Randomised controlled trial of continuous subcutaneous insulin infusion compared to multiple daily injection regimens in children and young people at diagnosis of type I diabetes mellitus

Background: Type I diabetes mellitus (TIDM) is a common disease of childhood. The daily management of TIDM is burdensome requiring daily injections of insulin, blood glucose monitoring and dietary manipulation. However it is the long term vascular complications of the disease which have greatest impact on morbidity, mortality and well being. Aim: To investigate two methods of insulin delivery [multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII)] during childhood and adolescence to examine the impact of treatment modalities on predictors of vascular complications of TIDM, adverse events and quality of life. A health economic evaluation will also be undertaken. Study Design: Randomised controlled study with in built pilot. During the six month pilot study 30 patients will be recruited from four centres. The full study will progress if = 50% of patients approached are successfully recruited and if there are no significant differences between those who accept and those who decline with regard to age, gender and social deprivation score. Patients and Methods: 316 participants aged 6 months - 15 years will be recruited at diagnosis of TIDM from 10 UK centres. Randomisation to CSII or MDI will be on a 1:1 ratio stratified for age and centre. The following observations will be made at baseline, 3, 6, 9 and 12 months: HbA1c, height, weight. Quality of life and health economic measures will be made at baseline, 6 and 12 months. Insulin doses will be assessed at 3, 6, 9 and 12 months.