Background: It is critical that Blood Glucose Monitoring System’s (BGMS) are easy to use since they are an important tool in the management of diabetes mellitus, including the prevention of micro and macrovascular complications. The GLUCOCARD® W BGMS is intended for consumer use and is an aid in monitoring the effectiveness of diabetes management. 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 for the GLUCOCARD® W BGMS.

Methods: A total of 148 untrained consumers with diabetes performed a fingerstick self-test and answered a questionnaire directed at Ease of Use of the device and test strip. The topics in the questionnaire included, “Inserting a Test Strip into Meter to Turn it On”; “Blood Draw into Test Strip (Capillary Action)”; “Reading the Meter Display”; “Removing Test Strip from Meter” and “Performing a Blood Glucose Test from your Fingertip.” 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/Ease/Ok) and Negative (Difficult/Very Difficult).

Results: The topics in the questionnaire received the following positive ratings (%): “Inserting a Test Strip into Meter to Turn it On”, 97.3% (144/148); “Blood Draw into Test Strip (Capillary Action)”, 100.0% (147/147, one subject did not rate this topic); “Reading the Meter Display” received a 99.3% (147/148); “Removing Test Strip from Meter”, 100.0% (148/148) and “Performing a Blood Glucose Test from your Fingertip”, 100.0% (148/148).

Conclusion: The GLUCOCARD® W BGMS scored an overall positive rating of 99.3% (average of the ratings) from the untrained consumers with diabetes evaluating the BGMS as Very Easy to Ok to use.


J. Walker: Employee; Self; Arkray, Inc. P. Gill: Employee; Self; Arkray, Inc. D. Maher: Employee; Self; Arkray, Inc. J.M. Gleisner: Employee; Self; Arkray, Inc..

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