User Performance Evaluation for DARIO™ BGMS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject has Type I or Type II diabetes
Subject speaks and reads English proficiently
Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
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 System (BGMS)
Subject is critically ill
Subject has an impairment that prevents him/her to follow the study procedures
Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study

Treatment and study plan

Dario Blood Glucose Monitoring System

Device

Finger-stick obtained with BGMS

YSI

Device

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

Primary outcomes

Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician

Time frame: 5 minutes

Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)

Sponsors and collaborators

Lead sponsor

LabStyle Innovations Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 6, 2015
Registry last updated: Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed