Evaluation of the efficiency of using glucose monitoring devices upon unsatisfactory diabetes compensation

Abstract

Rationale. The key purpose of modern glucose meters is to ensure regular self-monitoring of glucose level when receiving outpatient management, provided that fair diabetes compensation is achieved. Although glucose meters are not intended for assessing the glucose level in severe metabolic disorders (ketosis, ketoacidosis), since these conditions have a negative effect on device accuracy, in actual life a patient (or a physician) can face a situation when a glucose meter is the only tool for evaluating carbohydrate metabolism disorders.
 Objective. To evaluate clinical accuracy of Satellite Express PKG-03 glucose meter in measuring the glucose level in patients with type 1 and 2 diabetes mellitus (DM) receiving insulin therapy when the disease course is complicated by ketosis or ketoacidosis.
 Material and methods. Capillary blood was simultaneously collected in two groups of patients receiving insulin therapy from the same drop to evaluate the glucose blood level using the Satellite Express glucose meter and a SUPER GL laboratory analyzer of glucose and lactate levels. Acid-base imbalance was the key criterion for distributing patients into groups: no disorders were detected in group 1 patients, while group 2 patients had ketosis or ketoacidosis. The results were evaluated using the Clarke error grid.
 Results. Comparative analysis of blood samples collected from 77 patients showed that all deviations in glucose level indices measured using the Satellite Express glucose meter from the reference values belonged to zones A (the clinically valid values) and B (safe deviations) in patients without acid-base imbalance. In patients hospitalized for ketosis and ketoacidosis (group 2), the deviations from the reference values lay in zones A and B in 97%, while lying on the boundary between zones B and C only in 3%.

Quality of glycemic control in assessment of the requirement for insulin in patients with type 2 diabetes and comorbid pathology

“…В нашем исследовании таким биосенсором был портативный измеритель концентра-ции глюкозы в крови ПКГ-03 «Сателлит Экспресс» (ООО «Компания «ЭЛТА», Россия). Как показали результаты проведенного нами ранее клинического исследования АААА-А16-116020410106-0, 2015-11-01-2016-01-25 гг., прибор обеспечивает стабильную работу при проведе-нии самоконтроля (допускаемые значения системати-ческой погрешности измерений концентрации глюкозы в диапазоне до 5,55 ммоль/л составляют ±0,80 ммоль/л, а в диапазоне более 5,55 ммоль/л -±15%) и достаточную надежность даже в условиях развития острых осложне-ний СД (кетоз, кетоацидоз) -97% значений в зоне клини-чески верных и безопасных отклонений по шкале Кларка (Clarke Error Grid) [17].…”