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Ensaio clínico

Bionic Pancreas in CFRD

NCT: NCT06449677 · ACTIVE_NOT_RECRUITING

ID NCTNCT06449677
EstadoACTIVE_NOT_RECRUITING
Data de início2024-09-24
Conclusão2027-05-31
SponsorJaeb Center for Health Research (OTHER)
First posted
Last updated

Resumo breve

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.

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