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Dario™ Blood Glucose Monitoring System - User Performance Evaluation

NCT ID: NCT02053584

Last Updated: 2021-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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)".

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dario BGMS

Group Type EXPERIMENTAL

Dario™ Blood Glucose Meter

Intervention Type DEVICE

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

YSI2003

Intervention Type DEVICE

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

Interventions

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Dario™ Blood Glucose Meter

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

Intervention Type DEVICE

YSI2003

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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LabStyle Innovations Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julio Vainstein, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Other Identifiers

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CR-0002

Identifier Type: -

Identifier Source: org_study_id