DiabetesNCT06893341
Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events
A study testing The Sensing Device 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 in exhaled breath. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Diabetes, Hyperglycemia, Hypoglycemia
- What is being tested?
- The Sensing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 1 Dec 2026
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Who are diagnosed with type 1 diabetes.
- Who are between 12-19 years of age.
- That utilize a Dexcom (G6 or G7) continuous glucose monitoring device.
- That have an established working CGM for at least 12 hours (that does not need to be replaced within 24 hours).
- That are willing to share their daily CGM data for the study.
- That are the only individuals in their household with any type of diabetes diagnosis (type 1 or type 2).
- That are willing to return the device within 24-48 hours of study completion.
- That are located in Indianapolis, IN or its suburban areas.
Who cannot join
- That are smokers or use tobacco products or who live with someone who smokes in their vicinity.
- That have a condition or abnormality other than type 1 diabetes that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- That utilize closed-loop diabetes management systems.
- That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19.
- That themselves or a close family member (living within the same household at the time of the data collection period) is on a "ketogenic diet".
- That themselves or a close family member is working in an industry with high and continuous exposure to exogenous VOCs. Examples of such industries include beauty salons and paint manufacturers.
- That are unable or unwilling to cooperate with sample collection.
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
Indiana University
Indianapolis, Indiana, 46202
Mark Woollam, PhD, 267-249-4787, mwoollam@iu.edu
About this study
Official title: Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients 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 in exhaled breath.
Read the detailed description
A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.
- Conditions
- Diabetes, Hyperglycemia, Hypoglycemia
- Being tested
- The Sensing Device
- Keywords
- Volatile Organic Compound (VOC), Electronic Nose (e-Nose), Exhaled Breath, Noninvasive Health Monitoring
- 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.
The Sensing DeviceDevice
Children diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Children with Continuous Glucose Monitors | Experimental | These subjects will be given the Sensing Device, a wearable sensor that subjects can breathe into, which is being investigated in the current study as a potential medical device for noninvasive measurement of blood glucose. Receives: Device: The Sensing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Breath Sensor Data and Blood Glucose
Participants will wear the breath sensor device for 72 hours. Participants will provide at least 15 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, multiple during periods of hyperglycemia (blood glucose > 200 mg/dL), and multiple during periods of euglycemia. During each breath sample collection event, continuous CGM data will be recorded, and participants will also be asked to perform a finger-prick blood glucose test. Participants will return the device, and data from the wearable breath-based sensor will be analyzed using chemometrics and statistics to identify significant correlations between breath data and blood glucose levels.
Measured: While wearing the device, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start23 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 30 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 A DiMeglio, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893341
- Sponsor's protocol ID
- 22467
- Status last verified
- May 2026
- First submitted
- 18 Mar 2025
- Last updated
- 13 May 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.
Publications
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.
PubMed 28569238Woollam 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 35453137Daneshkhah 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 28294961
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT06893341
- Acronym / sponsor ID
- 22467
- Conditions
- Diabetes, Hyperglycemia, Hypoglycemia
- Keywords
- Volatile Organic Compound (VOC), Electronic Nose (e-Nose), Exhaled Breath, Noninvasive Health Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Mar 2025 (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 in exhaled breath.
Detailed description
A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.
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 with Continuous Glucose Monitors | Experimental | Device: The Sensing DeviceThese subjects will be given the Sensing Device, a wearable sensor that subjects can breathe into, which is being investigated in the current study as a potential medical device for noninvasive measurement of blood glucose. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Who are diagnosed with type 1 diabetes.
- Who are between 12-19 years of age.
- That utilize a Dexcom (G6 or G7) continuous glucose monitoring device.
- That have an established working CGM for at least 12 hours (that does not need to be replaced within 24 hours).
- That are willing to share their daily CGM data for the study.
Key exclusion criteria (7 listed)
- That are smokers or use tobacco products or who live with someone who smokes in their vicinity.
- That have a condition or abnormality other than type 1 diabetes that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- That utilize closed-loop diabetes management systems.
- That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19.
- That themselves or a close family member (living within the same household at the time of the data collection period) is on a "ketogenic diet".
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 |
|---|---|---|
| The Sensing DeviceChildren diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels. | Device | Diabetic Children with Continuous Glucose Monitors |
Primary outcome
Correlation between Breath Sensor Data and Blood Glucose
Time frame: While wearing the device, up to 72 hours
Participants will wear the breath sensor device for 72 hours. Participants will provide at least 15 direct breath samples during this time: one upon receipt of the device and in the presence of research staff, multiple during periods of hyperglycemia (blood glucose > 200 mg/dL), and multiple during periods of euglycemia. During each breath sample collection event, continuous CGM data will be recorded, and participants will also be asked to perform a finger-prick blood glucose test. Participants will return the device, and data from the wearable breath-based sensor will be analyzed using chemometrics and statistics to identify significant correlations between breath data and blood glucose levels.
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 13 May 2026.
- 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.
- 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 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.
- 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.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 A DiMeglio, MD 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 The Sensing Device 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 8 inclusion and 7 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 13 May 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@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Breath Sensor Data and Blood Glucose (time frame: While wearing the device, up to 72 hours). 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 NCT06893341, which also lists 3 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 13 May 2026.