Insulin pumps are no more clinically effective in children with type 1 diabetes than multiple daily injections (MDI) of insulin, a major UK randomised controlled trial has shown.
The SCIPI study involving 293 children with newly-diagnosed T1D found that at 12 months there was no difference in the major outcomes of glycaemic control, adverse events and quality of life for children randomised to continuous subcutaneous insulin infusion (CSII) or MDI regimens.
The study also found that insulin pumps were not cost effective.
Published in the BMJ, the study conducted in 15 paediatric diabetes centres in the UK randomised children aged up to 15 years of age to CSII treatment with insulin aspart, or MDI with the short-acting insulin analogue insulin aspart and a long-acting insulin analogue, either insulin glargine or detemir, according to local clinical practice.
At 12 months glycaemic control was suboptimal in both groups, with the mean HbA1c showing no clinically important differences (60.9mm/mol [9.7%] for CSII vs 58.5 mmol/mol [9.4%] for MDI).
Rates of severe hypoglycaemia and diabetic ketoacidosis were low in both groups.
Quality of life (QoL) scores were similar for children, though the QoL scores for parents of children using CSII were slightly better than those of parents using MDI.
In terms of cost, CSII was A$3400 more expensive than MDI per child with no gains in Quality Adjusted Life Years (QALYs).
The study investigators based at Alder Hey Hospital, Liverpool, said that while there may be different results with longer follow up and with newer technologies, the SCIPI study results ran counter to the strong opinions in favour of insulin pumps expressed by advocacy groups and some clinicians.
They noted that expensive insulin pumps had been adopted into practice despite trials of their efficacy being underpowered, of short duration and prone to selection bias by involving patients who switched from MDI therapy due to dissatisfaction or poor glycaemic control.
The findings from this adequately powered randomised controlled trial raised questions about the adoption of expensive new technologies in diabetes without robust evidence of benefit.
Funding of insulin pumps by healthcare providers should not be at the expense of other more effective interventions, particularly for under-serviced patient groups, warned lead investigator Professor Joanne Blair, consultant endocrinologist at Alder Hey Children’s NHS Foundation Trust.
“The SCIPI data suggest that the universal use of insulin pump therapy as a means of addressing the inequalities in outcomes in children with diabetes are unlikely to be successful,” she said