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 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

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.

scholarly journals System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015

2020 ◽  
Vol 8 (1) ◽  
pp. e001067 ◽  
Author(s):  
Stefan Pleus ◽  
Annette Baumstark ◽  
Nina Jendrike ◽  
Jochen Mende ◽  
Manuela Link ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Comparison Method ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation ◽  
Current Generation ◽  
Related Information ◽  
Registration Number ◽  
Minimal Deviation

ObjectiveAccuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data.Research design and methodsThe BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou, and WaveSense JAZZ Wireless were tested using capillary blood from 100 different subjects and assessing the percentage of results within ±15 mg/dL (0.83 mmol/L) or 15% of comparison method results for BG concentrations below or above 100 mg/dL (5.55 mmol/L), respectively. In addition, the minimal deviation from comparison method results within which ≥95% of results of the respective BGMS were found was calculated.ResultsIn total, 14 BGMS had ≥95% of results within ±15 mg/dL (0.83 mmol/L) or ±15% and 3 BGMS had ≥95% of results within ±10 mg/dL (0.55 mmol/L) or ±10% of the results obtained with the comparison method. The smallest deviation from comparison method results within which ≥95% of results were found was ±7.7 mg/dL (0.43 mmol/L) or ±7.7%; the highest deviation was ±19.7 mg/dL (1.09 mmol/L) or ±19.7%.ConclusionsThis accuracy evaluation shows that not all CE-labeled BGMS fulfill accuracy requirements of ISO 15197 reliably and that there is considerable variation even among BGMS fulfilling these criteria. This safety-related information should be taken into account by patients and healthcare professionals when making therapy decisions.Trial registration numberNCT03737188.

scholarly journals Accuracy Evaluation of Blood Glucose Monitoring Systems in Children on Overnight Closed-Loop Control

2014 ◽  
Vol 8 (5) ◽  
pp. 969-973 ◽  
Author(s):  
Daniel J. DeSalvo ◽  
Satya Shanmugham ◽  
Trang T. Ly ◽  
Darrell M. Wilson ◽  
Bruce A. Buckingham
Keyword(s):  
Blood Glucose ◽  
Closed Loop ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Closed Loop Control ◽  
Accuracy Evaluation ◽  
Loop Control

scholarly journals Accuracy Evaluation of Five Blood Glucose Monitoring Systems: The North American Comparator Trial

2013 ◽  
Vol 7 (5) ◽  
pp. 1294-1304 ◽  
Author(s):  
Solveig Halldorsdottir ◽  
Mary Ellen Warchal-Windham ◽  
Jane F. Wallace ◽  
Scott Pardo ◽  
Joan Lee Parkes ◽  
...  
Keyword(s):  
Blood Glucose ◽  
North American ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation ◽  
The North ◽  
Comparator Trial

scholarly journals Accuracy Beyond ISO: Introducing a New Method for Distinguishing Differences Between Blood Glucose Monitoring Systems Meeting ISO 15197:2013 Accuracy Requirements

2018 ◽  
Vol 12 (3) ◽  
pp. 650-656
Author(s):  
Scott Pardo ◽  
Rimma M. Shaginian ◽  
David A. Simmons
Keyword(s):  
Blood Glucose ◽  
Real World ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Sensitivity Analyses ◽  
Monitoring Systems ◽  
Self Monitoring ◽  
Drug Dosing ◽  
Using Data ◽  
Glycemic Targets

Background: Diabetes treatment is intended to maintain near-normal glycemic levels. Self-monitoring of blood glucose (SMBG) allows patients to track their BG levels compared with glycemic targets and is associated with improved health outcomes. Because of the importance of SMBG, it is essential that results are accurate to prevent errors in nutritional intake and drug dosing. This study presents a new methodology to evaluate the accuracy of BG monitoring systems (BGMSs). Methods: Sensitivity analyses were performed using real and simulated BGMS data to compute probabilities that, for any BG value, the BGMS result would be within prescribed error bounds and confidence limits compared with laboratory reference values. Multiple BG value ranges were used. Results: Probability curves were created using data from 3 simulated BGMSs and anonymized data from 3 real-world BGMSs. Accuracy probability curves from capillary fingertip blood samples (actual clinical data) showed that all 3 real-world BGMSs met EN ISO 15197:2015 accuracy criteria, since 99.63%, 99.63%, and 99.81% of results from the 3 BGMSs were within ±15 mg/dL or ±15% of reference for BG <100 mg/dL and ≥100 mg/dL, respectively. However, there was identifiable variability between BGMSs if BG was <70 mg/dL; one BGMS showed further reductions in accuracy if BG was <50 mg/dL. Conclusions: Probability curves highlight the importance of BGMS accuracy to help achieve optimal glycemic control while avoiding hypoglycemia or hyperglycemia. This may be especially significant in very low BG ranges where small errors in BGMS measurements can have substantial impacts on patient-related outcomes, including hypoglycemia risk.

The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria

2019 ◽  
Vol 13 (3) ◽  
pp. 252-258 ◽  
Author(s):  
Huizhen Chen ◽  
Qingtao Yao ◽  
Yang Dong ◽  
Zhimei Tang ◽  
Ruiying Li ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation
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