Status:
RECRUITING
Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events
Lead Sponsor:
Indiana University
Conditions:
Diabetes
Hyperglycemia
Eligibility:
All Genders
12-19 years
Phase:
NA
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 detectio...
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 insid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06893341
Start Date
October 23 2025
End Date
April 1 2026
Last Update
October 23 2025
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202