Self-monitoring of blood glucose with a focus on analytical quality: an overview

Kristensen, Gunn B.B.; Sandberg, Sverre

doi:10.1515/cclm.2010.186

Cited by 14 publications

(13 citation statements)

References 99 publications

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“…Inaccuracies might furthermore be explained by errors and differences resulting from the type of reference method used for device calibration. 17,18 The current study's clinical setting might be regarded as a limiting factor since accuracy testing is usually conducted in accordance with the relevant ISO standard, and therefore in a laboratory setting. Key differences in this regard would be the numbers of patients to be investigated (n = 100), requirements regarding the range of glucose concentrations to be included in the samples at levels < 50 mg/dl and > 300 mg/ dl, as well as testing in duplicate.…”

Section: Discussionmentioning

confidence: 99%

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Hasslacher

Kulozik

Platten

2014

J Diabetes Sci Technol

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Glucose monitoring systems (GMS) are routinely used by patients with diabetes to monitor glycemic control and modify treatment as needed. In this respect, the analytical performance of GMS is of course of crucial importance. The accuracy of GMS is usually assessed according to the Guidelines of the International Organization for Standardization (ISO). A new standard has recently been published with more stringent criteria than in the previous edition.1,2 Minimum acceptable system accuracy requirements for GMS now specify that ≥95% of the glucose meter results may not differ more than ±15 mg/dl from the reference method at glucose concentrations < 100 mg/dl (previously < 75 mg/dl) and ±15% (previously ±20%) at glucose concentrations ≥ 100 mg/dl.1 Furthermore, concerning prevalence and range of outliers, it is now specified that >99% of measured glucose values must fall in zones A and B of the consensus error grid.During the consultation process of the new criteria it has been suggested that the analytical performance of GMS is highly dependent on its intended use.3-6 For example, insulin-dependent patients under intensified glycemic control require highly accurate devices for adequate insulin dosing, whereas patients with Type 2 diabetes who are treated with medication with no or little risk of hypoglycemia could use less accurate GMS. It has, therefore, been suggested that the analytical accuracy of GMS should be tested not only in relation to BG level ranges below and above 100 mg/dL but also in relation to different glycemic ranges, as already previously proposed for continuous glucose monitoring systems. The aim of the present study was to analyze test results from 27 GMS obtained in a clinical setting, with regard to (1) analytical accuracy according to the new ISO accuracy limits as well as after stratification into 5 different BG level ranges and (2) frequency and extent of outliers. AbstractWe investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between...

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Section: Discussionmentioning

confidence: 99%

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Hasslacher

Kulozik

Platten

2014

J Diabetes Sci Technol

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“…The problem of generally high glucose levels being detected as a result of the renal threshold resulted in urine glucose tests being used to screen rather than monitor diabetes. It was only in the early 1980s that the direct measuring of blood glucose became widely accepted in the USA27 28 after it had become the widespread practice in Europe.…”

Section: Poc Testingmentioning

confidence: 99%

Historical perspectives in clinical pathology: a history of glucose measurement

et al. 2015

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This is the second in the series of historical articles dealing with developments in clinical pathology. As one of the most commonly measured analytes in pathology, the assessment of glucose dates back to the time of the ancient Egyptians. It was only in the 19th century that advances in chemistry led to the identification of the sugar in urine being glucose. The following century witnessed the development of more chemical and enzymatic methods which became incorporated into the modern analysers and point-of-care instruments which are as ubiquitous as the modern day cellphones. Tracking the milestones in these developments shows the striking paradigms and the many parallels in the development of other clinical chemistry methods.

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“…Advances in strip manufacturing processes and measurement techniques enable either universal coding, where the strips are produced reproducibly enough to require the same code for all lots, or non-evident coding, where the appropriate code is transferred from the strip packaging or from the strip characteristics. With either method, the end user is not required to input code-specific information into the meter, improving the ease of use of the system and reducing user-induced measurement error [137][138][139].…”

Section: Monitoring Systemsmentioning

confidence: 99%

Electrochemical Glucose Biosensors for Diabetes Care

Ocvirk¹,

Buck²,

DuVall³

2016

Trends in Bioelectroanalysis

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Blood glucose monitoring (BGM) is the most successful application of electrochemical biosensor technology and has motivated tremendous improvements in biology, chemistry, measurement, and fabrication methods of biosensors. The performance of electrochemical biosensors used for BGM has improved greatly over the last four decades. Technological advance has allowed to measure blood glucose (BG) over a wide range of glucose concentration, a wide temperature and hematocrit range in the presence of an abundance of interfering substances with ever-increasing accuracy, and precision in minute sample volumes. The use of optimized enzymes, mediators, and electrochemical measurement methods enables this tremendous progress in performance. Continuous glucose monitoring (CGM) systems based on minimally invasive amperometric sensors, inserted into the subcutaneous tissue, have significantly improved over initial offerings over the last 15 years with regard to time of use, accuracy, reliability, and convenience due to a multitude of parallel advances: materials needed for enzyme immobilization, polymeric cover membranes, and biocompatible coatings needed to tackle the response by the complex body interface have been developed; wireless transfer and processing of unprecedented data volume have been established; effortless and painless insertion schemes of ever smaller sensors have been realized in order to overcome the concerns of persons with diabetes (PwDs) to use a minimally invasive sensor; and scalable manufacturing technologies of miniaturized minimally invasive sensors have allowed for ever improved reproducibility and increased production volume. Looking ahead, the demands on blood glucose system performance G. Ocvirk (*) Roche Diabetes Care GmbH, Mannheim, Germany e-mail: gregor.ocvirk@roche.com H. Buck and S.H. DuVall Roche Diabetes Care, Inc., Indianapolis, IN, USA e-mail: harvey.buck@roche.com; stacy.duvall@roche.com are expected to grow even as the pressures to lower the cost of systems increase. The drive for the future is to continue to push the limits on system performance under real-life conditions while lowering cost, all while finding ways to provide the best medical value to PwDs and healthcare providers. Technical issues of commercially available CGM sensors remain to be solved which currently impede reliable hypo-and hyperglycemic alarms, safe insulin dosing recommendations, or insulin pump control at any time of use. It is realistic to assume that continuous glucose monitoring (CGM) systems will be adopted in the future by a larger population of PwDs. Yet it is also clear that BGM systems will remain a major choice of the great majority of PwDs on a global scale. This review offers a technical overview about user, system, and major regulatory requirements and available suitable sensor technology and demonstrated performance of electrochemical BGM and CGM systems from an industrial R&D perspective.

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Self-monitoring of blood glucose with a focus on analytical quality: an overview

Cited by 14 publications

References 99 publications

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Historical perspectives in clinical pathology: a history of glucose measurement

Electrochemical Glucose Biosensors for Diabetes Care

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