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

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02910674

Run by

LabStyle Innovations Ltd.

People needed

102

Starts

2016-07-01

Expected to finish

2016-08-01

Last updated by the study team

2021-04-13

Who can join

Age: 13 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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%.

Where it is running

• Barbara Davis Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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