Roche nets European approval for AI-powered CGM in Type 1, Type 2 diabetes

Roche has secured an approval in Europe for its artificial-intelligence-powered continuous glucose monitoring system with a green light for adults with Type 1 or Type 2 diabetes that rely on real-time readings to adjust their insulin doses.

The Accu-Chek SmartGuide system includes three components: the wearable sensor, which logs blood sugar levels every five minutes for up to 14 days, and two separate smartphone apps for recording data and predicting highs, lows and changes over time. 

“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,” Roche Diagnostics CEO Matt Sause said in a statement. “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.”

The CE mark approval comes just a few months after Roche raised the curtain on the system this past March at the International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy. 

There, the company presented sensor accuracy data demonstrating an overall mean absolute relative difference, or MARD, of 9.2% in a study of 48 participants compared to a standard blood sugar tracker. 

At the same time, the Accu-Chek SmartGuide’s AI algorithms are designed to forecast glucose level changes up to two hours into the future as well as alert the user to the risk of developing dangerously low blood sugar within 30 minutes or potentially overnight as they sleep.

Roche said it plans to launch the system in select European markets in the coming months.