Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Phase

N/A

Condition

Diabetes Prevention

Diabetes (Pediatric)

Diabetic Vitreous Hemorrhage

Treatment

The Sensing Device

Clinical Study ID

NCT06893341

22467

Ages 12-19
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 bereplaced 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

Exclusion Criteria:

That are smokers or use tobacco products or who live with someone who smokes intheir vicinity.
That have a condition or abnormality other than type 1 diabetes that in the opinionof the Investigator would compromise the safety of the subject or the quality of thedata.
That utilize closed-loop diabetes management systems.
That have symptoms or recently been diagnosed with an upper respiratory illnessincluding COVID-19.
That themselves or a close family member (living within the same household at thetime of the data collection period) is on a "ketogenic diet".
That themselves or a close family member is working in an industry with high andcontinuous exposure to exogenous VOCs. Examples of such industries include beautysalons and paint manufacturers.
That are unable or unwilling to cooperate with sample collection.

Study Design

The Sensing Device

October 23, 2025

April 01, 2026

Study Description

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.

Connect with a study center

Indiana University
Indianapolis, Indiana 46202
United States
Site Not Available
Indiana University
Indianapolis 4259418, Indiana 4921868 46202
United States
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.