Ethics approved protocol SHINE study.

<div><p>Aims</p><p>To present a study protocol for the development of an intervention to enhance safe insulin use for older or frail adults undergoing a surgical admission to hospital.</p><p>Design</p><p>Following the United Kingdom’s Medical Research Council and National Institute for Health and Care Research Frameworks for development and evaluation of complex interventions; this qualitative study will use a co-design approach using design thinking, to develop a theoretical model for the intervention.</p><p>Methods</p><p>Non-participatory observations, interviews and co-design workshops will be conducted with older or frail individuals with diabetes, their caregivers and healthcare staff responsible for their care during surgical admissions at a single National Health Service hospital in England. We will utilise their experiences and perspectives to establish priorities and generate ideas for the development of a conceptual model aimed at supporting the insulin safety review process in hospitals. Data will be analysed using framework analysis. People with diabetes were involved in the design of this study. The protocol was approved by the East-Midlands-Derby Research Ethics Committee (24/EM/0022). Study registered on Open Science Framework: <a href="https://osf.io/4wvu5" target="_blank">https://osf.io/4wvu5</a>.</p><p>Results</p><p>Results of this study will be shared with study participants and disseminated through presentations at conferences/meetings and peer-reviewed publications.</p><p>Conclusion</p><p>This article outlines the methodology for the planned study which will employ a novel methodology to tackle the problem of hospital insulin safety. Its findings will contribute to a better understanding of the multiple interacting components implicated in hospital insulin use (patient, staff, context) and support further work around system-based strategies to enhance insulin safety resilience in hospital.</p></div>