Roche Gets EU Nod for AI-Enabled CGM System

Roche has gained CE mark clearance for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. It’s been cleared for adults with type 1 and type 2 diabetes on flexible insulin therapy.

The Accu-Chek SmartGuide CGM sensor sends glucose values every five minutes to an accompanying app. The Predict app then uses the glucose values and other info to detect patterns and predict future glucose levels.

Integrated artificial intelligence (AI)-enabled predictive algorithms can then indicate hypoglycemia risk in the next half hour, forecast how levels will develop in the next few hours, and estimate the risk of nocturnal hypoglycemia. The CGM solution aims to support self-management decisions and proactive intervention before glucose levels need immediate attention.

Accu-Chek SmartGuide has an all-in-one applicator and 14-day wear time. It includes three elements: the CGM sensor, app, and Predict app. The company said clinical evaluations demonstrated an overall mean absolute relative difference (MARD) of 9.2% and 99.8%.

“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,” said Matt Sause, CEO of Roche Diagnostics. “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.”