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

• The integration of Accu-Chek SmartGuide's AI-enabled predictive CGM with the popular mySugr app delivers a simple, intuitive solution for people to manage their diabetes with greater ease.
• Accu-Chek SmartGuide is now available in 13 countries, with plans to accelerate access to over 30 countries across Europe, Latin America and Asia-Pacific by year-end.
• Real-world evidence from rollout and clinical perspectives presented at the European Association for the Study of Diabetes (EASD) Annual Meeting.

BASEL, Switzerland, Sept. 16, 2025 /PRNewswire/ -- 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,³ yet a significant proportion of people living with diabetes still do not meet glycaemic targets - even when using a CGM system.⁴ 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.⁶

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.

References

1. Ehrmann D et al., 2025: Improvements in Glycemic Control With a Digital Diabetes Logbook. Journal of Medical Internet Research Vol 27 (2025): https://www.jmir.org/2025/1/e68933/
2. Ehrmann D et al., 2024: Efficacy of a Digital Diabetes Logbook. Journal of Diabetes Science and Technology. doi:10.1177/19322968241239870
3. Carlson AL, et al., Diabetes Technol Ther., 2017 May;19(S2):S4-S11. doi: 10.1089/dia.2017.0024
4. DeSalvo DJ, et al., Journal of Diabetes Science and Technology. 2023;17(2):322-328
5. Parkes Error Grid - a tool to evaluate the accuracy of glucose monitoring systems (BGM and CGM)
6. Mader, J. K. et al., 1924-LB: Clinical Performance of a Novel CGM System. Diabetes 14 June 2024; 73 (Supplement_1): https://doi.org/10.2337/db24-1924-LB / Roche Data on file
7. Data on file, Roche Diabetes Care GmbH, 2025

About the Accu-Chek SmartGuide CGM solution
Accu-Chek SmartGuide is a continuous glucose monitoring (CGM) solution providing accurate real-time glucose readings and AI-enabled predictions for different timeframes. The current version of the solution includes three elements: the Accu-Chek SmartGuide CGM sensor, the Accu-Chek SmartGuide App and the Accu-Chek SmartGuide Predict App. With an all-in-one applicator and 14-day wear time, Accu-Chek SmartGuide is designed for people living with diabetes type 1 and type 2, 18 years of age and older. It aims at empowering people living with diabetes to be prepared for the future course of glucose levels and take preventive action by making the appropriate therapy adjustments in good time.

The Accu-Chek SmartGuide CGM solution seamlessly integrates with the Accu-Chek^® Care platform, offering healthcare professionals (HCP) access to comprehensive and accurate therapy-relevant data provided by the CGM solution. This integration allows HCPs to analyse together with their patients how lifestyle and therapy impact their glucose levels and make more informed decisions. Such personalised care can lead to improved outcomes.³

About mySugr
Founded in 2012 by people with diabetes for people with diabetes, the mySugr^® application supports people with diabetes by delivering a user-centric digital health solution that empowers users to take control of their daily therapy. As part of Roche since 2017, mySugr combines seamless data tracking—covering blood sugar levels, insulin use, meals, activity and more in the mySugr Logbook—with valuable tools like the mySugr Bolus Calculator to support accurate insulin dosing.

Available in over 84 countries and 25 languages, mySugr has more than 6 million registered accounts and an average user rating of 4.6 stars in app stores. The mySugr Logbook allows for data import from a range of devices including blood glucose meters and smart insulin pens, as well as health platforms. It has shown a reduction in severe hypo- and hyperglycaemic episodes¹ as well as an improvement in diabetes distress after 3 months². Data reports can be generated in the app to be used for discussion with healthcare providers.

About Roche 
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Media Relations
Justine Grosvenor
Phone: +41 79 567 96 33 / e-mail: justine.grosvenor@roche.com

Logo - https://mma.prnewswire.com/media/2339048/Roche_Logo.jpg