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CompletedNCT06642610Updated Sep 17, 2026

CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

An interventional study of CGM Dynamic Index (CDI) in Prediabetes, Cystic Fibrosis (CF) and Cystic Fibrosis-related Diabetes, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Indiana University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
12 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prediabetes
  • Cystic Fibrosis (CF)
  • Cystic Fibrosis-related Diabetes
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 14 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    CF without diabetes

    a person with cystic fibrosis and no diabetes

    Device: CGM Dynamic Index (CDI)

  • Other
    CF with Prediabetes

    a person with cystic fibrosis and prediabetes

    Device: CGM Dynamic Index (CDI)

Interventions

  • DeviceCGM 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.

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

06

What researchers measure

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

    Time frame: 10 days

07

Study locations

1 site
  • Indiana University Health, University Hospital
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06642610
Lead sponsor
Indiana University
Responsible party
Viral N. Shah (Professor of Medicine, Indiana University) — Principal investigator
First posted
Oct 15, 2024
Start date
Jun 15, 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Sep 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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