ADA: Next Generation “Artificial Pancreas” Improves Glycemic Control, A1c in T1D

CHICAGO (June 12, 2020)—A “next generation” automatic insulin delivery system (AID) improved daytime blood sugar control and improved A1c levels among adolescents and young adults with type 1 diabetes (T1D) without an increase hypoglycemia, according to research presented today at the American Diabetes Association’s® (ADA’s) 80th Scientific Sessions.

The results of this first comparison of a next generation AID system to a currently approved one were shared during the presentation, “FLAIR—An NIDDK-sponsored international, multi-site randomized crossover trial of AHCL vs 670G.”

Despite the use of multiple daily injections or insulin pumps and continuous glucose monitoring (CGM), many individuals with T1D require additional glycemic control—but without increasing the daily burden of living with diabetes.

Youth with T1D in particular often have difficulty achieving optimal glycemic control, which is essential to help reduce the risk for diabetes complications

AID systems—sometimes referred to as artificial pancreas—are rapidly becoming a standard of care in the management of T1D. The FLAIR (Fuzzy Logic Automated Insulin Regulation) study compared the efficacy and safety of 2 systems manufactured by Medtronic—the new Advanced Hybrid Closed-Loop (AHCL) and the 670GHybrid Closed-Loop (HCL). The latter is one of 2 FDA-approved AID systems

FLAIR enrolled 113 patients with T1D at 7 international diabetes centers. The participants, aged 14 to 29 years, used each AID system for 3 months in a randomized crossover trial.

Standardized pump training, including how to account for meals and exercise, was provided to all participants and their diabetes care partners.

Focusing on the biggest challenge for AID systems--how effective they are at preventing high blood glucose levels during the day--the researchers compared the 2 systems and evaluated how participants adjusted to the daily use of the technology.

Results showed:

• Percentage of time in range (TIR) over 24 hours (ie, blood sugar levels from 70-180 mg/dL) was superior with AHCL vs HCL. TIR went from 57% at baseline to 67% (AHCL) and 63% (HCL).

• The number of individuals achieving the international TIR consensus target of > 70% TIR increased nearly 3-fold from baseline when using AHCL vs increasing almost 2-fold with HCL.

• Baseline average A1c levels were 7.9% and A1c decreased to 7.4% with AHCL vs 7.6% with HCL.

• Both systems were safe when evaluating events of level 3 hypoglycemia or diabetic ketoacidosis.

• Responses to a user satisfaction survey showed patients preferred the AHCL over the HCL system.

“This age group has traditionally been the most difficult group in which to optimize glucose management and the FLAIR study shows that individuals using any type of therapy, even insulin injections without a pump or CGM system, can benefit from the next generation AHCL AID therapy,” said Richard Bergenstal, MD, co-primary investigator of FLAIR, executive director of the International Diabetes Center at HealthPartners, and past ADA President of Medicine & Science, in an ADA press release.

“There is much interest in the future of advanced technology to treat type 1 diabetes," he added, "and the AHCL system is a significant step forward for adolescents or young adults who have a hard time managing their glucose levels.”