Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices

Abstract

Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.

Maximal Glycemic Difference, the Possible Strongest Glycemic Variability Parameter to Predict Mortality in ICU Patients

“…The continuous blood glucose monitoring may provide more information about blood glucose variation and glucose complexity in critically ill patients [ 30 ]. However, the application of continuous blood glucose monitoring devices in the ICU still required more studies to verify their accuracy and validity [ 41 ]. So far, the conventional blood glucose monitoring every 4–6 h could be used instead of continuous monitoring.…”

Monitoring of Pediatric Type 1 Diabetes

“…Therefore, different studies have resulted in different MARD values for the same device (55). To date, head-to-head comparison of the accuracy of BGM and CGM systems has been limited due to differences in how these systems are assessed for accuracy (56) and at the present time there is no universally accepted protocol to compare the different devices to assess their accuracy.…”

“…The creation of the "integrated CGM" or iCGM distinction by the US Food and Drug Administration (FDA) in 2018 allowed for an approved CGM system to be used as part of an integrated system with other compatible medical devices and electronic interfaces. The increased demand for CGM accuracy and transparency required to receive this distinction may also pave the way for better CGM assessments in the future (56,57). Table 7 shows a comparison of the ISO and iCGM criteria.…”

“…Literature in this area is sparse and as the use of continuous glucose monitoring expands, further exploration of medications that may affect CGM accuracy will be important. (56).…”

Messwertunterschiede und Messgenauigkeit von Systemen zum kontinuierlichen Glukosemonitoring

“…Streng genommen wird dieser Plot nur den statischen Blutglukosemessungen gerecht, weil sich bei der interstitiellen Messung mit CGM physiologische Unterschiede ergeben, wenn sich die Glukosekonzentration rasch ändert. Der grün-umrandete Bereich umfasst die zu erwartenden Daten eines Blutglukosemessgerätes, der pinkfarbene Bereich die eines CGM-Systems (jeweils bei Patienten mit Typ-1-Diabetes)[18].…”