Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events
Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients With Diabetes
Indiana University
30 participants
Oct 23, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria7
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06893341