RecruitingNot ApplicableNCT06642610
CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis
CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
Sponsor
Indiana University
Enrollment
70 participants
Start Date
Jun 15, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The primary objective of this pilot study is to develop a CGM-based model to predict the progression from prediabetes to diabetes in individuals with cystic fibrosis.
Eligibility
Min Age: 12 YearsMax Age: 55 Years
Inclusion Criteria4
- CF individuals aged 12-55 years.
- CF without diabetes or with prediabetes (as defined by OGTT and HbA1c).
- Willing to use a continuous glucose monitoring system with compatible smart phone for glucose data collection.
- A person with CFRD and already using CGM, we will just collect their personal CGM data, and they are not required to have OGTT or HbA1c visit.
Exclusion Criteria7
- Pregnancy.
- History of transplant.
- Use of immunosuppressant drugs.
- Use of oral steroids or any medication known to interfere with glucose.
- Allergy to adhesives.
- Individuals with severe concurrent medical conditions that could confound glucose monitoring data (e.g., terminal illness, major organ failure).
- Conditions that may make unsafe for participants to do study or impair or confound the study at the discretion of the investigator
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Interventions
DEVICECGM Dynamic Index (CDI)
Participants will undergo one-time oral glucose tolerance test (OGTT) and a one-time use of a CGM device, which will be worn for up to 10 days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06642610
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