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. 2019 Sep;13(5):949-953.
doi: 10.1177/1932296819831071. Epub 2019 Feb 14.

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

Robert North  1 , Christine Pospisil  2 , Ryan J Clukey  3 , Christopher G Parkin  4
Affiliations

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

Robert North et al. J Diabetes Sci Technol. 2019 Sep.

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.

Keywords: diabetes; human factors; rtCGM; sensor; training; usability.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RN has received consulting fees from Dexcom, Inc. RJC has received consulting fees from Dexcom, Inc. CGP has received consulting fees from Dexcom, Inc, Insulet, Roche Diabetes Care, Senseonics, and Mannkind. CP is an employee of Dexcom, Inc.

Figures

Figure 1.
Figure 1.
Example page from participant workbook.
Figure 2.
Figure 2.
Comparison of overall ease-of-use ratings between systems.
Figure 3.
Figure 3.
Comparison of total mean combined scores for sensor insertion/transmitter insertion (A) and mean scores by individual metric (B). P values are shown for within-participant paired sample t-tests comparing the mean device scores.
Figure 4.
Figure 4.
Comparison of mean PCA scores for sensor insertion (A) and transmitter insertion (B). P values are shown for within-participant paired sample t-tests comparing the mean device scores.
See this image and copyright information in PMC

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