An interventional study of The Sensing Device in Diabetes, Hyperglycemia and Hypoglycemia, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Exclusion Criteria:
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.
Device: The Sensing Device
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.
Correlation between Breath Sensor Data and Blood Glucose
Participants will wear the breath sensor device for 72 hours. Participants will provide at least 15 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, multiple during periods of hyperglycemia (blood glucose \> 200 mg/dL), and multiple during periods of euglycemia. During each breath sample collection event, continuous CGM data will be recorded, and participants will also be asked to perform a finger-prick blood glucose test. 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.
Time frame: While wearing the device, up to 72 hours
Plan to share: No — Only the principal investigators and research personnel listed in the approved Institutional Review Board (IRB) protocol will have access to the individual participant data (IPD), which will be stored on REDCap.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2026, 13 months after the start.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 13 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
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