Standardized Evaluation of Nine Instruments for Self-Monitoring of Blood Glucose

Kristensen, Gunn B.B.; Monsen, Grete; Skeie, Svein; Sandberg, Sverre

doi:10.1089/dia.2008.0034

Cited by 50 publications

(56 citation statements)

References 26 publications

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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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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

View full text Add to dashboard Cite

show abstract

“…7 Another study found that 3 of 9 meters failed the ISO standard when testing was performed by patients, 12 while another study revealed that, during patient use of 21 GMs, 16% of BG measurements were more than 20% above or below the reference value. 13 The total error found in this GM testing is far greater than the current ISO standard of 5% or less. The authors suggested that, since "inaccurate BG monitoring systems bear the risk of false treatment decisions by the diabetes patient and subsequent possible severe health injury, manufacturers should regularly and effectively check the quality of BG meters and BG test strips."…”

Section: Re-certification For Determination Of Accuracy Post-food Andmentioning

confidence: 64%

New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011

Walsh

Roberts²,

Vigersky

et al. 2012

J Diabetes Sci Technol

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Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting. The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in postapproval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs' analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report.

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“…Insiders know how important it is to choose a "good" batch of test strips so that a BG test system can pass a test (e.g., for approval) and that there are considerable batch-to-batch differences in measurement quality. 5 This variability between batches of test strips can even exceed the acceptance limits of the present ISO norm. 6,7 We believe that it is mandatory that an independent professional institution sytematically evaluate the measurement quality of BG test systems under daily life conditions with random samples, even years after approval, because this task cannot be delegated to the people with diabetes.…”

Section: Evaluation Of the Performance Quality Of Blood Glucose Test mentioning

confidence: 97%

Considerations for an Institution for Evaluation of Diabetes Technology Devices to Improve Their Quality in the European Union

Heinemann¹,

Freckmann

Koschinsky³

2013

J Diabetes Sci Technol

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Standardized Evaluation of Nine Instruments for Self-Monitoring of Blood Glucose

Abstract: The quality of instruments for SMBG seems to have improved during recent years, although there are still analytical problems. A standardized evaluation protocol is necessary and should be regularly revised taking into account the development of new technology and the needs of the patients.

Cited by 50 publications

References 26 publications

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

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

New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011

Considerations for an Institution for Evaluation of Diabetes Technology Devices to Improve Their Quality in the European Union

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