Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2026-04-01

Brief Summary

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The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds in exhaled breath.

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Detailed Description

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A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.

Conditions

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Diabetes Hyperglycemia Hypoglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diabetic Children with Continuous Glucose Monitors

These subjects will be given the Sensing Device, a wearable sensor that subjects can breathe into, which is being investigated in the current study as a potential medical device for noninvasive measurement of blood glucose.

Group Type EXPERIMENTAL

The Sensing Device

Intervention Type DEVICE

Children diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.

Interventions

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The Sensing Device

Children diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No