Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensing Device and Tedlar Bags.
- Who it may be relevant to
- Registry conditions: Diabetes, Hyperglycemia, Hypoglycemia (Diabetic). Basic parameters: 7 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes
Overview
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).
Interventions
- Device 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 measures
- Sensor Features Correlate with Blood Glucose Measurements [Time frame: 1 week for the summer camp.]
Secondary outcome measures (1)
- GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data [Time frame: 1 week for the summer camp.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Jameson Camp — Indianapolis
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. PMID 40762732
- 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 39160864
- 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 40414890
- 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 28294961
- 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 35453137
- 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 28569238
Identifiers
NCT: NCT07696273 · 31571