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临床试验/NCT02053584
NCT02053584已完成不适用

Dario™ Blood Glucose Monitoring System - User Performance Evaluation

LabStyle Innovations Ltd.0 个研究点目标入组 230 人开始时间: 2013年6月1日最近更新:
适应症

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

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)

研究者

发起方
LabStyle Innovations Ltd.
申办方类型
Industry
责任方
Sponsor

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