Roche has gained CE mark clearance for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. It’s been cleared for adults with type 1 and type 2 diabetes on flexible insulin therapy.

罗氏公司的Accu-Chek SmartGuide连续血糖监测（CGM）解决方案已获得CE标志许可。对于患有1型和2型糖尿病的成年人来说，灵活的胰岛素治疗已经被清除。

The Accu-Chek SmartGuide CGM sensor sends glucose values every five minutes to an accompanying app. The Predict app then uses the glucose values and other info to detect patterns and predict future glucose levels.

Accu-Chek SmartGuide CGM传感器每五分钟向附带的应用程序发送一次血糖值。Predict应用程序然后使用葡萄糖值和其他信息来检测模式并预测未来的葡萄糖水平。

Integrated artificial intelligence (AI)-enabled predictive algorithms can then indicate hypoglycemia risk in the next half hour, forecast how levels will develop in the next few hours, and estimate the risk of nocturnal hypoglycemia. The CGM solution aims to support self-management decisions and proactive intervention before glucose levels need immediate attention..

集成人工智能（AI）的预测算法可以指示未来半小时内的低血糖风险，预测未来几个小时内血糖水平的发展，并估计夜间低血糖的风险。CGM解决方案旨在在血糖水平需要立即关注之前支持自我管理决策和主动干预。。

Accu-Chek SmartGuide has an all-in-one applicator and 14-day wear time. It includes three elements: the CGM sensor, app, and Predict app. The company said clinical evaluations demonstrated an overall mean absolute relative difference (MARD) of 9.2% and 99.8%.

Accu-Chek SmartGuide具有多功能治疗探头和14天的磨损时间。它包括三个要素：CGM传感器、应用程序和预测应用程序。该公司表示，临床评估显示总体平均绝对相对差异（MARD）为9.2%和99.8%。

“Maintaining optimal blood glucose levels and preventing adverse glycaemic episodes remains a complex task for people living with diabetes, often necessitating up to 180 therapy decisions a day,” said Matt Sause, CEO of Roche Diagnostics. “Our novel CGM solution with its predictive algorithms will help address significant unmet needs associated with diabetes management, empowering users to take control of their condition and live better and healthier lives.”.

罗氏诊断公司首席执行官马特·索斯（MattSause）说：“维持最佳血糖水平和预防不良血糖发作对于糖尿病患者来说仍然是一项复杂的任务，通常每天需要多达180个治疗决定。”。“我们新颖的CGM解决方案及其预测算法将有助于解决与糖尿病管理相关的重大未满足需求，使用户能够控制自己的病情，过上更好、更健康的生活。”。