NCT01795625已完成不适用
A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.
Johnson & Johnson Medical, China2 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2012年8月31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
- 301
- 试验地点
- 2
- 主要终点
- • Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample
研究概览
简要总结
The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is at least 18 years of age.
- •Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
- •Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
- •Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
- •Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
- •Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.
排除标准
- •Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
- •Subject has already participated in this study.
- •Subject is known pregnant
结局指标
主要结局
• Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample
时间窗: 56days
August 20,2012\~October 14,2012
次要结局
未报告次要终点
研究者
研究点 (2)
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