Breath sensor for detecting hypo- and hyperglycemia in teens with type 1 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

A portable electronic nose device samples exhaled breath to measure volatile organic compounds (VOCs) that may change during low or high blood sugar events. Teens aged 12–19 with type 1 diabetes who wear a Dexcom G6 or G7 will provide breath samples while their continuous glucose monitor collects glucose data. Sensor readings will be time-matched to CGM values to look for VOC patterns associated with hypoglycemia and hyperglycemia. The study aims to determine whether noninvasive breath signatures can reliably flag glycemic events compared with standard CGM measurements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).
* That are willing to share their daily CGM data for the study.
* That are the only individuals in their household with any type of diabetes diagnosis (type 1 or type 2).
* That are willing to return the device within 24-48 hours of study completion.
* That are located in Indianapolis, IN or its suburban areas.

Exclusion Criteria:

* 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.
* That themselves or a close family member (living within the same household at the time of the data collection period) is on a "ketogenic diet".
* That themselves or a close family member is working in an industry with high and continuous exposure to exogenous VOCs. Examples of such industries include beauty salons and paint manufacturers.
* That are unable or unwilling to cooperate with sample collection.

Where it's running

• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Linda A DiMeglio, MD — Indiana University
• Study coordinator: Mangilal Agarwal, PhD
• Email: agarwal@iupui.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.