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
Qualifiers
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
Treatments tested in this trial
- The Sensing Device
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Indiana University46202, IndianapolisIndiana, United States
Sponsors and collaborators
Indiana University
Lead sponsor
Source ClinicalTrials.gov