Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensor Features Correlate with Blood Glucose Measurements
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sensor Features Correlate with Blood Glucose Measurements
时间窗: 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.
次要结局
- GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data(1 week for the summer camp.)
研究者
Mangilal Agarwal
Professor of Biomedical Engineering and Informatics
Indiana University