Bionic Pancreas in CFRD
Recruiting now · Phase 3
Conditions studied: Cystic Fibrosis-related Diabetes
In brief
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.
Key facts
- Study ID
- NCT06449677
- Run by
- Jaeb Center for Health Research
- People needed
- 150
- Starts
- 2024-09-24
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2026-06-24
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Virginia-Center for Diabetes Technology — Charlottesville, Virginia, United States (enrolling)
- Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
- Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
- Columbia University Medical Center — New York, New York, United States (enrolling)
- University Hospitals of Cleveland — Cleveland, Ohio, United States (enrolling)
- University of Colorado-Barbara Davis Center for Diabetes — Aurora, Colorado, United States (enrolling)
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- University of Texas Health San Antonio — San Antonio, Texas, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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