Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Indiana University

Status: Enrolling

Conditions: Hypoglycemia; Diabetes; Hyperglycemia

Treatments: Device: The Sensing Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06893341

22467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Diabetic Children with Continuous Glucose Monitors

Experimental group

Description:

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.

Treatment:

Device: The Sensing Device