Recruiting

Biosensors

Sponsor:

Indiana University

Code:

NCT07696273

Conditions

Diabetes

Hyperglycemia

Hypoglycemia (Diabetic)

Eligibility Criteria

Sex: All

Age: 7 - 25

Healthy Volunteers: Not accepted

Interventions

Sensing Device and Tedlar Bags

Study Details

Brief summary:

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.

Conditions

Diabetes

Hyperglycemia

Hypoglycemia (Diabetic)

Study ID

NCT07696273

Start date

May 31, 2026

Status verified date

Jul, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors

Participants diagnosed with type 1 diabetes (T1D) or type 2 diabetes (T2D) will be recruited for the study. Following consent, enrolled subjects will donate breath samples for approximately one week over the course of the summer camp. Each subject will donate two breath samples during at least n = 15 breath collection events (n = 30 samples in total) for analysis by sensors and gas chromatography-mass spectrometry (GC-MS), while also collecting finger stick data right before (or after) each breath sample. The participant will also wear a CGM as a routine standard care procedure for diabetes management.

Interventions

Sensing Device and Tedlar Bags

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 outcome measure

  • Sensor Features Correlate with Blood Glucose Measurements [ Time Frame: 1 week for the summer camp. ]

Central Contacts and Locations

Central contacts

Mangilal Agarwal, PhD

317-278-9792agarwal@iu.edu

Akanksha Tipparti, M.S.

317-626-9725atippart@iu.edu

Locations

Jameson Camp

Recruiting

Indianapolis, Indiana, United States, 46231

Contacts

Joe Esten

608-390-6398JEsten@diabetes.org

Principal Investigator:

Linda DiMeglio, MD

More Information

Sponsor

Indiana University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Exhaled Breath Analysis
  • Volatile Organic Compounds (VOCs)
  • Metal Oxide Sensors
  • Gas Chromatography
  • Mass Spectrometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-10.