Bionic Pancreas in CFRD (NCT06449677)
A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado-Barbara Davis Center for Diabetes — Aurora, Colorado
Age range: 14 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- University of Colorado-Barbara Davis Center for Diabetes — Aurora, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- Emory University — Atlanta, Georgia
- Indiana University School of Medicine — Indianapolis, Indiana
- Johns Hopkins University School of Medicine — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- University of Minnesota — Minneapolis, Minnesota
- Children's Mercy Hospital — Kansas City, Missouri
- Columbia University Medical Center — New York, New York
- University Hospitals of Cleveland — Cleveland, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- UT Southwestern Medical Center — Dallas, Texas
- Baylor College of Medicine — Houston, Texas
- University of Texas Health San Antonio — San Antonio, Texas
- University of Utah — Salt Lake City, Utah
- University of Virginia-Center for Diabetes Technology — Charlottesville, Virginia
📞 Contact the Study Coordinator
Phone: (813) 975-8690
Email: jsibayan@jaeb.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis-related Diabetes
- SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes — Minneapolis, Minnesota
- Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis — Milwaukee, Wisconsin
- Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function — Kansas City, Kansas
Explore by condition: All Cystic Fibrosis-related Diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.