"In this six-month extension to the trial, we found that most adults continued to use CGM almost every day, and had sustained benefits in diabetes control as measured by HbA1c levels and the amount of time blood sugar was in the target range," said Dr. Aaron Kowalski, Program Director for Metabolic Control at JDRF. "These benefits persisted despite less intensive follow-up over the second half of the trial than the first, which was designed to approximate usual clinical practice."

He noted that just as important as the persistence of control that CGM devices helped patients achieve was the remarkably low rate of severe hypoglycemic events during the second six months of the study. Severe hypoglycemic events - which required the assistance of another person or medical professional - were experienced by 10% of the study participants during the first six months of the trial, but only by 4% in the second six months. The rate of severe hypoglycemic events fell from 21.8 events per 100 person-years during the first six months to 7.1 events per 100 person-years during the second six months. The rate was not associated with the HbA1c level of the trial participants at the time the study began.

According to Dr. Tamborlane, an investigator in both the JDRF CGM Trial and DCCT trials, the rate of severe hypoglycemia in people using CGM devices during the second six months of the JDRF trial was markedly lower than in the Diabetes Control and Complications Trial intensive treatment group - seven hypoglycemia events compared with 62 in the DCCT trial - even though the mean HbA1c of JDRF trial participants at 6.8% was lower than the DCCT trial participants' level of 7.1%.

"Plus, the total absence of severe hypoglycemia during the second six months of the study in the participants who began the trial with an HbA1c below 7% is particularly striking, especially since these subjects were able to maintain a mean HbA1c of 6.4%," Dr. Tamborlane said.

These studies are the third and fourth publications resulting from JDRF's groundbreaking CGM trials, established to clinically assess the benefits of CGM devices in helping people with type 1 diabetes manage their disease more effectively. In addition to results published last fall in The New England Journal of Medicine, results were published in May in Diabetes Care, showing that people with type 1 diabetes who have already been successful in achieving recommended blood sugar goals (below 7%) can further benefit from using continuous glucose monitoring (CGM) devices, while experiencing less hypoglycemia.

JDRF has actively shared the results of the CGM trial with health insurance plans, and as a result many of the nation's leading plans including Aetna, Cigna, Kaiser Permanente, United Healthcare, and Wellpoint now cover CGM for patients with type 1 diabetes. In addition, due to the JDRF trial, CGM is now included in national standards of care for type 1 diabetes, making doctors more likely to prescribe them for patients.

Source: Juvenile Diabetes Research Foundation International