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

Klaff, Leslie J.; Brazg, Ronald; Hughes, Kristen; Tideman, Ann M.; Schachner, Holly C.; Stenger, Patricia; Pardo, Scott; Dunne, Nancy; Parkes, Joan Lee

doi:10.1089/dia.2014.0069

Cited by 41 publications

(42 citation statements)

References 22 publications

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“…For the meters that were previously investigated, our results are generally similar to those of other studies. 9,18,20 However, the MARDs calculated in our study are higher than the MARDs for the same devices in some previous studies, 22,23 which might be due to the inclusion in our study of more samples in the hypoglycemic range and of samples with a wide range of hemoglobins, as well as the use of manipulated samples.…”

Section: Discussioncontrasting

confidence: 80%

“…Previous studies conducted in the United States did not investigate all the devices that we included in our study. [17][18][19][20][21] We chose to use the MARD in addition to RD plots and the ISO numerical criteria to assess accuracy. MARD calculation provides more detailed evaluation compared to the ISO criteria, which are binary classifications.…”

Section: Discussionmentioning

confidence: 99%

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Comparative Accuracy of 17 Point-of-Care Glucose Meters

Ekhlaspour

Mondesir

Lautsch

et al. 2016

J Diabetes Sci Technol

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Background: The accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia, calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of reference BG and hemoglobin values. Methods:Fresh, discarded blood samples from a hospital STAT laboratory were either used without modification, spiked with a glucose solution, or incubated at 37°C to produce 347 samples with an even distribution across reference BG levels from 20 to 440 mg/dl and hemoglobin values from 9 to 16 g/dl. We measured the BG of each sample with 17 different commercially available glucose meters and the reference method (YSI 2300) at the same time. We determined the mean absolute relative difference (MARD) for each glucose meter, overall and stratified by reference BG and by hemoglobin level. Results:The accuracy of different meters widely, exhibiting a range of MARDs from 5.6% to 20.8%. Accuracy was lower in the hypoglycemic range, but was not consistently lower in samples with anemic blood hemoglobin levels. Conclusions:The accuracy of commercially available glucose meters varies widely. Although the sample mix in this study was much more challenging than those that would be collected under most use conditions, some meters were robust to these challenges and exhibited high accuracy in this setting. These data on relative accuracy and robustness to challenging samples may be useful in informing the choice of a glucose meter.

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Section: Discussioncontrasting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Comparative Accuracy of 17 Point-of-Care Glucose Meters

Ekhlaspour

Mondesir

Lautsch

et al. 2016

J Diabetes Sci Technol

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show abstract

“…10,11,15,22,25,26 To ensure constant adherence of available SMBG systems to established standards, postmarket surveillance evaluations are recommended as being discussed in the current revision of the European directive for in vitro diagnostic medical devices. The results of our study indicate that the comparison method/system and the lot-to-lot variability can have an influence on SMBG system accuracy data.…”

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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“…Recent evaluations of current BGMs showed considerable differences in performance in the low-glucose range (3,4). This might be one reason why the FDA does not accept BG measurement data from point-of-care or self-monitoring BGMs as evidence for the efficacy of any insulins or antidiabetes drugs with regard to reduction in hypoglycemic events.…”

mentioning

confidence: 99%

“…Recent publications suggest that it is possible to achieve a large number of results in the low glycemic range by carefully adjusting subjects' BG concentrations in vivo (3,4). If in vivo adjustment does not yield enough low-BG results, a possible alternative is offered in form of the glucose clamp technique.…”

mentioning

confidence: 99%

Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That It Is Not Sufficient From a Clinical Point of View

Heinemann

Zijlstra

Pleus³

et al. 2015

Diabetes Care

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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

Abstract: When compared with other BGMSs, CN demonstrated the lowest mean deviation from the reference value (by MAD and MARD) across multiple glucose ranges.

Cited by 41 publications

References 22 publications

Comparative Accuracy of 17 Point-of-Care Glucose Meters

Comparative Accuracy of 17 Point-of-Care Glucose Meters

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

Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That It Is Not Sufficient From a Clinical Point of View

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