title: Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections.
abstract: BACKGROUND
  Intensive insulin therapy with continuous subcutaneous insulin infusion (CSII) devices or multiple daily injections (MDI) reduces the risk of long-term vascular complications of type I diabetes (TID). Both treatments are used routinely, but there is little evidence to demonstrate superiority of either treatment. If CSII treatment reduces the risk of long-term complications or is associated with an improved quality of life (QoL), the additional cost of this therapy may be compensated for by a reduction in long-term health expenditure. If there is no demonstrable difference between treatments, health-care resources may be better invested elsewhere. This study aims to address this gap in knowledge.
  
  
  METHODS
  This is a pragmatic, randomised controlled trial (RCT). Fifteen centres, selected to represent a population with a broad demographic, will recruit 316 patients, newly diagnosed with TID, aged between 7 months and 15 years. Exclusion criteria include additional pathologies or treatments likely to affect glycaemic control and a first-degree relative with TID. Randomisation to CSII or MDI is stratified for age, gender and recruiting centre. The randomised treatment starts within 15 days of diagnosis. Patients will be trained to adjust their insulin dose according to carbohydrate intake and blood glucose level. Study visits coincide with routine clinic appointments at 3, 6, 9 and 12 months when data relating to routine clinical assessments, adverse events and concomitant medications are collected. Health utilities questionnaires are completed at each visit and a diabetes-specific QoL questionnaire (PedsQL) at diagnosis, 6 and 12 months. The primary outcome is glycaemic control (HbA1c) at 12 months. Secondary outcome measures include QoL, insulin use, growth and weight gain, adverse events and a health economics appraisal.
  
  
  CONCLUSIONS
  This is the first adequately powered RCT comparing CSII and MDI in a non-selected population, treated according to standard practice guidelines. It will produce data that are meaningful to individual patients and local and national policymakers.
  
  
  BACKGROUND
  The study was registered with the European Clinical Trials Database on 4 November 2010, reference 2010-023792-25.
authors: Department of Endocrinology, Alder Hey Children's NHS Foundation Trust, Liverpool, L12 2AP, UK. jo.blair@alderhey.nhs.uk.
authors: Jo
authors: J
authors: Blair
authors: Department of Child Health, School of Medicine, Cardiff University, Cardiff, CF14 4XN, Wales, UK. GregoryJW@cardiff.ac.uk.
authors: John W
authors: JW
authors: Gregory
authors: Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, LL57 2PZ, UK. d.a.hughes@bangor.ac.uk.
authors: Dyfrig
authors: D
authors: Hughes
authors: Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, LL57 2PZ, UK. c.h.ridyard@bangor.ac.uk.
authors: Colin H
authors: CH
authors: Ridyard
authors: Liverpool Clinical Trials Research Centre, Liverpool, L12 2AP, UK. C.Gamble@liverpool.ac.uk.
authors: Carrol
authors: C
authors: Gamble
authors: Liverpool Clinical Trials Research Centre, Liverpool, L12 2AP, UK. A.Mckay@liverpool.ac.uk.
authors: Andrew
authors: A
authors: McKay
authors: Department of Endocrinology, Alder Hey Children's NHS Foundation Trust, Liverpool, L12 2AP, UK. mohammed.didi@alderhey.nhs.uk.
authors: Mohammed
authors: M
authors: Didi
authors: Department of Diabetes, Alder Hey Children's NHS Foundation Trust, Liverpool, L12 2AP, UK. keith.thornborough@alderhey.nhs.uk.
authors: Keith
authors: K
authors: Thornborough
authors: Liverpool Clinical Trials Research Centre, Liverpool, L12 2AP, UK. E.Bedson@liverpool.ac.uk.
authors: Emma
authors: E
authors: Bedson
authors: Liverpool Clinical Trials Research Centre, Liverpool, L12 2AP, UK. L.Awoyale@liverpool.ac.uk.
authors: Lola
authors: L
authors: Awoyale
authors: Liverpool Clinical Trials Research Centre, Liverpool, L12 2AP, UK. E.Cwiklinski@liverpool.ac.uk.
authors: Emma
authors: E
authors: Cwiklinski
authors: Department of Research, Alder Hey Children's NHS Foundation Trust, Liverpool, L12 2AP, UK. matthew.peak@alderhey.nhs.uk.|School of Health, University of Central Lancashire, Lancaster, PR1 2HE, UK. matthew.peak@alderhey.nhs.uk.
authors: Matthew
authors: M
authors: Peak
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007223:Infant; D055104:Infusions, Subcutaneous; D007267:Injections; D007328:Insulin / Q000008:administration & dosage*; D017063:Outcome Assessment, Health Care; D011788:Quality of Life
chemical_list: D007328:Insulin