NCT07696273

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
14mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
May 2026Oct 2027

Study Start

First participant enrolled

May 31, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 4, 2026

Last Update Submit

July 4, 2026

Conditions

DiabetesHyperglycemiaHypoglycemia (Diabetic)

Keywords

Exhaled Breath AnalysisVolatile Organic Compounds (VOCs)Metal Oxide SensorsGas ChromatographyMass Spectrometry

Outcome Measures

Primary Outcomes (1)

  • Sensor Features Correlate with Blood Glucose Measurements

    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.

    1 week for the summer camp.

Secondary Outcomes (1)

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

    1 week for the summer camp.

Study Arms (1)

Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors

EXPERIMENTAL

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.

Device: Sensing Device and Tedlar Bags

Interventions

Sensing Device and Tedlar BagsDEVICE

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.

Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors

Eligibility Criteria

Age7 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jameson Camp

Indianapolis, Indiana, 46231, United States

RECRUITING

Related Publications (6)

  • Woollam M, Christensen A, Schulz E, Eckerle S, Davis MD, Sanders DB, Agarwal M. Systematic comparison of methods for offline breath sampling. Anal Bioanal Chem. 2025 Sep;417(22):5061-5076. doi: 10.1007/s00216-025-06025-5. Epub 2025 Aug 5.

    PMID: 40762732BACKGROUND

  • Heranjal S, Maciel M, Kamalapally SNR, Ramrakhiani I, Schulz E, Cao S, Liu X, Relich RF, Wek R, Woollam M, Agarwal M. Establishing Healthy Breath Baselines With Tin Oxide Sensors: Fundamental Building Blocks for Noninvasive Health Monitoring. Mil Med. 2024 Aug 19;189(Suppl 3):221-229. doi: 10.1093/milmed/usae078.

    PMID: 39160864BACKGROUND

  • Woollam M, Angarita-Rivera P, Thakur S, Daneshkhah A, Siegel AP, Hardin DS, Agarwal M. Steps toward clinical validation of exhaled volatile organic compound biomarkers for hypoglycemia in persons with type 1 diabetes. Sci Rep. 2025 May 25;15(1):18257. doi: 10.1038/s41598-025-00284-z.

    PMID: 40414890BACKGROUND

  • Daneshkhah A, Shrestha S, Siegel A, Varahramyan K, Agarwal M. Cross-Selectivity Enhancement of Poly(vinylidene fluoride-hexafluoropropylene)-Based Sensor Arrays for Detecting Acetone and Ethanol. Sensors (Basel). 2017 Mar 15;17(3):595. doi: 10.3390/s17030595.

    PMID: 28294961BACKGROUND

  • Woollam M, Angarita-Rivera P, Siegel AP, Kalra V, Kapoor R, Agarwal M. Exhaled VOCs can discriminate subjects with COVID-19 from healthy controls. J Breath Res. 2022 May 6;16(3). doi: 10.1088/1752-7163/ac696a.

    PMID: 35453137BACKGROUND

  • Siegel AP, Daneshkhah A, Hardin DS, Shrestha S, Varahramyan K, Agarwal M. Analyzing breath samples of hypoglycemic events in type 1 diabetes patients: towards developing an alternative to diabetes alert dogs. J Breath Res. 2017 Jun 1;11(2):026007. doi: 10.1088/1752-7163/aa6ac6.

    PMID: 28569238BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusHyperglycemiaHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linda DiMeglio, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Mark Woollam, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mangilal Agarwal, PhD

CONTACT

317-278-9792agarwal@iu.edu

Akanksha Tipparti, M.S.

CONTACT

317-626-9725atippart@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biomedical Engineering and Informatics

Study Record Dates

First Submitted

July 4, 2026

First Posted

July 10, 2026

Study Start

May 31, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Only the principal investigators and research personnel listed in the approved Institutional Review Board (IRB) protocol will have access to the individual participant data (IPD), which will be stored on REDCap. The team does not anticipate submitting results or manuscripts to ICMJE journals.

Locations

US(1)