scholarly journals Accuracy of Two CE-Marked Blood Glucose Monitoring System Based on EN ISO 15197:2015

Diabetology ◽  
2021 ◽  
Vol 2 (4) ◽  
pp. 232-239
Author(s):  
Jung-Hee Kim ◽  
Maria Luisa Garo ◽  
Antonio Guerra ◽  
Maria Teresa Paparo ◽  
Antonio Russo
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Measurement Procedure ◽  
International Organization ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Diabetic Patients ◽  
Accuracy And Precision ◽  
Personalized Approach ◽  
Error Grid

Blood glucose monitoring systems (BGMS) are essential for the management of diabetic patients. Although International Organization for Standardization (ISO) 15197:2015 criteria require rigorous monitoring of BGMS devices before commercialization, manufacturing quality standards may decline after FDA or EU approval. This work aimed to demonstrate the accuracy and precision of two BGMS devices currently available on the market. A laboratory study was conducted from June to August 2021 using two BGMS devices. One hundred samples were collected and evaluated according to ISO 15197:2015 guidelines. Over 95% accuracy was achieved by both devices using stricter ISO criteria (at least 95% of values within ±10 mg/dL or ±10% of the results of the reference measurement procedure). Analysis of the error grid showed that 99.5% of the results were in zone A. Surveillance of the accuracy and precision of BGMS devices after FDA and EU approval is an essential procedure to help patients and physicians manage glycemia and determine an appropriate outcome and personalized approach to diabetes treatment.

Accuracy Evaluation of Five Blood Glucose Monitoring Systems in Patients from Different Departments

2019 ◽  
Vol 128 (04) ◽  
pp. 210-215
Author(s):  
Xiaona Li ◽  
Suhua Zheng ◽  
Suiyue Pan ◽  
Ting Yan ◽  
Jie Di ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
International Organization ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation ◽  
Self Monitoring ◽  
Comparison Measurements ◽  
Error Grid ◽  
Roche Cobas

Abstract Background Self-monitoring of blood glucose (SMBG) systems are expected to be accurate and provide reliable results. The international standard ISO (International Organization for Standardization) 15197:2013 is widely accepted for the accuracy evaluation for SMBG systems. Accuracy evaluation was performed for 5 different SMBG systems in patients from multi-departments at the hospital. Method A total of 120 patients from Changzhou Second People’s Hospital (Changzhou, China) were randomized and enrolled in the study. Accuracy evaluation was performed for 5 different SMBG systems: Gold AQ (Sinocare), Freestyle Optium Xceed (Abbott), Contour TS (Bayer), OneTouch Ultra (J&J) and Accu-Chek Performa (Roche). For each system, comparison measurements were performed with YSI 2300 STAT PLUS Glucose and Lactate Analyzer and Roche Cobas 8000 Modular Analyzer. Results All 5 systems showed that 100% of results fall within consensus error grid Zones A and B. Compared with YSI 2300 or Roche Cobas 8000 Modular Analyzer, Gold AQ system showed the highest accuracy. The linearity analysis also showed that Gold AQ had the highest correlation coefficient. Conclusion Compared with other SMBG systems, Gold AQ Glucose Monitoring System manufactured by Sinocare Inc. had the highest accuracy in measuring blood glucose level in patients from multi-departments at this hospital.

scholarly journals Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems

2020 ◽  
pp. 193229682094887
Author(s):  
Guido Freckmann ◽  
Annette Baumstark ◽  
Nina Jendrike ◽  
Jochen Mende ◽  
Sebastian Schauer ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Measurement Accuracy ◽  
Glucose Monitoring ◽  
Measurement Procedure ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Reference Measurement ◽  
Comparison Methods ◽  
The Impact ◽  
Apparent Level

Background: Measurement accuracy has been assessed for many different blood glucose monitoring systems (BGMS) over the years by different study groups. However, the choice of the comparison measurement procedure may impact the apparent level of accuracy found in such studies. Materials and Methods: Measurement accuracy of 18 different BGMS was assessed in a setting based on ISO 15197 using two different comparison methods in parallel: a glucose oxidase (GOD)-based and a hexokinase (HK)-based method. Accuracy limits of ISO 15197 were applied, and additional analyses were performed, including bias, linear regression, and mean absolute relative difference (MARD) to assess the impact of possible differences between comparison methods on the apparent level of accuracy. Results: While ≈80% of BGMS met the accuracy criteria of ISO 15197 when compared with the respective manufacturers’ reference measurement procedure, only two-thirds did so against both comparison methods. The mean relative bias ranged from −6.6% to +5.7% for the analysis against the GOD-based method and from −11.1% to +1.3% for the analysis against the HK-based method, whereas MARD results ranged from 3.7% to 9.8% and from 2.3% to 10.5%, respectively. Results of regression analysis showed slopes between 0.85 and 1.08 (GOD-based method) and between 0.81 and 1.01 (HK-based method). Conclusions: The results of this study indicate that there are systematic differences between the reference measurement procedures used for BGMS calibration as well as for system accuracy assessment. Because of the potential impact on therapy of patients with diabetes resulting from these differences, further steps toward harmonization of the measurement procedures’ results are important.

Do We Need the Replacement of YSI 2300? A View from the Clinical Laboratory

2021 ◽  
pp. 193229682110071
Author(s):  
Loukia Spanou ◽  
Konstantinos Makris
Keyword(s):  
Blood Glucose ◽  
Analytical Method ◽  
Clinical Laboratory ◽  
Glucose Monitoring ◽  
Point Of View ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Comparator Method ◽  
Specific Device ◽  
Overall Performance

In this issue of Journal of Diabetes Science and Technology, Baumstark et al. evaluated the analytical performance of a bench-top laboratory glucose analyzer (SUPER-GL) intended for replacement for the YSI2300-STAT analyzer, that served for several decades as a comparator method in clinical and analytical studies of blood glucose monitoring systems (BGMS). The authors concluded that the SUPER-GL’s overall performance is comparable to that of YSI2300-STAT, and has the potential to be a candidate comparator analyzer. However, the question is if we need to recommend as a “comparator method,” a specific device, that measure glucose using the same analytical method with most BGMS. In this analysis we present our point of view hoping to generate a discussion on the necessity for such a replacement.

Accuracy and precision assessment of a new blood glucose monitoring system

2016 ◽  
Vol 54 (1) ◽  
Author(s):  
Li-Nong Ji ◽  
Li-Xin Guo ◽  
Li-Bin Liu
Keyword(s):  
Blood Glucose ◽  
Glucose Concentration ◽  
Blood Glucose Concentration ◽  
Venous Blood ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Blood Samples ◽  
Glucose Testing ◽  
Blood Tests ◽  
Accuracy And Precision

AbstractBlood glucose self-monitoring by individuals with diabetes is essential in controlling blood glucose levels. The International Organization for Standardization (ISO) introduced new standards for blood glucose monitoring systems (BGMS) in 2013 (ISO 15197: 2013). The CONTOUR PLUSThis study evaluated the accuracy and precision of CONTOUR PLUS BGMS in quantitative glucose testing of capillary and venous whole blood samples obtained from 363 patients at three different hospitals.Results of fingertip and venous blood glucose measurements by the CONTOUR PLUS system were compared with laboratory reference values to determine accuracy. Accuracy was 98.1% (96.06%–99.22%) for fingertip blood tests and 98.1% (96.02%–99.21%) for venous blood tests. Precision was evaluated across a wide range of blood glucose values (5.1–17.2 mmol/L), testing three blood samples repeatedly 15 times with the CONTOUR PLUS blood glucose meter using test strips from three lots. All within-lot results met ISO criteria (i.e., SD<0.42 mmol/L for blood glucose concentration <5.55 mmol/L; CV<7.5% for blood glucose concentration ≥5.55 mmol/L). Between-lot variations were 1.5% for low blood glucose concentration, 2.4% for normal and 3.4% for high.Accuracy of both fingertip and venous blood glucose measurements by the CONTOUR PLUS system was >95%, confirming that the system meets ISO 15197: 2013 requirements.

scholarly journals System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197

2012 ◽  
Vol 6 (5) ◽  
pp. 1060-1075 ◽  
Author(s):  
Guido Freckmann ◽  
Christina Schmid ◽  
Annette Baumstark ◽  
Stefan Pleus ◽  
Manuela Link ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation ◽  
Self Monitoring

Indole as a new tentative marker in exhaled breath for non-invasive blood glucose monitoring of diabetic subjects

2021 ◽  
Author(s):  
Herbert Fink ◽  
Tim Maihöfer ◽  
Jeffrey Bender ◽  
Jochen Schulat
Keyword(s):  
Blood Glucose ◽  
Diabetes Management ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Glucose Measurement ◽  
Diabetic Patients ◽  
Exhaled Breath ◽  
Invasive Approach ◽  
Test Strips ◽  
Non Invasive

Abstract Blood glucose monitoring (BGM) is the most important part of diabetes management. In classical BGM, glucose measurement by test strips involves invasive finger pricking. We present results of a clinical study that focused on a non-invasive approach based on volatile organic compounds (VOCs) in exhaled breath. Main objective was the discovery of markers for prediction of blood glucose levels (BGL) in diabetic patients. Exhaled breath was measured repeatedly in 60 diabetic patients (30 type 1, 30 type 2) in fasting state and after a standardized meal. Proton Transfer Reaction Time of Flight Mass Spectrometry (PTR-ToF-MS) was used to sample breath every 15 minutes for a total of six hours. BGLs were tested in parallel via BGM test strips. VOC signals were plotted against glucose trends for each subject to identify correlations. Exhaled indole (a bacterial metabolite of tryptophan) showed significant mean correlation to BGL (with negative trend) and significant individual correlation in 36 patients. The type of diabetes did not affect this result. Additional experiments of one healthy male subject by ingestion of lactulose and 13C-labeled glucose (n=3) revealed that exhaled indole does not directly originate from food digestion by intestinal microbiota. As indole has been linked to human glucose metabolism, it might be a tentative marker in breath for non-invasive BGM. Clinical studies with greater diversity are required for confirmation of such results and further investigation of metabolic pathways.

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