Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

NCT06893341 | Recruiting FDA Device

• 1 other identifier: 22467
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation between Breath Sensor Data and Blood Glucose

  Participants will wear the breath sensor device for 72 hours. Participants will provide at least 15 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, multiple during periods of hyperglycemia (blood glucose \> 200 mg/dL), and multiple during periods of euglycemia. During each breath sample collection event, continuous CGM data will be recorded, and participants will also be asked to perform a finger-prick blood glucose test. Participants will return the device, and data from the wearable breath-based sensor will be analyzed using chemometrics and statistics to identify significant correlations between breath data and blood glucose levels.

  While wearing the device, up to 72 hours

Study Arms (1)

Diabetic Children with Continuous Glucose Monitors

EXPERIMENTAL

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.

Device: The Sensing Device

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.

Diabetic Children with Continuous Glucose Monitors

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (3)

• Siegel AP, Daneshkhah A, Hardin DS, Shrestha S, Varahramyan K, Agarwal M. Analyzing breath samples of hypoglycemic events in type 1 diabetes patients: towards developing an alternative to diabetes alert dogs. J Breath Res. 2017 Jun 1;11(2):026007. doi: 10.1088/1752-7163/aa6ac6.

  PMID: 28569238 BACKGROUND

• Woollam M, Angarita-Rivera P, Siegel AP, Kalra V, Kapoor R, Agarwal M. Exhaled VOCs can discriminate subjects with COVID-19 from healthy controls. J Breath Res. 2022 May 6;16(3). doi: 10.1088/1752-7163/ac696a.

  PMID: 35453137 BACKGROUND

• Daneshkhah A, Shrestha S, Siegel A, Varahramyan K, Agarwal M. Cross-Selectivity Enhancement of Poly(vinylidene fluoride-hexafluoropropylene)-Based Sensor Arrays for Detecting Acetone and Ethanol. Sensors (Basel). 2017 Mar 15;17(3):595. doi: 10.3390/s17030595.

  PMID: 28294961 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linda A DiMeglio, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mangilal Agarwal, PhD

CONTACT

317-278-9792; agarwal@iupui.edu

Mark D Woollam, PhD

CONTACT

267-249-4787; mwoollam@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Integrated Nanosystems Development Institute

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: October 23, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)