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
Qualifiers
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
Treatments tested in this trial
- Sensing Device and Tedlar Bags
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov