Roche gains CE Mark for AI glucose monitoring system for diabetes management
Betsy Goodfellow | July 9, 2024 | News story | Medical Communications | AI, Diabetes, Roche, diabetes, glucose monitoring
Roche has announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution.
This milestone should allow the solution to be available for use by patients with both type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy.
The Accu-Chek system measures glucose values in real time, sending these to the accompanying app every five minutes. The app then uses these values and any other available data to detect glucose patters and predict future glucose levels. The AI-enabled predictive algorithms can indicate any hypoglycaemia risk within the next half an hour, forecasting how glucose levels will develop over the next two hours, and estimating the risk of nocturnal hypoglycaemia.
According to the press release, ‘Clinical evaluations have demonstrated the new CGM solution’s high system accuracy, with an overall mean absolute relative difference (MARD) of 9.2% and 99.8% of measured glucose values falling within zones A and B on the Parkes Error Grid’, and all predictive features exceeded high performance requirements, for example accuracy, sensitivity, specificity and events detected.
Matt Sause, chief executive officer of Roche Diagnostics, commented: “Maintaining optimal blood glucose levels and preventing adverse glycaemic episodes remains a complex task for people living with diabetes, often necessitating up to 180 therapy decisions a day. Our novel CGM solution with its predictive algorithms will help address significant unmet needs associated with diabetes management, empowering users to take control of their condition and live better and healthier lives.”
Betsy Goodfellow
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