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Could a breath test replace finger pricks for diabetes?

NCT ID NCT07696273

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tests a small, noninvasive device that analyzes breath to detect high and low blood sugar events in children and young adults with diabetes. Participants aged 7–25 who already use a continuous glucose monitor will provide breath samples during normal, high, and low blood sugar periods. The goal is to see if the sensor can accurately estimate glucose levels without finger sticks.

What this could mean

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

Active substance
Miniaturized breath sensing device
What this could lead to
If successful, this could lead to a painless, noninvasive way for people with diabetes to monitor their blood sugar levels using just their breath.
What could go wrong
This is a small, early-stage study with only 40 participants. The device's accuracy is still being tested, and it may not work as well in real-world settings or for all age groups.

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 40 people

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

Started

May 2026

Expected to finish

Oct 2027

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

7 to 25 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 T1D or T2D. * Who are between 7-25 years of age. * That use a Dexcom (G6 or G7) CGM device. * That have an established working CGM for at least 12 hours. * That are willing to share their CGM data for the study duration. * That are willing and able to fill up a breath collection bag. * That are attending a diabetes camp in the state of Indiana. Exclusion Criteria: * That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp). * That have a condition or abnormality other than T1D/T2D that in the opinion of the Investigators would compromise the safety of the subject or the quality of the data. * That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral/bacterial infections). * That follow a "ketogenic diet". * That are unable or unwilling to cooperate with either of the sample collection modes.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus hyperglycemia hypoglycemia type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes Hyperglycemia Hypoglycemia (diabetic)

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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jameson Camp

    RECRUITING

    Indianapolis, Indiana, 46231, United States

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