Summary
The National Institute for Clinical Excellence (NICE) updated their guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. This review in the journal Diabetes, Obesity and Metabolism aimed to compare regulatory standards for CGM in the UK and Europe, with those applied in the USA by the Food and Drug Administration (FDA) and in Australia by the Australian Therapeutic Goods Administration (TGA). It describes the processes in place and highlights that the criteria applied in the UK for assessing accuracy do not translate into real-life performance.
The authors offer a framework to evaluate CGM accuracy studies critically and conclude that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications applied in the EU can have discrepancies. They argue that the UK can bolster regulation, but that this need to be balanced to ensure that innovation and timely access to technology for people with type 1 diabetes are not hindered.
0 Comments
Recommended Comments
There are no comments to display.
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now