Accuracy of Plasma Glucose Measurements in the Hypoglycemic Range

Genter, Pauline; Ipp, Eli

doi:10.2337/diacare.17.6.595

Cited by 32 publications

(20 citation statements)

References 5 publications

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“…In these studies, a bias of up to 8% between different comparison methods/systems was found. 20,21 In a recent study performed at our institute following requirements of ISO 15197:2013, accuracy results also differed depending on the applied comparison method/ system. 22 Therefore, a harmonized calibration of comparison methods/systems used for the calibration/evaluation of SMBG systems to a higher order standard is important.…”

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

“…While we and others have shown that this point-of-care device is very accurate in comparison with reference laboratory methods, 6,15,16 it is based on a glucose oxidase method, while several of the tested systems (e.g., the Roche Diagnostics and the Bayer devices) are based on glucose dehydrogenase as the key sensor enzyme. It has been shown that differences of 5-8% can easily occur between different enzymatic methods such as glucose oxidase and hexokinase, 17,18 which may account for some of the deviations observed in our study.…”

Section: Discussionmentioning

confidence: 61%

Evaluation of the Effects of Insufficient Blood Volume Samples on the Performance of Blood Glucose Self-Test Meters

Pfützner

Schipper

Ramljak

et al. 2013

J Diabetes Sci Technol

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“…A negative bias of 3-8% has been described between YSI 2300 STAT and the hexokinase-based Olympus AU640 reference method. 23,24 As such, different reference methods might introduce a deviation of the values, which is not caused by the device itself. While we believe that these limitations do not change the meaning of our hematocrit interference findings, they have to be considered when interpreting our data.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

Demircik¹,

Ramljak²,

Hermanns

et al. 2014

J Diabetes Sci Technol

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Prevalence of abnormal hematocrit values (HCT) in diabetic is a phenomenon that is underestimated by physicians and diabetes nurse educators. HCT is generally considered to be quite stable in the range of 40-45% and blood glucose meters for patient self-testing are usually set to function properly with HCT concentration in this "normal range." However, a thorough investigation of the hematocrit distribution in an urban community has demonstrated a HCT-range of 30-50% in a healthy reference population. In community patients, the observed HCT ranged between 20% and 60%, and in hospital patients it was 10% to 70%. Patients in the intensive care units showed levels between 15% and 40%.1 In older patients also suffering from various diseases, these variations can even be more pronounced and may have an impact on the patient's prognosis, for example, in patients with kidney disease.2 In daily routine, changes in the hematocrit levels can be the result of lifestyle interventions (eg, smoking, prolonged exercise), can come with demographic conditions (eg, age), and can be induced by disease-and drug-related conditions (eg, hematological disorders, hypermenorrhea, pregnancy, or renal disease) and by environmental conditions (eg, stay in high mountains, seasonal variation). [3][4][5] Hematocrit interference has previously been identified as a source for inaccuracies of blood glucose meter readings in daily routine. 6,7 In meters employing static electrochemistry, Method: Venous heparinized blood was freshly drawn, immediately aliquoted, and manipulated to contain 3 different blood glucose concentrations (50-80 mg/dL, 150-180 mg/dL, and 350-400 mg/dL) and 5 different HCT levels (20-25%, 30-35%, 40-45%, 50-55%, and 60-65%). After careful oxygenation to normal blood oxygen pressure, each of the 15 different samples was measured 8 times with 2 devices and 2 strip lots of each meter (32 measurements/meter/sample). YSI Stat 2300 served as laboratory reference method. Next to determination of the mean absolute relative deviation (MARD), stability to HCT influence was assumed, when less than 10% difference occurred between the highest and lowest mean glucose deviations in relation to HCT over all tested glucose ranges (HIF: hematocrit interference factor).

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Accuracy of Plasma Glucose Measurements in the Hypoglycemic Range

Abstract: We conclude that any interpretation or comparison of critical clinical and research measurements of glucose in different settings take into account methodological differences, particularly in the hypoglycemic range.

Cited by 32 publications

References 5 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

Evaluation of the Effects of Insufficient Blood Volume Samples on the Performance of Blood Glucose Self-Test Meters

Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

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