Blood Glucose Meters Employing Dynamic Electrochemistry are Stable against Hematocrit Interference in a Laboratory Setting

Pfützner, Andreas; Musholt, Petra B.; Schipper, Christina; Demircik, Filiz; Hengesbach, Carina; Flacke, Frank; Sieber, Jochen; Forst, Thomas

doi:10.1177/193229681300700613

Cited by 10 publications

(17 citation statements)

References 25 publications

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“…5 The following device, Ascensia Contour, showed MARD values against our YSI (Yellow Springs Analyzer) reference device of 8.6% and 6.2%, respectively, in our laboratory setting (reference: YSI). 6,7 We saw a major further accuracy improvement with the introduction of the Contour XT (4.8% in patients 8,9 ) and finally our first study with Contour Next, the same device and strip platform tested by Bendini et al, 1,2 resulted in an MARD 1.3% with samples processed in our laboratory. 10 One reason, why the accuracy of the Contour Next platform in comparison to other devices has finally reached such a high level, may be seen in the elimination of hematocrit interference by means of a mathematical correction algorithm.…”

Section: Original Articlementioning

confidence: 96%

Advances in Patient Self-Monitoring of Blood Glucose

Pfützner¹

2015

J Diabetes Sci Technol

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In 2 articles of the present issue, Bendini et al report about performance results obtained with 2 blood glucose monitoring systems of the Contour Next platform. Using several analysis methods, the authors demonstrate a very high accuracy, which meets all actual regulatory performance criteria. With consistent MARD results < 5% under daily routine conditions, this meter platform is finally fulfilling the accuracy request as set forth by the American Diabetes Association already in the late 1980s. This meter platform is representative for the successful effort of the device manufacturers who were consequently improving the analytical performance of blood glucose meters during the Past 2 decades, starting with an MARD of 12-15% at the end of the past century and reaching an excellent accuracy < 5% today.

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Section: Original Articlementioning

confidence: 96%

Advances in Patient Self-Monitoring of Blood Glucose

Pfützner¹

2015

J Diabetes Sci Technol

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“…This threshold has been applied by us in previous publications and appears to be a suitable benchmark parameter to differentiate between devices with or without hematocrit interference. [17][18][19][20] Our investigation has several important limitations, which prohibit a direct translation of our laboratory results into clinical practice recommendations. First, this investigation was performed in an artificial laboratory setting with manipulated venous samples.…”

Section: Discussionmentioning

confidence: 99%

“…The same meters or meters from the same manufacturers and based on the respective technology have also shown similar results in previous investigations. [17][18][19][20] These blood glucose measurement systems are also known to use mathematical algorithms to correct for hematocrit interference, but the exact nature of these procedures has not been disclosed to the public, but it is tempting to speculate that it may be a similar approach like dynamic electrochemistry. The meters that failed our hematocrit interference test are known to apply static electrochemistry, which explains the observed results.…”

Section: Discussionmentioning

confidence: 99%

“…As to be expected, the results are similar to those obtained with other blood glucose meters employing dynamic electrochemistry in a previous investigation. 18 Next to the sponsor device, 3 other meters were also demonstrating stability to hematocrit interference. The same meters or meters from the same manufacturers and based on the respective technology have also shown similar results in previous investigations.…”

Section: Discussionmentioning

confidence: 99%

“…15,16 An alternative approach to reduce hematocrit interference is the application of a physical and mathematical result correction also referred to "dynamic electrochemistry." We have been able to demonstrate in recent investigations that devices for patient self-testing employing dynamic electrochemistry are unaffected not only by hematocrit interference in the laboratory [17][18][19] but also in a clinical accuracy evaluation. 20 A new device employing dynamic electrochemistry, MyStar Extra (Sanofi, Frankfurt), has recently been introduced to the market.…”

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confidence: 95%

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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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Enzyme‐Based Glucose Sensor: From Invasive to Wearable Device

Lee

Hong

Baik

et al. 2018

Adv Healthcare Materials

609

396

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Blood glucose concentration is a key indicator of patients' health, particularly for symptoms associated with diabetes mellitus. Because of the large number of diabetic patients, many approaches for glucose measurement have been studied to enable continuous and accurate glucose level monitoring. Among them, electrochemical analysis is prominent because it is simple and quantitative. This technology has been incorporated into commercialized and research-level devices from simple test strips to wearable devices and implantable systems. Although directly monitoring blood glucose assures accurate information, the invasive needle-pinching step to collect blood often results in patients (particularly young patients) being reluctant to adopt the process. An implantable glucose sensor may avoid the burden of repeated blood collections, but it is quite invasive and requires periodic replacement of the sensor owing to biofouling and its short lifetime. Therefore, noninvasive methods to estimate blood glucose levels from tears, saliva, interstitial fluid (ISF), and sweat are currently being studied. This review discusses the evolution of enzyme-based electrochemical glucose sensors, including materials, device structures, fabrication processes, and system engineering. Furthermore, invasive and noninvasive blood glucose monitoring methods using various biofluids or blood are described, highlighting the recent progress in the development of enzyme-based glucose sensors and their integrated systems.

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Blood Glucose Meters Employing Dynamic Electrochemistry are Stable against Hematocrit Interference in a Laboratory Setting

Abstract: Abbreviations: (BG) blood glucose, (GDH) glucose dehydrogenase, (GOx) glucose oxidase, (HCT) hematocrit, (HIF) hematocrit interference factor, (MARD) mean absolute relative difference Keywords: blood glucose, dynamic electrochemistry, hematocrit, interference, patient self-monitoring

Cited by 10 publications

References 25 publications

Advances in Patient Self-Monitoring of Blood Glucose

Advances in Patient Self-Monitoring of Blood Glucose

Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

Enzyme‐Based Glucose Sensor: From Invasive to Wearable Device

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