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.
Cystic Fibrosis-related Diabetes
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.
Bionic Pancreas in CFRD
-
University of Colorado-Barbara Davis Center for Diabetes, Aurora, Colorado, United States, 80045
Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
University of Minnesota, Minneapolis, Minnesota, United States, 55455
Children's Mercy Hospital, Kansas City, Missouri, United States, 64108
University Hospitals of Cleveland, Cleveland, Ohio, United States, 44106
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104
University of Virginia-Center for Diabetes Technology, Charlottesville, Virginia, United States, 22903
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
14 Years to
ALL
No
Jaeb Center for Health Research,
Melissa Putman, MD, STUDY_CHAIR, Massachusetts General Hospital
Colleen Bauza, PhD, MPH, STUDY_DIRECTOR, Jaeb Center for Health Research
2026-03