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罗氏获得CE认证,推出Accu-Chek SmartGuide连续血糖监测和mySugr应用集成

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

AHHM 等信源发布 2025-09-17 15:22

可切换为仅中文


Roche 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..

罗氏公司在欧洲糖尿病研究协会(EASD)年会上分享了Accu-Chek SmartGuide持续血糖监测(CGM)解决方案推广的真实世界证据,并宣布其与mySugr糖尿病管理应用程序的整合,首次为更多糖尿病患者提供了一个启用人工智能的预测解决方案。

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.

2012年,mySugr应用程序最初由糖尿病患者为糖尿病患者在奥地利维也纳推出,如今该应用已在全球超过84个国家和地区以及25种语言中使用,帮助用户管理关键的治疗数据。mySugr血糖洞察(mySugr Glucose Insights)与Accu-Chek SmartGuide整合,并于近期获得了CE标志批准,预计将在今年晚些时候在部分国家率先推出。

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.

用户可以在一处查看和分析他们的CGM血糖值和预测,同时还可以使用mySugr应用的其他功能,例如在应用中拍摄和记录餐食照片以更好地了解血糖水平模式,查看来自其他连接设备的数据,以及使用mySugr胰岛素计算器来帮助进行胰岛素计算。

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..

使用mySugr Logbook明显减少了严重低血糖和高血糖发作次数,并在三个月后改善了糖尿病困扰。这一努力基于罗氏致力于满足糖尿病患者不断变化的需求。

'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.

“Accu-Chek SmartGuide CGM 解决方案因其提供的人工智能预测功能,为糖尿病患者带来了更大的安心,这是向前迈出的重要一步。它使患者能够在不良事件发生之前采取行动,”罗氏诊断生命周期负责人 Rodrigo Diaz de Vivar 表示。

'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.'.

“通过将我们的Accu-Chek SmartGuide解决方案与mySugr相结合,我们正在将我们的预测性CGM技术与全球最受欢迎的糖尿病管理应用之一结合起来,该应用拥有超过600万注册用户。此次整合提供了一个全面的工具,通过在一个地方可视化并分析所有治疗数据,简化了日常决策。”

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.

CGM技术正逐渐成为全球糖尿病护理的标准,但即使使用CGM系统,仍有相当一部分糖尿病患者未能达到血糖控制目标。Accu-Chek SmartGuide CGM解决方案是首款支持人工智能的CGM系统,能够预测未来长达两小时的血糖水平,并在夜间提供最长七小时的预测。

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..

这些预测功能赋予糖尿病患者更多的自主管理能力,并进一步支持他们积极管理糖尿病,使他们能够在并发症出现之前采取预防措施。

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.

谢菲尔德教学医院糖尿病临床负责人杰基·艾略特博士表示:“糖尿病患者的生活就像一场持续的平衡行动。他们需要的不仅是提供数据的解决方案,还要能够让他们自信、轻松地理解这些数据。预测性工具提供个性化的见解以及可靠、情境感知的警报,能让患者拥有更多的掌控力和安心感。”

By focusing on predictability and personalisation, we can help people navigate life with diabetes more seamlessly and with less worry.'.

通过关注可预测性和个性化,我们可以帮助糖尿病患者更无缝地、更少担忧地管理生活。

Clinical relevance

临床相关性

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.

临床评估表明,该解决方案具有高系统准确性,整体平均绝对相对差异(MARD)为9.2%,且99.8%的测量血糖值落在Parkes误差网格的A区和B区内。对预测能力的评估显示,所有高级预测功能均超过了高性能要求,例如:

accuracy, sensitivity, specificity, and events detected.6.

准确性、敏感性、特异性和检测到的事件。

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..

在9月15日星期一的EASD罗氏研讨会上,展示了来自Accu-Chek SmartGuide CGM推广的更多真实世界证据,以及临床视角和患者对预测糖尿病技术的需求。在研讨会期间,罗氏分享了Accu-Chek SmartGuide Predict应用用户的真实数据,涉及夜间低血糖预测使用的临床效果。

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.

在此分析中,使用 Night Low Predict 与显著降低夜间低血糖事件风险和低于目标范围时间相关。具体而言,它将发生 1 级低血糖事件的可能性降低了 20%。该工具还显示出对更严重事件的强大保护作用,将 2 级低血糖的风险降低了 31%。

Importantly, the analysis showed no increase in hyperglycaemic events at night, offering valuable support for proactive, targeted self-management of diabetes..

重要的是,分析显示夜间高血糖事件没有增加,为糖尿病的积极、有针对性的自我管理提供了宝贵的支持。

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.

自去年推出以来,Accu-Chek SmartGuide CGM已成功在13个国家上市,并计划到2025年底在欧洲、拉丁美洲和亚太地区覆盖超过30个国家。

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.

罗氏专注于为糖尿病和其他心代谢疾病患者提供整体护理,旨在针对这些疾病潜在的、相互关联的生物学机制,通过一系列诊断、治疗和数字解决方案改善患者的治疗效果。

References

参考文献

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/

Ehrmann D 等,2025:使用数字糖尿病记录本改善血糖控制。《医学互联网研究杂志》第 27 卷(2025):https://www.jmir.org/2025/1/e68933/

Ehrmann D et al., 2024: Efficacy of a Digital Diabetes Logbook. Journal of Diabetes Science and Technology. doi:10.1177/19322968241239870

Ehrmann D 等,2024:数字化糖尿病记录本的疗效。《糖尿病科学与技术杂志》。doi:10.1177/19322968241239870

Carlson AL, et al., Diabetes Technol Ther., 2017 May;19(S2):S4-S11. doi: 10.1089/dia.2017.0024

卡尔森 AL 等,《糖尿病技术与治疗》,2017年5月;19(S2):S4-S11。doi: 10.1089/dia.2017.0024

DeSalvo DJ, et al., Journal of Diabetes Science and Technology. 2023;17(2):322-328

德萨尔沃 DJ 等,《糖尿病科学与技术杂志》,2023年;第17卷第2期:322-328页

Parkes Error Grid - a tool to evaluate the accuracy of glucose monitoring systems (BGM and CGM)

帕克斯误差网格——一种用于评估血糖监测系统(BGM 和 CGM)准确性的工具

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

马德尔,J. K. 等人,1924-LB:一种新型CGM系统的临床表现。《糖尿病》2024年6月14日;73(增刊_1):https://doi.org/10.2337/db24-1924-LB / 罗氏数据存档

Data on file, Roche Diabetes Care GmbH, 2025

罗氏糖尿病护理有限公司,2025年,存档数据

About the Accu-Chek SmartGuide CGM solution

关于Accu-Chek SmartGuide CGM解决方案

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.

Accu-Chek SmartGuide 是一款连续血糖监测 (CGM) 解决方案,提供精确的实时血糖读数以及针对不同时段的人工智能预测功能。该解决方案的当前版本包含三个要素:Accu-Chek SmartGuide CGM 传感器、Accu-Chek SmartGuide 应用程序和 Accu-Chek SmartGuide 预测应用程序。

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..

Accu-Chek SmartGuide 配备一体化涂抹器,可佩戴14天,专为18岁及以上患有1型和2型糖尿病的人群设计。它旨在帮助糖尿病患者预测未来血糖水平的变化趋势,并通过及时进行适当的治疗调整采取预防措施。

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.

Accu-Chek SmartGuide CGM 解决方案与 Accu-Chek® Care 平台无缝集成,为医疗保健专业人员 (HCP) 提供由 CGM 解决方案生成的全面且准确的治疗相关数据。这种集成使医疗保健专业人员能够与患者一起分析生活方式和治疗对血糖水平的影响,从而做出更明智的决策。

Such personalised care can lead to improved outcomes.3.

这种个性化的护理可以改善结果。

About mySugr

关于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..

mySugr® 应用程序成立于2012年,由糖尿病患者为糖尿病患者创建,通过提供以用户为中心的数字健康解决方案来支持糖尿病患者,帮助用户掌控日常治疗。自2017年成为罗氏的一部分以来,mySugr 将无缝数据追踪——涵盖血糖水平、胰岛素使用、饮食、活动等记录在 mySugr 记录本中——与诸如 mySugr 胰岛素剂量计算器等实用工具相结合,以支持精确的胰岛素剂量计算。

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.

mySugr 已在超过 84 个国家和地区以及 25 种语言中可用,拥有超过 600 万注册账户,在应用商店中的平均用户评分为 4.6 星。mySugr 记录本支持从多种设备导入数据,包括血糖仪、智能胰岛素笔以及健康平台。

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..

它已经显示出在严重低血糖和高血糖发作方面的减少,以及在3个月后糖尿病困扰的改善。应用程序中可以生成数据报告,用于与医疗保健提供者讨论。

About Roche

关于罗氏

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.

罗氏公司成立于1896年,总部位于瑞士巴塞尔,是最早生产品牌药物的工业制造商之一。如今,罗氏已发展成为全球最大的生物技术公司,并在体外诊断领域处于全球领先地位。公司致力于科学卓越,通过发现和开发药物及诊断工具,改善和拯救世界各地人们的生命。

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..

我们是个性化医疗的先驱,希望进一步改变医疗服务的提供方式,以产生更大的影响。为了给每个人提供最好的护理,我们与许多利益相关者合作,将我们在诊断和制药领域的优势与临床实践中的数据洞察相结合。

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..

125 多年来,可持续发展一直是罗氏业务的重要组成部分。作为一家以科学为驱动的公司,我们对社会的最大贡献是开发创新药物和诊断技术,帮助人们过上更健康的生活。罗氏致力于基于科学的目标倡议和可持续市场倡议,到 2045 年实现净零排放。

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

基因泰克公司在美国是罗氏集团的全资成员。罗氏是日本中外制药公司的控股股东。