SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced that its t:slim X2 insulin pump with Control-IQ automated insulin delivery (AID) technology is now cleared for use with Eli Lilly and Company’s Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the European Union (EU)..

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，其具有Control-IQ自动胰岛素输送（AID）技术的t:slim X2胰岛素泵现已获准在欧盟（EU）与礼来公司和公司的Lyumjev®（胰岛素lispro aabc注射液）超快速作用胰岛素一起使用。。

“High satisfaction and quality of life benefits were recently shown in a clinical study using Lyumjev with Control-IQ technology,”1 said Jordan Pinsker, MD, Chief Medical Officer at Tandem Diabetes Care. “Ultra-rapid acting insulin is a popular choice for people living with diabetes due to its fast response time.

。“由于其快速反应时间，超速效胰岛素是糖尿病患者的热门选择。

We are proud to be able to offer Lyumjev compatibility with our t:slim X2 pump as part of an AID system in the EU, providing more flexibility for our customers in these countries.”.

我们很自豪能够为Lyumjev提供与我们的t:slim X2泵的兼容性，作为欧盟援助系统的一部分，为这些国家的客户提供更大的灵活性。”。

Lyumjev was authorized for general use in insulin pumps in the EU in 2020, but pump manufacturers are required to perform extensive testing to verify compatibility with individual insulin pumps and AID systems. Tandem and Lilly collaborated to support the clinical trial showing benefits of using Lyumjev with Control-IQ technology.

。Tandem和Lilly合作支持临床试验，显示使用Lyumjev和Control-IQ技术的好处。

The companies continue to work to secure Lyumjev compatibility for the t:slim X2 pump in other regions and to secure Lyumjev compatibility for the Tandem Mobi pump..

这些公司继续努力在其他地区确保t:slim X2泵的Lyumjev兼容性，并确保串联Mobi泵的Lyumjev兼容性。。

Please see Lyumjev Full Prescribing Information including Patient Prescribing Information. For additional questions, please access Lyumjev (previously Liumjev) | European Medicines Agency (EMA) (europa.eu).

请参阅Lyumjev完整的处方信息，包括患者处方信息。有关其他问题，请访问Lyumjev（以前是Liumjev）|欧洲药品管理局（EMA）（europa.eu）。

The t:slim X2 pump is currently cleared for use with Humalog and Novolog/NovoRapid U-100 insulins globally, and Admelog/Insulin lispro Sanofi and Trurapi/Insulin aspart Sanofi U-100 insulins in Canada and selected EU countries.

t:slim X2泵目前已获准在全球范围内与Humalog和Novolog/NovoRapid U-100胰岛素以及加拿大和选定的欧盟国家的Admelog/Insulin lispro-Sanofi和Trurapi/Insulin aspart-Sanofi U-100胰岛素一起使用。

Levy CJ, Bailey R, Laffel LM, et al. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):652-660.

Levy CJ，Bailey R，Laffel LM等。成人，青少年和1型糖尿病儿童使用控制智商技术对超快速赖脯胰岛素进行多中心评估。糖尿病技术。2024年9月；26（9）：652-660。

About Tandem Diabetes Care

关于串联糖尿病护理

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology.

Tandem Diabetes Care是一家全球胰岛素输送和糖尿病技术公司，生产和销售先进的自动胰岛素输送系统，可减轻糖尿病管理的负担，同时为患者及其亲人和医疗保健提供者创造新的可能性。该公司的泵产品组合采用串联Mobi系统和t:slim X2胰岛素泵，两者均采用Control-IQ高级混合闭环技术。

Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com..

Tandem Diabetes Care位于加利福尼亚州圣地亚哥。有关更多信息，请访问tandemdiabetes.com。。

Follow Tandem Diabetes Care on X @tandemdiabetes; use #tslimX2 #TandemMobi and #TandemDiabetes.

遵循X@tandemdiabetes的串联糖尿病护理；使用#tslimX2#TandemMobi和#tandemmeties。

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, t:slim X2, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All other third-party marks are the property of their respective owners..

©2024 Tandem Diabetes Care，Inc.保留所有权利。Tandem Diabetes Care、Tandem徽标、Control IQ、t:slim X2和Tandem Mobi是Tandem Diabetes Care，Inc.在美国和/或其他国家/地区的注册商标或商标。所有其他第三方标记均为其各自所有者的财产。。

Forward Looking Statement

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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements.

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”，涉及可能导致实际结果与前瞻性声明中预期或预测结果产生重大差异的风险和不确定性。

These forward-looking statements relate to, among other things, Tandem’s ability to expand compatibility of its technology with Lyumjev. These statements are subject to numerous risks and uncertainties, including Tandem’s ability to secure Lyumjev compatibility for the t:slim X2 pump in other regions and/or the timing thereof, the ability to secure Lyumjev compatibility for the Tandem Mobi pump in any region and/or the timing thereof, as well as other risks and uncertainties identified in the Company’s most recent Annual report on Form 10-K and its other filings with the Securities and Exchange Commissions.

这些前瞻性声明涉及Tandem扩大其技术与Lyumjev兼容性的能力。这些声明受到许多风险和不确定性的影响，包括Tandem在其他地区确保t:slim X2泵与Lyumjev兼容的能力和/或时间安排，在任何地区确保Tandem Mobi泵与Lyumjev兼容的能力和/或时间安排，以及公司最新10-K表年度报告及其向证券交易委员会提交的其他文件中确定的其他风险和不确定性。

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors..

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。由于新信息、未来事件或其他因素，公司没有义务更新或审查本新闻稿中的任何前瞻性声明。。

Important Safety Information

重要安全信息

RX ONLY. Indications for Use: The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices.

仅接收。使用适应症：t:slim X2胰岛素泵旨在以固定和可变的速率皮下输送胰岛素，用于治疗需要胰岛素的人的糖尿病。该泵能够与兼容的数字连接设备可靠、安全地通信。

Control-IQ technology is intended for use with a compatible continuous glucose monitor (CGM) and the t:slim X2 insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ技术旨在与兼容的连续血糖监测仪（CGM）和t:slim X2胰岛素泵一起使用，以根据CGM读数和预测的血糖值自动增加，减少和暂停基础胰岛素的输送。当预测葡萄糖值超过预定阈值时，它还可以提供校正推注。

The pump is indicated for use in persons six years of age and greater who require a total daily insulin dose of at least 10 units and who weigh at least 25 kilograms. The pump is intended for single patient use. Refer to the User Guide for a list of compatible insulins..

该泵适用于6岁及以上需要每日总胰岛素剂量至少10单位且体重至少25公斤的人群。。有关兼容绝缘材料的列表，请参阅《用户指南》。。

WARNING: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in users who require less than 10 units of insulin per day or who weigh less than 25 kilograms.

警告：6岁以下的任何人都不应使用Control IQ技术。它也不应该用于每天需要少于10单位胰岛素或体重小于25公斤的用户。

The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Do not use the System if using hydroxyurea.

该系统不适用于孕妇、透析患者或重症患者。如果使用羟基脲，请勿使用该系统。

Users of the pump and the System must: be willing and able to 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.

泵和系统的用户必须：愿意并能够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；；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。。