ReviewJournal of diabetes science and technology2015
Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.
Review in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
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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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022Guideline
- Screening for dysglycaemia in dental primary care practice settings: systematic review of the evidence.International dental journal · 2018Pooled it
- One minute of light-intensity stair-stepping decreases postprandial glycaemia in the evening in non-diabetic adults: A randomized controlled trial.Experimental physiology · 2026Trial
- Laser-Assisted Self-Monitoring of Blood Glucose: Analytical Performance, Clinical Accuracy, and Usability of the HandyRay-Glu System.Diagnostics (Basel, Switzerland) · 2026Article
- Evaluation of commercial point-of-care glucometers for detection and monitoring of neonatal hypoglycemia in resource-constrained settings.BMC pediatrics · 2025Article
- Exploring diet-induced ketosis with exogenous ketone supplementation as a potential intervention in post-traumatic stress disorder: a feasibility study.Frontiers in nutrition · 2024Article
- Intermittent scanning continuous glucose monitoring is safe and useful in postsurgical glucose monitoring after pancreatoduodenectomy.Acta diabetologica · 2023Article
- Narrative review of the role of technology in pediatric diabetes: from testing blood glucose to subcutaneous automated therapy and hope for cure.Translational pediatrics · 2023Review
- Diet-induced ketosis in adult patients with subacute acquired brain injury: a feasibility study.Frontiers in medicine · 2023Article
- Article
- Enhancing the Accuracy of Non-Invasive Glucose Sensing in Aqueous Solutions Using Combined Millimeter Wave and Near Infrared Transmission.Sensors (Basel, Switzerland) · 2021Article
- Radio-Frequency Biosensors for Real-Time and Continuous Glucose Detection.Sensors (Basel, Switzerland) · 2021Review
- Accuracy of five plasma calibrated glucometers to screen for and diagnose gestational diabetes mellitus in a low resource clinic setting.Journal of clinical & translational endocrinology · 2019Article
- Analysis of "Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations".Journal of diabetes science and technology · 2019Article
- The Progress of Glucose Monitoring-A Review of Invasive to Minimally and Non-Invasive Techniques, Devices and Sensors.Sensors (Basel, Switzerland) · 2019Review
- Evaluation of accuracy dependence of Raman spectroscopic models on the ratio of calibration and validation points for non-invasive glucose sensing.Analytical and bioanalytical chemistry · 2018Article
- A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.Journal of clinical and diagnostic research : JCDR · 2017Article
- Interferences and Limitations in Blood Glucose Self-Testing: An Overview of the Current Knowledge.Journal of diabetes science and technology · 2016Review
- Accuracy of Glucose Meter among Adults in a Semi-urban Area in Kathmandu, Nepal.JNMA; journal of the Nepal Medical AssociationArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems.
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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.