Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, open label, controlled, single center study. 40 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria.
Primary Goal
* To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology.
Secondary Goal
* To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology.
详细描述
Primary Endpoint Parameter
• Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology. Safety will be established by paucity of adverse events. Adverse Events occurrence will be documented throughout the study.
Secondary Endpoint Parameters
Efficacy of the GlucoSat technology will be assessed by:
- Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device. Inter device variability should be within 15%.
- Patient satisfaction questionnaire.
- Physician satisfaction will be assessed by questionnaire.
研究设计
- 研究类型
- Observational
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/Female aged 18 and up.
- •Subject was diagnosed as a diabetes patient or healthy subject.
- •Subject able to comprehend and give informed consent for participation in this study.
- •Signed Informed Consent Form
排除标准
- •Pregnancy or breast feeding.
- •Patients treated with steroid.
- •Concomitant Coumadin use
- •Recent (within the last 3 months) myocardial infarction or CVA (stroke).
- •Any chronic unstable disease within the last 3 months.
- •Acute bleeding disorders.
- •HIV positive.
- •Hepatitis B/C positive.
- •Needing emergency surgery
- •Known cognitive or psychiatric disorder
- •Physician objection
- •Concurrent participation in any other clinical trial