 Statistical analysis. Statistica StatSoft Inc., USA, version 8.0 software will be used for data processing. The following descriptive statistical parameters will be used: median, inter-quartile interval Me 25;75 and mass share . Non- parametric criteria will be used used for non-normalized distribution Mann - Whitney U-criterion for paired comparison of independent samples. The χ2 criterion was used for comparison of parameters distribution in population samples. Non - parametric Spearmans correlation will be used for correlation analysis. Standard deviation MSD will be used to evaluate the rate of hypoglycemia events, frequency of plasma glucose level self-control, utilization of bolus calculator, plasma glucose level variability, and for certain items of QoL Questionnaires. A P value of less than 0.05 will be considered to indicate statistical significance for comparisons of the primary outcome, baseline characteristics, and safety. 