MON-181 Evaluation of the GLUCOCARD Shine Connex Bluetooth Enabled Blood Glucose Monitoring System's Ease of Use

Background: It is important that a Blood Glucose Monitoring System (BGMS) is easy to use since it is a critical tool used in the self-management of diabetes, including the prevention of micro and macrovascular complications. The “Ease of Use” consumer study is typically evaluated as part of the FDA 510(k) approval process for BGMS. Purpose: The objective of this study was to further verify the Ease of Use of the GLUCOCARD Shine Connex Bluetooth Enabled BGMS. Methods: A total of 20 subjects with confirmed diabetes between the ages of 40 to 89 participated in the IRB-approved study at ARKRAY in Minneapolis, MN during October 2018. 80.0% of the subjects fell between the ages of 60 to 89 years of age. The subjects were asked to perform a fingerstick self-test and answer a questionnaire directed at the Ease of Use of the device and test strip. All the subjects responded to the topics in the questionnaire which included, “Removing a Test Strip from Bottle”, “Inserting a Test Strip into the Meter”, “Removing a Test Strip from the Meter”, “Performing a Blood Glucose Test from your Fingertip” and “Reading Meter Display”. The subjects were asked to rate the topics as Very Easy, Easy, OK, Difficult, or Very Difficult. For evaluation purposes, these topics were grouped as Positive [Very Easy/Easy/OK] and Negative [Difficult/Very Difficult]. Results: From the questionnaire, “Removing a Test Strip from Bottle” and “Inserting a Test Strip into the Meter” received a 95.0% positive rating while all the remaining topics received a 100.0% positive rating, including “Removing a Test Strip from the Meter”, “Performing a Blood Glucose Test from your Fingertip” and “Reading Meter Display”. Conclusion: The GLUCOCARD Shine Connex Bluetooth Enabled BGMS scored a 98.0% positive overall average Ease of Use rating by the subjects.