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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.

• Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.

• At healthy baseline status at time of CGM wear and OGTT.

Locations
United States
Wisconsin
The Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
julie A. Biller, MD
jbiller@mcw.edu
414-955-7040
Backup
Patricia Pfahler, RN
patricia.pfahler@froedtert.com
414-805-6765
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 30
Treatments
Cystic Fibrosis
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov