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Biosensors 2018, 8(2), 50; https://doi.org/10.3390/bios8020050

Limits to the Evaluation of the Accuracy of Continuous Glucose Monitoring Systems by Clinical Trials

1
Institute for Design and Control of Mechatronical Systems, Johannes Kepler University Linz, 4040 Linz, Austria
2
Science & Co, 41462 Neuss, Germany
3
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, 89081 Ulm, Germany
These authors contributed equally to this work.
*
Author to whom correspondence should be addressed.
Received: 13 April 2018 / Revised: 11 May 2018 / Accepted: 14 May 2018 / Published: 18 May 2018
(This article belongs to the Special Issue Continuous Glucose Monitoring)
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Abstract

Systems for continuous glucose monitoring (CGM) are evolving quickly, and the data obtained are expected to become the basis for clinical decisions for many patients with diabetes in the near future. However, this requires that their analytical accuracy is sufficient. This accuracy is usually determined with clinical studies by comparing the data obtained by the given CGM system with blood glucose (BG) point measurements made with a so-called reference method. The latter is assumed to indicate the correct value of the target quantity. Unfortunately, due to the nature of the clinical trials and the approach used, such a comparison is subject to several effects which may lead to misleading results. While some reasons for the differences between the values obtained with CGM and BG point measurements are relatively well-known (e.g., measurement in different body compartments), others related to the clinical study protocols are less visible, but also quite important. In this review, we present a general picture of the topic as well as tools which allow to correct or at least to estimate the uncertainty of measures of CGM system performance. View Full-Text
Keywords: blood glucose; diabetes; continuous glucose monitoring; quality of measurement blood glucose; diabetes; continuous glucose monitoring; quality of measurement
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Schrangl, P.; Reiterer, F.; Heinemann, L.; Freckmann, G.; del Re, L. Limits to the Evaluation of the Accuracy of Continuous Glucose Monitoring Systems by Clinical Trials. Biosensors 2018, 8, 50.

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