NCT01328717已完成不适用
Clinical Trial Protocol for Contour Link System With Contour Sensor
Ascensia Diabetes Care2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method
研究概览
简要总结
Subjects with diabetes and study staff used an investigational blood glucose monitoring system.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 years of age and above
- •Diagnosed as having type 1 or type 2 diabetes
- •Currently self-testing blood glucose at home for at least three months
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
排除标准
- •Gestational Diabetes
- •Hemophilia or any other bleeding disorder
- •Employee of competitive medical device company
结局指标
主要结局
Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method
时间窗: 1 hour
Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results \>=75mg/dL) and within +/- 15mg/dL(for reference BG results \<75mg/dL) of the reference method results.
次要结局
- Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)(1 hour)
研究者
研究点 (2)
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