DiabetesNCT07696273
Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia
A study testing Sensing Device and Tedlar Bags in people with Diabetes and Hyperglycemia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Diabetes, Hyperglycemia, Hypoglycemia (Diabetic)
- What is being tested?
- Sensing Device and Tedlar Bags
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jameson Camp
Indianapolis, Indiana, 46231
Joe Esten, 608-390-6398, JEsten@diabetes.org
Linda DiMeglio, MD
About this study
Official title: Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes
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.
Read the detailed description
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).
- Conditions
- Diabetes, Hyperglycemia, Hypoglycemia (Diabetic)
- Being tested
- Sensing Device and Tedlar Bags
- Keywords
- Exhaled Breath Analysis, Volatile Organic Compounds (VOCs), Metal Oxide Sensors, Gas Chromatography, Mass Spectrometry
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sensing Device and Tedlar Bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week for the summer camp.
Secondary outcomes (1)
GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data
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.
Measured: 1 week for the summer camp.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start31 May 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mangilal Agarwal, Indiana University
- Investigators
- Linda DiMeglio, MD, Principal investigator, Indiana UniversityMark Woollam, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696273
- Sponsor's protocol ID
- 31571
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40762732Heranjal 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.
PubMed 39160864Woollam 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.
PubMed 40414890Daneshkhah 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.
PubMed 28294961Woollam 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.
PubMed 35453137Siegel 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.
PubMed 28569238
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes
- ClinicalTrials.gov ID
- NCT07696273
- Acronym / sponsor ID
- 31571
- Conditions
- Diabetes, Hyperglycemia, Hypoglycemia (Diabetic)
- Keywords
- Exhaled Breath Analysis, Volatile Organic Compounds (VOCs), Metal Oxide Sensors, Gas Chromatography, Mass Spectrometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 31 May 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors | Experimental | Device: Sensing Device and Tedlar BagsParticipants 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. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensing Device and Tedlar BagsChildren 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. | Device | Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors |
Primary outcome
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.
1 secondary outcome
GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data
Time frame: 1 week for the summer camp.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 40762732Woollam 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.
- Background: PubMed 39160864Heranjal 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.
- Background: PubMed 40414890Woollam 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.
- Background: PubMed 28294961Daneshkhah 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.
- Background: PubMed 35453137Woollam 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.
- Background: PubMed 28569238Siegel 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda DiMeglio, MD principal investigator
Indiana University
Mark Woollam, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensing Device and Tedlar Bags in people with Diabetes and Hyperglycemia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mangilal Agarwal, PhD (317-278-9792, agarwal@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor Features Correlate with Blood Glucose Measurements (time frame: 1 week for the summer camp.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07696273, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.