Bionic Pancreas in CFRD
- Conditions
- Cystic Fibrosis-related Diabetes
- Interventions
- Device: iLet Bionic Pancreas System (BP)Device: Usual Care (UC)
- Registration Number
- NCT06449677
- Lead Sponsor
- Jaeb Center for Health Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UC Group Usual Care (UC) Participants randomized to the Usual Care (UC) group will use their existing insulin delivery method in conjunction with a study CGM during the first 13-week of the study (RCT phase). The UC group will then initiate use of the BP System for the remaining 13 weeks of the study (Extension Phase). UC Group iLet Bionic Pancreas System (BP) Participants randomized to the Usual Care (UC) group will use their existing insulin delivery method in conjunction with a study CGM during the first 13-week of the study (RCT phase). The UC group will then initiate use of the BP System for the remaining 13 weeks of the study (Extension Phase). BP Group iLet Bionic Pancreas System (BP) Participants randomized to the intervention group will use the BP group using the iLet Bionic Pancreas System (BP) and continuous glucose monitoring (CGM) during the first 13-week of the study (RCT phase). After the RCT phase, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system.
- Primary Outcome Measures
Name Time Method CGM-measured Time In Target Range of 70-180 mg/dL (TIR) 13 weeks CGM-measured time in target range of 70-180 mg/dL (TIR)
- Secondary Outcome Measures
Name Time Method CGM-measured Time In Range <54 mg/dL 13 weeks CGM-measured time in range \<54 mg/dL
Trial Locations
- Locations (13)
Emory University
🇺🇸Atlanta, Georgia, United States
University of Colorado-Barbara Davis Center for Diabetes
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Health San Antonio
🇺🇸San Antonio, Texas, United States
University of Virginia-Center for Diabetes Technology
🇺🇸Charlottesville, Virginia, United States