User Performance Evaluation for DARIO™ BGMS

Completed · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02357043

Run by

LabStyle Innovations Ltd.

People needed

368

Starts

2014-12-01

Expected to finish

2015-03-01

Last updated by the study team

2021-06-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Remington-Davis, Inc. — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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