Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Dario™ Blood Glucose Meter; Device: YSI2003

• Registration Number: NCT02053584
• Lead Sponsor: LabStyle Innovations Ltd.

Brief 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.

Detailed 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 Timeline

• Study Start: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Results First Submitted: 2014-09-08
• Status Verified: 2016-07
• Results First Submitted QC: 2021-12-19
• Last Update Submitted: 2021-12-19
• Results First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

• Male or female between the age 18 and 80
• Type 1 and Type 2 diabetes

Exclusion Criteria

• Drug and alcohol abuse
• Investigator discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dario BGMS	Dario™ Blood Glucose Meter	-
Dario BGMS	YSI2003	-

Primary Outcome Measures

Name	Time	Method
BGMS Accuracy Assessment When Used by Layperson	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)

Secondary Outcome Measures

Name	Time	Method
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	Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.