Recruiting

Continuous Glucose Monitoring

Sponsor:

Medical College of Wisconsin

Code:

NCT06560463

Conditions

Cystic Fibrosis-related Diabetes

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Access to Dexcom G7 CGM Data

Study Details

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

Study ID

NCT06560463

Start date

Jan 13, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.
2. Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.
3. At healthy baseline status at time of CGM wear and OGTT.

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Cystic Fibrosis

Interventions

Access to Dexcom G7 CGM Data

Eligible patients will undergo Continuous Glucose Monitoring using the Dexcom G7

Primary outcome measure

  • Blood glucose measurement [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Locations

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Julie Biller, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • cystic fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-31.