Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
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 in exhaled breath.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Who are diagnosed with type 1 diabetes.
Who are between 12-19 years of age.
That utilize a Dexcom (G6 or G7) continuous glucose monitoring device.
That have an established working CGM for at least 12 hours (that does not need to be replaced within 24 hours).
Disqualifiers
That are smokers or use tobacco products or who live with someone who smokes in their vicinity.
That have a condition or abnormality other than type 1 diabetes that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
That utilize closed-loop diabetes management systems.
That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19.
Trial design
Design model
Single group
Treatments tested in this trial
The Sensing Device
DeviceChildren diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Diabetic Children with Continuous Glucose MonitorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlation between Breath Sensor Data and Blood Glucose
Participants will wear the breath sensor device for 72 hours. Participants will provide at least 15 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, multiple during periods of hyperglycemia (blood glucose \> 200 mg/dL), and multiple during periods of euglycemia. During each breath sample collection event, continuous CGM data will be recorded, and participants will also be asked to perform a finger-prick blood glucose test. Participants will return the device, and data from the wearable breath-based sensor will be analyzed using chemometrics and statistics to identify significant correlations between breath data and blood glucose levels.
Time frame
While wearing the device, up to 72 hoursSponsors and contacts
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Source ClinicalTrials.gov