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Tandem Diabetes Care's t:slim X2™胰岛素泵是首个与Abbott新型FreeStyle Libre®2 Plus传感器集成的自动胰岛素输送系统

Tandem Diabetes Care’s t:slim X2 ™ Insulin Pump is the First Automated Insulin Delivery System to Integrate with Abbott’s New FreeStyle Libre ® 2 Plus Sensor

businesswire 等信源发布 2024-01-08 19:59

可切换为仅中文


ABBOTT PARK, Ill. & SAN DIEGO--(BUSINESS WIRE)--Abbott (NYSE: ABT), the global health care company, and Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced that the t:slim X2 insulin pump with Control-IQ technology is the first automated insulin delivery (AID) system to integrate with the newly available FreeStyle Libre 2 Plus sensor, Abbott’s latest continuous glucose monitoring (CGM) technology.

伊利诺伊州雅培公园和圣地亚哥--(商业新闻短讯)--全球医疗保健公司雅培(纽约证券交易所:ABT)和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,具有Control-IQ技术的t:slim X2胰岛素泵是第一个与新推出的FreeStyle Libre 2 Plus传感器(雅培最新的连续血糖监测(CGM)技术)集成的自动胰岛素输送(AID)系统。

For the first time, FreeStyle Libre technology users in the United States are now able to experience the therapeutic benefits of a hybrid closed-loop system that helps predict and prevent high and low blood sugar..

美国的FreeStyle Libre技术用户现在首次能够体验混合闭环系统的治疗益处,该系统有助于预测和预防高血糖和低血糖。。

Tandem’s t:slim X2 insulin pump connects wirelessly to the FreeStyle Libre 2 Plus sensor, which sends automatic glucose readings every minute2,3 to the pump. Users can conveniently see their minute-to-minute glucose data on the pump and accompanying t:connect mobile app.4 The pump’s Control-IQ technology predicts glucose levels 30 minutes into the future, automatically adjusting insulin delivery every five minutes based on CGM readings and can deliver automatic correction boluses (up to one per hour) to help prevent hyperglycemia.5 When left untreated, hyperglycemia can lead to long-term diabetes complications, such as nerve and kidney damage or disease of the eyes..

Tandem的t:slim X2胰岛素泵与FreeStyle Libre 2 Plus传感器无线连接,该传感器每分钟向泵发送自动血糖读数2,3。用户可以方便地在泵和随附的t:connect移动应用程序上查看他们每分钟的血糖数据。4泵的控制智商技术预测未来30分钟的血糖水平,根据CGM读数每五分钟自动调整胰岛素输送量,并可以自动校正推注(每小时最多一次),以帮助预防高血糖。5如果不及时治疗,高血糖会导致长期糖尿病并发症,如神经和肾脏损伤或眼部疾病。。

“Tandem’s leadership in AID innovation is underscored with this milestone of launching the first insulin pump to be compatible with Abbott’s CGM technology in the U.S.,” said John Sheridan, president and chief executive officer of Tandem Diabetes Care. “This represents another step forward in our commitment to provide customizable solutions to help reduce burden and create new possibilities for people living with diabetes.”.

Tandem Diabetes Care总裁兼首席执行官约翰·谢里登(JohnSheridan)表示:“Tandem在美国推出首款与雅培CGM技术兼容的胰岛素泵,这一里程碑突显了Tandem在援助创新方面的领先地位。”。“这是我们承诺提供可定制解决方案的又一步,以帮助减轻负担,为糖尿病患者创造新的可能性。”。

Abbott’s latest addition to the FreeStyle Libre portfolio is the FreeStyle Libre 2 Plus sensor, which is the modified FreeStyle Libre 2 sensor cleared in 2023 by the U.S. Food & Drug Administration for use with AID systems. It is the first and only CGM available in the United States with a wear time of 15 days1 for both adults and children.

雅培最新推出的FreeStyle Libre组合是FreeStyle Libre 2 Plus传感器,它是美国食品和药物管理局于2023年批准用于AID系统的改进型FreeStyle Libre 2传感器。这是美国第一款也是唯一一款CGM,成人和儿童的佩戴时间均为15天1。

Demonstrating proven accuracy in overall glucose readings with an 8.2% MARD6, the sensor is small, discreet7 and comfortable8 to wear..

MARD6为8.2%,证明了葡萄糖总读数的准确性,该传感器体积小,不受干扰,佩戴舒适。。

“Our FreeStyle Libre portfolio empowers people living with diabetes to have more control over their health and eases the burden of their condition by using a continuous glucose monitoring system with unsurpassed accuracy6 that is simple, easy and affordable to use,” said Jared Watkin, executive vice president of Abbott’s diabetes care business.

雅培糖尿病护理业务执行副总裁贾里德·沃特金(JaredWatkin)表示:“我们的自由式自由泳组合使糖尿病患者能够更好地控制自己的健康,并通过使用具有无与伦比准确性的连续血糖监测系统6来减轻病情负担,该系统简单、方便且价格合理。”。

“Through the integration of Tandem’s t:slim X2 insulin pump with our FreeStyle Libre 2 Plus sensor, people only need two sensors a month, which ensures both a more convenient and more affordable experience.”.

“通过将Tandem的t:slim X2胰岛素泵与我们的FreeStyle Libre 2 Plus传感器集成,人们每月只需要两个传感器,这确保了更方便和更实惠的体验。”。

Tandem will email instructions to all in-warranty t:slim X2 users in the U.S. offering the option to add the new FreeStyle Libre 2 Plus sensor integration at no cost via remote software update. t:slim X2 pumps pre-loaded with the updated software are now shipping to new customers. Information about the software update process for existing in-warranty pump users, including system requirements, is available at tandemdiabetes.com/softwareupdate..

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,提供通过远程软件更新免费添加新FreeStyle Libre 2 Plus传感器集成的选项。t: 预装有更新软件的slim X2泵现在正在向新客户发货。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/softwareupdate。。

The FreeStyle Libre 2 Plus sensor is available now at participating durable medical equipment (DME) suppliers. Please contact Abbott’s Customer Care Team at 1-844-330-5535 for a list of the participating DMEs.

FreeStyle Libre 2 Plus传感器现已在参与耐用医疗设备(DME)供应商处提供。请致电1-844-330-5535联系雅培客户服务团队,获取参与DME的列表。

For more information on how to access the t:slim X2 insulin pump and FreeStyle Libre 2 Plus sensor integration, please visit: tandemdiabetes.com/products.

有关如何访问t:slim X2胰岛素泵和FreeStyle Libre 2 Plus传感器集成的更多信息,请访问:tandemdeabetes.com/products。

1. Based on patient applied sensors currently on the market in the US.

1、基于目前美国市场上患者应用的传感器。

2. FreeStyle Libre 2 Plus sensor connects via Bluetooth to the Tandem t:slim X2 insulin pump. Glucose data is visualized on the t:connect mobile app and t:slim X2 insulin pump.

2.FreeStyle Libre 2 Plus传感器通过蓝牙连接到串联t:slim X2胰岛素泵。葡萄糖数据在t:connect移动应用程序和t:slim X2胰岛素泵上可视化。

3. Not applicable to insulin delivery adjustment frequency. Refer to Tandem t:slim X2 pump User Guide for specific details about how the Control-IQ technology algorithm adjusts insulin delivery.

3、不适用于胰岛素输送调整频率。有关Control-IQ技术算法如何调整胰岛素输送的具体细节,请参阅Tandem t:slim X2泵用户指南。

4. The information on the t:connect mobile app display may not be identical to the current status of your pump. Wireless uploads from the t:connect mobile app to the cloud-based t:connect web application require a compatible phone and an internet or wireless data connection. Uploads to the t:connect web application do not take place in real time and should not be relied upon by healthcare providers or caregivers for remote patient monitoring.

4.t:connect移动应用程序显示屏上的信息可能与泵的当前状态不相同。从t:connect移动应用程序到基于云的t:connect web应用程序的无线上传需要兼容的手机和互联网或无线数据连接。上传到t:connect web应用程序不是实时进行的,医疗保健提供者或护理人员不应依赖它进行远程患者监测。

Standard carrier data rates may apply..

标准运营商数据率可能适用。。

5. If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL and delivers 60% of that value.

如果预测葡萄糖值高于180 mg/dL,Control-IQ technology将使用个人档案设置和110 mg/dL的目标计算校正推注,并提供该值的60%。

6. Data on file, Abbott Diabetes Care, Inc. FreeStyle Libre 2 User’s Manual

6、存档数据,雅培糖尿病护理公司FreeStyle Libre 2用户手册

7. Data on file, Abbott Diabetes Care, Inc.

7.Abbott Diabetes Care,Inc.存档数据。

8. Haak, T. Diabetes Therapy (2017): https://doi.org/10.1007/s13300-016-0223-6.

8.Haak,T。糖尿病治疗(2017):https://doi.org/10.1007/s13300-016-0223-6.

About Abbott

关于雅培

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 60 countries..

雅培(Abbott)是一家全球医疗保健领导者,致力于帮助人们在生命的各个阶段都生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域,拥有诊断、医疗器械、营养品和品牌仿制药领域的领先业务和产品。我们的115000名同事为60多个国家的人民服务。。

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott, on Facebook at www.facebook.com/Abbott and on Twitter/X @AbbottNews.

请通过www.abbott.com、LinkedIn、Facebook、Twitter/X@AbbottNews与我们联系。

About Tandem Diabetes Care

关于串联糖尿病护理

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 www.facebook.com/TandemDiabetes.

关注Facebook上的串联糖尿病护理,网址为www.Facebook.com/tandemdeabetes。

Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.

在LinkedIn上关注串联糖尿病护理https://www.linkedin.com/company/tandemdiabetes.

© 2024 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.

©2024 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。

Important Safety Information – FreeStyle Libre Systems

重要安全信息–FreeStyle Libre系统

Failure to use FreeStyle Libre systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose reading and alarms (if enabled) do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions.

未能按照标签中的说明使用FreeStyle Libre系统可能会导致错过严重的低血糖或高糖事件和/或做出治疗决定,从而导致受伤。如果血糖读数和警报(如果启用)与症状或预期不匹配,则使用血糖仪的指尖值进行治疗决策。

Seek medical attention when appropriate or contact Abbott at 855-632-8658 or freestyle.abbott/us-en/safety-information.html for safety info..

适当时寻求医疗救助,或致电855-632-8658联系雅培或freestyle.Abbott/us-en/safety-information.html获取安全信息。。

The sensor house, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.

sensor house、FreeStyle、Libre和相关品牌标志是雅培的标志,经许可使用。

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 – t:slim X2 Insulin Pump

重要安全信息–t:slim X2胰岛素泵

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.

仅接收。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。。

Forward-looking Statements – Tandem Diabetes Care

前瞻性声明-串联糖尿病护理

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, our ability to provide the software update for current t:slim X2 pump users and the t:slim X2 pumps pre-loaded with Freestyle Libre 2 Plus sensor 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”。这些前瞻性声明涉及我们为当前t:slim X2泵用户和预装Freestyle Libre 2 Plus传感器集成软件的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 sustain commercial scale manufacturing of the t:slim X2 pumps pre-loaded with Freestyle Libre 2 Plus sensor 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 Freestyle Libre 2 Plus sensor integration software.

这些声明受到许多风险和不确定性的影响,包括我们能够维持预装有Freestyle Libre 2 Plus传感器集成软件的t:slim X2泵的商业规模制造,我们能够操作和维护一个系统,以促进现有t:slim X2泵客户升级其现有设备的在线培训,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Freestyle Libre 2 Plus传感器集成软件的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。。