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

NCT06560463 | Recruiting

• 1 other identifier: PRO00051083
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis-related Diabetes; Cystic Fibrosis

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• Blood glucose measurement

  Blood glucose levels will be continuously monitored over a ten-day period using a Dexcom G7 continuous glucose monitor (CGM)

  10 days

Study Arms (1)

Cystic Fibrosis

Device: Access to Dexcom G7 CGM Data

Interventions

Access to Dexcom G7 CGM Data DEVICE

Eligible patients will undergo Continuous Glucose Monitoring using the Dexcom G7

Cystic Fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with Cystic Fibrosis, age 18 years and older, who receive care in the Froedtert and MCW Adult Cystic Fibrosis program.

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with CFRD and treating with diabetogenic medications.
• s/p transplant
• pregnancy
• failure to wear CGM for entirety of 10 days

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

julie A. Biller, MD

CONTACT

414-955-7040; jbiller@mcw.edu

Patricia Pfahler, RN

CONTACT

414-805-6765; patricia.pfahler@froedtert.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Professor | Medicine

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: August 19, 2024
• Study Start: January 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

US (1)