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

RecruitingNAAges 7 Years - 25 YearsAllIndiana University
NCT07696273 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sensing Device and Tedlar Bags
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Where

1 site
Jameson Camp
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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