Wearables Integrated Technology to support healthy behaviours in general practice patients with type 2 diabetes (WEAR-IT): study protocol for a cluster randomised controlled trial.

introductionType 2 diabetes is a prevalent chronic disease, associated with health complications, premature morbidity and significant healthcare costs. Optimal lifestyle behaviour control and patient self-management are crucial for improving diabetes control; however, they are difficult to achieve in primary care. There is limited research on the use of information from wearable devices to encourage behaviour change. This study will examine the effectiveness and cost-effectiveness of a multi-component health behaviour intervention in achieving clinically significant reductions in haemoglobin A1c (HbA1c) among general practice patients with type 2 diabetes. METHODS AND ANALYSIS: The study uses a cluster-randomised controlled design, with general practices randomly assigned to either the Wearables Integrated Technology (WEAR-IT) intervention (n=15) or usual care (n=15). To achieve a sample size of 375 participants, 12-13 patients per practice will be recruited. Patients diagnosed with type 2 diabetes will be eligible to participate if they are aged 18-75 years; have had poorly controlled diabetes (HbA1c≥7.5%), with the cognitive capacity and ability to access the intervention application via an iOS or Android smart device. The WEAR-IT self-management intervention combines information from wearable devices (physical activity, blood glucose and blood pressure) and the electronic medical record, with goal setting and coaching support. The intervention will be primarily delivered by the general practice nurse, with review and confirmation of goals by the general practitioner. Participants attending the usual care practices will receive standard care. Outcome measures, including HbA1c, lipids, blood pressure, quality of life, dietary and exercise behaviours and cost-effectiveness, will be collected at baseline, 6-month (primary endpoint) and 12-month post-randomisation. The primary analysis will compare the change in HbA1c between the intervention and control groups at 6-month follow-up, with long-term outcomes assessed at 12-month post-randomisation. ETHICS AND DISSEMINATION: The study was approved by Bond University (BH00137). Results will be disseminated through peer-reviewed journal publications, conference presentations and summaries to participating sites and patients. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12624000957594).