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Bionic Pancreas in CFRD
NCT06449677 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-09-24 |
| Est. Completion | 2027-03-30 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06449677 reports 16 study locations spanning 14 distinct geographic areas — top geographies include Texas, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06449677?
The interventions under investigation include: iLet Bionic Pancreas System (BP) (DEVICE), Usual Care (UC) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06449677?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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