Metabolic Effects of Hybrid Closed-loop Insulin Delivery in People With Diabetes After Pancreatectomy: a Randomized Cross-over Controlled Trial

What this Trial Is About

This research investigates the use of hybrid closed-loop (HCL) automated insulin delivery systems in people with diabetes caused by partial or total removal of the pancreas (pancreatectomy). This condition often leads to difficult-to-manage blood sugar levels which impact quality of life. While HCL systems have been studied in type 1 diabetes, there is limited evidence on their effectiveness in post-pancreatectomy diabetes, especially for commercially available devices. The study compares two 3-month treatment periods in a randomized crossover design. One period involves using the MiniMed 780 insulin pump combined with the Simplera continuous glucose monitoring system, which automatically adjusts insulin delivery. The other period involves usual diabetes treatment alongside continuous glucose monitoring with the Simplera device alone. Participants will alternate between these treatments to evaluate differences. Participants will manage insulin delivery and glucose monitoring during both periods using the devices. The study will measure how much time participants' glucose levels remain within the target range of 70 to 180 mg/dL over 3 months with each treatment. Secondary measures include blood sugar control (HbA1c), time spent below target glucose levels, glucose variation, and frequency of metabolic events. Safety, treatment adherence, and other health assessments will also be monitored throughout the study which is expected to run until late 2027.

Hybrid Closed-Loop Insulin Delivery After Pancreatectomy