OneTouch Verio Flex System Accuracy Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- To meet the requirements of ISO 15197:2015
研究概览
简要总结
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197
详细描述
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Subjects must be registered into the LFSS Patient Registry to participate in the study.
- •Each Participant must read and sign the approved Informed Consent Form.
- •Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy.
排除标准
- •> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.
结局指标
主要结局
To meet the requirements of ISO 15197:2015
时间窗: Four weeks
In order to meet the requirements of ISO 15197:2015 1. For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals \< 5.55 mmol/L (\< 100 mg/dL) or within + 15 % at glucose concentrations \> 5.55 mmol/L (\> 100 mg/dL). 2. 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.
次要结局
未报告次要终点