Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-25
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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".
Trial design
Design model
Single group
Treatments tested in this trial
Sensing Device and Tedlar Bags
DeviceChildren 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Diabetic Children Attending a Summer Youth Camp with Continuous Glucose MonitorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensor Features Correlate with Blood Glucose Measurements
Detection of exhaled VOC concentrations via the miniaturized laboratory device that correlate with hyper- and hypoglycemic episodes determined through finger stick and CGM data. It is anticipated that the device will be capable of noninvasively estimating blood glucose levels with approximately 30% agreement relative to CGM measurements, while accurately identifying hypo- and hyperglycemic events with greater than 85-90% sensitivity/specificity.
Time frame
1 week for the summer camp.Secondary outcomes
1
GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data
Specific VOCs identified through GC-MS analysis are expected to correlate not only with blood glucose levels and hypo-/hyperglycemic events, but also with extracted features of the sensor response. It is anticipated that select VOCs will exhibit statistically significant correlations (R \> 0.70) with glycemic measures and may demonstrate stronger associations with blood glucose levels and glycemic state classification compared to the metal oxide gas sensor array.
Time frame
1 week for the summer camp.Sponsors and contacts
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Source ClinicalTrials.gov