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NCT Number: NCT07696273

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

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 (VOCs) in exhaled breath.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Hypoglycemia (Diabetic) Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jameson Camp

Indianapolis, Indiana, 46231, United States

Location status: Recruiting

Location contact

Joe Esten

CONTACT

[email protected]

608-390-6398

Linda DiMeglio, MD

PRINCIPAL_INVESTIGATOR

About this study

At this stage, the team will deploy two different analytical platforms in parallel in a clinical study to survey exhaled breath volatile organic compound (VOC) profiles at a diabetes youth camp. The ultimate objective is to determine whether a miniaturized laboratory device incorporating metal oxide gas sensors can reliably distinguish specific VOCs associated with glycemic events under real-world conditions. Sensor responses will be validated through parallel breath collection using Tedlar (plastic) bags, followed by confirmatory analysis via gas chromatography-mass spectrometry (GC-MS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Sensing Device and Tedlar Bags

Device

Children diagnosed with diabetes that wear a continuous glucose monitor (CGM) will provide breath samples into the miniaturized sensing device (as well as Tedlar bags for GC-MS analysis) during euglycemia, hypoglycemia, and hyperglycemia. The breath data will be analyzed to draw correlations with blood glucose levels measured via CGMs and finger prick tests.

Primary outcomes

  1. Sensor Features Correlate with Blood Glucose Measurements

    Time frame: 1 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.

Secondary outcomes

  1. GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data

    Time frame: 1 week for the summer camp.

    Specific VOCs identified through GC-MS analysis are expected to correlate not only with blood glucose levels and hypo-/hyperglycemic events, but also with extracted features of the sensor response. It is anticipated that select VOCs will exhibit statistically significant correlations (R > 0.70) with glycemic measures and may demonstrate stronger associations with blood glucose levels and glycemic state classification compared to the metal oxide gas sensor array.

Study contacts

Contact information is provided by the study sponsor or research team.

Akanksha Tipparti, M.S.

CONTACT

[email protected]

317-626-9725

Mangilal Agarwal, PhD

CONTACT

[email protected]

317-278-9792

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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