Roche, a prominent diabetes technology company based in Basel, Switzerland, has achieved a significant milestone by securing the CE mark for the integration of its Accu-Chek SmartGuide CGM with the mySugr app. This announcement was made at the prestigious European Association for the Study of Diabetes (EASD) annual meeting held in Vienna, Austria.
The Accu-Chek SmartGuide, initially introduced at the 2024 Advanced Technologies & Treatments for Diabetes (ATTD) conference, incorporates predictive AI technology. This AI-powered CGM system, which obtained the CE mark in July 2024, is designed to enhance glycemic control by leveraging predictive algorithms based on real-time glucose data to offer insights that can mitigate the risks of hypoglycemia and hyperglycemia.
The integration of Roche’s Accu-Chek SmartGuide CGM with the mySugr diabetes management app provides users with improved access to AI-driven predictive CGM capabilities. By consolidating CGM glucose values and predictions within the mySugr app, alongside features like meal logging, data visualization from connected devices, and insulin calculation assistance, users can streamline their diabetes management process effectively.
In a bid to expand the reach of this integrated solution, Roche plans to initiate the rollout in select countries later this year. Currently available in 13 countries, the Accu-Chek SmartGuide is set to be accessible in over 30 countries by the end of 2025, encompassing regions in Europe, Latin America, and the Asia-Pacific.
Rodrigo Diaz de Vivar, the lifecycle leader for patient insights at Roche Diagnostics, emphasized the significant advancement represented by the Accu-Chek SmartGuide CGM solution. By merging predictive CGM technology with the popular mySugr app, which boasts over 6 million registered accounts, Roche aims to empower individuals with diabetes to proactively manage their condition by visualizing and analyzing their therapy data conveniently in one place.
Roche’s presence at EASD 2025 showcased compelling clinical evidence supporting the accuracy and performance of its CGM system. The evaluations revealed an impressive mean absolute relative difference (MARD) of 9.2% and 99.8% of glucose values falling within clinically acceptable zones. Additionally, Roche highlighted the superior performance of its predictive features in terms of accuracy, sensitivity, specificity, and event detection.
Real-world data presented at EASD underscored the positive impact of Roche’s Predict app on reducing hypoglycemic events, particularly during the night. The implementation of Night Low Predict demonstrated a notable decrease in the risk of hypoglycemia, with a 20% reduction in Level 1 hypoglycemic events and a 31% decrease in Level 2 hypoglycemia risk. Importantly, there was no observed increase in nighttime hyperglycemic events, reflecting the system’s ability to support targeted self-management of diabetes.
Roche’s commitment to delivering comprehensive care for individuals with diabetes and cardiometabolic conditions was reiterated, emphasizing the company’s approach of addressing the interconnected biology of these diseases through a range of diagnostic, therapeutic, and digital solutions to enhance patient outcomes.
In conclusion, Roche’s achievement of the CE mark for its integrated CGM solution and the positive clinical data presented at EASD 2025 reaffirm the company’s dedication to advancing diabetes care through innovative technologies. The seamless integration of AI-driven predictive capabilities within the mySugr app signifies a significant leap towards empowering individuals with diabetes to make informed decisions and improve their quality of life.
- Roche’s CE mark for CGM integration with mySugr app enhances diabetes management
- Accu-Chek SmartGuide CGM demonstrates high accuracy and performance in clinical evaluations
- Real-world data shows significant reduction in hypoglycemic events with Roche’s Predict app
- Roche’s holistic approach aims to improve patient outcomes in diabetes and cardiometabolic diseases
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