Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks

NCT Number	NCT07011147
Lead Sponsor	University of Colorado, Denver Collaborators: Massachusetts General Hospital, Beta Bionics, Inc., Ann & Robert H Lurie Children's Hospital of Chicago
Conditions	Type 1 Diabetes (T1D), Type 2 Diabetes, Diabetes, Autoimmune, Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus, Type I, Diabetes, Type II, Diabetes +3 more
Enrollment	240 participants
Start Date	2026-01-16
Primary Completion	2027-06-30 (estimated)
Study Completion	2029-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-11