RECRUITING

Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis

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

Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. CFRD is extremely common in people with CF, occurring in approximately 40-50% of adults with CF. Impaired glucose tolerance or dysglycemia is also very common in CF. It is standard of care to screen for CFRD annually from the age of 10 years with a two-hour Oral Glucose Tolerance Test (OGTT) with 75 g dextrose. The gold standard screening for CFRD is the OGTT which is problematic as it is time consuming for patient and staff and adherence to annual screening is low among CF centers. Survival has improved dramatically with the advent of CFTR modulators and it is presumed that the incidence of CFRD will increase with increased life expectancy. The Cystic Fibrosis Foundation (CFF) has developed the oldest disease specific patient registry, consisting of approximately 35000 patients, so there is vast historical information available on individual patients and larger datasets on the CF community as a whole. Based on the 2021 CFF patient registry data, the current life expectancy for CF patients born between 2017 and 2021 is 53 years - a 15 year increase from a decade ago.

Official Title

Comparison of Continous Glucose Monitor and OGTT As a Screen for Cystic Fibrosis Related Diabetes and Impaired Glucose Tolerance

Quick Facts

Study Start:2024-11
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06560463

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.
  2. 2. Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.
  3. 3. At healthy baseline status at time of CGM wear and OGTT.
  1. 1. Diagnosed with CFRD and treating with diabetogenic medications.
  2. 2. s/p transplant
  3. 3. pregnancy
  4. 4. failure to wear CGM for entirety of 10 days

Contacts and Locations

Study Contact

julie A. Biller, MD
CONTACT
414-955-7040
jbiller@mcw.edu
Patricia Pfahler, RN
CONTACT
414-805-6765
patricia.pfahler@froedtert.com

Study Locations (Sites)

The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

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 Date2024-11
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-11
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • cystic fibrosis

Additional Relevant MeSH Terms

  • Cystic Fibrosis-related Diabetes
  • Cystic Fibrosis