Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management

Author:

Eichenlaub Manuel1ORCID,Pleus Stefan1ORCID,Shaginian Rimma2,Richardson James2,Pardo Scott3,Stuhr Andreas4,Freckmann Guido1ORCID

Affiliation:

1. Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany

2. Ascensia Diabetes Care Holdings AG, Global Medical Affairs, Basel, Switzerland

3. Ascensia Diabetes Care, Global Clinical Affairs, Valhalla, USA

4. Ascensia Diabetes Care, Global Medical Affairs, Parsippany, USA

Abstract

Background: The accuracy of blood glucose monitoring systems (BGMS) is crucial for the safe and effective management of diabetes mellitus. Despite standardization of accuracy assessment procedures and requirements, various studies have shown that the accuracy of BGMS on the market can vary considerably. This article therefore provides health care professionals and users with an intuitive illustration of the impact of BGMS accuracy on clinical decision making. Material and Methods: Several hypothetical patient scenarios based on blood glucose (BG) levels in the low, normal, and high BG range are devised. Using data from a recent BGMS accuracy study, a method for calculating the expected range of BG readings from four examined BGMS at the selected BG levels is introduced. Based on these ranges, it is illustrated how clinical decisions and subsequent outcomes of the hypothetical patients are affected by the expected inaccuracies of the BGMS. Results: The range of expected BGMS readings for the same true BG level can vary considerably between different BGMS. The discussion of hypothetical patient scenarios revealed that the use of some BGMS could be associated with an increased risk of adverse events such as failure to detect hypoglycemia, driving with an unsafe BG level, delay of treatment intervention in diabetes during pregnancy, or the failure to prevent diabetic ketoacidosis. Conclusions: This article can support both health care professionals and patients to understand the impact of BGMS accuracy in a relatable, clinical context. Furthermore, it is suggested that current accuracy requirements might be insufficient for the prevention of adverse clinical outcomes in certain circumstances.

Funder

Ascensia Diabetes Care Holdings AG

Publisher

SAGE Publications

Subject

Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine

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