To investigate psychosocial features in continuous subcutaneous insulin infusion therapy (CSII) in children with type 1 diabetes (T1DM)

Over the past decade continuous subcutaneous insulin infusion (CSII) is on the rise among paediatric patients with type 1 diabetes mellitus (T1DM). The focus of research has mainly been on metabolic outcomes with conflicting results. From the patient’s perspective, the greatest benefits may lie in aspects beyond glycaemic control, such as Health Related Quality of Life (HRQOL), parental stress and fear of hypoglycaemia. These putative psychosocial benefits of CSII are seriously understudied. A pilot study conducted by the applicant showed improved HRQOL, reduced diabetes burden, parental stress and fear of hypoglycaemia. A multicentre prospective randomised controlled intervention trial with waiting-list-control-group will be performed in children with T1DM and their main carer. 272 patients from 18 diabetes centres who are eligible for transfer to CSII within the next two CSII-education programmes will be randomly assigned to either an intervention or a waiting-list control group. The intervention group will receive transition to CSII immediately; the waiting-list group will receive standard treatment (multiple daily injection therapy, MDI) and additional optimisation of MDI, and will be transferred to CSII six months later. Main outcomes are health related quality of life (HRQOL) (child) and diabetes burden (carer), secondary outcomes are fear of hypoglycaemia, parental stress, HbA1c, absent days on work or school, and satisfaction with care. The study addresses an area of major clinical interest and may generate therapeutic recommendations for children with T1DM.