Submitted on behalf of the Stepping Up Study Investigators.

Introduction: The improved utilisation of scarce Credentialled Diabetes Educator- Registered Nurse (CDE-RN) resources is required in T2D where demand exceeds availability and glycaemia remains suboptimal. Aim and rationale: Stepping Up Study is a National Health and Medical Research Council (NHMRC) funded cluster-randomised trial evaluating the effectiveness of enhancing the role of the General Practitioner/Practice Nurse (GP/PN) team with CDE-RN support in initiating a basal / prandial insulin regimen for people with sub-optimally managed T2D on maximum oral therapy. Method: 290 patients from 58 Victorian urban and rural practices will be recruited over 12 months. Each practice will be randomised to Control or Intervention group. Intervention Practices will be trained in the Stepping Up program focusing on the GP/PN team in partnership identifying patients, and clear “in-practice system” for managing workflow. The study provides simple protocols and tools supporting therapy changes, with CDE-RN support and endocrinologist oversight when required in a “hub and spoke” manner. Measure of Results: The primary outcome of the study will be the absolute HbA1c mean difference between intervention and control group patients at 6 and 12 months. Secondary outcomes include the proportion of patients commencing insulin therapy, achieving disease control, cost utility and patient outcomes (eg. quality of life, satisfaction with care). Data will be collected at baseline and 12 months. Conclusion: This study will translate a known efficacious intervention (insulin therapy) to the real-world Australian primary care setting, where T2D patients receive 80% of their care. Insulin therapy should be timely and routinely integrated into primary care which is the only feasible, sustainable and generalisable setting within which to develop comprehensive, effective models of care for uncomplicated T2D patients, with support as required from endocrinologists and CDE-RNs.