Bionic Pancreas in CFRD
ConditionCystic Fibrosis-related Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14+
SponsorJaeb Center for Health Research
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 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.
Eligibility criteria
Qualifiers
Age ≥ 14 years old at time of signing informed consent
Able to provide informed consent (and assent for participants <18 years old)
Sweat chloride equal to or greater than 60 mmol/liter by quantitative pilocarpine iontophoresis test (QPIT) (when not taking a cystic fibrosis transmembrane conductance regulator (CFTR) modulator)
Two well-characterized mutations in the CFTR gene
Disqualifiers
None
Trial design
Treatments tested in this trial
- iLet Bionic Pancreas System (BP)
- Usual Care (UC)
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Massachusetts General Hospital
Collaborator
Beta Bionics, Inc.
Collaborator
Source ClinicalTrials.gov