Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia
4. juli 2026 oppdatert av: Mangilal Agarwal, Indiana University
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mangilal Agarwal, PhD
- Telefonnummer: 317-278-9792
- E-post: agarwal@iu.edu
Studer Kontakt Backup
- Navn: Akanksha Tipparti, M.S.
- Telefonnummer: 317-626-9725
- E-post: atippart@iu.edu
Studiesteder
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Indiana
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Indianapolis, Indiana, Forente stater, 46231
- Rekruttering
- Jameson Camp
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Hovedetterforsker:
- Linda DiMeglio, MD
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Ta kontakt med:
- Joe Esten
- Telefonnummer: 608-390-6398
- E-post: JEsten@diabetes.org
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sensor Features Correlate with Blood Glucose Measurements
Tidsramme: 1 week for the summer camp.
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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.
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1 week for the summer camp.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data
Tidsramme: 1 week for the summer camp.
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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.
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1 week for the summer camp.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Linda DiMeglio, MD, Indiana University
- Hovedetterforsker: Mark Woollam, PhD, Indiana University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. mai 2026
Primær fullføring (Antatt)
1. september 2027
Studiet fullført (Antatt)
1. oktober 2027
Datoer for studieregistrering
Først innsendt
4. juli 2026
Først innsendt som oppfylte QC-kriteriene
4. juli 2026
Først lagt ut (Faktiske)
10. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 31571
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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