CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis
Not Applicable
Not yet recruiting
- Conditions
- PrediabetesCystic Fibrosis (CF)Cystic Fibrosis-related Diabetes
- Registration Number
- NCT06642610
- Lead Sponsor
- Indiana University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis 10 days Estimating the "optimal" cut-offs of the CDI marker, to distinguish between CF groups
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Indiana University Health, University Hospital
🇺🇸Indianapolis, Indiana, United States