Accuracy assessment of the blood glucose meter "Satellite Express" for glycemic control in children with diabetes
Background: Monitoring glycemic control in diabetes includes daily measurements of glucose levels at home, along with periodic monitoring of glycemia indicators on the whole. The main purpose of monitoring glycemic control is to accurately and authentically assess the glycemic level reached by each patient in order to ensure the glycemic goals achievement. Glycemic control assessment at a certain point in time is best achieved by self-monitoring the level of glucose in the blood, in that allows you to assess the presence of hyperglycemia and hypoglycemia to optimize the treatment strategy. Aims: Accuracy assessment of a medical device «Portable blood glucose concentration meter with electrochemical single-use strip PKG-03 «Satellite Express» for glycemic control of children with diabetes. Materials and methods: In a group of children with diabetes (n=105, age from 1 month to 17 years), simultaneously was taken capillary blood from one drop to assess the accuracy of glycemia levels on the «Satellite Express» glucose meter and on the laboratory glucose and lactate analyzer SUPER GL. Results: In a comparative analysis of 660 blood samples on the Clark error scale, was found that all deviations of glycemia values obtained with the «Satellite Express» glucose meter were in zones A (99.7% - clinically correct values) and B (0.3% - safe deviations). The limits of permissible systematic error of measurements that meet the requirements of the National Standard of Russian Federation GOST R ISO 15197-2015 in terms of clause 6.3 System Accuracy amounted to 96.8% of deviations of glucose meter indications from reference values, which matches to areas of clinically correct and safe deviations. Conclusion: Using the «Satellite Express» glucose meter in clinical practice makes it possible to control glycemia qualitatively and it is safe for children aged from 1 month to 17 years.