Wearables Integrated Technology to support healthy behaviours in people with Type 2 Diabetes (Wear- IT): Study protocol for a cluster randomised controlled trial

Participants in this group will receive usual care, plus the Wear-IT intervention. Those attending the usual care practices will receive standard care. An 8-week self-management care plan, incorporating wearable devices, will be provided to patients in the intervention group. Outcomes will be assessed 6- and 12-months post-randomisation. The program will include: Initial Consultation (Care plan and goal setting through CareMonitor). Practice nurses will invite consenting patients to attend a face-to-face 45 minute consultation following practice randomisation and intervention training. Patients will work with their care team to develop a care plan using CareMonitor, including individualised target ranges for diet, exercise, Body Mass Index, Cigarette consumption, alcohol consumption, HbA1c, lipids and blood pressure. This will enable patients to monitor their own targets and behaviours through their wearable devices. The following will be tracked using wearable devices: • Physical activity and exercise: Individual patient activity goals may include reducing sedentary behaviour and increasing anaerobic or resistance exercise, in line with best-evidence guidelines. Patients will be able to access daily and weekly summaries of their physical activity and exercise goal progress. • Dietary intake: Over a two-week period, the flash glucometer will provide real-time feedback to patients on their blood glucose levels including post-prandial elevation. Patients will be prompted to consider the dietary cause of the variation to their blood glucose and provided with strategies to reduce the likelihood of this occurring again. Blood glucose can be monitored via daily or weekly summaries and as time in target blood glucose range. • Blood pressure: Periodic monitoring of blood pressure will enable the care team to assess blood pressure control and response leading up to an appointment or after a change in therapy. Patients with elevated blood pressure during periodic monitoring will be prompted to consult their care plan within CareMonitor and ensure they are adhering to their therapeutic and medication recommendations. The practice nurse will guide patients in downloading and using the CareMonitor app via their smartphone, tablet or smart device. Patients will be supported by the practice nurse to link the CareMonitor app with the wearables provided for the study and demonstrate their use. Provided wearables will include: (i) a physical activity monitor to track physical activity; (ii) a glucose monitor to periodically track blood glucose levels; and (iii) a blood pressure monitor to periodically track blood pressure. While some patients may already use a physical activity monitor, they will be encouraged to wear the study-provided monitor to standardise data. The practice nurse will help the patient set evidence-based individual activity and treatment goals, which will be reviewed and endorsed by the GP. Weeks 1-4 (Remote patient intervention). The intervention wearable devices will be used in combination to deliver a comprehensive assessment of health behaviour and diabetes control over a period of 4 weeks. • Patients will be asked to commence wearing their physical activity monitor immediately and throughout the 4-week period. Patients will be encouraged to monitor physical activity continuously over the intervention period and will access daily and/or weekly summaries to assess if they are meeting their goals. • Patients will be asked to commence blood pressure monitoring on day 5 of the intervention period and be asked to record it in the morning and evening for 7 continuous days as per Heart Foundation advice on home blood pressure monitoring • Patients will be asked to commence their continuous blood glucose monitoring at the start of week 3 for a 2-week period. The blood glucose device sits on top of the skin and continuously monitors glucose levels. These devices are disposable, expiring after 2 weeks of use. • Patients will be periodically prompted to watch brief educational videos about managing their diabetes (e.g., “Importance of blood pressure and diabetes”). These videos were designed by Western Sydney Diabetes (study partners) and repurposed for the study. They are not a readily available resource. Follow-up Consultation (Review and update of care plan if needed). The patient will be invited to return for a 30 minute with the practice nurse, and review by their GP. This consultation will involve reviewing the patient’s data from their wearable devices and assess whether they have been meeting their care goals. Goals will be updated as needed to assist patients in achieving these. The care team will discuss potential ways to improve their physical activity, glucose levels and blood pressure. This may include a medication review if considered necessary by their GP. Weeks 5-8 (Remote patient intervention). The patient will repeat the intervention as per weeks 1-4, with the implemented changes as discussed in their follow-up consultation. Patients will be able to see how these changes impact their wearable outputs. Patients will be informed they can book a 30 minute follow-up appointment with their care team if they have further questions about the changes to their care plan.