NCT07696273NARecruiting

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

Indiana University

Start Date

5/31/2026

Completion Date

10/1/2027

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.

Detailed 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 Criteria

Age Range: 7 years to 25 years

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 opinion of the Investigators would compromise the safety of the subject or the quality of the data. * That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral/bacterial infections). * That follow a "ketogenic diet". * That are unable or unwilling to cooperate with either of the sample collection modes.

Interventions

DEVICE

Sensing Device and Tedlar Bags

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Conditions

DiabetesHyperglycemiaHypoglycemia (Diabetic)

Locations

Jameson Camp

Indianapolis, Indiana 46231

United States