User Performance Evaluation for DARIO™ BGMS

NCT ID: NCT02357043

Last Updated: 2021-06-15

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

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.

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 Blood Glucose Monitoring System

Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).

Group Type EXPERIMENTAL

Dario Blood Glucose Monitoring System

Intervention Type DEVICE

Finger-stick obtained with BGMS

YSI

Intervention Type DEVICE

Finger-stick sample obtained by nurse/technician to be tested with YSI

Interventions

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Dario Blood Glucose Monitoring System

Finger-stick obtained with BGMS

Intervention Type DEVICE

YSI

Finger-stick sample obtained by nurse/technician to be tested with YSI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject has Type I or Type II diabetes
2. Subject speaks and reads English proficiently
3. Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
4. 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

1. Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
2. Subject is critically ill
3. Subject has an impairment that prevents him/her to follow the study procedures
4. Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study
Eligible Sex

ALL

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

Locations

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Remington-Davis, Inc.

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CP-0002

Identifier Type: -

Identifier Source: org_study_id

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