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

Recruiting now

Conditions studied: Cystic Fibrosis-related Diabetes, Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT06560463

Run by

Medical College of Wisconsin

People needed

30

Starts

2025-01-13

Expected to finish

2027-09-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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