Diabetes, Hyperglycemia, Hypoglycemia (Diabetic)
Conditions
Keywords
Exhaled Breath Analysis, Volatile Organic Compounds (VOCs), Metal Oxide Sensors, Gas Chromatography, Mass Spectrometry
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.
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
DEVICESensing 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.
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor Features Correlate with Blood Glucose Measurements | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data | 1 week for the summer camp. | 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. |
Countries
United States
Contacts
CONTACTMangilal Agarwal, PhD
CONTACTAkanksha Tipparti, M.S.
PRINCIPAL_INVESTIGATORLinda DiMeglio, MD
Indiana University
PRINCIPAL_INVESTIGATORMark Woollam, PhD
Indiana University
Outcome results
None listed