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Monitoring Exhaled Breath for Diabetes Management

This study is testing a new device, called The Sensing Device, to see if it can detect changes in blood sugar (glucose) levels by analyzing your breath. The goal is to find out if this device can noninvasively identify when your blood sugar is too high (hyperglycemia) or too low (hypoglycemia). You can join if you are 12-19 years old, have type 1 diabetes, and use a Dexcom G6 or G7 continuous glucose monitor (CGM). Researchers will compare the breath data from The Sensing Device with your CGM readings to see how well they match. The study aims to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 30 participants. It is testing a device that senses chemicals in breath.
What's involved
You would provide breath samples into The Sensing Device while wearing it for up to 72 hours. You would also share your daily continuous glucose monitor (CGM) data.
Compensation
Not stated in the trial record.
Follow-up
Your breath and CGM data will be collected for up to 72 hours while wearing the device.

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NCT06893341

Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Recruiting
NAAges 12–19InterventionalDiagnostic
Indiana University
~30 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:The Sensing Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation between Breath Sensor Data and Blood Glucose
Measured over While wearing the device, up to 72 hours

Conditions

Diabetes
Hyperglycemia
Hypoglycemia

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Linda A DiMeglio, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Mangilal Agarwal, PhD
[email protected]
317-278-9792
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Correlation between Breath Sensor Data and Blood GlucoseWhile wearing the device, up to 72 hours

    Participants will wear the breath sensor device for 72 hours. Participants will provide at least 15 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, multiple during periods of hyperglycemia (blood glucose \> 200 mg/dL), and multiple during periods of euglycemia. During each breath sample collection event, continuous CGM data will be recorded, and participants will also be asked to perform a finger-prick blood glucose test. Participants will return the device, and data from the wearable breath-based sensor will be analyzed using chemometrics and statistics to identify significant correlations between breath data and blood glucose levels.