Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Interstitial fluid glucose readings
研究概览
简要总结
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which can cause discomfort or inconvenience; these and other factors can lead to decreased willingness to perform these checks that are vital to DM management. While technology has evolved, a needle-free glucose monitoring device is currently not available. The investigators are studying a glucose sensor that adheres to the skin, similarly to a temporary tattoo. This sensor can now obtain continuous readings. As it has not yet been tested in individuals with DM, this study will examine its accuracy and acceptability in these patients. Results from this clinical trial could serve as the basis for further development of a non-invasive, wearable glucose sensor that can provide measurements of glucose levels continuously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or etiology of diabetes
- •Ability to provide informed consent for participation.
排除标准
- •Individuals without diabetes
- •Those who cannot speak or read English. We are limiting participation to those who read and speak English, as this is a pilot study of a small number of participants, that will very unlikely offer the prospect of direct benefit from participating.
- •Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.
结局指标
主要结局
Interstitial fluid glucose readings
时间窗: Hourly, up to 8 hours
Needle-less measurements with an epidermal sensor - pls note, study is to assess how sensor readings compare with those from a glucometer
次要结局
- Acceptablility of sensor(At end of study testing sessions, at 8 hours)
研究者
Edward Chao
Clinical Professor of Medicine
University of California, San Diego