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

Dario Blood Glucose Monitoring System - Android Devices User Performance

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.

The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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%.