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User Performance Evaluation for DARIO™ BGMS | Clinical Trials | Clareo Health

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User Performance Evaluation for DARIO™ BGMS

User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)

NCT02357043•LabStyle Innovations Ltd.

Summary

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

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (1)

Remington-Davis, Inc.

Columbus, Ohio, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

June 15, 2021

Enrollment

368

ACTUAL participants

Conditions

Diabetes

Interventions

Dario Blood Glucose Monitoring System

DEVICE

YSI

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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User Performance Evaluation for DARIO™ BGMS

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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