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

July 27, 2025 updated by: Viral N. Shah, Indiana University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eslam Montaser, PhD
  • Phone Number: 4344660570
  • Email: emontase@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health, University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Study Population

Cross-sectional study with CGM data collection for people with CF, prediabetes and diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CF without diabetes
a person with cystic fibrosis and no diabetes
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.
Other Names:
  • CGM Dynamic Index (CDI) mathematical model
Other: CF with Prediabetes
a person with cystic fibrosis and prediabetes
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.
Other Names:
  • CGM Dynamic Index (CDI) mathematical model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24262
  • DartCF funded by NIH/ NIDDK (Other Grant/Funding Number: Dartmouth Cystic Fibrosis Research Center (DartCF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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