User Performance of the ONYX PLUS 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
- 134
- 试验地点
- 4
- 主要终点
- Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
研究概览
简要总结
The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS 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
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
排除标准
- •Hemophilia or 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 ONYX PLUS BGMS
- •Working for a medical laboratory, hospital, or other clinical setting that involves training on or 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 goal for the intended use population:
- •At least 70% of subjects will be younger than age 65
- •At least 20% of subjects will have type 1 diabetes
研究组 & 干预措施
Users of the Monitoring System
Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
干预措施: ONYX PLUS Investigational Blood Glucose Monitoring System (Device)
结局指标
主要结局
Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/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 percent of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) and +/- 15% (\>= 100mg/dL YSI capillary plasma).
次要结局
- Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS(1 hour)
- Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method(1 hour)
- Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff(1 hour)
- Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose(1 hour)