The aim of this study was to compare the metabolic outcomes, safety, and caregiver treatment satisfaction of basal–bolus multiple daily injection (MDI) therapy with mealtime insulin aspart (IAsp) or human insulin (HI) (both with basal NPH insulin), or of continuous subcutaneous infusion (CSII) with IAsp in preschool-age children with type 1 diabetes mellitus.
Methods:
After a 3-week HI MDI run-in, 61 children <7 years old were randomized to IAsp MDI or HI MDI or allocated to IAsp CSII for 26 weeks. Efficacy measures were glycated hemoglobin (A1C) and overall metabolic control at study end point. Safety evaluation included hypoglycemia and adverse events. Caregiver treatment satisfaction was evaluated using a World Health Organization questionnaire with 7-point scale answers.
Results:
A1C level and overall metabolic control remained unchanged in all groups. Minor hypoglycemic episodes were equivalent between groups; few major hypoglycemic events occurred. Caregivers of children receiving IAsp CSII documented a greater increase in treatment satisfaction total scores (P = 0.04 vs. HI MDI and IAsp MDI group) and expressed satisfaction with the frequency of hypoglycemic events.
Conclusions:
After 26 weeks of treatment with IAsp CSII, IAsp MDI, or HI MDI, all metabolic control parameters remained unchanged and equivalent. Caregiver treatment satisfaction was higher in parents who chose IAsp CSII pump therapy for their children.
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