Primary care based transition to insulin to improve outcomes in type 2 diabetes: Results of the Stepping Upcluster randomised controlled trial — ASN Events
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Primary care based transition to insulin to improve outcomes in type 2 diabetes: Results of the Stepping Upcluster randomised controlled trial (#307)

John Furler 1 , David O'Neal 2 , Jane Speight 3 4 , Jo-Anne Manski-Nankervis , Alexandra Gorelik , Elizabeth Holmes-Truscott 3 4 , Louise Ginnivan 1 , Doris Young 1 , James Best 5 , Elizabeth Patterson 6 , Danny Liew 7 , Leonie Segal 8 , Carl May 9 , Irene Blackberry 1 10
  1. Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia
  2. Department of Medicine, St Vincent's Hospital, Melbourne, Vic, Australia
  3. The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Victoria, Australia
  4. Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, Victoria, Australia
  5. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
  6. Department of Nursing, University of Melbourne, Carlton, Victoria, Australia
  7. Melbourne EpiCentre, Royal Melbourne Hospital and University of Melbourne, Melbourne, Vic, Australia
  8. School of Population Health, Division of Health Sciences, University of South Australia, Adelaide, SA, Australia
  9. Faculty of Health Sciences, University of Southampton, Southampton, United Kingdom
  10. La Trobe University, Wodonga, Victoria, Australia

Background: Insulin is effective in achieving glycaemic targets, yet insulin initiation is often delayed in primary care. Stepping Up1 is an education and practice systems change intervention developed to address this issue. It consists of on-site training for general practitioners (GPs) and practice nurses (PNs), simple clinical algorithms for initiation and up-titration of insulin (glargine +/- glulisine) and endocrinologist and RN-CDE support as required.

Aim: To examine the effectiveness of Stepping Up compared to usual care.

Method: A cluster randomized controlled trial was conducted involving 266 patients from 74 practices in Victoria. Eligible patients were aged 18 - 80 years with T2D, on ≥2 oral hypoglycaemic agents and HbA1c >7.5% (53 mmol/mol).  Multilevel mixed-effects linear regression with adjustment for clustering effect was used to explore the primary outcome of change in HbA1c at 12 months follow up. Two sample test of proportion using groups was used to explore  secondary outcomes of the number of participants who commenced insulin and the proportion who achieved HbA1c <7.0%.

Results: The intervention and control groups were similar at baseline. 61% of patients were male, median (IQR) age 63 (55-69) years, diabetes duration 9 (5, 13) years, average HbA1c 8.6% (71mmol/mol). Interim results from 245 participants that have completed the trial shows a significant difference in HbA1C between groups favouring the intervention (mean difference =-0.8%; 95%CI -1.4, -0.4 [-9mmol/mol; 95%CI -15, -4]). Insulin was more likely to be initiated in the intervention group (98/141 (70%) versus 23/104 (22%), p<0.001) and HbA1c ≤7% [53mmol/mol] was more likely to be achieved (51/141 (36%) versus 21/104 (20%), p=0.009). No episodes of severe hypoglycaemia were reported.  

Conclusion: Stepping Up, an educational and practice system change intervention specifically targeting insulin therapy, led to a clinically significant improvement in glycaemic control amongst patients with T2D in general practice. This pragmatic translational study has important implications for the organisation of care for people with T2D in primary care. 

  1. Furler, J. et al (2014). Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the Stepping Up to insulin cluster randomized controlled trial protocol. Implementation Science, 9, 20. doi: 10.1186/1748-5908-9-20