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Miniaturized Breath Sensor for Diabetes Management

This study is testing a new, small device called a Sensing Device that can detect changes in blood sugar (glucose) levels by analyzing your breath. We want to see if this device can tell when someone with diabetes has high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia) by looking for specific chemicals in their breath. You can join if you are 7 to 25 years old, have type 1 or type 2 diabetes, use a Dexcom G6 or G7 continuous glucose monitor (CGM), and are attending a diabetes camp in Indiana. The main goal is to see if the signals from this breath sensor match your blood glucose readings from your CGM over one week during the summer camp.

Study design
This interventional study plans to enroll 40 participants. It is testing a Sensing Device and Tedlar Bags.
What's involved
You would provide breath samples into the miniaturized sensing device and Tedlar bags during normal, low, and high blood sugar levels. You also need to share your CGM data for the study duration and be able to fill a breath collection bag.
Compensation
Not stated in the trial record.
Follow-up
Your sensor features will be correlated with blood glucose measurements for 1 week during the summer camp.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07696273

Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia

Recruiting
NAAges 7–25InterventionalDiagnostic
Indiana University
~40 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Sensing Device and Tedlar Bags

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensor Features Correlate with Blood Glucose Measurements
Measured over 1 week for the summer camp.

Conditions

Diabetes
Hyperglycemia
Hypoglycemia (Diabetic)

Explore related trials

Type 1 Diabetes MellitusType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Linda DiMeglio, MD · PRINCIPAL_INVESTIGATOR · Indiana University
  • Mark Woollam, PhD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Mangilal Agarwal, PhD
[email protected]
317-278-9792
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Who are diagnosed with T1D or T2D.
Who are between 7-25 years of age.
That use a Dexcom (G6 or G7) CGM device.
That have an established working CGM for at least 12 hours.
That are willing to share their CGM data for the study duration.
That are willing and able to fill up a breath collection bag.
That are attending a diabetes camp in the state of Indiana.

Exclusion

That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp).
That have a condition or abnormality other than T1D/T2D that in the opinion of the Investigators would compromise the safety of the subject or the quality of the data.
That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral/bacterial infections).
That follow a "ketogenic diet".
That are unable or unwilling to cooperate with either of the sample collection modes.

What this trial measures

  • Sensor Features Correlate with Blood Glucose Measurements1 week for the summer camp.

    Detection of exhaled VOC concentrations via the miniaturized laboratory device that correlate with hyper- and hypoglycemic episodes determined through finger stick and CGM data. It is anticipated that the device will be capable of noninvasively estimating blood glucose levels with approximately 30% agreement relative to CGM measurements, while accurately identifying hypo- and hyperglycemic events with greater than 85-90% sensitivity/specificity.