Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07696273
Status
Recruiting
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Conditions

  • Diabetes
  • Hyperglycemia
  • Hypoglycemia (Diabetic)

Eligibility Criteria

Sex
ALL
Age
7 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Sensing Device and Tedlar Bags — DEVICE
    Children diagnosed with diabetes that wear a continuous glucose monitor (CGM) will provide breath samples into the miniaturized sensing device (as well as Tedlar bags for GC-MS analysis) during euglycemia, hypoglycemia, and hyperglycemia. The breath data will be analyzed to draw correlations with blood glucose levels measured via CGMs and finger prick tests.

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 (VOCs) in exhaled breath.

Key Dates

First listed
Jul 10, 2026
Start date
May 31, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Oct 1, 2027

Study Design

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

Arms

  • Experimental: Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors
    Participants diagnosed with type 1 diabetes (T1D) or type 2 diabetes (T2D) will be recruited for the study. Following consent, enrolled subjects will donate breath samples for approximately one week over the course of the summer camp. Each subject will donate two breath samples during at least n = 15 breath collection events (n = 30 samples in total) for analysis by sensors and gas chromatography-mass spectrometry (GC-MS), while also collecting finger stick data right before (or after) each breath sample. The participant will also wear a CGM as a routine standard care procedure for diabetes management.

Primary Outcome Measure

Sensor Features Correlate with Blood Glucose Measurements [ Time Frame: 1 week for the summer camp. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jameson CampIndianapolisIndiana46231
Joe Esten
[email protected]
608-390-6398
Linda DiMeglio, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Jameson Camp· Indianapolis, IN

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