Results of Clinical and Laboratory Testing of the Satellite® Online Glucose Meter in Children with Diabetes Mellitus

Self-control is one of the components of achieving the target values of glycemia in patients with diabetes mellitus. When conducting self-monitoring, the accuracy and reliability of blood glucose measurements are primarily important, especially in children. Aim – to evaluate the use of a medical device for in vitro diagnostics “Blood glucose monitoring system (hereinafter referred to as glucometer) Satellite® Online” for compliance with the requirements of GOST R ISO 15197-2015 for the quality and safety of glycemic control in children with diabetes mellitus. Material and methods. The accuracy of measurements of glycemia using the Satellite® Online glucose meter, as well as its functional characteristics, was evaluated in a group consisting of 120 children aged one month to 17 years inclusive, who suffered from type 1 and type 2 diabetes mellitus. Results. Analysis of precision (repeatability) and intermediate measurement precision on the Satellite® Online glucometer showed a high degree of similarity of results. When comparing the results of 761 blood samples using a Consistent Error Grid for diabetes mellitus, it was found that all values were in zone A, that is, 100% clinically correct values were obtained. 99.6% of the Satellite® Online glucometer readings were within the permissible system error from the reference values, which corresponds to clinically correct and safe deviations (> 95%). The functional characteristics of the Satellite® Online glucose meter provided accurate measurements of glycemia by users. Conclusion. The use of the Satellite® Online glucometer allows high-quality and safe control of glycemia in children with diabetes mellitus aged 1 month to 17 years inclusive.