Benefits of a bolus calculator in pre- and postprandial glycaemic control and meal flexibility of paediatric patients using continuous subcutaneous insulin infusion (CSII).

AIMS: To assess the efficacy in pre- and postprandial glycaemic control and the impact on treatment satisfaction of a bolus calculator (Bolus Wizard) incorporated into the insulin pump in Type 1 diabetic (T1D) paediatric patients using continuous subcutaneous insulin infusion (CSII) treatment at various stages of pubertal development.
METHODS: Thirty-six T1D patients on CSII treatment (19 males; mean age 13.9 +/- 3.5 years; range 4.9-17.8 years), were prospectively enrolled into this two-period crossover study. Eighteen patients were randomized to begin phase A using the Bolus Wizard, followed by phase B, using their current conventional insulin dosing method to determine pre-meal boluses. The remaining subjects were randomized to begin with phase B followed by phase A. Each study period lasted 2 weeks. A questionnaire assessing treatment satisfaction with the Bolus Wizard was compiled.
RESULTS: There was a significant reduction in blood glucose levels before and 2 h after meals and in the number of correction boluses during phase A with respect to phase B of the study. The lower frequency of hypoglycaemic events during phase A did not reach statistical significance. There were no differences between the two phases: insulin requirement, daily bolus rate (%) and meal bolus quantity.
CONCLUSIONS: When paediatric patients used CSII, the bolus insulin dose calculated using the Bolus Wizard was more effective in improving pre- and postprandial glycaemic control with fewer correction boluses, without differences in the prandial insulin requirements and without restriction in the carbohydrate content of meals. The use of the Bolus Wizard was easy and was associated with a high level of satisfaction in these patients.

RCT Entities:   Population Interventions Outcomes