Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197

Abstract

Blood glucose monitoring systems (BGMS) are often used by diabetes patients on an insulin regimen as basis for their therapeutic decisions, like administration of insulin or rescue carbohydrates. Accuracy of the results displayed by BGMS is therefore an important issue in the use of BGMS, because only sufficiently high accuracy allows diabetes patients ade quate diabetes control.According to the International Organization for Standard ization's (ISO) standard ISO 15197:2013, which establishes minimum requirements for BGMS for selfmonitoring that should result in acceptable performance and which also describes procedures for demonstrating compliance with these minimum requirements, accuracy comprises the two concepts of trueness and precision. 1 Trueness describes how large the deviation between an average of replicate measurement results and a comparative (ie, reference) results is. Trueness is inversely related to the systematic measurement error (bias), so that maxi mum trueness is achieved in absence of bias. Precision on the 821105D STXXX10.1177/1932296818821105Journal of Diabetes Science and TechnologyJendrike et al. research-article2018Abstract Background: Analytical quality of blood glucose monitoring systems (BGMS) is an important aspect for many diabetes patients. Sufficiently high analytical quality is required for adequate diabetes therapy. Methods:In this study, system accuracy and measurement precision of a BGMS were assessed based on ISO 15197:2013. For system accuracy, this standard requires a specific glucose distribution and at least 95% of results obtained with the BGMS in capillary blood to fall within ±15 mg/dl or ±15% (at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively) of corresponding comparison method results, and at least 99% of results to be found within clinically acceptable consensus error grid (CEG) zones A and B. Based on ISO 15197:2013, intermediate measurement precision, using control solution, and measurement repeatability, using venous blood samples, were analyzed by calculation of standard deviations (SDs) and coefficients of variation (CV) at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively, although ISO 15197:2013 does not specify acceptance criteria.Results: The BGMS fulfilled system accuracy requirements with ≥99% of results within ±15 mg/dl or ±15% of the comparison method results, and 100% of results in CEG zones A and B. Intermediate measurement precision analysis showed SD ≤2.2 mg/dl and CV ≤2.3%. Analysis of measurement repeatability showed SD ≤2.1 mg/dl and CV ≤2.4%. Conclusion:System accuracy requirements of ISO 15197:2013 were fulfilled by the BGMS. As ISO 15197:2013 does not specify precision requirements, precision analysis results were compared with those reported for other BGMS in the literature and found to be similar.

Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany

“…Data from international studies concerning the analytical performance of glucometers Sufficiently robust BGMS are a prerequisite for appropriate and safe blood glucose self-monitoring in patients with diabetes. The measurement accuracy of glucometer devices significantly impacts the quality of clinical care and therapy adjustment for these patients (Jendrike et al, 2019). It can be regarded as proven that more significant errors in SMBG devices lead to greater predicted risks of undetected hypoglycemia (Breton and Kovatchev, 2010).…”

Getting More Information From Glucose Meter Evaluations

“…In Figure 1, all glucose meters meet the ISO 15197 specification but differences among meters are more readily visualized in a graph than in a table. Thus, the meter with square markers has Journal of Diabetes Science and Technology 13 (6) 95% of its values between −5% and 6%, whereas the meter with diamond markers has 95% of its values between −12% and 12%. Note also that it is easy to see when the percentages are not symmetrical about zero, as the meter with circle markers shows, which has a positive bias and 95% of its values between −3% and 8%.…”

“…Unfortunately, meters that fail to provide a result are often discarded and mentioned only in passing if at all. 6 Although meter failures cannot contribute to difference statistics, there is reason to record this information, as failure to obtain a result is an adverse event. In the ISO standard, the system accuracy protocol is carried out by trained health care professionals.…”