title: 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.
abstract: BACKGROUND
  Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.
  
  
  METHODS
  This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.
  
  
  CONCLUSIONS
  The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.
authors: General Practice and Primary Healthcare Academic Center, University of Melbourne, 200 Berkeley St, Carlton, VIC 3053, Australia. j.furler@unimelb.edu.au.
authors: John S
authors: JS
authors: Furler
authors: Doris
authors: D
authors: Young
authors: James
authors: J
authors: Best
authors: Elizabeth
authors: E
authors: Patterson
authors: David
authors: D
authors: O'Neal
authors: Danny
authors: D
authors: Liew
authors: Jane
authors: J
authors: Speight
authors: Leonie
authors: L
authors: Segal
authors: Carl
authors: C
authors: May
authors: Jo-Anne
authors: JA
authors: Manski-Nankervis
authors: Elizabeth
authors: E
authors: Holmes-Truscott
authors: Louise
authors: L
authors: Ginnivan
authors: Irene D
authors: ID
authors: Blackberry
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team / Q000458:organization & administration*; D011320:Primary Health Care / Q000458:organization & administration*; D012107:Research Design; D057170:Translational Research, Biomedical
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents