Testing a Next-generation Artificial Pancreas Device for Managing Type 1 Diabetes
A clinical trial showed that a next-generation artificial pancreas device outperformed a commercially available first-generation device in adolescents and young adults with type 1 diabetes by increasing time that participants’ blood glucose (sugar) levels were in a healthy range without increasing episodes of dangerously low blood glucose (hypoglycemia). These results are important because glucose management is extremely challenging during adolescence and young adulthood. Artificial pancreas technology, or a closed-loop system, aims to automate type 1 diabetes management by measuring blood glucose levels using a continuous glucose monitor and automatically delivering insulin when needed using an insulin pump. In 2016, the U.S. Food and Drug Administration approved Medtronic’s MiniMed™ 670G as the first commercially available closed-loop system in the United States. However, research on real-world use of the 670G device shows a high discontinuation rate, especially in adolescents and young adults, suggesting that improvements are needed. In a recent clinical trial, researchers compared a next-generation, experimental closed-loop device from the same company with the 670G system. The experimental device had improvements such as advanced computer algorithms that control insulin delivery and easier operation.
The trial enrolled 113 female and male adolescents and young adults with type 1 diabetes ages 14-29 years. Participants were randomly assigned to use either the experimental device or the commercial 670G device for 12 weeks, and then were switched to the other device for 12 more weeks. The results showed that the experimental device improved the amount of time that participants’ blood glucose levels were in a healthy, target range both during the daytime hours and during the entire 24-hour day and night period, without increased episodes of hypoglycemia. The improvements translated to about 1 hour more per day in the target glucose range than achieved when using the 670G device. Participants also reported greater user satisfaction with the experimental device compared to the commercial device.
These trial results showed that the next-generation device outperformed the 670G device and was also more user-friendly. Identifying new and improved type 1 diabetes management technologies—particularly for groups for whom glucose management is challenging—could help people achieve recommended blood glucose levels with less burden, toward improving their short- and long-term health.
Bergenstal RM, Nimri R, Beck RW,…Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): A multicentre, randomised, crossover trial. Lancet 397: 208-219, 2021.