Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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)". ;

Study Design

Related Conditions & MeSH terms

Diabetes

Clinical Trial Details

NCT number	NCT02053584
Study type	Interventional
Source	LabStyle Innovations Ltd.
Contact
Status	Completed
Phase	N/A
Start date	June 2013
Completion date	June 2013

View Details

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