CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

This study is testing a new tool called the CGM Dynamic Index (CDI) to see if it can predict when people with cystic fibrosis (CF) who have prediabetes might develop full diabetes. The study aims to create a model using data from a continuous glucose monitoring (CGM) device. You might be able to join if you are 12 to 55 years old, have CF without diabetes or with prediabetes, and are willing to use a CGM device. For people with CF-related diabetes already using CGM, their existing data will be collected. The goal is to see how well the CDI predicts prediabetes progression within 10 days. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 70 participants. It is a pilot study focused on developing a CGM-based model.
What's involved
Participants will undergo a one-time oral glucose tolerance test (OGTT) and wear a continuous glucose monitoring (CGM) device for up to 10 days. If you have CF-related diabetes and already use CGM, only your personal CGM data will be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 10 days, indicating a short follow-up period.

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NCT06642610

CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

Recruiting
NAAges 12–55Interventional
Indiana University
~70 participants
Updated 2025-07-29 on ClinicalTrials.gov
What's tested:CGM Dynamic Index (CDI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis
Measured over 10 days
Prediabetes
Cystic Fibrosis (CF)
Cystic Fibrosis-related Diabetes
1 sites across 1 states
Indiana1

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Eligibility criteria

Inclusion

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.

Exclusion

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
  • CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis10 days

    Estimating the "optimal" cut-offs of the CDI marker, to distinguish between CF groups