RECRUITING

Bionic Pancreas in CFRD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-24
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06449677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Colleen Bauza, PhD, MPH
CONTACT
813-975-8690
cbauza@jaeb.org

Principal Investigator

Melissa Putman, MD
STUDY_CHAIR
Massachusetts General Hospital
Colleen Bauza, PhD, MPH
STUDY_DIRECTOR
Jaeb Center for Health Research

Study Locations (Sites)

University of Colorado-Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Virginia-Center for Diabetes Technology
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

  • Melissa Putman, MD, STUDY_CHAIR, Massachusetts General Hospital
  • Colleen Bauza, PhD, MPH, STUDY_DIRECTOR, Jaeb Center for Health Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-24
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-24
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Cystic Fibrosis-related Diabetes