CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

NCT ID: NCT06642610

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetes Cystic Fibrosis (CF) Cystic Fibrosis-related Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CF without diabetes

a person with cystic fibrosis and no diabetes

Group Type OTHER

CGM Dynamic Index (CDI)

Intervention Type 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.

CF with Prediabetes

a person with cystic fibrosis and prediabetes

Group Type OTHER

CGM Dynamic Index (CDI)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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CGM Dynamic Index (CDI) mathematical model

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Viral N. Shah

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University Health, University Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eslam Montaser, PhD

Role: CONTACT

4344660570

Facility Contacts

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Kathy Bohanan

Role: primary

317-278-0727

Other Identifiers

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DartCF funded by NIH/ NIDDK

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24262

Identifier Type: -

Identifier Source: org_study_id

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