Standardized Evaluation of Instruments for Self-Monitoring of Blood Glucose by Patients and a Technologist

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

doi:10.1373/clinchem.2004.031575

Cited by 65 publications

(55 citation statements)

References 10 publications

(1 reference statement)

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“…For one of the instruments, the Accu-Chek Sensor, one lot showed a significantly larger deviation from the reference method than the other two lots. Between-lot variation is important in instrument evaluations, and more than one lot should always be included (24,25 ).…”

Section: Discussionmentioning

confidence: 99%

Between-Lot Variation in External Quality Assessment of Glucose: Clinical Importance and Effect on Participant Performance Evaluation

et al. 2005

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Background: External quality assessment schemes (EQAS) are conducted to evaluate user performance (participant assessment) and to assess different methods and instruments (method assessment). The quality of control materials is crucial to achieving these goals. Inconsistencies in between-lot variations detected by use of different control and sample materials may affect EQAS outcomes. Methods: For the Accu-Chek Sensor, Precision Xtra, Ascensia Elite, and HemoCue 201 glucometers, 3 different lots of glucose strips were used with each instrument. Method assessment results from analysis of capillary blood and 3 control materials were used to calculate between-lot differences. A simulation study was performed to evaluate the effect of between-lot variation on participant assessment results. Results: With the Precision Xtra, the results obtained with EQA control material mirrored those obtained with capillary blood, but for the other instruments, we found between-lot differences of as much as 1.3 mmol/L, which were substantially greater than those found with capillary blood and of clinical importance at decision limits. The simulation study showed an effect on participant assessment results related to the target values, with the percentage of poor results decreasing (38%, 10%, and 4%) with the use of common, method-specific, and lot-specific target values, respectively. Conclusions: Between-lot variation may influence participant EQA results for participant and method assessments. The clinical relevance of between-lot variation

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Section: Discussionmentioning

confidence: 99%

Between-Lot Variation in External Quality Assessment of Glucose: Clinical Importance and Effect on Participant Performance Evaluation

et al. 2005

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“…Moreover, an analysis of published studies of glucose meters demonstrated that the studies suffered from deficiencies in study design, methodology, and reporting (134 ), raising the possibility that the reported total error underestimates the true total error of the meters. A standardized method for evaluating meters has been developed in Norway (134 ), and the Norwegian health authorities have decided that all SMBG instruments marketed in Norway should be examined by a similar procedure (135 ). Results of evaluations of 9 brands of meters according to this method showed that 3 of 9 meters did not meet the ISO criteria, and none met the 1996 ADA criteria in the hands of patients (135 ).…”

Section: Gppmentioning

confidence: 99%

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

et al. 2011

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BACKGROUND Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence Based Laboratory Medicine Committee of the AACC jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. CONTENT In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A1c (Hb A1c) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

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“…However, the within-participant CVs should be interpreted with caution because some of the participants might have analyzed the sample more than twice and reported the 2 best results (16 ). Regarding total error, because we used method-specific target values, it is difficult to compare the results from this study with the quality goals set by the ADA or ISO 15197 (6 -8 ).…”

Section: Discussionmentioning

confidence: 95%

“…In Norway, health authorities have stipulated that all SMBG instruments with test strips should be examined by a standardized procedure that implies testing simultaneously by an experienced technologist and a group of patients before test strips are reimbursed by the government (16 ). An additional effect of running an EQAS for glucose for diabetes patients is that it will give an opportunity to continuously monitor the quality of SMBG technology on the market.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2006

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Background:The analytical quality of self-monitoring of blood glucose (SMBG) is not satisfactory, and the need for standardized control routines for SMBG has been underscored. The objective of this study was to investigate whether an external quality assessment scheme (EQAS) designed for office laboratories could improve the quality of SMBG measurements. Methods: From October 2001 through March 2004, we conducted 6 glucose surveys for diabetes patients and coordinated them with an EQAS for office laboratories.Patients received 2 control samples by post twice a year. They measured each control sample in duplicate in accordance with written instructions, returned the results, and received an assessment of their analytical performance. Participants who got a poor evaluation were followed up by phone and were offered guidance. Results: Participating in an EQA program over a period of 3 years decreased the percentage of poor results among diabetes patients significantly, from 11.2% to 1.9% in the first and last surveys, respectively. Betweenparticipant CVs improved from 5.5% to 3.7% and were comparable to results from office laboratories. It was difficult to sort out factors contributing to quality improvement. Conclusions: Implementing a traditional EQAS among diabetes patients may improve the analytical quality of SMBG and could be convenient for motivated patients. Further evaluation of the clinical usefulness of implementing such a program is needed, however, and costs

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Standardized Evaluation of Instruments for Self-Monitoring of Blood Glucose by Patients and a Technologist

Cited by 65 publications

References 10 publications

Between-Lot Variation in External Quality Assessment of Glucose: Clinical Importance and Effect on Participant Performance Evaluation

Between-Lot Variation in External Quality Assessment of Glucose: Clinical Importance and Effect on Participant Performance Evaluation

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

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

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