CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

NCT06642610 | Recruiting DMC FDA Device

• 2 other identifiers: 24262DartCF funded by NIH/ NIDDK
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

  10 days

Study Arms (2)

CF without diabetes

OTHER

a person with cystic fibrosis and no diabetes

Device: CGM Dynamic Index (CDI)

CF with Prediabetes

OTHER

a person with cystic fibrosis and prediabetes

Device: CGM Dynamic Index (CDI)

Interventions

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.

Also known as: CGM Dynamic Index (CDI) mathematical model

CF with Prediabetes; CF without diabetes

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health, University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Cystic Fibrosis

Interventions

Models, Theoretical

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Eslam Montaser, PhD

CONTACT

4344660570; emontase@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)