Bionic Pancreas in CFRD

Recruiting Phase 3 Interventional Study
Cystic Fibrosis-related Diabetes
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
14 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Jaeb Center for Health Research · Other
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About This Trial
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 week…
Trial Locations
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Eligibility Criteria
Inclusion 1. Age ≥ 14 years old at time of signing informed consent 2. Able to provide informed consent (and assent for participants \<18 years old) 3. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following cri…
Contacts

Judy Sibayan, MPH

813-975-8690

jsibayan@jaeb.org

CONTACT