Abstract

Abstract Diabetic foot syndrome is a secondary disease of diabetes mellitus that can lead to amputations, reduced mobility and in some cases death if treatment is delayed. The objective of this study was to collect user requirements for the development of a shoe insole accompanied by a medical app for continuous pressure measurement, applying a usercentered Design Thinking process.We conducted a systematic competitor analysis and performed 10 context-interviews with both health care professionals (HCPs) (n=7) and patients with diabetic foot syndrome (n=3) at the University Hospital Graz (Austria) and a medical supply store. Structured interview guides, tailored to user groups were used for qualitative interviews. Questionnaires on the acceptance of eHealth applications were designed for quantitative analysis (n=14 patients, n=7 HCPs). The competitor analysis identified 12 inshoe- systems for plantar pressure measurement for patients with diabetes. No current system on the EU market meets the requirements of the users interviewed in this study. Quantitative evaluation showed that 95% of future users would support the use of a medical app to monitor plantar pressure in patients with diabetic foot syndrome. Based on the identified user requirements, a first user interface was developed iteratively. Usability tests of the prototype resulted in a score of 71.7 on the System Usability Scale. The medical app will be further developed and tested in clinical studies.

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