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No more finger pricks? breath sensor may spot blood sugar swings

NCT ID NCT06893341

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a wearable breath sensor can detect high or low blood sugar in teens with type 1 diabetes. Participants wear the device for 72 hours and provide breath samples while checking blood sugar with a finger prick. The goal is to see if breath chemicals can replace needles for monitoring.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 19 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: * Who are diagnosed with type 1 diabetes. * Who are between 12-19 years of age. * That utilize a Dexcom (G6 or G7) continuous glucose monitoring device. * That have an established working CGM for at least 12 hours (that does not need to be replaced within 24 hours). * That are willing to share their daily CGM data for the study. * That are the only individuals in their household with any type of diabetes diagnosis (type 1 or type 2). * That are willing to return the device within 24-48 hours of study completion. * That are located in Indianapolis, IN or its suburban areas. Exclusion Criteria: * That are smokers or use tobacco products or who live with someone who smokes in their vicinity. * That have a condition or abnormality other than type 1 diabetes that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data. * That utilize closed-loop diabetes management systems. * That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19. * That themselves or a close family member (living within the same household at the time of the data collection period) is on a "ketogenic diet". * That themselves or a close family member is working in an industry with high and continuous exposure to exogenous VOCs. Examples of such industries include beauty salons and paint manufacturers. * That are unable or unwilling to cooperate with sample collection.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus hyperglycemia hypoglycemia type 1 diabetes mellitus

As listed by the trial registrant

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

Diabetes Hyperglycemia Hypoglycemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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