Clinical trial NCT06893341: Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events
Official title: Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients with Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Hyperglycemia
Hypoglycemia
Keywords: Volatile Organic Compound (VOC)
Electronic Nose (e-Nose)
Exhaled Breath
Noninvasive Health Monitoring
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between Breath Sensor Data and Blood Glucose
timeFrame: While wearing the device, up to 25 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Linda A DiMeglio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.