% in the older teens/young adults. In contrast, in the males the NAFLD prevalence rose with age from 13.6% to 24.2% to 53%.

The reason for the sex difference in the direction of NAFLD with age may be that puberty in boys is associated with increased insulin resistance, whereas high estrogen levels in females may be protective against NAFLD, Dr. Gupta said.

In an interview, Dr. Gupta advised that all children with a BMI of more than the 95th percentile or with insulin resistance or hypercholesterolemia should undergo LFT. If elevated, the LFT should be repeated in the next 3-6 months. Children with persistently elevated ALT should be further evaluated for viral markers to rule out other known causes of liver disorders.

In addition to lifestyle modification to promote weight loss and improved insulin sensitivity, metformin also can be used to treat NAFLD in children, he said.

Males with NAFLD had higher triglycerides than did the females with NAFLD, and also had lower HDL.

Source DR. GUPTA

Major Finding: Nonalcoholic fatty liver disease in obese children, adolescents, and young adults was twice as high among males as females, with 27% vs. 13% having ALT levels above 40 IU/L. The NAFLD prevalence increased with age in males but decreased with age in females.

Data Source: A prospective, cross-sectional study of 156 obese youth aged 5-20 years.

Disclosures: Dr. Gupta stated that he had no conflicts of interest.

BOSTON — Nonalcoholic fatty liver disease was found in 19% of 156 obese children and young adults aged 5-20 years in a cross-sectional analysis.

In the study, more than half of the males aged 16-20 years had NAFLD, reported Dr. Rish Gupta at the meeting.

The findings suggest that liver function testing (LFT) should be considered in obese children with dyslipidemia and/or insulin resistance, said Dr. Gupta, a pediatric endocrinology fellow at the State University of New York Downstate Medical Center, Brooklyn.

The multiethnic group of 86 females and 70 males all had BMIs greater than the 95th percentile, but did not have diabetes, abnormal thyroid function, or liver disease due to hepatitis or Wilson's disease. Thirty (19%) had levels of ALT greater than 40 IU/L, generally considered the cutoff to indicate NAFLD.

The subjects with elevated ALT did not differ from those with ALT levels at or below 40 IU/L in age (average, 12 years) or BMI (34 kg/m

The prevalence of NAFLD was twice as high in the males as the females, with 27% vs. 13% having ALT levels above 40 IU/L. Males with NAFLD had significantly higher triglycerides than did the females with NAFLD (231 vs. 193 mg/dL), and also had lower HDL (34 vs. 35 mg/dL).

The prevalence of NAFLD rose with age for the entire study group, from 14.5% for 5- to 10-year-olds to 18% for 11- to 15-year-olds, to 31% for 16- to 20-year-olds. However, when broken down by sex, the relation between NAFLD and age went in opposite directions. It actually dropped with age in the females, from 15.1% in the youngest group to 14.7% in the 11- to 15-year group to 7.1% in the older teens/young adults. In contrast, in the males the NAFLD prevalence rose with age from 13.6% to 24.2% to 53%.

The reason for the sex difference in the direction of NAFLD with age may be that puberty in boys is associated with increased insulin resistance, whereas high estrogen levels in females may be protective against NAFLD, Dr. Gupta said.

In an interview, Dr. Gupta advised that all children with a BMI of more than the 95th percentile or with insulin resistance or hypercholesterolemia should undergo LFT. If elevated, the LFT should be repeated in the next 3-6 months. Children with persistently elevated ALT should be further evaluated for viral markers to rule out other known causes of liver disorders.

In addition to lifestyle modification to promote weight loss and improved insulin sensitivity, metformin also can be used to treat NAFLD in children, he said.

Males with NAFLD had higher triglycerides than did the females with NAFLD, and also had lower HDL.

Source DR. GUPTA

ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.

Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over 3 years (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing at the meeting.

In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.

In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.

The subject population was about 40% male, about 75% white, and slightly less than 25% were African American. They had a mean age of 58 years, a mean body weight of 94 kg a mean BMI of 33 kg/m

Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual-care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.

The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3 mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.

Neither overall nor serious adverse events differed between the two groups. Although the sample wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.

About 3,000 diabetes education programs around the country are now recognized by the ADA. In order for this intervention to take place, staff would need to be trained to administer it and policies would need to change to allow reimbursement for treatment of prediabetes, Dr. Goff noted.

Disclosures: Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.

ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.

Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over 3 years (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing at the meeting.

In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.

In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.

The subject population was about 40% male, about 75% white, and slightly less than 25% were African American. They had a mean age of 58 years, a mean body weight of 94 kg a mean BMI of 33 kg/m

Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual-care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.

The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3 mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.

Neither overall nor serious adverse events differed between the two groups. Although the sample wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.

About 3,000 diabetes education programs around the country are now recognized by the ADA. In order for this intervention to take place, staff would need to be trained to administer it and policies would need to change to allow reimbursement for treatment of prediabetes, Dr. Goff noted.

Disclosures: Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.

ORLANDO — A community-based lifestyle intervention program significantly reduced body weight and waist circumference and lowered fasting blood glucose levels at 1 year compared with usual care in a study of 301 adults with prediabetes.

Results of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) study were presented by Dr. David C. Goff, chair of the department of epidemiology and prevention at Wake Forest University. The intervention was modeled after the landmark Diabetes Prevention Program (DPP) study, in which individuals at high risk for type 2 diabetes who received individual lifestyle counseling had a 58% reduction in the development of diabetes over 3 years (N. Engl. J. Med. 2002;346:393-403). Both studies were funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

“In the 7 years since publication of the DPP, there has been great interest in developing and testing ways to translate those behavioral weight loss approaches to community settings in ways that can reach the large population of people with prediabetes,” Dr. Goff said during a press briefing at the meeting.

In HELP PD, the DPP intervention was modified to a group-based counseling session with about 10-14 people per group. In another difference, specially trained lay community health workers who had brought their diabetes under control delivered the intervention, which included encouragement to change eating behaviors and to exercise for up to 180 minutes per week, with an emphasis on walking.

In the intervention group, sessions were held weekly for the first 6 months and monthly for the next 18 months. The usual-care group received two individual sessions with a registered dietician during the first 3 months of the study and a monthly newsletter throughout the 2 years. Telephone calls were also included.

The subject population was about 40% male, about 75% white, and slightly less than 25% were African American. They had a mean age of 58 years, a mean body weight of 94 kg a mean BMI of 33 kg/m

Subjects in the intervention group lost an average of 7 kg in the first intervention year, compared with a loss of 1.5 kg in the usual-care group. Waist circumference was reduced by 5.9 cm in the intervention group, compared with less than 1 cm with usual care.

The primary end point, fasting glucose, dropped by 4.2 mg/dL in the first year, compared with 0.3 mg/dL in the usual-care group. All of these comparisons are highly statistically significant. Fasting insulin levels also declined, Dr. Goff said.

Neither overall nor serious adverse events differed between the two groups. Although the sample wasn't large enough to assess the development of diabetes with statistical significance, there have been fewer cases among the intervention group participants, consistent with the 4-mg/dL reduction in fasting glucose. Monitoring for diabetes will be continued into a second year along with the other parameters, he said.

About 3,000 diabetes education programs around the country are now recognized by the ADA. In order for this intervention to take place, staff would need to be trained to administer it and policies would need to change to allow reimbursement for treatment of prediabetes, Dr. Goff noted.

Disclosures: Dr. Goff stated that he has received funding for diabetes-related research from Merck and has served on a safety monitoring board for Takeda.