Real-World Study of the iLet Bionic Pancreas for Adults With Insulin-Treated Type 1 or Type 2 Diabetes in Primary Care Settings

What this Trial Is About

Researchers are investigating the use of the iLet Bionic Pancreas BP system in adults with insulin-treated diabetes, including both type 1 and type 2 diabetes. This randomized controlled trial aims to compare the efficacy and safety of the iLet BP to standard care ordered by primary care providers. The main goal is to determine if the iLet BP can be effectively used in primary care settings and whether it leads to greater reductions in HbA1c over 13 weeks compared to routine care. Participants will be randomly assigned to either use the iLet BP system for 13 weeks or continue their routine diabetes care. Those in the iLet BP group will receive training on the device and supporting tools like continuous glucose monitors CGM, blood glucose meters, and ketone meters, along with regular follow-up calls. Routine care participants continue their current treatments and will also receive training on the study blood glucose meter and have follow-up calls. At the end of 13 weeks, routine care participants have the option to join an observational extension phase using the iLet BP for an additional 13 weeks. Throughout the study, participants will complete virtual screening, mid-study follow-up calls, and final visits. They will wear CGM devices to collect glucose data and perform fingerstick HbA1c blood tests. Researchers will evaluate blood sugar control by measuring HbA1c and various CGM glucose parameters during both the randomized and extension phases. Safety and adherence will be monitored through follow-up calls and device usage, with the study lasting up to 26 weeks for those in the extension phase.

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery