Bionic Pancreas in CFRD

Phase 3

Recruiting

• Conditions: Cystic Fibrosis-related Diabetes

• 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

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-10
• Study Start: 2024-09-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-09
• Primary Completion: 2025-11
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 (16)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Colorado-Barbara Davis Center for Diabetes; 🇺🇸 Aurora, Colorado, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Emory University; 🇺🇸 Atlanta, Georgia, 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

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