ReviewJournal of diabetes science and technology2010
A review of standards and statistics used to describe blood glucose monitor performance.
Review in Journal of diabetes science and technology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 96 citations in OpenAlex.
- Accuracy and reliability of a subcutaneous continuous glucose monitoring device in critically ill patients.Journal of clinical monitoring and computing · 2018Trial
- Performance of the CONTOUR® TS Blood Glucose Monitoring System.Journal of diabetes science and technology · 2011Trial
- Assessment of analytical performance of a glucometer in Indian adults at a tertiary care hospital.BMC endocrine disorders · 2025Article
- Differential signaling effects of blood glucose on delay discounting in individuals with and without type 1 diabetes.Journal of behavioral medicine · 2024Article
- Deep self-supervised machine learning algorithms with a novel feature elimination and selection approaches for blood test-based multi-dimensional health risks classification.BMC bioinformatics · 2024Article
- Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.Journal of diabetes science and technology · 2023Article
- Validation of equations to estimate kidney function with and without adjustment by race/color in Brazilian adults (ELSA-Brazil).Revista brasileira de epidemiologia = Brazilian journal of epidemiology · 2023Article
- Diabetes Complications and Related Comorbidities Impair the Accuracy of FreeStyle Libre, a Flash Continuous Glucose Monitoring System, in Patients with Type 2 Diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022Article
- Glucose biosensors in clinical practice: principles, limits and perspectives of currently used devices.Theranostics · 2022Review
- Utility of point-of-care vs reference laboratory testing for the evaluation of glucose levels.Diabetic medicine : a journal of the British Diabetic Association · 2019Article
- Quality of medical products for diabetes management: a systematic review.BMJ global health · 2019Article
- Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test Strip.Journal of diabetes science and technology · 2018Article
- Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia.Journal of diabetes science and technology · 2018Article
- Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip Product.Journal of diabetes science and technology · 2017Article
- Why the Diabetes Technology Society Surveillance Protocol for Glucose Meters Needs to Be Revised.Journal of diabetes science and technology · 2017Article
- Why the New FDA Glucose Meter POCT Guidance Is Disappointing.Journal of diabetes science and technology · 2017Article
- Point and trend accuracy of a continuous intravenous microdialysis-based glucose-monitoring device in critically ill patients: a prospective study.Annals of intensive care · 2016Article
- Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting.Journal of diabetes science and technology · 2016Article
- Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting.Journal of diabetes science and technology · 2015Article
- Evaluation of CareSens POCT Devices for Glucose Testing in the Routine Hospital Setting.Journal of clinical and diagnostic research : JCDR · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Glucose performance is reviewed in the context of total error, which includes error from all sources, not just analytical. Many standards require less than 100% of results to be within specific tolerance limits. Analytical error represents the difference between tested glucose and reference method glucose. Medical errors include analytical errors whose magnitude is great enough to likely result in patient harm. The 95% requirements of International Organization for Standardization 15197 and others make little sense, as up to 5% of results can be medically unacceptable. The current American Diabetes Association standard lacks a specification for user error. Error grids can meaningfully specify allowable glucose error. Infrequently, glucose meters do not provide a glucose result; such an occurrence can be devastating when associated with a life-threatening event. Nonreporting failures are ignored by standards. Estimates of analytical error can be classified into the four following categories: imprecision, random patient interferences, protocol-independent bias, and protocol-dependent bias. Methods to estimate total error are parametric, nonparametric, modeling, or direct. The Westgard method underestimates total error by failing to account for random patient interferences. Lawton's method is a more complete model. Bland-Altman, mountain plots, and error grids are direct methods and are easier to use as they do not require modeling. Three types of protocols can be used to estimate glucose errors: method comparison, special studies and risk management, and monitoring performance of meters in the field. Current standards for glucose meter performance are inadequate. The level of performance required in regulatory standards should be based on clinical needs but can only deal with currently achievable performance. Clinical standards state what is needed, whether it can be achieved or not. Rational regulatory decisions about glucose monitors should be based on robust statistical analyses of performance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.