Literature DB >> 24124957

Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial.

Solveig Halldorsdottir1, Mary Ellen Warchal-Windham, Jane F Wallace, Scott Pardo, Joan Lee Parkes, David A Simmons.   

Abstract

BACKGROUND: This study evaluated differences in accuracy between the CONTOUR® NEXT EZ (EZ) blood glucose monitoring system (BGMS) and four other BGMSs [ACCU-CHEK® Aviva (ACAP), FreeStyle Freedom Lite® (FFL), ONE TOUCH® Ultra®2 (OTU2), and TRUEtrack® (TT)].
METHODS: Up to three capillary blood samples (N = 393) were collected from 146 subjects with and without diabetes. One sample per subject was tested with fresh (natural) blood; the other samples were glycolyzed to lower blood glucose to <70 mg/dl. Meter results were compared with results from plasma from the same sample tested on a Yellow Springs Instruments (YSI) 2300 STAT PlusTM glucose analyzer. Blood glucose monitoring system accuracy was compared using mean absolute relative difference (MARD; from laboratory reference method results) and other analyses. Separate analyses on fresh (natural) samples only were conducted to determine potential effects of glycolysis on MARD values of systems utilizing glucose-oxidase-based test strip chemistry.
RESULTS: Across the tested glucose range, the EZ had the lowest MARD of 4.7%; the ACAP, FFL, OTU2, and TT had MARD values of 6.3%, 18.3%, 23.4%, and 26.2%, respectively. For samples with glucose concentrations <70 mg/dl, the EZ had the lowest MARD (0.65%), compared with the ACAP (2.5%), FFL (18.3%), OTU2 (22.4%), and TT (33.2%) systems.
CONCLUSIONS: The EZ had the lowest MARD across the tested glucose ranges when compared with four other BGMSs when all samples were analyzed as well as when natural samples only were analyzed.
© 2013 Diabetes Technology Society.

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Year:  2013        PMID: 24124957      PMCID: PMC3876374          DOI: 10.1177/193229681300700520

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


  11 in total

1.  A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose.

Authors:  J L Parkes; S L Slatin; S Pardo; B H Ginsberg
Journal:  Diabetes Care       Date:  2000-08       Impact factor: 19.112

2.  Performance evaluation of a new blood glucose monitor that requires no coding: the OneTouch Vita System.

Authors:  Joanna K Young; John M Ellison; Robert Marshall
Journal:  J Diabetes Sci Technol       Date:  2008-09

3.  Accuracy and reliability of continuous glucose monitoring systems: a head-to-head comparison.

Authors:  Yoeri M Luijf; Julia K Mader; Werner Doll; Thomas Pieber; Anne Farret; Jerome Place; Eric Renard; Daniela Bruttomesso; Alessio Filippi; Angelo Avogaro; Sabine Arnolds; Carsten Benesch; Lutz Heinemann; J Hans DeVries
Journal:  Diabetes Technol Ther       Date:  2013-05-07       Impact factor: 6.118

4.  System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197.

Authors:  Guido Freckmann; Christina Schmid; Annette Baumstark; Stefan Pleus; Manuela Link; Cornelia Haug
Journal:  J Diabetes Sci Technol       Date:  2012-09-01

5.  Performance of a new blood glucose monitoring system in the hands of intended users.

Authors:  Timothy S Bailey; Jane F Wallace; Joan Lee Parkes; Scott Pardo; Ji Yu; Holly C Schachner; David A Simmons; Amy Chu
Journal:  Diabetes Technol Ther       Date:  2012-06-29       Impact factor: 6.118

6.  Clinical assessment of the accuracy of blood glucose measurement devices.

Authors:  Andreas Pfützner; Michael Mitri; Petra B Musholt; Daniela Sachsenheimer; Marcus Borchert; Andrew Yap; Thomas Forst
Journal:  Curr Med Res Opin       Date:  2012-03-21       Impact factor: 2.580

7.  System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197.

Authors:  Guido Freckmann; Annette Baumstark; Nina Jendrike; Eva Zschornack; Serge Kocher; Jacques Tshiananga; Frank Heister; Cornelia Haug
Journal:  Diabetes Technol Ther       Date:  2010-03       Impact factor: 6.118

8.  Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects.

Authors:  Cornelius Tack; Harald Pohlmeier; Thomas Behnke; Volkmar Schmid; Marco Grenningloh; Thomas Forst; Andreas Pfützner
Journal:  Diabetes Technol Ther       Date:  2011-12-16       Impact factor: 6.118

9.  Accuracy and precision of four value-added blood glucose meters: the Abbott Optium, the DDI Prodigy, the HDI True Track, and the HypoGuard Assure Pro.

Authors:  Catherine A Sheffield; Michael P Kane; Gary Bakst; Robert S Busch; Jill M Abelseth; Robert A Hamilton
Journal:  Diabetes Technol Ther       Date:  2009-09       Impact factor: 6.118

10.  A comparative effectiveness analysis of three continuous glucose monitors.

Authors:  Edward R Damiano; Firas H El-Khatib; Hui Zheng; David M Nathan; Steven J Russell
Journal:  Diabetes Care       Date:  2012-12-28       Impact factor: 19.112

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  19 in total

1.  Analysis of "Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial".

Authors:  Paul A Fournier
Journal:  J Diabetes Sci Technol       Date:  2013-09-01

Review 2.  Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.

Authors:  Guido Freckmann; Christina Schmid; Annette Baumstark; Malte Rutschmann; Cornelia Haug; Lutz Heinemann
Journal:  J Diabetes Sci Technol       Date:  2015-04-14

3.  System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method.

Authors:  Manuela Link; Christina Schmid; Stefan Pleus; Annette Baumstark; Delia Rittmeyer; Cornelia Haug; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2015-04-14

4.  Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test Strip.

Authors:  Steven Setford; Mike Grady; Stephen Mackintosh; Robert Donald; Brian Levy
Journal:  J Diabetes Sci Technol       Date:  2018-05-30

5.  Strengths and Limitations of New Approaches for Graphical Presentation of Blood Glucose Monitoring System Accuracy Data.

Authors:  Stefan Pleus; Frank Flacke; Jochen Sieber; Cornelia Haug; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2017-04-26

6.  Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings.

Authors:  Stefan Pleus; Michael Schoemaker; Karin Morgenstern; Günther Schmelzeisen-Redeker; Cornelia Haug; Manuela Link; Eva Zschornack; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2015-04-07

Review 7.  Improving the Glucose Meter Error Grid With the Taguchi Loss Function.

Authors:  Jan S Krouwer
Journal:  J Diabetes Sci Technol       Date:  2016-06-28

8.  Comparative Accuracy of 17 Point-of-Care Glucose Meters.

Authors:  Laya Ekhlaspour; Debbie Mondesir; Norman Lautsch; Courtney Balliro; Mallory Hillard; Kendra Magyar; Laura Goergen Radocchia; Aryan Esmaeili; Manasi Sinha; Steven J Russell
Journal:  J Diabetes Sci Technol       Date:  2016-10-03

9.  A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in Spain.

Authors:  José Luis Bedini; Jane F Wallace; Thorsten Petruschke; Scott Pardo
Journal:  J Diabetes Sci Technol       Date:  2015-08-07

10.  Accuracy evaluation of blood glucose monitoring systems in children on overnight closed-loop control.

Authors:  Daniel J DeSalvo; Satya Shanmugham; Trang T Ly; Darrell M Wilson; Bruce A Buckingham
Journal:  J Diabetes Sci Technol       Date:  2014-05-21
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