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Recruiting Phase 3 Interventional

Bionic Pancreas in CFRD

ClinicalTrials.gov ID: NCT06449677

Public ClinicalTrials.gov record NCT06449677. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 30, 2026, 8:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06449677
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
150 participants

Conditions and interventions

Eligibility (public fields only)

Age range
14 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 23, 2024
Primary completion
Sep 29, 2026
Completion
Mar 29, 2027
Last update posted
Jun 23, 2026

2024 – 2027

United States locations

U.S. sites
16
U.S. states
14
U.S. cities
16
Facility City State ZIP Site status
University of Colorado-Barbara Davis Center for Diabetes Aurora Colorado 80045 Recruiting
Yale University School of Medicine New Haven Connecticut 06511 Recruiting
Emory University Atlanta Georgia 30329 Recruiting
Indiana University School of Medicine Indianapolis Indiana 46202 Recruiting
Johns Hopkins University School of Medicine Baltimore Maryland 21287 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
University of Minnesota Minneapolis Minnesota 55455 Recruiting
Children's Mercy Hospital Kansas City Missouri 64108 Recruiting
Columbia University Medical Center New York New York 10032 Recruiting
University Hospitals of Cleveland Cleveland Ohio 44106 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Completed
UT Southwestern Medical Center Dallas Texas 75235 Recruiting
Baylor College of Medicine Houston Texas 77030 Recruiting
University of Texas Health San Antonio San Antonio Texas 78207 Recruiting
University of Utah Salt Lake City Utah 84132 Recruiting
University of Virginia-Center for Diabetes Technology Charlottesville Virginia 22903 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Recently updated Cystic Fibrosis-related Diabetes trials

Other public records listing Cystic Fibrosis-related Diabetes. Sorted by last update posted; newest first. Not a recommendation.

All Cystic Fibrosis-related Diabetes trials →

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06449677, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 23, 2026 · Synced Jul 30, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06449677 live on ClinicalTrials.gov.

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