Accuracy Evaluation of Contour Next Compared with Five Blood Glucose Monitoring Systems Across a Wide Range of Blood Glucose Concentrations Occurring in a Clinical Research Setting

2015 ◽  
Vol 17 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Leslie J. Klaff ◽  
Ronald Brazg ◽  
Kristen Hughes ◽  
Ann M. Tideman ◽  
Holly C. Schachner ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Clinical Research ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation ◽  
Research Setting ◽  
Wide Range ◽  
Blood Glucose Concentrations

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 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

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

scholarly journals Accuracy Evaluation of CONTOUR®PLUS Compared With Four Blood Glucose Monitoring Systems

2015 ◽  
Vol 6 (3) ◽  
pp. 377-388 ◽  
Author(s):  
Nancy Dunne ◽  
Maria T. Viggiani ◽  
Scott Pardo ◽  
Cynthia Robinson ◽  
Joan Lee Parkes
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation

Accuracy Evaluation of Four Blood Glucose Monitoring Systems in the Hands of Intended Users and Trained Personnel Based on ISO 15197 Requirements

2017 ◽  
Vol 19 (4) ◽  
pp. 246-254 ◽  
Author(s):  
Guido Freckmann ◽  
Annette Baumstark ◽  
Nina Jendrike ◽  
Delia Rittmeyer ◽  
Stefan Pleus ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Accuracy Evaluation ◽  
Trained Personnel
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