Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Prediabetes
Conditions
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.
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.
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed