Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197

Baumstark, Annette; Pleus, Stefan; Schmid, Christina; Link, Manuela; Haug, Cornelia; Freckmann, Guido

doi:10.1177/193229681200600511

Cited by 83 publications

(70 citation statements)

References 24 publications

(32 reference statements)

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“…Manufacturing defects and test-strip lot-to-lot variations directly impact accuracy and introduce bias (156,157). Bias is typically measured in the hypoglycemic range, target range, and hyperglycemic range.…”

Section: What Impacts Accuracy?mentioning

confidence: 99%

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

et al. 2016

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Section: What Impacts Accuracy?mentioning

confidence: 99%

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

et al. 2016

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“…System accuracy and other performance data of the systems investigated have also been reported in other studies. [9][10][11][12][13][14][15][16][17][18][19] However, in our study, each system was evaluated by using 2 established comparison methods/systems, a GOD-based method/YSI 2300 STAT Plus glucose analyzer and a HK-based method/cobas c111 analyzer; the use of 2 methods allows for an investigation of possible impacts of the used comparison method/system on system accuracy.…”

Section: Discussionmentioning

confidence: 99%

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

Link¹,

Schmid²,

Pleus³

et al. 2015

J Diabetes Sci Technol

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The accuracy of blood glucose (BG) measurement results obtained with systems for self-monitoring of blood glucose (SMBG) by people with diabetes is crucial for adequate therapeutic decisions. Requirements for SMBG systems, for example, acceptable system accuracy, are established in the International Organization for Standardization (ISO) standard 15197. Manufacturers often provide evidence of conformity with this standard to obtain the Conformité Européenne (CE) mark for their system; in the European Union this mark, is a minimum requirement for being marketed. Background: The standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek® Aviva, Contour®XT, GlucoCheck XL, GlucoMen® LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used.

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“…Reviewing recent evidence, Schweitzer had to take pride in the impressive performance achieved by Accu-Chek BG meter systems. [28][29][30] He also made reference to the Roche CGM sensor in development as a promising new device soon to be offered.…”

Section: Technology-we Have a Solid Foundationmentioning

confidence: 99%

“…[28][29][30] The studies have been undertaken by independent and reputable research and technology institutions and were conducted in line with international ISO standards and guidelines. Hattemer presented the analysis of the three studies and gave his own verdict on the subject.…”

Section: Picking the Right Metermentioning

confidence: 99%

6^thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia

Alzaid

Schlaeger²,

Hinzmann³

2013

Diabetes Technology & Therapeutics

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International experts in the fields of diabetes, diabetes technology, endocrinology, and pediatrics gathered for the 6 th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and beyond. The aim of this meeting was to continue setting up a global network of experts in this field and provide an international platform for exchange of ideas to improve life for people with diabetes. The 2013 meeting comprised a comprehensive scientific program, parallel interactive workshops, and two keynote lectures. All these discussions were intended to help identify gaps and areas where further scientific work and clinical studies are warranted. Opening Lecture: News from the World of DiabetesSatish Garg, University of Colorado Denver, Aurora, Colorado Drugs can't do it alone, we need technology too S atish Garg, in his opening lecture, gave insights into the status of diabetes care in general, described the direction of the ongoing diabetes research, and unveiled exciting technological advances coming our way in the near future. He argued that diabetes technology has a major contribution to make on the quality of life and the day-to-day interaction between patient and disease. He put forward a poignant question, saying that we are almost spoiled for choice by the number of antidiabetes agents currently available to treat diabetes, but has that changed patient outcome?Garg advocated that drugs cannot do it alone and that there is a clear gap in the management of diabetes that may be filled in by diabetes-related technologies. Diabetes: uncontrollable costGarg presented recently published data that show the cost of diabetes alone amounts to a staggering $245 billion per year in the United States.1 This figure is expected to rise in the future. Almost one-third of people with diabetes belong to the elderly age group (above 65 years of age), meaning that most individuals have been systematically excluded from research trials and clinical studies. Garg made a timely and passionate plea that elderly people with diabetes must not be left out of the diabetes research agenda.A closer examination of the cost of diabetes expenditure reveals that 80% of the money is used to pay for services and late complications. Eight percent of the total expenditure is used for diabetes technology. Garg suggested that people with diabetes should be cared for from the outset to reduce the expense incurred due to late complications. Glycated hemoglobin and hypoglycemia as measures of healthcare outcomeRecent clinical data of 25,000 people with type 1 diabetes attending 67 leading diabetes centers across the United States were presented by Garg. The T1D Exchange Study 2 is an observational study that showed several interesting findings. First, despite all existing efforts, the pursuit of the target glycated hemoglobin (HbA1c) level remains elusive for many people with diabetes across the United States. Second, the incidence of hypoglycemia remains a major concern for many people with diabetes, especially the elderly. Another and...

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Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197

Cited by 83 publications

References 24 publications

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

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

6^thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia

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Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197

Cited by 83 publications

References 24 publications

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

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

6thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia

Contact Info

Product

Resources

About

6^thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia