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Bionic Pancreas in CFRD

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 18, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Mar 30, 2027 to May 31, 2027
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 16 of 16 sites
  2. Site contacts updated at 2 of 16 sitesv22
  3. Primary completion date: Nov 2025 to Sep 30, 2026
    • Study completion date: Mar 2026 to Mar 30, 2027
    • Site details revised at 3 of 16 sites
    v21
  4. Site contacts updated at 2 of 16 sitesv20
  5. Site contacts updated at 1 of 16 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 14 to 16v18
  2. Site details revised at 4 of 14 sitesv17
  3. Study sites: 13 to 14v16
  4. Site contacts updated at 2 of 13 sitesv15
  5. Study sites: 12 to 13v14
  6. Study sites: 11 to 12v13
  7. Study sites: 10 to 11v12
  8. Study sites: 9 to 10v11
  9. Study sites: 8 to 9v10
  10. Study sites: 7 to 8v9
  11. Study sites: 6 to 7v8
  12. Study sites: 5 to 6v7
  13. Study sites: 4 to 5v6
  14. Study sites: 3 to 4v5
  15. Study sites: 2 to 3v4
  16. Study sites: 1 to 2v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2024 to Sep 24, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06449677
Lead Sponsor Jaeb Center for Health Research
Collaborators: Cystic Fibrosis Foundation, Massachusetts General Hospital, Beta Bionics, Inc.
Conditions
(from sponsor)		 Cystic Fibrosis-related Diabetes
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov