Safety and Feasibility of a Fully Automated Insulin Delivery System: FCL@Home, a Multicenter Randomized Clinical Trial in Individuals With Type 1 Diabetes.

Abstract

Automated insulin delivery (AID) requiring manual premeal boluses are the standard of care for people with type 1 diabetes (T1D). We evaluated the safety and feasibility of the Automated Insulin Delivery as an Adaptive NETwork (AIDANET) system used without meal announcements in both supervised and home settings across a diverse population of people with T1D. Adults (age >25 years), young adults (age 18-25 years), and adolescents (age 14-18 years) were enrolled at three sites in the U.S. to compare the AIDANET system used in fully closed-loop (FCL) with usual care (UC) in a randomized crossover study. Participants spent ∼5 days using FCL in a supervised environment followed by ∼7 days of use at home. The prespecified primary outcome was defined as the change in mean sensor glucose (MSG) between the 2nd week of UC and the week of the FCL at-home period. Overall, 34 participants (12 adults, 10 young adults, 12 adolescents; mean age 25.4 ± 12.6 years; 62% female; mean HbA1c 8.0 ± 1.1%; 94% hybrid closed loop users during UC) completed the study. MSG improved from 178 to 164 mg/dL (UC vs. FCL P = 0.0058). The percentages of time in range (70-180 mg/dL), time in tight range (70-140 mg/dL), and time above range (>180 mg/dL and >250 mg/dL) also significantly improved, primarily overnight. The percentage of time <70 and <54 mg/dL were significantly noninferior in FCL compared with UC. FCL therapy with the AIDANET system can significantly improve average glycemic control while removing the need for mealtime bolusing for a broad population of people with T1D.