Miniature breath sensors to detect hypo- and hyperglycemia in young people with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study tests a miniaturized device that uses metal oxide gas sensors to detect volatile compounds in exhaled breath and see if they correlate with glycemic events. Two analytical platforms are used in parallel: the miniaturized sensor array and conventional GC-MS analysis of breath samples. Participants are youths with diabetes at a diabetes camp who already use CGMs and are willing to provide breath samples. Breath samples are collected alongside CGM data to validate whether the sensor can distinguish glycemic states in real-world conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jameson Camp
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Linda DiMeglio, MD — Indiana University
• Study coordinator: Mangilal Agarwal, PhD
• Email: agarwal@iu.edu
• Phone: 317-278-9792

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.