Dario™ Blood Glucose Monitoring System - User Performance Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 主要终点
- BGMS Accuracy Assessment When Used by Layperson
研究概览
简要总结
The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person.
The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.
详细描述
Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: "The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL)".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •Male or female between the age 18 and 80
- •Type 1 and Type 2 diabetes
排除标准
- •Drug and alcohol abuse
- •Investigator discretion
结局指标
主要结局
BGMS Accuracy Assessment When Used by Layperson
时间窗: Within 6 seconds of applying blood drop to strip
The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)
次要结局
- Evaluation of the Ease of Use of the Dario BGMS by the Lay-person(Within a couple of hours from the time labelling material was provided to the subject)