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RECRUITINGINTERVENTIONAL

CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

CGM 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)

Indiana University Health, University Hospital
Indianapolis, Indiana, United States