Continuous vs. Intermittent Insulin Delivery in Children and Adolescents with Type 1 Diabetes Mellitus

Summary

This multicenter, open label, parallel group, randomized controlled trial was conducted to compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes mellitus (T1DM) in children and adolescents (7 mo – 15 y) in UK. A total of 294 participants with a new diagnosis of T1DM were randomized, stratified by age and treating center, to start treatment with CSII (n=145) or MDI (n=149) within 14 days of diagnosis. Primary outcome was glycemic control, as measured by glycated hemoglobin (HbA1c), at 12 months. At 12 months, mean HbA1c was comparable with clinically unimportant differences between CSII and MDI participants (60.9 mmol/mol vs 58.5 mmol/mol; mean difference 2.4 mmol/mol; 95% CI -0.4 to 5.3; P=0.09). Achievement of HbA1c lower than 58 mmol/mol was low among the two groups (66/143 (46%) CSII participants vs. 78/142 (55%) MDI participants (RR 0.84; 95% CI 0.67 to 1.06). Parents (but not children) reported superior pediatric quality of life inventory scores for those patients treated with CSII compared to those treated with MDI. The authors concluded that during the first year following diagnosis of T1DM, no clinical benefit of CSII over MDI was identified in children and young people in the UK setting, and treatment with either regimen was suboptimal in achieving HbA1c thresholds. CSII was not cost-effective.