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What You Should Know:
你应该知道的:
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Dexcom
德康
, announced today that the U.S. Food and Drug Administration (FDA) has cleared the
,今天宣布美国食品和药物管理局 (FDA) 已批准
Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
德康G7 15天连续血糖监测(CGM)系统
for individuals over the age of 18 with diabetes.
适用于18岁以上患有糖尿病的个体。
– The Dexcom G7 15 Day system boasts an overall Mean Absolute Relative Difference (MARD) of 8.0% and builds upon the proven performance of Dexcom CGM technology, which has been clinically demonstrated to lower A1C, reduce hyper- and hypoglycemia, and increase time in range.
Dexcom G7 15天系统整体平均绝对相对差异(MARD)为8.0%,并且基于Dexcom CGM技术已被临床验证的性能,该技术能够降低A1C、减少高血糖和低血糖,并增加血糖在目标范围内的时间。
Dexcom G7 Features
Dexcom G7 特点
The Dexcom G7 15 Day system offers up to 15.5 days of wear allowing users to benefit from fewer monthly sensors and reduced monthly waste. The waterproof CGM system provides an overall MARD of 8.0%.
Dexcom G7 15天系统提供长达15.5天的使用时间,使用户能够减少每月传感器的更换次数和降低每月的废弃物。这款防水的CGM系统整体MARD值为8.0%。
Other key features of Dexcom G7 include:
Dexcom G7 的其他主要特点包括:
Apple Watch Connectivity:
Apple Watch 连接性:
Direct sensor connection to Apple Watch, allowing users to view glucose numbers without their iPhone.
直接传感器连接到 Apple Watch,允许用户在没有 iPhone 的情况下查看血糖数值。
Automated Logging:
自动日志记录:
Automated activity logging, simplified meal logging, and new medication logging to help users understand the impact of these factors on glucose levels.
自动活动记录、简化的饮食记录和新的药物记录,帮助用户了解这些因素对血糖水平的影响。
12-Hour Grace Period:
12小时宽限期:
A 12-hour grace period for sensor replacement, ensuring a smoother transition between sessions.
传感器更换享有 12 小时的宽限期,确保会话之间的过渡更加顺畅。
Mobile App with Dexcom Clarity:
使用Dexcom Clarity的移动应用:
An innovative and user-friendly mobile app with Dexcom Clarity integration for easy viewing of glucose patterns, trends, and statistics through interactive reports.
一款创新且用户友好的移动应用程序,集成了Dexcom Clarity功能,可通过交互式报告轻松查看血糖模式、趋势和统计数据。
Remote Glucose Sharing:
远程血糖共享:
Ability to remotely share glucose numbers with caregivers and loved ones.
能够远程与护理人员和亲人分享血糖数值。
Customizable Alerts:
可定制的警报:
Enhanced and customizable alert settings.
增强且可定制的警报设置。
“The approval of Dexcom G7 15 Day marks another major innovation for Dexcom,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “By listening to the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology.
“德康G7 15天的获批标志着德康另一项重大创新,”德康执行副总裁兼首席运营官杰克·里奇表示。“通过倾听用户的需求,我们很自豪能够提供使用寿命最长、最精准的可穿戴连续血糖监测系统(CGM),让人们借助我们业界领先的技术更好地掌控糖尿病。”
This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing. We look forward to bringing it to market in the second half of this year, but in the meantime, we encourage our users to upgrade to our current G7 system to gain the benefits of the most connected CGM brand in the world.”.
这一里程碑为CGM树立了新标准,证明了我们在葡萄糖生物传感领域的持续领导地位。我们期待在今年下半年将其推向市场,但在此期间,我们鼓励用户升级到我们目前的G7系统,以获得全球连接性最强的CGM品牌带来的优势。"
Dexcom is also working with insulin pump partners to ensure compatibility of Dexcom G7 15 Day with automated insulin delivery systems upon its launch.
Dexcom 还在与胰岛素泵合作伙伴共同努力,以确保 Dexcom G7 15 Day 在上市时与自动胰岛素输送系统的兼容性。
Availability
可用性
The Dexcom G7 15 Day is expected to launch in the U.S. in the second half of 2025.
Dexcom G7 15 Day 预计将在2025年下半年在美国上市。