Title
Limits to the evaluation of the accuracy of continuous glucose monitoring systems by clinical trials
Date Issued
18 May 2018
Access level
open access
Resource Type
journal article
Author(s)
Schrangl P.
Reiterer F.
Heinemann L.
Freckmann G.
Universidad Johannes Kepler de Linz
Publisher(s)
MDPI
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.
Volume
8
Issue
2
Language
English
OCDE Knowledge area
Endocrinología, Metabolismo (incluyendo diabetes, hormonas)
Scopus EID
2-s2.0-85047836171
PubMed ID
Source
Biosensors
ISSN of the container
20796374
Sources of information: Directorio de Producción Científica Scopus