Performance of the Ninja 3 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
- 219
- 试验地点
- 4
- 主要终点
- Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method
研究概览
简要总结
The purpose of this study was to determine if 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
- •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
- •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 Ninja 3 BGMS
- •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.
- •The enrollment criteria for the study population:
- •At least 60% of subjects will be younger than age 65
- •At least 20% of subjects will have type 1 diabetes
- •At least 50% of subjects with type 2 diabetes wil be insulin users.
结局指标
主要结局
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method
时间窗: 1 hour
Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma).
次要结局
- Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method(1 hour)
- Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method(1 hour)
- Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements(1 hour)
- Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method(1 hour)
- Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff(1 hour)