A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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

• Using the same insulin regimen for ≥1 month prior to screening and collection of baseline CGM data, with no plans to change regimen during the study: either multiple daily injections of insulin (MDI), basal-only without bolus insulin, an insulin pump without automation, or an automated insulin delivery (AID) system other than the BP (which is an exclusion)

• 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.

⁃ Enrolled in the Cystic Fibrosis Foundation Patient Registry (participants may enroll in the Registry at the time of enrollment if not already enrolled).

⁃ No plans for trips of more than 14 consecutive days outside the United States during the period of study participation

⁃ Investigator believes that the participant can safely use the iLet and will follow the protocol • The investigator will take into account the participant's HbA1c level (there is no upper limit for eligibility), compliance with current diabetes management, prior acute diabetic complications, cognitive ability, and general medical condition. For this reason, there is no upper limit on HbA1c specified for eligibility.

Locations
United States
Colorado
University of Colorado-Barbara Davis Center for Diabetes
RECRUITING
Aurora
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
New York
Columbia University Medical Center
RECRUITING
New York
Ohio
University Hospitals of Cleveland
RECRUITING
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
ACTIVE_NOT_RECRUITING
Philadelphia
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
University of Texas Health San Antonio
RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia-Center for Diabetes Technology
RECRUITING
Charlottesville
Contact Information
Primary
Colleen Bauza, PhD, MPH
cbauza@jaeb.org
813-975-8690
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2026-03
Participants
Target number of participants: 150
Treatments
Active_comparator: UC Group
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).
Experimental: BP Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation, Massachusetts General Hospital, Beta Bionics, Inc.
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov