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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dario Blood Glucose Monitoring System - Android Devices User Performance

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Dario Blood Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One Arm<br>This is a comparative diagnostic study, no interventional actions are being taken. | Device: Dario Blood Glucose Monitoring System<br>* Accuracy with usability assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Glucose Concentrations (%) | Accuracy acceptability is defined as follows: Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations < 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL. The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus. | 1 Day | 
| Average Rank of the Indication of How Would Rate Your Success in Operating Dario BGMS | Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful. Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS? | 1 Day | 
| Average Rank of the Indication of How Easy Was it to Operate the Dario™ BGMS on the First Time? | Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy. An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time? | 1 Day | 
| Percent of Participants Responding 'YES' on the Question Did You Successfully Obtain Measurement Result Using the Dario™ BGMS? | The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS? 100% of subjects (102 of 102) answered Yes to this question. | 1 Day |