Abstract
Background: It is important that Blood Glucose Monitoring Systems (BGMS) are easy to use, since it is a critical tool used in the self-management of diabetes mellitus, 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 evaluate the Ease of Use of the GLUCOCARD Shine Express Audio Enabled BGMS. Methods: A total of 20 subjects aged 30 to 91 participated in the study by performing a fingerstick self-test and answering 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 Test Strip from Bottle", "Inserting Test Strip into Meter", "Removing Test Strip from Meter", "Performing Blood Glucose Test from your Fingertip", "Understanding Audio Voice", "Following Voice Instructions" 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]. Additionally, subjects were asked if an audio enabled BGMS would improve their glucose monitoring. Results: From the questionnaire,100% of the Ease of Use responses provided were positive (very easy, easy or ok). Additionally, approximately 2/3 (65%) of the subjects responded that hearing their readings aloud would help them have better control of their blood glucose levels, approximately 1/3 (35%) reported that using a talking meter would make them more likely to monitor their blood glucose, and over half (55%) responded that using a talking meter would make testing easier. Conclusion: The GLUCOCARD Shine Express Audio Enabled BGMS scored an overall average 100% positive Ease of Use rating by the subjects. Additionally, it appears that the audio playback would be an accepted feature, which could play a part in helping individuals control their blood glucose levels.
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