Dario™ Blood Glucose Monitoring System - User Performance Evaluation

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 Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Dario™ Blood Glucose Meter; Device: YSI2003

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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dario BGMS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BGMS Accuracy Assessment When Used by Layperson	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)	Within 6 seconds of applying blood drop to strip

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Ease of Use of the Dario BGMS by the Lay-person	Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.	Within a couple of hours from the time labelling material was provided to the subject

Collaborators and Investigators

• Sponsor: LabStyle Innovations Ltd.
• Investigators: Principal Investigator: Julio Vainstein, MD, Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CR-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No