In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

2003 ◽  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Diagnostic Test ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Self Testing ◽  
In Vitro Diagnostic ◽  
Systems Requirements

Evaluation of 12 Blood Glucose Monitoring Systems for Self-Testing: System Accuracy and Measurement Reproducibility

2014 ◽  
Vol 16 (2) ◽  
pp. 113-122 ◽  
Author(s):  
Guido Freckmann ◽  
Annette Baumstark ◽  
Christina Schmid ◽  
Stefan Pleus ◽  
Manuela Link ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Testing System ◽  
Measurement Reproducibility ◽  
Self Testing

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.

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
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