Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT06642610

Conditions

Prediabetes

Cystic Fibrosis (CF)

Cystic Fibrosis-related Diabetes

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

Interventions

CGM Dynamic Index (CDI)

Study Details

Brief 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.

Conditions

Prediabetes

Cystic Fibrosis (CF)

Cystic Fibrosis-related Diabetes

Study ID

NCT06642610

Start date

Jun 15, 2025

Status verified date

Jul, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: CF without diabetes

a person with cystic fibrosis and no diabetes

other: CF with Prediabetes

a person with cystic fibrosis and prediabetes

Interventions

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.

Primary outcome measure

  • CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Eslam Montaser, PhD

4344660570emontase@iu.edu

Locations

Indiana University Health, University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

More Information

Sponsor

Indiana University

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2025-07-29.