Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes
Indiana University
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 (VOCs) in exhaled breath.
Description
At this stage, the team will deploy two different analytical platforms in parallel in a clinical study to survey exhaled breath volatile organic compound (VOC) profiles at a diabetes youth camp. The ultimate objective is to determine whether a miniaturized laboratory device incorporating metal oxide gas sensors can reliably distinguish specific VOCs associated with glycemic events under real-world conditions. Sensor responses will be validated through parallel breath collection using Tedlar (plastic) bags, followed by confirmatory analysis via gas chromatography-mass spectrometry (GC-MS).
Eligibility
- Age range
- 7–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Who are diagnosed with T1D or T2D. * Who are between 7-25 years of age. * That use a Dexcom (G6 or G7) CGM device. * That have an established working CGM for at least 12 hours. * That are willing to share their CGM data for the study duration. * That are willing and able to fill up a breath collection bag. * That are attending a diabetes camp in the state of Indiana. Exclusion Criteria: * That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp). * That have a condition or abnormality other than T1D/T2D that in the opini…
Interventions
- DeviceSensing Device and Tedlar Bags
Children diagnosed with diabetes that wear a continuous glucose monitor (CGM) will provide breath samples into the miniaturized sensing device (as well as Tedlar bags for GC-MS analysis) during euglycemia, hypoglycemia, and hyperglycemia. The breath data will be analyzed to draw correlations with blood glucose levels measured via CGMs and finger prick tests.
Location
- Jameson CampIndianapolis, Indiana