Actively Recruiting
Bionic Pancreas in CFRD
Led by Jaeb Center for Health Research · Updated on 2026-02-23
150
Participants Needed
16
Research Sites
131 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 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.
CONDITIONS
Official Title
Bionic Pancreas in CFRD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older at time of informed consent
- Able to provide informed consent (and assent if under 18 years old)
- Diagnosed with cystic fibrosis by clinical features plus sweat chloride ≥60 mmol/l or two CFTR gene mutations
- Clinical diagnosis of cystic fibrosis-related diabetes, treated with insulin for at least 3 months prior to screening
- Using the same insulin regimen for at least 1 month prior to screening with no plans to change during study
- Total daily insulin dose of at least 0.1 units/kg
- Able to read and speak English to understand pump interface and materials
- For participants under 18, living with a parent or guardian knowledgeable about emergency hypoglycemia procedures and willing care partner linked to Dexcom Follow app
- For participants over 18 living alone, a relative or acquaintance within 30 minutes willing to be contacted and linked to Dexcom Follow app
- No use of non-insulin glucose-lowering medications except metformin within 3 months prior and willing to avoid such medications during study
- Willing and able to switch to an approved rapid-acting insulin if not currently using one approved for the iLet
- Has or will obtain commercial glucagon for severe hypoglycemia treatment
- Willing to authorize study team to contact primary physician
- Enrolled in the Cystic Fibrosis Foundation Patient Registry or willing to enroll
- No plans for trips over 14 consecutive days outside the US during study
- Investigator believes participant can safely use the iLet and comply with protocol
You will not qualify if you...
- Current use of the iLet Bionic Pancreas or other automated insulin delivery system not FDA approved for type 1 diabetes
- Known hemoglobinopathy (except sickle cell trait)
- Participation in another diabetes-related interventional trial
- History of allergy or severe reaction to adhesive or tape used in study
- Pregnant, breastfeeding, planning pregnancy within 7 months, or sexually active and able to become pregnant without contraception
- Current use of hydroxyurea or unable to avoid it during study
- Started or stopped a CFTR modulator within 4 weeks prior to screening (dose changes allowed)
- Anticipated lung or liver transplant or transplant within 1 year prior to screening with unstable rejection or medication doses
- Acute pulmonary exacerbation or hospitalization or IV antibiotics within 4 weeks prior to screening
- History of complete pancreatectomy
- Currently using enteral tube feedings for nutrition
- Medical conditions or medications that could affect study results or safety, including unstable coronary artery disease, severe heart failure, recent stroke or TIA, severe liver disease, renal failure requiring dialysis, untreated mental illness or eating disorders, substance abuse, or medications affecting decision-making
- Employment or family relation to Beta Bionics or direct involvement in the clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here