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Studies

Interventional Recruiting Phase 3

NCT06449677 on ClinicalTrials.gov

Bionic Pancreas in CFRD

Official title: A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes

  • Sponsor: Jaeb Center for Health Research
  • Collaborators: Cystic Fibrosis Foundation, Massachusetts General Hospital, Beta Bionics, Inc.
  • Enrollment: 150 (Estimated)
  • Study start: 2024-09-24 (Actual)
  • Primary completion: 2026-09-30 (Estimated)
  • Study completion: 2027-03-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 13-week RCT followed by a 13-week Extension Phase in which all participants use the iLet BP System
  • Masking: None
  • PrimaryPurpose: Treatment

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.

Conditions

  • Cystic Fibrosis-related Diabetes

Intervention / Treatment

  • Device: iLet Bionic Pancreas System (BP)
  • Device: Usual Care (UC)

Primary Outcome Measures

  • 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)

Countries

United States

Locations and Investigators

  • University of Colorado-Barbara Davis Center for Diabetes, Aurora, United States (Recruiting)
    • Christine Hovater
    • Christine L Chan, MD (Principal Investigator)
    • Paul Wadwa, MD
    • Gregory Forlenza, MD, MS
    • Erin Cobry, MD
  • Yale University School of Medicine, New Haven, United States (Recruiting)
    • Amy Steffen, BSN
    • Michelle Van Name, MD (Principal Investigator)
    • Stuart Weinzimer, MD
    • Marie Egan, MD
    • Amy Darukhanavala, MD
  • Emory University, Atlanta, United States (Recruiting)
    • Demetria Oliver
    • Tanicia Daley, MD, MPH (Principal Investigator)
    • Kristina Cossen, MD
  • Indiana University School of Medicine, Indianapolis, United States (Recruiting)
    • Kathy Bohanan
    • Viral Shah, MD (Principal Investigator)
    • Cynthia Brown, MD, MS
    • Zunera Tariq, MD, MPH
  • Johns Hopkins University School of Medicine, Baltimore, United States (Recruiting)
    • Lee Bromberger
    • Scott Blackman, MD, PhD (Principal Investigator)
    • Malinda Wu, MD, MSCR
    • Aniket Sidhaye, MD
  • Massachusetts General Hospital, Boston, United States (Recruiting)
    • Annabelle Ashley, BSN
    • Melissa Putman, MD (Principal Investigator)
    • Kristen Flint, MD
  • University of Minnesota, Minneapolis, United States (Recruiting)
    • Cathy Larson
    • Amir Moheet, MD (Principal Investigator)
    • Antoinette Moran, MD
    • Tasma Harindhanavudhi, MD
  • Children's Mercy Hospital, Kansas City, United States (Recruiting)
    • Kelsye Howell
    • Cintya Schweisberger, DO (Principal Investigator)
    • Hugo Escobar, MD
    • Wayne Moore, MD, PhD
  • Columbia University Medical Center, New York, United States (Recruiting)
    • Amy Doytchinov, BSN
    • Kristen Williams, MD (Principal Investigator)
    • Jacqueline Lonier, MD
    • Robin Goland, MD
    • Hossein Sadeghi, MD
  • University Hospitals of Cleveland, Cleveland, United States (Recruiting)
    • Cindy Schaefer, BSN
    • Terri Casey, BSN
    • Beth Kaminski, MD (Principal Investigator)
    • Katherine Kutney, MD
    • Erica Roesch, MD
    • Alex Gifford, MD
  • Children's Hospital of Philadelphia, Philadelphia, United States (Completed)
  • UT Southwestern Medical Center, Dallas, United States (Recruiting)
    • Lindsay Allen
    • Melissa Ham, MD (Principal Investigator)
    • Meghana Sathe, MD
    • Preeti Sharma, MD
  • Baylor College of Medicine, Houston, United States (Recruiting)
    • Alonso Damian Jimenez Trejo
    • Lina Merjaneh, MD (Principal Investigator)
    • Daniel DeSalvo, MD
    • Fadel Ruiz, MD
    • Michelle Mann, MD
    • Jessica Farrell, NP-C
  • University of Texas Health San Antonio, San Antonio, United States (Recruiting)
    • Sara Olivarri
    • Maria S Rayas, MD (Principal Investigator)
    • Ruby Favela-Prezas, MSN, APRN, FNP
  • University of Utah, Salt Lake City, United States (Recruiting)
    • Judy Jensen
    • Katie Kaput, DO (Principal Investigator)
    • Marie Couldwell, MD
    • Karma Elliott, MD
  • University of Virginia-Center for Diabetes Technology, Charlottesville, United States (Recruiting)
    • Sara Prince
    • Sue Brown, MD (Principal Investigator)
    • Jennifer Kirby, MD

Study Officials