Comparison of Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Regimens in Children With Type 1 Diabetes: A Randomized Open Crossover Trial

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Abstract
Objective. To compare the efficacy and feasibility of continuous subcutaneous insulin infusion (CSII) with multiple daily insulin injections (MDI) in children with type 1 diabetes. Methods. The study sample included 23 children (10 males) aged 9.4 to 13.9 years with type 1 diabetes. An open randomized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables: diabetic control, incidence of adverse events, daily insulin requirement, body mass index standard deviation scores, treatment satisfaction, and quality of life. Results. The changes in HbA1c and fructoseamine values were similar in the 2 arms over time. At the end of the study, mean HbA1c level measured 8.05 ± 0.78%. There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events. There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI, yielding a rate of 0.26 events per patient-year. There were no episodes of diabetic ketoacidosis. Body mass index standard deviation scores decreased during CSII and increased during MDI, as did mean insulin dose. Patients expressed a higher treatment satisfaction from CSII than MDI, although there was no difference in quality of life between the 2 modes. Conclusions. Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes, with similar diabetes control and a very low rate of adverse events. We suggest that both modes be available to the diabetic team to better tailor therapy.