Breath Sensor Study to Detect High and Low Blood Sugar in Youth with Diabetes at Indiana Camp

What this Trial Is About

Researchers are evaluating whether a set of miniaturized biosensors can noninvasively detect high or low blood sugar events in young people diagnosed with type 1 or type 2 diabetes. The study aims to identify specific volatile organic compounds VOCs in exhaled breath that correspond to these glycemic changes. This diagnostic study takes place in a real-world setting at a diabetes youth camp. Participants diagnosed with diabetes will provide breath samples during a summer camp lasting about one week. They will use a miniaturized device with metal oxide gas sensors to collect breath samples, which will be analyzed alongside samples collected in Tedlar bags and confirmed by gas chromatography-mass spectrometry GC-MS. Blood sugar levels will be tracked with continuous glucose monitors CGMs and finger stick tests to validate the sensor data. During the study, participants will give two breath samples during at least 15 collection events, totaling about 30 samples over the camp week. They will wear their CGM devices as part of their regular diabetes care. Researchers will compare sensor responses and GC-MS results with blood glucose readings to determine if breath analysis can reliably identify blood sugar changes. The study involves close monitoring throughout the camp period and aims to correlate breath sensor features with glucose measurements.

Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia