Study of AIDANET Automated Insulin Delivery Algorithm in Adults With Type 1 Diabetes Comparing Fully Closed-Loop and Hybrid Closed-Loop Modes

What this Trial Is About

Researchers are evaluating the AIDANET automated insulin delivery algorithm in adults with Type 1 Diabetes. This randomized cross-over trial compares AIDANET used in three modes fully closed loop FCL, hybrid closed loop HCL, and a mixed mode allowing users to switch between FCL and HCL. The study aims to assess glycemic control by comparing AIDANET with usual care automated insulin delivery systems currently used by participants. Participants will use the AIDANET system in three separate 4-week phases, first using either the HCL or FCL mode in random order. Then, they will use the mixed FCL-HCL mode for 4 weeks, choosing their preferred mode daily. Additionally, participants will spend 4 weeks using their usual care automated insulin delivery system either before or after the AIDANET phases, depending on their assigned group. The system uses continuous glucose monitoring and an insulin pump managed via a smartphone app. During the study, participants will wear a Dexcom continuous glucose monitor and use the study devices at home. Researchers will monitor blood sugar control, focusing on the time spent in the target glucose range 70-180 mgdL over 16 weeks. Participants will be trained on study devices, upload data regularly, and follow study procedures. The total participation involves multiple phases over several months with ongoing monitoring and data collection.

A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)