Personalized Fingertip Glucose Measurement With a Touch Sensor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Accuracy: glucose readings in mg/dL
研究概览
简要总结
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which causes discomfort or inconvenience eventually lead to decreased willingness to perform such needle-based check-ups that are vital to DM management. While technology has evolved, currently there is no glucose monitoring device that is needle-free. The investigators are studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's fingertip. As it has not yet been tested in individuals with DM, the team 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 glucose sensor.
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
- 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
- •Having a hemoglobin A1c < 9.0%, and taking medication for diabetes. Individuals will bring their own lab report.
- •Ability to provide informed consent for participation.
排除标准
- •Individuals without diabetes
- •Uncontrolled medical conditions, including diabetes with a hemoglobin A1c > 9.0%, hypertension, heart, kidney, or liver failure.
- •Those who cannot speak or read English. Participation will be limited 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
Accuracy: glucose readings in mg/dL
时间窗: 1 day
Correlation of touch sensor glucose readings compared with glucometer measurements
次要结局
- Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest(1 day)
研究者
Edward Chao
Clinical Professor of Medicine
University of California, San Diego