Actively Recruiting
A Randomized Trial of the Insulin-only Bionic Pancreas System in Cystic Fibrosis-Related Diabetes
Led by Jaeb Center for Health Research · Updated on 2026-02-23
150
Participants Needed
16
Research Sites
25 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This randomized controlled trial evaluates the insulin-only configuration of the iLet Bionic Pancreas System (BP) compared to usual insulin delivery methods and continuous glucose monitoring (CGM) in people aged 14 years and older with cystic fibrosis-related diabetes (CFRD). The study aims to assess the efficacy and safety of the BP system over a 13-week period, followed by an extension phase where all participants use the BP system. The lead sponsor is the Jaeb Center for Health Research. Participants are randomly assigned to either continue their usual insulin therapy with study CGM for the first 13 weeks or use the iLet Bionic Pancreas System with CGM during this period. After the initial phase, both groups use the BP system for an additional 13 weeks in the extension phase. The BP system includes an infusion pump, touchscreen, Bluetooth connectivity, and insulin dosing algorithms that adjust insulin delivery based on CGM glucose readings. Throughout the study, participants will be monitored using CGM to measure time spent in the target glucose range (70-180 mg/dL) and time spent with very low glucose (<54 mg/dL). Assessments include glucose monitoring, safety evaluations, and adherence to treatment protocols. The total participation time covers 26 weeks, including both the randomized and extension phases. Participants will also continue their usual care and have access to support during the trial period.
CONDITIONS
Brief Title
Bionic Pancreas in CFRD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older at the time of consent
- Able to provide informed consent (and assent if under 18 years old)
- Confirmed cystic fibrosis diagnosis by clinical features and sweat chloride ≥60 mmol/l or two CFTR gene mutations
- Clinical diagnosis of cystic fibrosis-related diabetes treated with insulin for 3 or more months
- Stable insulin regimen for at least 1 month before screening with no planned changes during study
- Total daily insulin dose of at least 0.1 units/kg
- Able to speak and read English to understand the pump interface and written materials
- For participants under 18, living with a knowledgeable parent/legal guardian and having a designated care partner linked to the glucose monitoring app
- For participants over 18 who live alone, having a relative or acquaintance nearby willing to provide emergency contact and a designated care partner linked to the glucose monitoring app
- No use of non-insulin glucose-lowering drugs except metformin within 3 months prior to consent and willingness to avoid such drugs during the study
- Willing to switch to approved rapid-acting insulin if not currently using one compatible with the device
- Access to commercial glucagon for severe hypoglycemia treatment
- Willing to authorize study team to contact primary physician
- Enrolled or willing to enroll in the Cystic Fibrosis Foundation Patient Registry
- No plans for trips over 14 consecutive days outside the US during the study
- Investigator believes participant can safely use the iLet system and follow protocol
You will not qualify if you...
- Current use of the iLet Bionic Pancreas or an automated insulin delivery system approved for type 1 diabetes
- Known hemoglobinopathy (except sickle cell trait)
- Participation in another diabetes-related interventional trial
- History of severe allergy to adhesives or tapes used in the study
- Pregnant, breastfeeding, planning pregnancy within 7 months, or sexually active without contraception
- Current use or inability to avoid hydroxyurea during the study
- Started or stopped a CFTR modulator within 4 weeks prior to screening (dose changes allowed)
- Anticipated or recent lung or liver transplant within one year
- Acute pulmonary exacerbation, hospitalization, or IV antibiotics within 4 weeks prior to screening
- History of complete pancreatectomy
- Current use of enteral tube feedings
- Medical conditions or medications that may interfere with study results or participant safety, including substance abuse, unstable heart disease, severe liver disease, dialysis, untreated mental illness, or recent eating disorders
- Employment or close relations with Beta Bionics or direct involvement in this clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 13 weeks
Participants use either their existing insulin delivery method with a study continuous glucose monitor or the iLet Bionic Pancreas System to manage cystic fibrosis-related diabetes during the initial 13 weeks of the study.
Visits as scheduled during the 13-week randomized controlled trial phase
Duration - 13 weeks
Participants continue using the iLet Bionic Pancreas System during a 13-week Extension Phase following the initial trial phase.
Visits as scheduled during the 13-week Extension Phase
Trial Site Locations
Total: 16 locations
1
University of Colorado-Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30329
Actively Recruiting
4
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
9
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
10
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Completed
12
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
13
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Texas Health San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
15
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
16
University of Virginia-Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
J
Judy Sibayan, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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