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NCT06449677 · ClinicalTrials.gov registry record · Phase 3

Bionic Pancreas in CFRD

A Phase 3 study of Cystic Fibrosis-related Diabetes, sponsored by Jaeb Center for Health Research.

Recruiting
Registry status
Phase 3
Development phase
150
Enrollment target
16
Study locations

NCT06449677 is a Phase 3 study of Cystic Fibrosis-related Diabetes that is actively recruiting participants, run by Jaeb Center for Health Research. The registered enrollment target is 150 participants, above the 93-participant average among 10 other Cystic Fibrosis-related Diabetes trials with a reported enrollment target (61% higher). The trial reports 16 study locations across 14 states.

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The verdict

NCT06449677, a Phase 3 study of Cystic Fibrosis-related Diabetes, is actively recruiting participants, sponsored by Jaeb Center for Health Research.

RECRUITING
Registry status
Phase 3
Development phase
150 participants
Enrollment target
16
Study locations

Study 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 Studied

Cystic Fibrosis-related Diabetes

Interventions

  • DEVICE iLet Bionic Pancreas System (BP)
  • DEVICE Usual Care (UC)

Study Locations (16)

Texas

  • UT Southwestern Medical Center - Dallas
  • Baylor College of Medicine - Houston
  • University of Texas Health San Antonio - San Antonio

Colorado

  • University of Colorado-Barbara Davis Center for Diabetes - Aurora

Connecticut

  • Yale University School of Medicine - New Haven

Georgia

  • Emory University - Atlanta

Indiana

  • Indiana University School of Medicine - Indianapolis

Maryland

  • Johns Hopkins University School of Medicine - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-09-24
Est. Completion 2027-03-30
Phase Phase 3

Sponsor

Jaeb Center for Health Research

119 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06449677

The ClinicalTrials.gov registry entry for NCT06449677 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 93-participant average among 10 other Cystic Fibrosis-related Diabetes trials with a reported enrollment target (61% higher). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis-related Diabetes appearing as the primary indexed condition, and to 2 interventions - of which iLet Bionic Pancreas System (BP) is the first listed.

NCT06449677 reports 16 study locations spanning 14 distinct geographic areas - top geographies include Texas, Colorado, Connecticut.

Frequently Asked Questions

What is clinical trial NCT06449677 about?

NCT06449677 is a clinical study titled "Bionic Pancreas in CFRD". 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 s...

What is the current status of trial NCT06449677?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2024-09-24. Estimated completion is 2027-03-30.

What conditions does trial NCT06449677 study?

This clinical trial studies the following conditions: Cystic Fibrosis-related Diabetes.

What interventions are being tested in trial NCT06449677?

The interventions under investigation include: iLet Bionic Pancreas System (BP) (DEVICE), Usual Care (UC) (DEVICE).

Who is sponsoring clinical trial NCT06449677?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06449677 being conducted?

This trial has 16 study locations across Colorado, Connecticut, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.