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

NCT07696273 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Sensing Device and Tedlar Bags

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.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Linda DiMeglio, MD · Indiana University

  • Mark Woollam, PhD · Indiana University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-09-01
Completion
2027-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696273 on ClinicalTrials.gov