A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes
Jaeb Center for Health Research
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.
Eligibility
- Age range
- 14+ years
- Sex
- All
- Healthy volunteers
- No
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 criteria: * 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 4. Clinical diagnosis of CFRD, defi…
Interventions
- DeviceiLet Bionic Pancreas System (BP)
The iLet Bionic Pancreas System (BP) consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a CGM sensor.
- DeviceUsual Care (UC)
Usual Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump.
Locations (16)
- University of Colorado-Barbara Davis Center for DiabetesAurora, Colorado
- Yale University School of MedicineNew Haven, Connecticut
- Emory UniversityAtlanta, Georgia
- Indiana University School of MedicineIndianapolis, Indiana
- Johns Hopkins University School of MedicineBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts