University of Leicester
Browse
Diabetes Obesity Metabolism - 2022 - Pemberton - CGM accuracy Contrasting CE marking with the governmental controls of the.pdf (1007.41 kB)

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

Download (1007.41 kB)
journal contribution
posted on 2023-02-10, 16:48 authored by John S Pemberton, Emma G Wilmot, Katharine Barnard-Kelly, Lalantha Leelarathna, Nick Oliver, Tabitha Randell, Craig E Taplin, Pratik Choudhary, Peter Adolfsson
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 United Kingdom (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 minimised 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. This article is protected by copyright. All rights reserved.

History

Author affiliation

Leicester Diabetes Research Centre, University of Leicester

Version

  • AM (Accepted Manuscript)

Published in

Diabetes, obesity & metabolism

Publisher

Wiley

issn

1462-8902

eissn

1463-1326

Copyright date

2023

Available date

2023-12-30

Spatial coverage

England

Language

eng

Usage metrics

    University of Leicester Publications

    Categories

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC