Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports

Mahoney, John J.; Ellison, John M.

doi:10.1373/clinchem.2006.083493

Cited by 43 publications

(29 citation statements)

References 60 publications

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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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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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“…evaluations of BG system accuracy are available from several sources [1][2][3] (see Supplementary Table S1; Supplementary Data are available online at www.liebertonline.com/dia). International guidelines reflect procedures designed to produce conclusions with the greatest degree of confidence.…”

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

“…BG system accuracy studies also require a protocol that incorporates the use of fresh human whole blood because a standard reference material for whole blood is not available. 1,2,10 Four potential sources of error must be considered in the evaluation of a BG system 11 :…”

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

Assessing the Quality of Publications Evaluating the Accuracy of Blood Glucose Monitoring Systems

Thorpe¹

2013

Diabetes Technology & Therapeutics

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Many studies determine the performance of blood glucose monitoring (BG) systems. Correct evaluation is, however, complex, and apparent contradiction of results creates confusion. This study aimed to provide an overview of frequently made errors and to develop easy-to-use checklists to verify the quality of such studies. Building on the work from Mahoney and Ellison and subsequent re-evaluation, study designs of accuracy studies were assessed, and best practice and internationally accepted norms were determined. Key issues were collated, and two simplified checklists were developed: one for the assessment of analytical accuracy studies and a second for guidance with studies assessing the influence of interferences. The checklists have been used in a feasibility study with 20 representative studies selected from a literature search between 2007 and 2012. This check revealed that limitations in the designs and methods of studies assessing the performance of BG systems are common. The use of the accuracy checklist with the 20 representative studies showed that only 20% were in agreement with most of the issues deemed important and that 40% showed clear nonconcordance with ISO 15197. The use of the interference checklist showed that only 50% of the publications were in good agreement with the quality checks. In agreement with previous studies, which concluded many evaluations are performed poorly and present questionable conclusions, the use of these checklists demonstrated that few publications adhered to international guidelines and recommendations. Taking this into consideration, it becomes obvious that the publications must be examined in more detail to establish their quality and the validity of conclusions drawn. Rationale and ObjectiveB lood glucose (BG) systems have been widely available for many years and have become the subject of an extensive range of studies evaluating the accuracy of these products. Such studies can involve a single BG system or several. Considering the number of publications comparing the accuracy of several systems, the number of publications has been increasing significantly over the last 5 years. A nondefinitive estimate based on the search undertaken is provided in Figure 1.Building on the work from Mahoney and Ellison 1,2 and subsequent re-evaluation, 3 study designs of accuracy studies were assessed, and best practice and internationally accepted norms were determined. The evaluation of BG system accuracy and the influence of interferences is complex, and testing must be carefully designed and performed. 4 Clinicians and technicians performing such studies need to be aware of numerous factors in order to obtain data free of protocol-bias or patient-specific bias.5 A wide range of variables must be taken into account to ensure any inaccuracy of results is due to the BG system and not due to other factors such as the reference method, variations in the specimens compared, experimental artifact, random patient interferences, or using the meter outside the manufacturer's claim...

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“…1 Several authors have described strategies to assess the discrepancies more consistently. [2][3][4] Factors that contribute to error with glucose meters include user error, environmental error, and several sources of analytical error.…”

Section: Introductionmentioning

confidence: 99%

Estimates of Total Analytical Error in Consumer and Hospital Glucose Meters Contributed by Hematocrit, Maltose, and Ascorbate

Lyon

DuBois²,

Fick

et al. 2010

J Diabetes Sci Technol

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Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports

Cited by 43 publications

References 60 publications

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

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

Assessing the Quality of Publications Evaluating the Accuracy of Blood Glucose Monitoring Systems

Estimates of Total Analytical Error in Consumer and Hospital Glucose Meters Contributed by Hematocrit, Maltose, and Ascorbate

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