L. Ginnivan¹, I. Blackberry¹, J. Manski-Nankervis¹, D. Young¹, J. Best², E. Patterson³, D. Liew4, D. O’Neal5, J. Furler¹

¹General Practice and Primary Health Care Academic Centre, The University of Melbourne, Carlton, Vic.

² Melbourne Medical School, The University of Melbourne, Carlton, Vic

³ Melbourne School of Health Sciences, the University of Melbourne, Carlton, Vic

4 Melbourne Epicentre, the University of Melbourne, c/o the Royal Melbourne Hospital, Parkville, Vic

5 Department of Medicine, St Vincent’s Hospital, the University of Melbourne, Fitzroy, Vic

Most people with type 2 diabetes will require insulin yet this is often delayed in general practice. Stepping Up is a cluster randomised controlled trial that examines the effectiveness of an intervention in general practice to help people with sub-optimally managed type 2 diabetes move onto insulin in a timely evidence-based manner. The Stepping Up model of care improves the utilisation of scarce Credentialled Diabetes Educator- Registered Nurse (CDE-RN) resources required in T2D, where demand exceeds availability and glycaemia remains suboptimal.

The model of care being tested is based on an enhanced role for the Practice Nurse in working with patients to transition to insulin. The model was developed in keeping with the MRC Framework for development and testing of complex interventions. Development of the Stepping Up model of care:

92 patients commenced insulin at 24 weeks

Primary Care: GPs & PNs with CDE-RN oversight & endo if required - mean reduction in HbA1c 2.6%

V Benchmark: diabetes specialist care

(i.e. Endocrinologists and Diabetes Educators) - mean reduction in HbA1c 1.8%

1. What is the effect of the Stepping Up Program on glycaemic outcomes in people with T2D as measured by HbA1c (Primary Outcome)?

2. What is the effect of the Stepping Up Program on The average HbA1c level at which insulin is initiated ? The proportion of patients who achieve glycaemic

control or achieve individualised targets? What is the impact of ‘Stepping Up’ on the health and

psychological wellbeing of people with type 2 diabetes ? What is the cost-utility of the Stepping Up Program?

1. Participants in the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group participants at 12 months (primary outcome)

2. 60% of participants in the intervention arm will transfer to insulin by 12 months compared to 20% of control arm (secondary outcome)

3. 25% of participants in the intervention arm will achieve disease control (defined as HbA1c as <7.0%) compared to 15% of the control arm at 12 months

Inclusion criteria: Insulin naïve T2D patients; HbA1c ≥ 7.5%; Age 18 to 80 Y; At least 2 OHAs at maximal tolerated doses, or in the opinion of GP insulin is appropriate to consider, even if the patient is on less than 2 OHAs (stable doses for 3 months)

Exclusion criteria: T1D; Previous or current treatment with insulin (excluding short term <2 weeks); Satisfactory FBGL (mean <6.0mmol/L) with elevated PPGL (mean >10.0mmol/L); Language (all material in English only); Cognitive or psych impairment; any impairment precluding reliable BGL monitoring/administration of insulin; significant renal impairment (egfr < 20); Any recent (<3months) or ongoing life-threatening illness; Pregnancy or planned pregnancy

Intervention V Control (usual care) Practices: General Practitioners and Practice Nurses in partnership identifying patients (n.290) requiring insulin

Intervention Practices: Simple, robust protocols and tools supporting insulin initiation in the Primary Care setting with support from Credentialed Diabetes Educator RN and Endocrinologist in “hub and spoke” manner

GPs and PNs working in partnership with patients to initiate and titrate insulin in primary care

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.

The patients, GPs & Practice Nurses in the study The core Stepping Up team (JF, IB, JMN, & DO’N)

Roche Diagnostics contributed the funds to support the CDE-RN role in the study, supplies Performa Nano meters, & specially configured Smartpix devices to upload data to a server.

Sanofi provides starter packs of Lantus and Apidra Solostar insulin, & support for my presence at ADA/ADEA 2013.

BD supplies needle starter packs.