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SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced the launch of updated t:slim X2™ insulin pump software with Dexcom G7 Continuous Glucose Monitoring (CGM) integration in the United States. Tandem’s #1-rated automated insulin delivery (AID) system* with Control-IQ technology is the only AID option in the world today to use Dexcom’s latest CGM technology..
圣地亚哥--(商业新闻短讯)--领先的胰岛素输送和糖尿病技术公司Tandem Diabetes Care,Inc.(纳斯达克:TNDM)今天宣布推出更新的t:slim X2™在美国集成了Dexcom G7连续血糖监测(CGM)的胰岛素泵软件。Tandem的#1级自动胰岛素输送(AID)系统*采用Control-IQ技术,是当今世界上唯一使用Dexcom最新CGM技术的AID选项。。
Tandem will email instructions to all in-warranty t:slim X2 users in the United States to offer the option to add the new feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software are now shipping to new customers.
Tandem将通过电子邮件向美国所有保修期内的t:slim X2用户发送说明,以提供通过远程软件更新免费添加新功能的选项。t: 预装有更新软件的slim X2泵现在正在向新客户发货。
“With this launch we are offering more than 300,000 current t:slim X2 users the ability to integrate with Dexcom’s most advanced CGM technology, demonstrating our commitment to continued leadership in advancing AID systems,” said John Sheridan, president and chief executive officer of Tandem Diabetes Care.
Tandem Diabetes Care总裁兼首席执行官约翰·谢里丹(JohnSheridan)表示:“通过此次发布,我们将为超过30万名当前t:slim X2用户提供与Dexcom最先进的CGM技术集成的能力,表明我们致力于在推进援助系统方面继续保持领先地位。”。
“As we celebrate our 10-year partnership with Dexcom, we remain committed to sustaining our rapid pace of innovation to further our mission of helping improve the lives of people with diabetes.”.
“在我们庆祝与Dexcom合作10年之际,我们仍然致力于保持快速的创新步伐,以进一步推动我们帮助改善糖尿病患者生活的使命。”。
With the integration of Dexcom G7, t:slim X2 insulin pump users can now:
通过集成Dexcom G7,t:slim X2胰岛素泵用户现在可以:
Spend more time in closed loop with little to no wait time between Dexcom G7 CGM sensor sessions.**
在Dexcom G7 CGM传感器会话之间花费更多时间进行闭环,几乎没有等待时间**
Use either a Dexcom G6 or Dexcom G7 CGM sensor, allowing even more choice in their diabetes management.
使用Dexcom G6或Dexcom G7 CGM传感器,可以在糖尿病管理中提供更多选择。
Dexcom G7, which is 60 percent smaller than its Dexcom G6 predecessor, offers a range of new features, including:
Dexcom G7比其Dexcom G6的前身小60%,它提供了一系列新功能,包括:
Improved accuracy***
提高了准确性***
A 30-minute sensor warmup time, compared to 2 hours previously
传感器预热时间为30分钟,而之前为2小时
A 12-hour grace period to replace finished sensors for a more seamless transition between sessions and flexibility for when to change sensors
12小时宽限期,用于更换已完成的传感器,以便在会话之间实现更无缝的过渡,并灵活地更换传感器
“The Dexcom G7 and t:slim X2 insulin pump integration is the culmination of years of partnership and a shared commitment to improve the lives of people with diabetes,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “We’re excited to bring our newest technology to Tandem users so they can experience the benefits of the smallest, most accurate, easy to use CGM connected to AID systems.”.
Dexcom执行副总裁兼首席运营官杰克·利奇(JakeLeach)表示:“Dexcom G7和t:slim X2胰岛素泵的整合是多年合作的结晶,也是改善糖尿病患者生活的共同承诺。”。“我们很高兴能将我们的最新技术带给Tandem用户,这样他们就可以体验到与AID系统相连的最小、最准确、易于使用的CGM的好处。”。
For additional product and safety information, or to begin the order process for a new Tandem pump with Dexcom G7 integration, visit tandemdiabetes.com/products.
有关其他产品和安全信息,或要开始使用Dexcom G7集成的新串联泵的订购流程,请访问tandemdeties.com/products。
Information about the software update process for existing in-warranty pump users, including system requirements, is available at tandemdiabetes.com/G7update.
有关现有保修期内泵用户的软件更新过程的信息,包括系统要求,请访问tandemdeabetes.com/G7update。
The t:slim X2 pump with Dexcom G7 integration is expected to launch in additional countries outside the U.S. in early 2024.
带有Dexcom G7集成的t:slim X2泵预计将于2024年初在美国以外的其他国家推出。
* dQ&A US Q1 2023 Diabetes Connections Patient Panel Report
*dQ&A美国2023年第1季度糖尿病联系患者小组报告
** No wait time claim based on user inserting a new, unpaired Dexcom G7 at least 30 minutes before the old, paired Dexcom G7 sensor expires. See User Guide for more details on the sensor start process.
**无等待时间声明基于用户在旧的成对Dexcom G7传感器过期前至少30分钟插入新的未配对Dexcom G7。有关传感器启动过程的更多详细信息,请参阅《用户指南》。
*** Dexcom, data on file, 2022.
***Dexcom,档案数据,2022年。
About Tandem Diabetes Care, Inc.
关于Tandem Diabetes Care,Inc。
Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin.
Tandem Diabetes Care,Inc.,一家总部位于加利福尼亚州圣地亚哥的全球胰岛素输送和糖尿病技术公司,通过积极不同的体验,为糖尿病患者及其亲人和医疗保健提供者创造了新的可能性。该公司以人为中心的设计、开发和支持方法为胰岛素使用者提供创新的产品和服务。
Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com..
Tandem生产并销售具有Control-IQ技术的t:slim X2胰岛素泵。有关更多信息,请访问tandemdiabetes.com。。
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2 and #TandemDiabetes.
关注Twitter@tandemdiabetes上的串联糖尿病护理;使用#tslimX2和#TandemDiabetes。
Follow Tandem Diabetes Care on Facebook at facebook.com/TandemDiabetes.
关注Facebook上的Tandem Diabetes Care,网址为Facebook.com/TandemDiabetes。
Follow Tandem Diabetes Care on LinkedIn at linkedin.com/company/tandemdiabetes.
关注LinkedIn上的串联糖尿病护理,网址为LinkedIn.com/company/tandemdeties。
Forward-looking Statements
前瞻性声明
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated timing for the international availability of the t:slim X2 pump with Dexcom G7 integration as well as our ability to provide the software update for current t:slim X2 pump users and the t:slim X2 pumps pre-loaded with Dexcom G7 integration software.
本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的“前瞻性声明”。除其他外,这些前瞻性陈述涉及到具有Dexcom G7集成的t:slim X2泵在国际上的预期可用时间,以及我们为当前t:slim X2泵用户和预装有Dexcom G7集成软件的t:slim X2泵提供软件更新的能力。
These statements are subject to numerous risks and uncertainties, including our ability to start commercial scale manufacturing of the t:slim X2 pumps pre-loaded with Dexcom G7 integration software, our ability to operate and maintain a system to facilitate online training for existing t:slim X2 pump customers upgrading their existing devices, and the risk that we may encounter other challenges that may delay the availability of t:slim X2 pumps pre-loaded with Dexcom G7 integration software.
这些声明受到许多风险和不确定性的影响,包括我们开始商业规模生产预装Dexcom G7集成软件的t:slim X2泵的能力,我们操作和维护系统以促进现有t:slim X2泵客户升级其现有设备的在线培训的能力,以及我们可能遇到其他挑战的风险,这些挑战可能会延迟预装Dexcom G7集成软件的t:slim X2泵的可用性。
These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.
这些风险和其他风险在我们最新的10-K表年度报告、10-Q表季度报告以及向美国证券交易委员会提交的其他文件的“风险因素”标题下进行了更详细的识别和描述。提醒读者不要过度依赖这些前瞻性声明,这些声明仅在本发布之日起生效。
Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors..
实际结果可能与前瞻性声明中的预期或预测结果存在重大差异。由于新信息、未来事件或其他因素,Tandem没有义务更新或审查本新闻稿中的任何前瞻性声明。。
Responsible use of Control-IQ technology
负责任地使用控制智商技术
Control-IQ technology does not prevent all highs and lows. Users must still bolus for meals and actively manage their diabetes. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
控制智商技术并不能阻止所有的高低。用户仍然必须在用餐时推注,并积极管理他们的糖尿病。有关其他重要的安全信息,请访问tandemdeabetes.com/safetyinfo。
Important Safety Information: RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin.
重要安全信息:仅限RX。t:slim X2泵和Control IQ技术适用于单个患者。t:slim X2泵和Control IQ技术适用于NovoLog或Humalog U-100胰岛素。t: slim X2胰岛素泵:具有可互操作技术的t:slim X2胰岛素泵旨在以固定和可变速率皮下输送胰岛素,用于治疗需要胰岛素的人的糖尿病。
The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals 6 years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.
该泵能够与兼容的数字连接设备(包括自动胰岛素给药软件)可靠安全地通信,以接收、执行和确认来自这些设备的命令。该泵适用于6岁及以上的个人。Control-IQ技术:Control-IQ技术旨在与兼容的集成连续血糖监测仪(iCGM,单独出售)和替代控制器启用(ACE)泵一起使用,以根据iCGM读数和预测的葡萄糖值自动增加,减少和暂停基础胰岛素的输送。
It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 6 years of age and greater..
当预测葡萄糖值超过预定阈值时,它还可以提供校正推注。Control-IQ技术旨在管理6岁及以上人群的1型糖尿病。。
WARNING: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.
警告:6岁以下的人不应使用Control IQ技术。它也不应该用于每天需要少于10单位胰岛素或体重低于55磅的患者。
Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of the t:slim X2 pump and Control-IQ technology must: use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders.
控制智商技术不适用于孕妇、透析患者或重症患者。如果使用羟基脲,请勿使用Control-IQ技术。t:slim X2泵和Control IQ技术的用户必须:根据各自的使用说明使用胰岛素泵、CGM和所有其他系统组件;按照医疗保健提供者的建议测试血糖水平;展示足够的碳水化合物计数技能;保持足够的糖尿病自我护理技能;定期咨询医疗保健提供者;并具有足够的视觉和/或听觉来识别泵的所有功能,包括警报、警报和提醒。
The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information..
在MRI、CT或透热治疗之前,必须拆除t:slim X2泵。有关其他重要的安全信息,请访问tandemdeabetes.com/safetyinfo。。
© 2023 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners..
©2023 Tandem Diabetes Care,Inc.保留所有权利。Tandem Diabetes Care、Tandem徽标、Control IQ和t:slim X2是Tandem Diabetes Care,Inc.在美国和/或其他国家/地区的注册商标或商标。所有第三方标记均为其各自所有者的财产。。