Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06893341
Status
Recruiting
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Conditions

  • Diabetes
  • Hyperglycemia
  • Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
12 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • The Sensing Device — DEVICE
    Children diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.

Study Details

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.

Key Dates

Start date
Oct 23, 2025
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diabetic Children with Continuous Glucose Monitors
    These subjects will be given the Sensing Device, a wearable sensor that subjects can breathe into, which is being investigated in the current study as a potential medical device for noninvasive measurement of blood glucose.

Primary Outcome Measure

Correlation between Breath Sensor Data and Blood Glucose [ Time Frame: While wearing the device, up to 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Mark Woollam, PhD
[email protected]
267-249-4787

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Indiana University· Indianapolis, IN

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