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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06449677
Study type Interventional
Source Jaeb Center for Health Research
Contact Colleen Bauza, PhD, MPH
Phone 813-975-8690
Email cbauza@jaeb.org
Status Not yet recruiting
Phase Phase 3
Start date June 2024
Completion date March 2026

See also
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