Introduction: Intensive insulin treatment regimens, multiple daily injections (MDI) and continuous subcutaneous insulin infusions (CSII) are used widely in the NHS, despite a lack of evidence that more expensive treatment with CSII is superior to MDI. In this presentation, data from previous observational and interventional studies will be reviewed. The findings of the SCIPI study (SubCuntaneous Insulin: Pumps or Injections?), which compared the effectiveness, safety, quality of life (QoL) and incremental cost per quality-adjusted life-year (QALY) gained of CSII to MDI, will then be discussed.
Methods: SCIPI was a pragmatic, randomised controlled trial with 1:1 web-based block randomisation of newly diagnosed patients, stratified by age and centre. CSII or MDI was initiated within 14 days of diagnosis. Primary outcome: HbA1c 12 months after diagnosis.
Results: Two hundred and ninety three participants median age 9.8 years (0.7 to 16.0) were randomised (CSII:149, MDI:144). HbA1c was comparable between groups: age adjusted least-squares mean CSII: 60.9 mmol/mol (95% CI 58.5 to 63.3) MDI: 58.5 mmol/mol (95% CI 56.1 to 60.9). Severe hypoglycaemia and diabetic ketoacidosis was reported in six and two participants randomised to CSII respectively, and two and zero participants randomised to MDI. 68 adverse events (14 serious) were reported during CSII treatment and 25 (8 serious) during MDI treatment. Growth outcomes did not differ. Insulin use was 0.1 units/kilogram /day higher with CSII (95%CI 0.0 to 0.2, P=0.01). QoL reported by parents, but not participants, was slightly higher for those randomised to CSII. CSII was more expensive than MDI: £1,863 (95% CI £1,620 to £2,137) with no additional QALY gains, −0.006 (95% CI −0.031 to 0.018).
Conclusions: No clinical benefit of CSII over MDI was identified. CSII is not a cost-effective treatment in patients representative of the study population. Further research should focus on determining the perceived benefits of CSII and developing validated tools to measure them.
22 - 24 Nov 2017
British Society for Paediatric Endocrinology and Diabetes