Recruiting NCT06893341

Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

No phase Interventional Diabetes Hyperglycemia Hypoglycemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: The Sensing Device.
Who it may be relevant to: Registry conditions: Diabetes, Hyperglycemia, Hypoglycemia. Basic parameters: 12 years — 19 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients With Diabetes

Overview

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.

Interventions

Device 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 measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

United States · 1 center

Indiana University — Indianapolis

Publications

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
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
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

Identifiers

NCT: NCT06893341 · 22467

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗