CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Dario™ Blood Glucose Meter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02053584
NCT02053584N/ACompleted
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Dario™ Blood Glucose Monitoring System - User Performance Evaluation

LabStyle Innovations Ltd.·interventional·Posted Feb 3, 2014·Updated Dec 21, 2021

In Brief

A clinical study evaluating Dario™ Blood Glucose Meter and YSI2003 for Diabetes. Completed, enrolled 230 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2014
Enrollment StartJun 1, 2013
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 12.4 years ago

Interventions

Dario™ Blood Glucose Meterdevice

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

YSI2003device

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