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NCT Number: NCT06642610

CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

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.

Recruiting

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Key information

Conditions

PreDiabetes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis (CF) Cystic Fibrosis-related Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Prediabetic State Respiratory Tract Diseases

Age range

12 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, University Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Kathy Bohanan

CONTACT

[email protected]

317-278-0727

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGM Dynamic Index (CDI)

Device

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.

Other names: CGM Dynamic Index (CDI) mathematical model

Primary outcomes

  1. CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis

    Time frame: 10 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eslam Montaser, PhD

CONTACT

[email protected]

4344660570

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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