The Basel, Switzerland-based company — one of the largest diabetes tech companies in the world — announced the milestone, along with new real-world evidence for its continuous glucose monitoring (CGM) solution, at the European Association for the Study of Diabetes (EASD) annual meeting in Vienna, Austria.
Roche first unveiled its Accu-Chek SmartGuide in an event at the 2024 Advanced Technologies & Treatments for Diabetes (ATTD) conference. It won CE mark for the AI-powered CGM in July 2024. With the Predict app, users can better manage their glycemic control. It uses predictive algorithms informed by real-time glucose values and delivers insights to reduce the risk of hypoglycemia or hyperglycemia.
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The AI features help provide actionable information, utilizing real-time CGM sensor data and user-entered information. It has three key predictive functionalities that show state-of-the-art accuracy and performance.
Now, the system’s integration with the mySugr diabetes management app delivers more access to AI-enabled predictive CGM. Users can view and analyze CGM glucose values and predictions in one place, alongside other mySugr app functionalities. Those include taking photos of and logging meals in the app to better understand blood glucose level patterns, seeing data from other connected devices and using the mySugr bolus calculator to help with insulin calculations.
Roche plans to begin its rollout of this integration in the first available countries later this year. It currently offers Accu-Chek SmartGuide in 13 countries and plans to make it available in more than 30 countries by the end of 2025. That expansion includes Europe, Latin America and Asia-Pacific.
“The Accu-Chek SmartGuide CGM solution is a significant step towards providing greater peace of mind for people living with diabetes, due to the AI-enabled predictive capabilities it offers. This empowers patients to take action before undesired events occur,” said Rodrigo Diaz de Vivar, lifecycle leader, patient insights, Roche Diagnostics. “By bringing together our Accu-Chek SmartGuide solution with mySugr, we are combining our predictive CGM technology with one of the world’s most popular diabetes management apps that has more than 6 million registered accounts. This integration offers a comprehensive tool that simplifies daily decision-making by visualising and analysing all their therapy data in one place.”
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Roche said that clinical evaluations demonstrated its system’s high accuracy, with an overall mean absolute relative difference (MARD) of 9.2% and 99.8% of measured glucose values falling within zones A and B on the Parkes Error Grid.
All predictive features exceeded high performance requirements, such as accuracy, sensitivity, specificity and events detected, Roche said.
Further real-world evidence presented at EASD highlighted the company’s Predict app users and the clinical effect of Night Low Predict use. This feature led to a significant reduction in the risk of hypoglycemic events and time below range overnight. Specifically, it reduced the likelihood of Level 1 hypoglycaemic events by 20%.
Roche said the tool demonstrated a strong protective effect against more severe events, lowering the risk of Level 2 hypoglycaemia by 31%. The analysis also showed no increase in hyperglycemic events at night, delivering proactive, targeted self-management of diabetes.
“Roche is focused on providing holistic care to people living with diabetes and other cardiometabolic diseases, aiming to target the underlying, interconnected biology of these conditions, with a suite of diagnostic, therapeutic and digital solutions that improve patient outcomes,” the company said.
