Do Currently Available Blood Glucose Monitors Meet Regulatory Standards? 1-Day Public Meeting in Arlington, Virginia

Klonoff, David C.; Reyes, Juliet S.

doi:10.1177/193229681300700432

Cited by 29Diabetes Management and ResearchClinical Laboratory Practices and Quality ControlHealthcare Regulation

Do Currently Available Blood Glucose Monitors Meet Regulatory Standards? 1-Day Public Meeting in Arlington, Virginia

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Klonoff, David C., Reyes, Juliet S.·2013·Journal of Diabetes Science and Technology

DOI 10.1177/193229681300700432PMC PMC3879774

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Abstract

Blood glucose monitors (BGMs) are approved by regulatory agencies based on their performance during strict testing conducted by their manufacturers. However, after approval, there is uncertainty whether BGMs maintain the accuracy levels that were achieved in the initial data. The availability of inaccurate BGM systems pose a public health problem because their readings serve as a basis for treatment decisions that can be incorrect. Several articles have concluded that BGMs in the marketplace may not consistently provide accurate results in accordance with the regulatory standards that led to approval. To address this growing concern, Diabetes Technology Society organized and conducted a 1-day public meeting on May 21, 2013, in Arlington, VA, presided by its president, David Klonoff, M.D., FACP, Fellow AIMBE, to determine whether BGMs on the market meet regulatory standards. The meeting consisted of four sessions in which Food and Drug Administration diabetes experts as well as leading academic clinicians and clinical chemists participated: (1) How is BGM performance determined? (2) Do approved BGMs perform according to International Organization for Standardization standards? (3) How do approved BGMs perform when used by patients and health care professionals? (4) What could be the consequence of poor BGM performance?

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According to the FDA, some manufacturers or testing institutions commissioned by these manufacturers might be tempted to falsify data for market approval.
“Furthermore, according to the FDA, some manufacturers or testing institutions commissioned by these manufacturers might be tempted to falsify data for market approval.38”
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PREFACE
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Authors: Klonoff, D. C., & Reyes, J. S.
Affiliations: Mills Peninsula Health Services (US)
Diabetes Technology Society (US)
Corresponding author: Klonoff, David C.
ORCID: Klonoff, David C.
Venue: Journal of Diabetes Science and Technology
Publisher: SAGE Publications
Published: 2013-07
Volume: 7
Issue: 4
Pages: 1071-1083
ISSN: 1932-2968 (ISSN-L)
DOI: 10.1177/193229681300700432
PMC: PMC3879774
OpenAlex: W2171006131
Cited by: 29
References: 14
Citations by year: 2021: 1 · 2020: 1 · 2019: 2 · 2018: 1 · 2017: 3 · 2016: 5 · 2015: 11 · 2014: 4 · 2013: 1
Type: conference abstract
Language: en
Open access: bronze
doi.org
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Journal of Diabetes Science and Technology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
Keywords: blood glucose meters, meter accuracy, regulatory standards, FDA approval, ISO standards, diabetes technology, in vivo performance, clinical decision-making, public health risk
MeSH terms: Blood Glucose, Diabetes Mellitus, Humans, Product Surveillance, Postmarketing, Reference Standards, United States, United States Food and Drug Administration, Virginia, Blood Glucose Self-Monitoring, Device Approval, Internationality

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Do Currently Available Blood Glucose Monitors Meet Regulatory Standards? 1-Day Public Meeting in Arlington, Virginia

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