Recruiting

BiosensorsMonitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Sponsor:

Indiana University

Code:

NCT06893341

Conditions

Diabetes

Hyperglycemia

Hypoglycemia

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Not accepted

Interventions

The Sensing Device

Study Details

Brief 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 in exhaled breath.

Conditions

Diabetes

Hyperglycemia

Hypoglycemia

Study ID

NCT06893341

Start date

Oct 23, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

The Sensing 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mangilal Agarwal, PhD

317-278-9792 agarwal@iupui.edu

Mark D Woollam, PhD

267-249-4787 mwoollam@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mark Woollam, PhD

267-249-4787 mwoollam@iu.edu

More Information

Sponsor

Indiana University

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

Volatile Organic Compound (VOC)
Electronic Nose (e-Nose)
Exhaled Breath
Noninvasive Health Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-13.