Impact of Human Factors Testing on Medical Device Design: Validation of an Automated CGM Sensor Applicator

Abstract

Improving user engagement with continuous glucose monitoring (CGM) is considered a major requirement for achieving optimal treatment efficacy. Human factors testing is needed to ensure that CGM product designs and requisite training simplify the user experience and enhance usability and patient safety. Dexcom, Inc, recently introduced a novel, “one-button” automatic sensor applicator (ASA) for use with the Dexcom G6 (rtCGM) system. The device was developed utilizing all phases of the human factors testing process. We recruited eight certified diabetes educators from independent health care institutions to conduct a comparative ease-of-use analysis to confirm the usability of the ASA. Participants judged the instructions and device to be easier to use than the previous sensor applicator.