CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review

Pemberton, John S; Wilmot, Emma G; Barnard‐Kelly, Katharine; Leelarathna, Lalantha; Oliver, Nick; Randell, Tabitha; Taplin, Craig E; Choudhary, Pratik; Adolfsson, Peter

Abstract

The National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. Manufacturers can trade in the UK with Conformité Européenne (CE) marking without an initial national assessment. The regulatory process for CGM CE marking, in contrast to the Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) process, is described. Manufacturers operating in the UK provided clinical accuracy studies submitted for CE marking. Critical appraisal of the studies shows several CGM devices have CE marking for wide-ranging indications beyond available data, unlike FDA and TGA approval. The FDA and TGA use tighter controls, requiring comprehensive product-specific clinical data evaluation. In 2018, the FDA published the integrated CGM (iCGM) criteria permitting interoperability. Applying the iCGM criteria to clinical data provided by manufacturers trading in the UK identified several study protocols that minimized glucose variability, thereby improving CGM accuracy on all metrics. These results do not translate into real-life performance. Furthermore, for many CGM devices available in the UK, accuracy reported in the hypoglycaemic range is below iCGM standards, or measurement is absent. We offer a framework to evaluate CGM accuracy studies critically. The review concludes that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications can have discrepancies. The UK can bolster regulation with UK Conformity Assessed marking from January 2025. However, balanced regulation is needed to ensure innovation and timely technological access are not hindered.

• Journal Article Type: Article
• Acceptance Date: Dec 23, 2022
• Online Publication Date: Dec 30, 2022
• Publication Date: 2023-04
• Deposit Date: Feb 14, 2024
• Journal: Diabetes, Obesity and Metabolism
• Print ISSN: 1462-8902
• Electronic ISSN: 1463-1326
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 25
• Issue: 4
• Pages: 916-939
• DOI: https://doi.org/10.1111/dom.14962
• Keywords: Type 2 diabetes, Continuous Glucose monitoring (CGM), Accuracy, CE marking, Type 1 diabetes
• Public URL: https://nottingham-repository.worktribe.com/output/16216126
• Publisher URL: https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.14962