NCT00877461已完成不适用
Glucose Monitor Accuracy Investigation (Ⅰ)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- glucose
研究概览
简要总结
According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips and vein as samples to evaluate the accuracy of portable BGM.
详细描述
The clinical medical technologists collected blood samples from 308 volunteers including 87 diabetics and 221 healthy people. The range of the blood glucose concentration was from 41.2mg/dL to 521mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches the requirement of ISO15197(2003).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteers with diabetes and non-diabetes
排除标准
- •hypertension,fever,AIDS,hemophilia
结局指标
主要结局
glucose
时间窗: 10 min
次要结局
未报告次要终点
研究者
研究点 (1)
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