Study protocol for a XXXX of insulin delivery by continuous subcutaneous infusion compared to @entity2794 .

@entity1 @entity6 @entity1735 @entity23 @entity1723 @entity1017 @entity2794 @entity413
BACKGROUND: Intensive insulin therapy with continuous subcutaneous insulin infusion (CSII) devices or @entity2794 ( @entity2794 ) reduces the risk of long-term vascular complications of @entity1723 ( @entity1723 ). 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/DESIGN: This is a pragmatic, @entity23 ( @entity23 ). Fifteen centres, selected to represent a population with a broad demographic, will recruit 316 @entity1 , newly diagnosed with @entity1723 , 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 @entity1723 . Randomisation to CSII or @entity2794 is stratified for age, gender and recruiting centre. The randomised treatment starts within 15  days of diagnosis. @entity1 will be trained to adjust their insulin dose according to @entity1735 intake and blood @entity413 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 @entity6 -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 @entity1017 , adverse events and a health economics appraisal. DISCUSSION: This is the first adequately powered @entity23 comparing CSII and @entity2794 in a non-selected population, treated according to standard practice guidelines. It will produce data that are meaningful to individual @entity1 and local and national policymakers. TRIAL REGISTRATION: The study was registered with the European Clinical Trials Database on 4 November 2010, reference 2010-023792-25 .
