NCT06560463 Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis
| NCT ID | NCT06560463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Cystic Fibrosis-related Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-01-13 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06560463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis-related Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06560463 currently recruiting?
Yes, NCT06560463 is actively recruiting participants. Contact the research team at jbiller@mcw.edu for enrollment information.
Where is the NCT06560463 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06560463 clinical trial?
NCT06560463 is sponsored by Medical College of Wisconsin. The trial plans to enroll 30 participants.
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