• Dtsch. Med. Wochenschr. · Apr 2022

    [Analytical Quality of Glucose Measurements in Germany].

    • Guido Freckmann, Lutz Heinemann, Stefan Pleus, Astrid Petersmann, Patricia Kaiser, and Matthias Nauck.
    • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm.
    • Dtsch. Med. Wochenschr. 2022 Apr 1; 147 (7): 407-413.

    AbstractThe measurement quality of systems used for determination of glucose concentrations has to be sufficiently high to obtain measurement results that are reliable in a clinical context regarding the intended use (e. g., diabetes diagnosis and monitoring). The "Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen" (guideline of the German Medical Association on quality assurance in medical laboratory examinations) includes specifications on the internal and external quality assurance that are legally binding for glucose measurements in healthcare. In the opinion of the authors, however, there is room for improvement, and examples are provided. Systems for self-monitoring of blood glucose by patients do not fall under any legally binding requirements for quality assurance. With systems for continuous glucose monitoring, there are currently no technological means to regularly check measurement quality. Additionally, repeated manufacturer-independent evaluations, which could lead to improved measurement quality, are not available.Thieme. All rights reserved.

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