Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

NCT ID: NCT02910674

Last Updated: 2021-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

Detailed Description

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The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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One Arm

This is a comparative diagnostic study, no interventional actions are being taken.

Group Type OTHER

Dario Blood Glucose Monitoring System

Intervention Type DEVICE

Accuracy with usability assessment

Interventions

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Dario Blood Glucose Monitoring System

Accuracy with usability assessment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject has Type 1 or Type II diabetes
* Subject speaks and reads English proficiently
* Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study)

Exclusion Criteria

* Subject has medical training or works in the field of blood glucose monitoring systems.
* Subject is critically ill.
* Subject has an impairment that prevents him/her from following the study procedures.
* Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
* Hematocrit levels outside the range of 20%-60%.
Minimum Eligible Age

13 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LabStyle Innovations Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barbara Davis Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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CP-0004

Identifier Type: -

Identifier Source: org_study_id

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