Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Launched by INDIANA UNIVERSITY · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to detect blood sugar levels in young people with type 1 diabetes by analyzing their breath. Researchers want to see if a special device can spot when someone is experiencing high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia) by looking for specific substances in the air they exhale. The goal is to find a noninvasive method to help manage diabetes more easily.

To be eligible for this study, participants must be between 12 and 19 years old, have been diagnosed with type 1 diabetes, and use a specific continuous glucose monitoring device called Dexcom (either G6 or G7) for at least 12 hours. They should also be the only person in their household with any type of diabetes. Those who smoke, have certain health conditions, or live with someone on a special diet may not be able to participate. If selected, participants will need to share their glucose monitoring data and return the study device after a short period. The trial will take place in Indianapolis, IN, and participants can expect a straightforward process with the potential for valuable insights into diabetes management.

Gender

ALL

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.