Type 1 diabetes is a common chronic condition of childhood that requires subcutaneous injection of insulin in doses calculated according to carbohydrate consumption, physical activity and blood glucose measurements. Poor glycaemic control is associated with poor clinical outcomes, including impaired memory, poorer cognitive outcomes, increased risk of depression and poor growth. In the longer term, vascular complications result in blindness, renal failure, premature heart disease, stroke and amputation. Substantial uncertainty exists as to whether newer forms of treatment, particularly continuous subcutaneous insulin infusion (CSII) are clinically superior to multiple daily injections (MDI).
The present study was a pragmatic, multicentre, open-label, parallel group, randomised controlled trial, randomising participants to either CSII or MDI. Study centres were paediatric diabetes clinics experienced in the use of CSII. Eligible participants had a new diagnosis of type 1 diabetes and were aged between 7 months and 15 years. Randomised treatment started within 14 days of diagnosis of type 1 diabetes. All participants completed a structured education programme on type 1 diabetes and its treatment, which included training on CSII and MDI. Study visits were at 3, 6, 9 and 12 months. The primary outcome measure was HbA1c measured at 12 months. There were a number of secondary outcomes, including the percentage of participants in each arm with HbA1c within the national target range and the incidence of severe hypoglycaemia and diabetic ketoacidosis.
Potential participants were identified from 15 centres in the UK. A total of 976 individuals were assessed for eligibility and of these 689 met eligibility and were invited to participate. A total of 293 consented to participate and were randomised resulting in 144 allocated to CSII and 149 allocated to MDI. Baseline characteristics were similar between the two arms. Intention to treat analysis showed no difference in the primary outcome of HbA1c at 12 months between the two arms (adjusted mean [95% CI] mmol/mol; CSII 60.9 [58.5 to 63.3] vs. MDI 58.5 [56.1 to 60.9]; adjusted mean difference 2.4 [-0.4 to 5.3], P=0.09). There were also no significant differences between the groups for all but one of the secondary outcomes (insulin requirements were slightly higher in those treated with CSII, adjusted mean difference 0.1 units/kg/day, 95% confidence interval 0.0 to 0.2, P=0.01).
In conclusion, the authors state that CSII is neither more clinically effective nor more cost effective than MDI.
You can read the full report here.