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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

PrediabetesCystic Fibrosis-related DiabetesCystic Fibrosis (CF)

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)

Indiana University Health, University Hospital

Indianapolis, Indiana, United States

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