Results and Feasibility of an External Quality Assessment Scheme for Self-Monitoring of Blood Glucose

Kristensen, Gunn B.B.; Nerhus, Kari; Thue, Geir; Sandberg, Sverre

doi:10.1373/clinchem.2006.068114

Cited by 27 publications

(24 citation statements)

References 17 publications

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“…The obtained results depended on the control material employed and were less favorable than the results of Kristensen and colleagues. 20 Imprecision CV across various glucose meters ranged from 2.2 to 12.9% for artificial control samples, 3.66 to 12.9% for plasma control samples, and 4.74 to 12.8% for conserved blood. The author concludes that, at present, EQA surveys are suitable for checking the imprecision of POCT glucose analyzers only.…”

Section: External Quality Assessmentmentioning

confidence: 97%

Quality Control of Self-Monitoring of Blood Glucose: Why and How?

Solnica

Naskalski

2007

J Diabetes Sci Technol

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The control of analytical quality of self-monitoring of blood glucose (SMBG) is recommended as a routine procedure in diabetes management. This control procedure should be easily accessible to patients, convenient, not time-consuming, and provide a reliable assessment of glucose meter performance. Optimally it should be located in the diabetes outpatient clinic. Presently there are two approaches to carrying out SMBG quality control. The first is based on the comparison of results obtained by a controlled glucose meter and use of the laboratory method or point-of-care testing device as a surrogate reference analyzer. The second one is a traditionally organized external quality assessment scheme with use of a dedicated control material, which is distributed to all participants. The recommended allowable meter error in SMBG can be realistically set at 10%.

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Section: External Quality Assessmentmentioning

confidence: 97%

Quality Control of Self-Monitoring of Blood Glucose: Why and How?

Solnica

Naskalski

2007

J Diabetes Sci Technol

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“…The presence of galactose did not affect the results of glucose concentration mea surements [145]. Kristensen et al demonstrated in 2006 that the introduction of an external quality control system increased the reliability of the results of determination of blood glucose obtained by patients at home by procedures using test strips [146].…”

Section: 11mentioning

confidence: 99%

Methods for the determination of glucose in blood. Part 2

Buzanovskii¹

2015

Ref. J. Chem.

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The chronological development of destructive and nondestructive methods designed to determine the glucose concentration in plasma, serum, and whole blood is presented in the review. Destructive procedures are divided into spectrophotometric, spectrofluorimetric, diffraction, amper ometric, potentiometric, conductometric, chromatographic, gas chromatographic-mass spectromet ric, titrimetric, and calorimetric types, as well as reflectance photometry. A brief overview of these methods and the results of comparative tests are given; the procedures are systematized. It is noted that certain types of enzymatic spectrophotometric and amperometric methods have received wide accep tance for analyzes in clinical diagnostic laboratories. Outside clinical laboratories, enzymatic amper ometric and spectrophotometric procedures and reflectance photometry procedures using test strips are widely used. Chromatography-mass spectrometry procedures are often applied to certify standard serum samples. Spectrofluorimetric, diffraction, and chromatographic techniques are common in sci entific biomedical research. Nondestructive methods like nonenzymatic spectrophotometric, nonen zymatic amperometric, potentiometric, conductometric, titrimetric, and calorimetric procedures, as well as a number of enzymatic spectrophotometric procedures, in most cases, are not used in modern clinical and diagnostic practice.

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“…The regulatory bodies need to consider tightening the acceptable minimal standard of accuracy [2,4,14,48,49] and precision for all glucose meters. Strip lots should also be randomly tested by an independent, scientifically based, regulatory entity for efficacy, and the results should be made available to the public in a timely manner.…”

Section: Recommendations For Changementioning

confidence: 99%

Interfering Factors in Quality of Glucose Measurement

Hellman¹

2014

Frontiers in Diabetes

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The use of point-of-care (POC) glucose meters has revolutionized the measurement of blood glucose, but the new technologies have also introduced challenges due to interfering factors which may affect the accuracy of the measurements. Although new regulatory standards have just been proposed, both the ISO 15197 revised standard and the two new FDA standards, none of these standards solve some of the current problems faced by the clinicians and patients. Among the most serious problems are clinical 'outliers', where the POC glucose measurement is misleading, leading to clinical errors and patient harm. In addition to the above issues, this chapter looks at the special problems of using POC glucose measurement in inpatient units and particularly in critical care settings, the impact of glucose meter accuracy in clinical decisions and the pitfalls that may occur, the distinction between total analytical error and the total error (which is usually significantly larger and more important clinically), and the problems in pediatric care which add to the complexity of ascertaining the true glucose values of the patient. We provide recommendations for changes in both regulatory bodies, both for premarket approval and postmarket monitoring of both POC glucose devices and glucose reagent strips. © 2015 S. Karger AG, BaselThe development of point-of-care (POC) glucose meters has revolutionized the measurement of blood glucose both for in-and outpatients, greatly adding to the tools available for the care of diabetes and resulting in improved clinical outcomes. But with the new technology have come challenges, for the new meters have interfering factors that need to be understood and dealt with by those who use and rely upon the information derived from POC glucose meters.The invention of the first widely used POC blood glucose measurement tool, the Dextrostix, was in 1963 [1], followed 7 years later by the Ames Reflectance Meter. The use of POC glucose meters has continued to increase every year. In 2008, more than 44 million tests were performed daily worldwide. POC glucose testing resulted in USD 8.8 billion in annual revenue in 2008 [2]. The glucose meters and strips have

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Results and Feasibility of an External Quality Assessment Scheme for Self-Monitoring of Blood Glucose

Cited by 27 publications

References 17 publications

Quality Control of Self-Monitoring of Blood Glucose: Why and How?

Quality Control of Self-Monitoring of Blood Glucose: Why and How?

Methods for the determination of glucose in blood. Part 2

Interfering Factors in Quality of Glucose Measurement

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