Bionic Pancreas in CFRD

NCT06449677 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: BPCFRD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Cystic Fibrosis-related Diabetes

Keywords

Cystic fibrosis-related diabetes (CFRD); iLet bionic pancreas; Automated insulin delivery; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• CGM-measured Time In Target Range of 70-180 mg/dL (TIR)

  CGM-measured time in target range of 70-180 mg/dL (TIR)

  13 weeks

Secondary Outcomes (1)

• CGM-measured Time In Range <54 mg/dL

  13 weeks

Other Outcomes (45)

• CGM-measured Mean Glucose

  13 weeks

• CGM-measured Time In Range >180 mg/dL

  13 weeks

• CGM-measured Time In Range >250 mg/dL

  13 weeks

Study Arms (2)

UC Group

ACTIVE COMPARATOR

Participants randomized to the Usual Care (UC) group will use their existing insulin delivery method in conjunction with a study CGM during the first 13-week of the study (RCT phase). The UC group will then initiate use of the BP System for the remaining 13 weeks of the study (Extension Phase).

Device: iLet Bionic Pancreas System (BP); Device: Usual Care (UC)

BP Group

EXPERIMENTAL

Participants randomized to the intervention group will use the BP group using the iLet Bionic Pancreas System (BP) and continuous glucose monitoring (CGM) during the first 13-week of the study (RCT phase). After the RCT phase, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system.

Device: iLet Bionic Pancreas System (BP)

Interventions

iLet Bionic Pancreas System (BP) DEVICE

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.

BP Group; UC Group

Usual Care (UC) DEVICE

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.

UC Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 14 years old at time of signing informed consent
• Able to provide informed consent (and assent for participants \<18 years old)
• 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
• Clinical diagnosis of CFRD, defined as a person with CF and diabetes mellitus, treated with insulin for ≥3 months prior to screening
• Total daily insulin dose must be ≥0.1 units/kg
• Able to speak and read English sufficient to understand the pump user interface and provide written materials for safe operation of the BP
• For pediatric participants, this applies to both the participant and caregiver
• For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.
• For participants \>18 years old who live alone, participant has a relative or acquaintance who lives within 30 minutes of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and cannot be reached. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.
• No use of a non-insulin glucose-lowering medication, except metformin, that is not approved for use in T1D within 3 months prior to signing informed consent and willing to not use any such medications during the course of the trial. Note: such drugs cannot be used even if prescribed for weight loss rather than glucose-lowering.
• If not currently using a rapid-acting insulin that is approved for use in the iLet pump, willing and able to switch to an approved insulin when using the BP.
• Participant has commercial glucagon available for treatment of severe hypoglycemia or will obtain it prior to randomization
• Willing to authorize the study team to contact the participant's primary physician to inform them about their participation in this study.

You may not qualify if:

• Current use of the BP or an AID system not FDA approved for T1D
• Current participation in another diabetes-related interventional trial
• Established history of allergy or severe reaction to adhesive or tape that must be used in the study
• Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 7 months, or sexually active and can become pregnant but not using contraception
• Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor)
• Have started or stopped a CFTR modulator in the 4 weeks prior to screening.
• Modifications of the dosing of a CFTR modulator is acceptable
• Anticipated lung or liver transplant (on transplant list)
• Lung or liver transplant within one year prior to screening. If they have had a transplant more than a year ago, but they:
• Have had a rejection episode occur in prior 8 weeks, individual is excluded.
• Their doses of corticosteroids and/or calcineurin inhibitors have not been stable for one month prior to enrollment and/or is expected to change significantly over the course of the study, individual is excluded.
• Acute pulmonary exacerbation or hospitalization within the 4 weeks prior to screening or treatment with IV antibiotics in the 4 weeks prior to screening
• History of a complete pancreatectomy
• Currently using enteral tube feedings for nutritional support
• Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:

Sponsors & Collaborators

• Cystic Fibrosis Foundation: collaborator
• Massachusetts General Hospital: collaborator
• Beta Bionics, Inc.: collaborator
• Jaeb Center for Health Research: lead

Study Sites (16)

University of Colorado-Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

COMPLETED

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health San Antonio

San Antonio, Texas, 78207, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Virginia-Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

RECRUITING

Study Officials

• Melissa Putman, MD

  Massachusetts General Hospital

  STUDY CHAIR

• Judy Sibayan, MPH

  Jaeb Center for Health Research

  STUDY DIRECTOR

Central Study Contacts

Judy Sibayan, MPH

CONTACT

813-975-8690; jsibayan@jaeb.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 13-week RCT followed by a 13-week Extension Phase in which all participants use the iLet BP System

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 10, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)