A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range

Abstract

The performance of blood glucose (BG) measurement systems (BG meters plus test strips) is a much debated and researched topic. Reliable BG measurements are needed to ensure that patients with diabetes make the same clinical decisions (eg, select appropriate insulin dose) as they would do if the glucose measurements were made with a laboratory or even better with a reference method. 1 BG systems are considered accurate if they show high precision and high trueness, that is, both the random error (measurement imprecision or variability) and the systematic error (measurement bias) are low. 2 The evaluation of BG systems should be performed in accordance with standard guidelines like the International Organization for Standardization (ISO) (ISO 15197:2013 In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus). Such guidelines describe in detail test procedures to be followed. They also specify the allowed measurement deviation of the measurement results from the laboratory measurements and the maximum number of inaccurate results or outliers acceptable. The analytical goals defined by the ISO guidelines are now widely adopted by manufacturers of BG systems and regulatory agencies.Despite the prerequisite of demonstrating compliance with ISO 15197 before market approval of a new BG system, the performance of currently available BG systems (= after market approval) has been fiercely debated after reports Abstract Background: The objective was to evaluate the performance (in terms of accuracy, precision, and trueness) of 5 CE-certified and commercially available blood glucose (BG) systems (meters plus test strips) using an innovative clinical-experimental study design with a 3-step glucose clamp approach and frequent capillary BG measurements. Methods:Sixteen subjects with type 1 diabetes participated in this open label, single center trial. BG was clamped at 3 levels for 60 minutes each: 60-100-200 mg/dL. Medical staff performed regular finger pricks (up to 10 per BG level) to obtain capillary blood samples for paired BG measurements with the 5 BG systems and a laboratory method as comparison. Conclusions: This 3 range glucose clamp approach enables a systematic performance evaluation of BG systems under controlled and reproducible conditions. The random error of the tested BG systems was comparable, but some showed a lower systematic error than others. These BG systems allow an accurate glucose measurement at low, normal and high BG levels. Results

Retrospective Analysis of Continuous Glucose Monitoring Data With the Surveillance Error Grid Supports Nonadjunctive Dosing Decisions

“…Although personal blood glucose meters are generally accurate, 8 , 9 obtaining and testing a blood sample is a multistep process that is painful and burdensome. 10 , 11 Many patients test infrequently (35% of patients in a T1D Exchange clinic registry study 12 tested 0-3 times per day), resulting in long between-test intervals.…”

Analysis of “Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations”

“…Although mean bias is shown for different methods further details and values relating to reference/comparison method performance, traceability, calibration, and quality control would have been useful. This is particularly relevant to the YSI comparison method, which although in widespread use, is complex and variable in terms of reported maintenance 21 calibration and checks, 22,23 traceability, 24 target and acceptance values, imprecision, and the exact procedure used for sample analysis. 15,21,25…”