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

Investigation of a Wearable Device for Detecting Blood Sugar Levels in Individuals with Type 1 Diabetes

M
Mangilal Agarwal

Primary Investigator

Enrolling By Invitation
12 years - 19 years
All
Phase N/A
10 participants needed
2 Locations

Brief description of study

Scosche Industries, Inc. has developed a completely noninvasive device which detects exhaled volatile organic compound (VOC) biomarkers. This wearable device was designed with the goal of early detection of hyperglycemia and possibly hypoglycemia in patients with diabetes. At this time, the device can be worn on the body (e.g. on a lanyard around the neck or on a wristband/armband) or can be placed at bedside during sleeping hours. The purpose of the current study is to collect initial pilot data to determine whether hyper-/hypoglycemic events in children and young adolescents with type 1 diabetes can be detected utilizing this VOC sensing device. 
 
Use of this VOC sensor to analyze breath samples and track blood glucosevels is investigational only, that is, it is not approved by the Foodd Drug Administration (FDA).
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants for this study will be recruited at the Clinical Research Center at IU Hospital or the Methodist Diabetes Center at Methodist Hospital when they are there for scheduled visits or routine medical procedures.

Detailed description of study

This study involves monitoring chemical signals in breath using the wearable device over the course of 25 hours.

  • Each participant will wear this noninvasive Device for 25 hours on a lanyard around their neck (or kept bedside while sleeping or removed for swimming or showering).
  • At the same time, they will continue to wear their usual invasive continuous glucose monitor (CGM).
  • We will also ask participants to perform five Direct Breath samples where they breathe into the device for 15 seconds.
  • At the end of the study, data collected from the VOC sensor will be compared to the data from the participant’s CGM to determine if the VOC sensor can accurately detect the hypo- and hyperglycemic events captured by the CGM. 
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 1 Diabetes, T1D
  • Age: 12 years - 19 years
  • Gender: All

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.
•    Who are English speaking participants.
•    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.
 

This study investigates a wearable device that senses chemicals in the breath to detect blood sugar levels in people with Type 1 diabetes. Type 1 diabetes is a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels.

Participants will wear the device for 25 hours to monitor breath chemicals. They will also use their usual continuous glucose monitor (CGM). During the study, participants will breathe into the device five times for 15 seconds each. The data from the wearable device will be compared to the CGM data to check if the device accurately detects changes in blood sugar levels.

  • Who can participate: Participants must be aged 12-19, have Type 1 diabetes, and use a Dexcom continuous glucose monitor. They should live in Indianapolis or nearby areas and be willing to share CGM data.
  • Study details: Participants will wear a noninvasive device for 25 hours and provide breath samples. They will continue using their regular glucose monitor. Data from both devices will be compared.
  • Study timelines: The study will last 25 hours.
Updated on 20 Oct 2025. Study ID: PENDO-IIR-22467, 22467
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only