Clinical Trial

Bionic Pancreas in CFRD

Recruiting Phase 3
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Summary
This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2024-06-03; most recent amendment 2026-06-23.
Status change: Not Yet Recruiting → Recruiting 2024-10-01
Trial Details
NCT Number NCT06449677
Lead Sponsor Jaeb Center for Health Research
Collaborators: Cystic Fibrosis Foundation, Massachusetts General Hospital, Beta Bionics, Inc.
Conditions Cystic Fibrosis-related Diabetes
Enrollment 150 participants
Start Date 2024-09-24
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-24