title: The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial.
abstract: BACKGROUND
  People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education.
  
  
  METHODS
  A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months.
  
  
  BACKGROUND
  The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups.
  
  
  BACKGROUND
  ISRCTN 61215213.
authors.affiliation: Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.
authors.forename: David
authors.initials: D
authors.lastname: White
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, UK.
authors.forename: Norman
authors.initials: N
authors.lastname: Waugh
authors.affiliation: Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
authors.forename: Jackie
authors.initials: J
authors.lastname: Elliott
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Lawton
authors.affiliation: Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: Katharine
authors.initials: K
authors.lastname: Barnard
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Campbell
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Dixon
authors.affiliation: Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Heller
mesh_terms: D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007273:Injections, Intramuscular; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D010353:Patient Education as Topic / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007328:Insulin; C517652:hemoglobin A1c protein, human
keywords: Diabetes Mellitus; Insulin Infusion Systems; Insulin/administration & dosage*; Patient Education as Topic/methods*; Type 1/therapy*