Form And Function Glucometer Evaluation For Specialized Populations

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Patient self-management technologies (glucometer, blood pressure monitor, etc.) are a critical component of chronic disease care. Although these technologies are intended to support patient activities, low device usability can produce design imped-iments that may negatively impact patient adherence and hence treatment outcomes. In particular, patients with disabilities, who are the majority of the chronic disease population, are typically excluded from medical device usability studies required for FDA approval. This study aims to develop a usability method to: 1) evaluate patient self-management technology and 2) inform design decision making for disabled pa-tients. The study will focus on handheld device use (glucometers) for diabetic patients with mobility and vision impairment. An initial expert usability analysis was per-formed for 13 glucometers to determine the design features that are most problematic for disabled users. The usability analysis informed the design of an experiment to test disabled user performance and satisfaction for several meter interaction tasks. Com-mon diabetes disabilities were simulated in healthy subjects through the use of glasses (retinopathy, glaucoma) and gloves (arthritis, neuropathy) to evaluate the experimental protocol prior to future testing in the actual disease population. Results suggested a preference of participants for large text, large protruding buttons, and contrast color between case and buttons to facilitate locating buttons. Future studies will integrate the disabled diabetic population in the data collection and integration of these results in the design of a new glucometer. This work can inform regulatory guidelines for usability testing with disabled patients and the patient-centric design practices of medical device manufacturers.