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Dario™ Blood Glucose Monitoring System - User Performance Evaluation

NCT02053584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2021-12-21

Study results available
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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.

Conditions

Interventions

DEVICE

Dario™ Blood Glucose Meter

Each subject will undergo a finger prick and also provide a venous blood sample

DEVICE

YSI2003

Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.

Sponsors & Collaborators

  • LabStyle Innovations Ltd.

    lead INDUSTRY

Principal Investigators

  • Julio Vainstein, MD · Wolfson Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053584 on ClinicalTrials.gov