User Performance of the Karajishi Contour Blood Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
研究概览
简要总结
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training 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
- Supportive Care
- 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
- •People with type 1 or type 2 diabetes
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
排除标准
- •Hemophilia or any other bleeding disorder
- •Pregnancy
- •Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
- •Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter)
- •Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- •Working for a competitive medical device company, or having an immediate family member who works for such a company
- •A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
研究组 & 干预措施
Intended Users of the Monitoring System
Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:
- At least 60% of subjects will be younger than age 65
- At least 10% of subjects will have type 1 diabetes
干预措施: Karajishi Contour Investigational BG Monitoring System (Device)
结局指标
主要结局
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
时间窗: 1 hour
Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject 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 +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).
次要结局
- Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method(1 hour)
- Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method(1 hour)
- Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff(1 hour)
- Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements(1 hour)