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

Abstract

Type 2 diabetes is increasing in Australia. Lifestyle behaviours and patient self-management are crucial for improving diabetes control but are difficult to achieve in primary care. While wearable devices and integrated digital care may be effective, there is limited rigorous intervention research in this area. This study will examine the effectiveness and cost effectiveness of a multi-component health behaviour intervention in achieving clinically significant reductions in HbA1c among general practice patients with long term type 2 diabetes. A cluster randomised controlled design will be used, with general practices randomly assigned to either Wear-IT intervention (n=15) or usual care (n=15). Up to 13 patients per practice (N=375 total) will be recruited from each general practice. Patients, diagnosed type 2 diabetes, will be eligible to participate if they are aged 18-75 years; have a most recent HbA1c > 7.5%; and are able to access the intervention application via an iOS or Android smart device. The Wear-IT self-management intervention combining information from wearable devices (physical activity, blood glucose and blood pressure) and the patient’s medical record with goal setting and coaching support will be administered by the practice nurse, with review and endorsement of goals by the GP. Those attending the usual care practices will receive standard care. Outcome measures (HbA1c, cost-effectiveness, fasting lipids, blood pressure, quality of life) will be collected at baseline, 6- and 12-months follow-up . The primary analysis will compare change in HbA1C between the intervention and control groups at 6 months follow-up, with long-term outcomes assessed at 12-months.