User Performance Evaluation for DARIO™ BGMS

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Dario Blood Glucose Monitoring System
* Device: YSI


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dario Blood Glucose Monitoring System<br>Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS). | Device: Dario Blood Glucose Monitoring System<br>* Finger-stick obtained with BGMS<br>Device: YSI<br>* Finger-stick sample obtained by nurse/technician to be tested with YSI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician | Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician) | 5 minutes |