Assessing Glucose Monitor Performance—A Standardized Approach

Mahoney, John J.; Ellison, John M.

doi:10.1089/dia.2007.0245

Cited by 48 publications

(28 citation statements)

References 16 publications

(5 reference statements)

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“…In agreement with previous studies that concluded most evaluations are performed poorly and present questionable conclusions, 1,2 preliminary use of the checklists demonstrated that only few publications adhered to international guidelines and recommendations for appropriate study design or fully address many of the variables that can adversely impact on the validity of conclusions. The easy-to-use checklists help raise awareness of important issues involved, identify limitations in study design, and will aid readers drawing clear and valid conclusions from the increasing number of publications in the BG system area.…”

Section: Discussionsupporting

confidence: 82%

“…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%

“…1,2 It seems that publications rarely adhere to all the points outlined in guidelines and that many studies do not follow published recommendations for study design and methodology or do not appear to address many of the variables that can adversely impact validity. To establish if an accuracy study is valid, a wide range of details must be checked, an issue complicated by publication word count restrictions that may necessitate additional protocol information being made available elsewhere.…”

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 82%

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

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

Thorpe¹

2013

Diabetes Technology & Therapeutics

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“…The influences of hematocrit were more pronounced with the consumer devices Meter 3 and Meter 4 ( Figures 1C and 1D). It is noteworthy that for Meters 3 and Meter 4 , hematocrit modifies glucose measurement (β 3 ≠ 0) and does not directly affect meter results (β 2 = 0).…”

Section: Resultsmentioning

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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Current literature in diabetes

2008

Diabetes Metabolism Res

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of diabetes/metabolism. Each bibliography is divided into 26 sections: 1 Reviews; 2 General; 3 Genetics; 4 Epidemiology; 5 Immunology; 6 Obesity; 7 Prediction and Prevention; 8 Intervention: a) General; b) Care; c) Drug Therapy; d)Economics; e) Gene therapy; f) Nursing; g) Nutrition; h) Surgery; i) Transplantation; 9 Pathology and Complications: a) General; b) Cardiovascular; c) Eye disease; d) Gestational and fetal; e) Neurological; f) Podiatrical; g) Renal; 10 Endocrinology & Metabolism; 11 Experimental Studies; 12 Diagnosis and Techniques. Within each section, articles are listed in alphabetical order with respect to author

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Assessing Glucose Monitor Performance—A Standardized Approach

Abstract: We propose a standardized 14-step checklist that facilitates the incorporation of international consensus standards, quality guidelines, and acceptance criteria into the design and reporting of glucose monitor evaluation protocols.

Cited by 48 publications

References 16 publications

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

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

Current literature in diabetes

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