Roche announced that its Accu-Chek SmartGuide continuous glucose monitoring (CGM) system has received CE Mark for integration with the mySugr diabetes management app, creating an enhanced and intuitive solution for people living with diabetes. The announcement was made at the European Association for the Study of Diabetes (EASD) Annual Meeting, where Roche also presented new real-world evidence from the rollout of the Accu-Chek SmartGuide solution.

Accu-Chek SmartGuide is the first AI-enabled CGM capable of predicting glucose levels up to two hours ahead, and overnight for up to seven hours. This predictive technology empowers people with diabetes to take preventive action before complications arise, offering greater confidence and peace of mind in daily management.

The integration with mySugr enables users to view and analyze glucose values and predictive insights alongside other key functionalities, such as meal logging, data from connected devices, and the mySugr Bolus Calculator for insulin support. Initially launched in 2012 in Vienna by people with diabetes for people with diabetes, the mySugr app now serves more than six million registered users in over 84 countries and 25 languages. Clinical studies have shown that use of the mySugr Logbook is linked to fewer severe hypo- and hyperglycaemic events as well as reduced diabetes-related distress.

“By bringing together Accu-Chek SmartGuide with mySugr, we are combining our predictive CGM technology with one of the world’s most widely used diabetes management apps,” said Rodrigo Diaz de Vivar, Lifecycle Leader Patient Insights, Roche Diagnostics. “This integration provides a comprehensive tool that simplifies decision-making and gives people living with diabetes more control through meaningful, real-time insights.”

Clinical evaluations have confirmed the high accuracy of the Accu-Chek SmartGuide CGM, with a mean absolute relative difference (MARD) of 9.2 percent and 99.8 percent of values within the safe zones of the Parkes Error Grid. Predictive features have also demonstrated strong performance across accuracy, sensitivity, specificity, and event detection.

New real-world data presented at Roche’s EASD symposium highlighted the benefits of Night Low Predict, one of the system’s advanced features. Analysis showed a 20 percent reduction in the risk of Level 1 hypoglycaemic events and a 31 percent reduction in Level 2 events overnight, with no increase in hyperglycaemia. These findings underscore the potential of predictive technology to support safer and more proactive self-management.

Dr. Jackie Elliott, Clinical Lead for Diabetes at Sheffield Teaching Hospitals, noted: “Living with diabetes is a constant balancing act. Predictive tools that provide personalized insights and context-aware alarms can make a meaningful difference, offering people more confidence and freedom in their daily lives.”