Developing a Smart Sensing Sock to Prevent Diabetic Foot Ulcers: Qualitative Focus Group and Interview Study.

Background: Diabetic foot ulcers are common and costly. Most cases are preventable, although few interventions exist to reliably support patients in performing self-care. Emerging technologies are showing promise in this domain, although patient and health care provider perspectives are rarely incorporated into digital intervention designs.

Objective: This study explored patient and health care provider feedback on a smart sensing sock to detect shear strain and alert the wearer to change their behavior (ie, pause activity and check their feet) and considered how patient experience and attitudes toward self-care are likely to impact uptake and long-term effective engagement with the device to curate guiding principles for successful future intervention development.

Methods: This qualitative study combined semistructured interviews and a focus group alongside a participant advisory group that was consulted throughout the study. In total, 20 people with diabetic neuropathy (n=16, 80% with history of diabetic foot ulcers) and 2 carers were recruited directly from podiatry clinics as well as via a recruitment network and national health mobile app for one-to-one interviews either in person or via landline or video call. A total of 6 podiatrists were recruited via professional networks for 1 virtual focus group. Participants were asked about their experience of diabetic foot health and for feedback on the proposed device, including how it might work for them in daily life or clinical practice. The data were analyzed thematically.

Results: Three main themes were generated, each raising a barrier to the use of the sock complemented by potential solutions: (1) patient buy-in-challenged by lack of awareness of risk and potentially addressed through using the device to collect and record evidence to enhance clinical messaging; (2) effective engagement-challenged by difficulties accepting and actioning information and requiring simple, specific, and supportive instructions in line with podiatrist advice; and (3) sustained use-challenged by difficulties coping, with the possibility to gain control through an early warning system.

Conclusions: While both patients and podiatrists were interested in the concept, it would need to be packaged as part of a wider health intervention to overcome barriers to uptake and longer-term effective engagement. This study recommends specific considerations for the framing of feedback messages and instructions as well as provision of support for health care providers to integrate the use of such smart devices into practice. The guiding principles generated by this study can orient future research and development of smart sensing devices for diabetic foot care to help optimize patient engagement and improve health outcomes.