Benefits of Usability Evaluation in the Development Process of Diabetes Technologies Using the Example of a Continuous Glucose Monitoring System Prototype.

BACKGROUND:Usability engineering analyzes the interaction between the intended users and a device. Its implementation is mandatory for manufacturers to obtain regulatory approval for the European market. The aim of this evaluation was assessing the role of usability testing in the development process. For this purpose, a continuous glucose monitoring (CGM) device under development was investigated to determine whether it could be used safely and effectively by the intended users. METHODS:Conduct of the usability testing was based on the international standard IEC 62366-1. Medical device use of CGM-experienced and non-experienced users (n = 15 each) was observed without initial training in use scenarios containing 18 tasks. The success rate of task completion was determined and the System Usability Scale (SUS) score was calculated from a questionnaire. A prototype of the FiberSense CGM System (EyeSense GmbH, Großostheim, Germany), comprising of a single-use sensor and a reusable detector, was investigated. RESULTS:Most use errors made by both user groups were related to ease of handling of the reusable detectors. The SUS scores achieved in this study were below the pre-defined SUS score acceptance criterion of ≥68. The most frequently mentioned reason for use errors was an incomprehensible and non-chronological instructions for use (IFU). CONCLUSIONS:The evaluation provides valuable insights on how to improve usability of the prototype device and demonstrates the value of conducting structured usability testing prior to product finalization. The results reflected areas for improvement of the user interface, mainly by restructuring the IFU, provision of an additional leaflet, and device training prior to use.