Roche receives CE Mark for Accu-Chek SmartGuide Continuous Glucose Monitoring and mySugr App integration, offering an enhanced diabetes management experienc

Original from: PR Newswire

Roche (SIX: RO, ROG; OTCQX: RHHBY) shared real-world evidence from the rollout of Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution at the European Association for the Study of Diabetes (EASD) annual meeting today, and announced its integration with the mySugr diabetes management app, providing many more people with diabetes access to an AI-enabled predictive solution for the first time.

Initially launched in 2012 in Vienna, Austria, by people with diabetes for people with diabetes, the mySugr app is today available in over 84 countries and 25 languages, enabling users to manage key therapy data. mySugr Glucose Insights, the Accu-Chek SmartGuide integration with the mySugr app, just received CE mark approval and is set to launch in the first countries later this year. Users can view and analyse their CGM glucose values and predictions in one place, alongside other mySugr app functionalities such as 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. The use of the mySugr Logbook has clearly shown a reduction in severe hypo- and hyperglycaemic episodes1 as well as an improvement in diabetes distress after three months.2 This effort builds on Roche's commitment to meet the evolving needs of people with diabetes.

"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."

CGM technology is increasingly being adopted as the standard of care for diabetes worldwide, yet a significant proportion of people living with diabetes still do not meet glycaemic targets - even when using a CGM system. The Accu-Chek SmartGuide CGM solution is the first AI-enabled CGM system that can predict glucose levels up to two hours ahead and overnight for up to seven hours. These predictive features empower and further support people with diabetes to proactively manage their diabetes, enabling them to take preventative action before a complication arises.

Dr Jackie Elliott, Clinical Lead for Diabetes at Sheffield Teaching Hospitals, said: "Living with diabetes is a constant balancing act. What people with diabetes need are solutions that don't just deliver data but also empower them to make sense of it with confidence and ease. Predictive tools that give personalised insights and trustworthy, context-aware alarms offer people more control and peace of mind. By focusing on predictability and personalisation, we can help people navigate life with diabetes more seamlessly and with less worry."

Clinical relevance

Clinical evaluations have demonstrated the solution's high system 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.5 The evaluation of the predictive capabilities showed that all advanced predictive features exceeded high performance requirements as e.g. accuracy, sensitivity, specificity, and events detected.

Further real-world evidence from the Accu-Chek SmartGuide CGM rollout, as well as clinical perspectives and patient calls for predictive diabetes technologies, was presented at a Roche symposium at EASD on Monday 15 September. During the symposium Roche shared real-world data from Accu-Chek SmartGuide Predict app users on the clinical effect of Night Low Predict use.

In this analysis, using Night Low Predict was linked to a significant reduction in the risk of hypoglycaemic events and time below range overnight. Specifically, it reduced the likelihood of Level 1 hypoglycaemic events by 20%. The tool also demonstrated a strong protective effect against more severe events, lowering the risk of Level 2 hypoglycaemia by 31%7. Importantly, the analysis showed no increase in hyperglycaemic events at night, offering valuable support for proactive, targeted self-management of diabetes.

Since its launch last year, the Accu-Chek SmartGuide CGM has been successfully rolled out in 13 countries, with access planned across more than 30 countries by the end of 2025 in Europe, Latin America, and Asia-Pacific.

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.

Source: Roche receives CE Mark for Accu-Chek SmartGuide Continuous Glucose Monitoring and mySugr App integration, offering an enhanced diabetes management experienc