A Prospective, Multicenter, Open-label, Self-controlled Clinical Trial Protocol to Evaluate the Efficacy and Safety of a Multi-parameter Non-Invasive Glucose Sensors for Measuring Blood Glucose.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The results were analyzed by consensus error grid (CEG)
研究概览
简要总结
This was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes.
Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous blood glucose or fingertip blood glucose to evaluate System accuracy capability.
详细描述
At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were collected from each subject during fasting, after breakfast and after lunch.After the end of blood glucose measurement, the data were recorded, including adverse events and device defects during the test. The subjects were required to stay in the examination room for 5-10 minutes, during which they completed the product use evaluation questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diabetes (type 1 or type 2 );
- •Participants who could understand the purpose of the trial and signed the informed consent form.
排除标准
- •Conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc.
- •Diseases that affect the accuracy of hand measurement, such as Parkinson's disease, upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc.
- •Fever (axillary temperature >37.3℃) and severe dehydration during screening;
- •Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent;
- •Those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc.
- •Those suffering from mental illness, lack of self-control or unable to express their personal willingness clearly;
- •Participants who participated in other drug or device clinical trials within 2 weeks before signing the informed consent (except those who failed in screening);
- •Other persons deemed by the investigator to be ineligible for clinical trial participation.
结局指标
主要结局
The results were analyzed by consensus error grid (CEG)
时间窗: After 2 days of blood glucose measurements
The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)
次要结局
- Mean Absolute Relative Difference (MARD)(The day after the blood glucose measurement)
- The 20/20% agreement rates(The day after the blood glucose measurement)
- Accessibility evaluation Questionnaire for non-invasive glucose meter(The day after the blood glucose measurement)