At a glance
ClinicalIndex Comparison RecordN/ACompleted· 368 enrolled
Drug / intervention
Dario Blood Glucose Monitoring System +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.
User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)
In Brief
A clinical study evaluating Dario Blood Glucose Monitoring System and YSI for Diabetes. Completed, enrolled 368 participants across 1 site.
Detailed Summary
The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedFeb 2015
Primary CompletionMar 2015
TodayJul 2026
First PostedFeb 6, 2015
Enrollment StartDec 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.4 years ago
Interventions
Dario Blood Glucose Monitoring Systemdevice
Finger-stick obtained with BGMS
YSIdevice
Finger-stick sample obtained by nurse/technician to be tested with YSI