Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes

This 13 week multicenter randomized trial evaluated the efficacy and safety of an insulin only bionic pancreas (iLet) in 326 participants (ages 6–79) with type 1 diabetes. The bionic pancreas, initialized solely by body weight and requiring only qualitative meal announcements (no carbohydrate counting), was compared to standard care (any insulin delivery method with continuous glucose monitoring). At 13 weeks, the bionic pancreas group showed a significant reduction in glycated hemoglobin levels (7.3% vs. 7.7% in standard care; adjusted difference  0.5%, P<0.001) and increased time in the target glucose range (70–180 mg/dL) by 2.6 hours/day, without increasing hypoglycemia. Severe hypoglycemia rates were similar between groups (17.7 vs. 10.8 events/100 participant years). The bionic pancreas demonstrated superior glycemic control while simplifying management.

This 13 week multicenter randomized trial evaluated the efficacy and safety of an insulin only bionic pancreas (iLet) in 326 participants (ages 6–79) with type 1 diabetes. The bionic pancreas, initialized solely by body weight and requiring only qualitative meal announcements (no carbohydrate counting), was compared to standard care (any insulin delivery method with continuous glucose monitoring). At 13 weeks, the bionic pancreas group showed a significant reduction in glycated hemoglobin levels (7.3% vs. 7.7% in standard care; adjusted difference  0.5%, P<0.001) and increased time in the target glucose range (70–180 mg/dL) by 2.6 hours/day, without increasing hypoglycemia. Severe hypoglycemia rates were similar between groups (17.7 vs. 10.8 events/100 participant years). The bionic pancreas demonstrated superior glycemic control while simplifying management.