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Bionic Pancreas in CFRD

NCT06449677 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-23

No results posted yet for this 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

  • Cystic Fibrosis-related Diabetes

Interventions

DEVICE

iLet Bionic Pancreas System (BP)

The iLet Bionic Pancreas System (BP) consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a CGM sensor.

DEVICE

Usual Care (UC)

Usual Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Beta Bionics, Inc.

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Melissa Putman, MD · Massachusetts General Hospital

  • Judy Sibayan, MPH · Jaeb Center for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2026-09-30
Completion
2027-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449677 on ClinicalTrials.gov