Breath sensor for detecting hypo- and hyperglycemia in teens with type 1 diabetes
Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients With Diabetes
This test checks whether a breath-based VOC sensor can spot low or high blood sugar in 12–19-year-olds with type 1 diabetes who use a Dexcom CGM.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 19 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06893341 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 12–19-year-olds with diagnosed type 1 diabetes who use a Dexcom G6 or G7 CGM, are the only household member with diabetes, are non-smokers, and live in Indianapolis or nearby suburbs.
Not a fit: People who smoke or live with smokers, use closed-loop insulin systems, have other conditions that alter breath chemistry, or live outside the Indianapolis area are unlikely to be eligible or to benefit from this pilot.
Why it matters
Potential benefit: If successful, a breath sensor could provide a noninvasive way to warn people of low or high blood sugar, potentially reducing missed events and the need for extra fingersticks.
How similar studies have performed: Trained dogs and small pilot VOC studies suggest breath signals can reflect glucose extremes, but electronic-nose approaches for glycemic detection remain largely exploratory with limited clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.