Roche has secured the CE Mark for its Accu-Chek SmartGuide, an AI-enabled continuous glucose monitoring (CGM) solution.

This approval enables the device to be available for adults with type 1 and type 2 diabetes on flexible insulin therapy.

The Accu-Chek SmartGuide CGM solution delivers 14 days of real-time glucose values to boost proactive intervention and diabetes management.

The CGM sensor transmits glucose readings to the accompanying app every five minutes.

The Accu-Chek SmartGuide Predict app then uses these readings, along with other data, to identify glucose patterns and forecast future levels.

Its AI algorithms can predict hypoglycaemia within the next 30 minutes, forecast glucose trends for the following two hours, and assess the risk of nocturnal hypoglycaemia.

Roche's latest CGM solution is designed to reduce concerns about nighttime hypoglycaemia for both individuals with diabetes and their caregivers.

It supports informed self-management decisions, allowing for proactive measures before glucose levels become critical.

Clinical evaluations confirmed the high accuracy of the new CGM solution, with a mean absolute relative difference (MARD) of 9.2% and 99.8% of glucose values within the acceptable range on the Parkes Error Grid.

The predictive capabilities of the Accu-Chek SmartGuide have been evaluated, demonstrating that all advanced predictive features meet high-performance standards, including accuracy, sensitivity, specificity, and event detection.

The solution is expected to launch in selected European markets in the upcoming months.

Roche Diagnostics CEO Matt Sause said: “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.”

Last month, the company launched an in vitro diagnostic assay, Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries that accept the CE mark.