GLUCOME USABILITY STUDY

Twenty (20) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. The GlucoMe device, in its original packaging, along with the user manual and QuickStart guide will be provided to the patient in a simulated home-use environment. The patient labeling will be in the format intended for distribution. Ten (10) subjects identified as potential end users of the GlucoMe device will receive the user manual and QuickStart guide. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will not receive the user manual, but will receive the QuickStart guide. All subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device. The observer examination and user post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.