Investigation of quality of life and family burden issues during insulin pump therapy in children with Type 1 diabetes mellitus--a large-scale multicentre pilot study.

AIMS: To investigate psychosocial aspects of continuous subcutaneous insulin infusion (CSII) therapy in children with Type 1 diabetes and to identify relevant and sensitive measures.

METHODS: We performed a multi-centre prospective pre-/post-study with children (53 girls, 64 boys, age 10.5 +/- 3.7 years, mean +/- sd) with Type 1 diabetes and their main carer from 18 German diabetic centres. Twenty-five children aged 8-11 years and 63 adolescents aged 12-16 years and their parents, plus 29 parents of children aged 4-7 years completed standardized questionnaires on generic and diabetes-specific quality of life (QOL), generic parenting stress, mealtime behaviour, fear of hypoglycaemia and family conflict immediately before and 6 months after transition to CSII.

RESULTS: After transition to CSII, diabetes-specific QOL of children increased significantly (P < 0.001) in all age groups, with moderate to large effect sizes (children aged 4-7 years: Cohen's effect sized = 1.3; 8-11 years: d = 0.9, adolescents 12-16 years: d = 0.6). Parents reported reduced frequency (P < 0.01, d = 0.4-0.7) and difficulty (P < 0.01, d = 0.3-0.6) of overall parenting stress and decreased worries about hypoglycaemia (P < 0.01, d = 0.4-0.6). Parents of younger children (4-7 years) reported reduced problems with nutrition management (frequency: P < 0.001, d = 1.1; difficulty: P < 0.05, d = 0.7).

CONCLUSIONS: CSII may have substantial psychosocial benefits. Controlled studies are needed.