Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia
Purpose
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.
Conditions
- Diabetes
- Hyperglycemia
- Hypoglycemia (Diabetic)
Eligibility
- Eligible Ages
- Between 7 Years and 25 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
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).