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Recruiting NCT06642610

CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

No phase Interventional Prediabetes Cystic Fibrosis (CF) Cystic Fibrosis-related Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CGM Dynamic Index (CDI).
Who it may be relevant to
Registry conditions: Prediabetes, Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes. Basic parameters: 12 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Indiana University Health, University Hospital — Indianapolis

Identifiers

NCT: NCT06642610 · 24262 · DartCF funded by NIH/ NIDDK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗