Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Not Applicable

Not yet recruiting

• Conditions: Diabetes; Hyperglycemia; Hypoglycemia

• Registration Number: NCT06893341
• Lead Sponsor: Indiana University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-05-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation between Breath Sensor Data and Blood Glucose	While wearing the device, up to 25 hours	Participants will wear the breath sensor device for 25 hours. During this time, the device will perform automated breath sampling every 15 minutes. Participants will additionally provide 5 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, two during periods of hyperglycemia (blood glucose \> 200 mg/dL), and two during periods of normoglycemia. 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.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States