Roche bags CE Mark for Accu-Chek SmartGuide CGM solution

Roche has announced a significant advancement in diabetes management with the CE Mark approval of its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This approval paves the way for the deployment of this cutting-edge technology to adults over the age of 18 who are managing their diabetes with flexible insulin therapy.

The Accu-Chek SmartGuide CGM solution is set to transform how individuals with type 1 and type 2 diabetes monitor and manage their glucose levels. Roche Diagnostics CEO, Matt Sause, highlighted the daily challenges those with diabetes face, which can include making up to 180 therapy decisions. The new CGM system utilizes predictive algorithms designed to empower users, enabling them to proactively manage their condition, reduce diabetes-related anxiety, and improve their overall quality of life.

The Accu-Chek SmartGuide system works by sending real-time glucose measurements every five minutes to the Accu-Chek SmartGuide app. These measurements are analyzed by the Accu-Chek SmartGuide Predict app, which uses AI-enabled predictive algorithms to forecast future glucose levels and potential hypoglycemic events within the next 30 minutes and up to two hours ahead. This predictive capability is critical for preventing severe hypoglycemic episodes that may require medical intervention, which average sufferers experience twice weekly.

Clinical evaluations of the Accu-Chek SmartGuide CGM system have shown high accuracy, with an overall mean absolute relative difference (MARD) of 9.2% and 99.8% of glucose values falling within the clinically acceptable zones A and B of the Parkes Error Grid. The system includes a sensor with a 14-day wear time and an all-in-one applicator, designed to simplify the user experience for those managing diabetes.

The Accu-Chek SmartGuide solution is also integrated with the Accu-Chek Care platform, which offers healthcare professionals access to detailed, therapy-relevant data. This integration allows for a more nuanced analysis of how lifestyle changes and therapy adjustments impact glucose levels, facilitating more informed decision-making and personalized care strategies, potentially leading to better health outcomes.

With its predictive features and user-friendly design, the Accu-Chek SmartGuide CGM solution stands to significantly influence the future of diabetes care. By providing a tool that not only tracks glucose levels but also predicts and prevents adverse events, Roche is leading the way in the development of technologies that support both patients and healthcare providers in managing chronic conditions more effectively.

As Roche continues to roll out this technology to markets requiring CE Mark approval, the potential for improved diabetes management on a global scale grows, marking a pivotal moment in the ongoing battle against the diabetes epidemic.