The effect of bolus and food calculator Diabetics on glucose variability in children with type 1 diabetes treated with insulin pump: the results of RCT.

Background: The calculation of prandial insulin dose is a complex process in which many factors should be considered. High glucose variability during the day, arising from difficulties which include errors made in food counting and inappropriate insulin adjustments, influence hemoglobin A1c levels. During this study, in children using insulin pumps to manage type 1 diabetes, we compared 2-h postprandial blood glucose levels (BGL) and glucose variability when calorie tables and mental calculation were used, to when Diabetics software was used.

Methods: This 3-month, randomized, open-label study involved 48 children aged 1-18 yr. Patients were educated in food counting system used in the Warsaw Pump Therapy School (WPTS) where the carbohydrate unit (CU) and the fat-protein unit (FPU) are taken into account. The children were randomly allocated to an experimental group (A) who used diabetics software and a control group (B) who used caloric tables and mental calculations.

Results: We observed significant differences (p < 0.05) between the groups in 2-h postprandial BGL's and the glucose variability parameters mean(T), SD(T), % BGL in the target range 70-180 mg/dL, and high blood glucose index HBGI. We did not observe statistically significant differences in hypoglycemic events or low blood glucose index (LBGI) nor in HbA1c or insulin requirements.

Conclusions: The use of the Diabetics software by patients educated at the WPTS is safe and reduces 2-h postprandial BGL's and glucose variability.