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Glucose sensor may flag diabetes risk in cystic fibrosis

NCT ID NCT06642610

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

People with cystic fibrosis often develop prediabetes and then diabetes, but doctors lack a good way to predict who will progress. This pilot study at Indiana University tests whether a continuous glucose monitor worn for up to 10 days, combined with a mathematical model called the CGM Dynamic Index, can identify prediabetes in people with CF. Participants aged 12 to 55 take a one-time oral glucose tolerance test and wear the monitor. Researchers aim to find the best cutoff values for the index that separate different CF groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a continuous glucose monitor worn for up to 10 days, combined with a mathematical model called the CGM Dynamic Index
What this could lead to
If it works, this could give doctors a way to spot cystic fibrosis-related diabetes earlier, when diet or treatment changes might help more.
What could go wrong
This is a small pilot study of 14 people, so the model may not hold up in larger groups or predict diabetes reliably. CGM sensors can also irritate the skin or give noisy readings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cystic fibrosis cystic fibrosis-related diabetes prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis (CF) Cystic fibrosis-related diabetes Prediabetes

Contacts and locations

Locations

  • Indiana University Health, University Hospital

    Indianapolis, Indiana, 46202, United States

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