Performance of the G3 Blood Glucose Monitoring System With TATSU Strip
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 4
- 主要终点
- Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method
研究概览
简要总结
The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
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 older
- •Type 1 or type 2 diabetes
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
排除标准
- •Pregnancy
- •Hemophilia or any other bleeding disorder
- •Previously participated in a study using the G3 system
- •Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
- •A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
- •Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
结局指标
主要结局
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method
时间窗: 1 hour
Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 5to15% (\>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.
次要结局
- Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method(1 hour)
- Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction(1 hour)