Evaluation of the clinical safety and analytical reliability of blood glucose self-control tools "Glucocard Sigma" and "Glucocard Sigma-mini" in type 1 diabetes children.

Abstract

Rationale. Arkray blood glucose meters have become widely used in Russia since 2013. Studies focused on their accuracy, where Arkray Glucocard II glucose meter is used as the reference monitoring system, have been published. Since insulin dose to be injected relies upon readings of a personal blood glucose meter, the system being used must comply with the clinical safety and analytical accuracy criteria for glucose meters.
 Objective — to assess clinical safety and analytical accuracy of the results of studying blood glucose level measured using Glucocard Sigma and Glucocard Sigma Mini blood glucose meters.
 Material and methods. Glucose level in a drop of capillary blood was studied in 48 pediatric and adolescent patients with type 1 diabetes mellitus (DMT1). The mean age of the patients was 9.4±5.6 years; average duration of the disease, 4.2±2.7 years. Parallel studies on glycaemia using the Glucocard Sigma and Glucocard Sigma Mini glucose meters being tested, as well as a BIOSEN C-line stationary biochemical analyzer system, were carried out at the Department of Diabetes Mellitus of the Institute of Pediatric Endocrinology and the Biochemical Laboratory of the Endocrinology Research Center of the Ministry of Healthcare of the Russian Federation. A total of 320 samples were examined. The hexokinase method performed on a BIOSEN C-line biochemical analyzer system was used as the reference method for measuring blood glucose level.
 Results. Assessment of clinical safety demonstrated that 100% of test results belonged to zone A (will not result in patient error) and B (will not result in patient error or there will be a minor error not affecting patient’s condition). These findings fully comply with the ISO 15197-2016 standard. Investigation of the analytical accuracy of Glucocard Sigma and Glucocard Sigma Mini glucose meters (capillary blood, glucose blood level >4.2 mmol/L) compared to the results obtained using the BIOSEN C-line biochemical analyzer system showed a <5% deviation in 118 (51.3%) measurements; <10%, in 202 (87.8%) measurements; less than 15%, 222 (96.5%) measurements; and less than 20%, in 230 (100%) measurements. These results comply both with the ISO 15197-2015 criteria and stricter criteria ISO 15197-2016.
 Conclusion. The high accuracy of Glucocard Sigma and Glucocard Sigma Mini glucose meters has been confirmed. The accuracy of these glucose meters complies with the State Standard GOST ISO 15197-2015 and the ISO 15197-2016 standard.