Evaluating MiniMed 780 Hybrid Closed-Loop Insulin Delivery and Simplera Monitoring for Diabetes Management After Pancreatectomy A Randomized Cross-Over Study

What this Trial Is About

Researchers are studying individuals with diabetes caused by total or partial pancreatectomy, who often face difficulties managing fluctuating blood glucose levels that impact quality of life. This trial evaluates the use of hybrid closed-loop HCL automated insulin delivery systems, specifically the MiniMed 780 combined with Simplera, to improve metabolic outcomes and glucose control. There is limited evidence on commercially available monohormonal HCL systems for this condition, making this study important to support broader access. The study involves a 3-month treatment period using the MiniMed 780 HCL system combined with the Simplera continuous glucose monitoring device. Participants will also undergo a 3-month control period using their usual diabetes treatment alongside the Simplera device for glucose monitoring. The trial uses a randomized crossover design where participants receive both the HCL system and their usual treatment in different sequences. During the study, participants manage insulin delivery with an external pump and glucose monitoring via a sensor placed on the upper arm. Researchers will measure the percentage of time glucose levels remain within the target range 70-180 mgdL over each 3-month period. Additional assessments include HbA1c levels, frequency of low blood sugar events, glucose variability, and acute metabolic episodes. Participants are monitored for safety and effectiveness throughout the study duration.

Hybrid Closed-Loop Insulin Delivery After Pancreatectomy