Work

Minimum expectations for market authorization of continuous glucose monitoring devices in Europe—‘ eCGM ’ compliance status

Year: 2024

Type: article

Abstract: Accurate determination of blood glucose concentrations is essential for daily diabetes management, for people with type 1 diabetes (T1D), type 2 diabetes (T2D) and gestational diabetes (GDM), in particular for those using insulin in their treatment.Capillary blood glucose meters (BGM) are the most common devices used for this purpose and typically measure glucose levels from whole blood following fingerpricking.1 However, the displayed test results actually reflect glucose concentrations in the plasma, which may be 10%-15% higher than in whole blood. 2 The accuracy of BGM systems is covered by ISO 15197:2013, which ensures they meet minimum specific design verification and performance validation standards.The use of BGM for measuring glucose levels for people with diabetes, especially T1D, is increasingly being replaced by continuous glucose monitoring (CGM) systems, which measure glucose levels in the interstitial fluid (ISF) and convert this reading into a close approximation of plasmaglucose levels, using advanced algorithms.The widespread use of CGM technology has been driven in the last decade, in part by the availability of affordable CGM systems with proven accuracy at least

Source: Diabetes Obesity and Metabolism

DOI: 10.1111/dom.16153