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

Blood Glucose Monitoring Systems

2013 ◽  
pp. 15-82 ◽  
Author(s):  
Francesco Valgimigli ◽  
Fabrizio Mastrantonio ◽  
Fausto Lucarelli
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems

scholarly journals User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors

2018 ◽  
Vol 9 (2) ◽  
pp. 683-697 ◽  
Author(s):  
Guido Freckmann ◽  
Nina Jendrike ◽  
Annette Baumstark ◽  
Stefan Pleus ◽  
Christina Liebing ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
User Performance

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 Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197

2015 ◽  
Vol 10 (1) ◽  
pp. 85-92 ◽  
Author(s):  
José Luis Bedini ◽  
Jane F. Wallace ◽  
Scott Pardo ◽  
Thorsten Petruschke
Keyword(s):  
Performance Evaluation ◽  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems
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