Tandem Diabetes Care, Inc. a global insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Android version of the Tandem Mobi mobile app.

Tandem Diabetes Care, Inc. 是一家全球胰岛素输送和糖尿病技术公司，今天宣布美国食品和药物管理局 (FDA) 已批准 Tandem Mobi 移动应用程序的安卓版本。

Tandem Mobi, the world’s smallest, durable automated insulin delivery system 1, is powered by Control-IQ+ technology. Proven Control-IQ+ benefits include:

Tandem Mobi，全球最小、最耐用的自动胰岛素输送系统1，由Control-IQ+技术驱动。经过验证的Control-IQ+优势包括：

Day 1 improvements2*

第一天改进2*

79% time in range3†

79% 的时间在范围内3†

90% overnight time in range4*

90% 的夜间时间在范围内4*

“We’re excited to bring Tandem Mobi and the best-in-class outcomes of Control-IQ+ to Android users,” said John Sheridan, president and chief executive officer. “This latest integration gives Android users access to the life-changing benefits of Control-IQ+ on a system that emphasizes convenience, discretion, and customization.”.

“我们很高兴将Tandem Mobi和Control-IQ+的卓越成果带给安卓用户，”总裁兼首席执行官约翰·谢里丹表示。“这次最新的整合让安卓用户能够在强调便利性、隐蔽性和定制化的系统中体验到Control-IQ+带来的改变生活的益处。”

The Tandem Mobi mobile app is a secure, user-friendly mobile application designed to seamlessly pair with the Tandem Mobi insulin pump. It enables users to manage their diabetes directly from their personal, compatible smartphone, which will now include Android devices. The app’s intuitive interface and secure connectivity to the Tandem Source platform helps support better engagement between patients and their healthcare providers, facilitating more informed treatment decisions and improved outcomes..

Tandem Mobi移动应用程序是一款安全、用户友好的移动应用，旨在与Tandem Mobi胰岛素泵无缝配对。它使用户能够直接通过个人的兼容智能手机（现在包括安卓设备）管理糖尿病。该应用直观的界面和与Tandem Source平台的安全连接有助于加强患者与医疗保健提供者之间的互动，帮助做出更明智的治疗决策并改善治疗效果。

“With the Tandem Mobi mobile app, we’re delivering a solution that meets patients where they are, on the devices they use every day, while maintaining the safety, reliability, and innovation they expect from Tandem,” said Dr. Jordan Pinsker, chief medical officer.

“通过Tandem Mobi移动应用程序，我们提供了一种解决方案，可以在患者日常使用的设备上满足他们的需求，同时保持他们对Tandem所期望的安全性、可靠性和创新性，”首席医疗官乔丹·平斯克博士表示。

A limited release is expected to start in December 2025, followed by commercial availability in early 2026. Once available, the Tandem Mobi Android app will be downloadable from the Google Play Store on compatible smartphones, including Google Pixel models 6 through 10 and Samsung Galaxy models S21 through S25.

预计有限发布将在2025年12月开始，随后在2026年初实现商业可用性。一旦可用，Tandem Mobi安卓应用程序将可以从Google Play商店下载，兼容的智能手机包括谷歌Pixel 6至10型号以及三星Galaxy S21至S25型号。

A full compatibility list will be published closer to commercial availability..

完整的兼容性列表将在接近商业可用性时发布。

To sign up for early access participation, please visit:

要注册参与早期访问，请访问：

https://www.tandemdiabetes.com/TandemMobiAndroid

https://www.tandemdiabetes.com/TandemMobiAndroid

About Tandem Diabetes Care, Inc.

关于Tandem Diabetes Care公司。

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化胰岛素输送系统，减轻糖尿病管理的负担，同时为患者、他们的亲人以及医疗保健提供者创造新的可能性。公司的泵产品组合包括 Tandem Mobi 系统和 t:slim X2 胰岛素泵，两者均采用 Control-IQ+ 先进的混合闭环技术。

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

Tandem Diabetes Care 总部位于加利福尼亚州圣地亚哥。欲了解更多信息，请访问 tandemdiabetes.com。

Follow @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X.

在TikTok上关注@TandemDiabetesCare，以及在Facebook、Instagram、LinkedIn和X上关注@TandemDiabetes。

*Studies were conducted using a t:slim X2 insulin pump with Control-IQ technology and a Dexcom G6 sensor. † With optimized Correction Factor based on “rule of less than 1600.”

*研究使用了带有Control-IQ技术的t:slim X2胰岛素泵和Dexcom G6传感器进行。† 基于“小于1600规则”优化的校正因子。

References

参考文献

As of Oct., 2025. Data on file, Tandem Diabetes Care.

截至2025年10月。数据存档，Tandem Diabetes Care。

Beck RW, et al. Diabetes Technol Ther. 2023;25(5):329-342.

贝克 RW 等。糖尿病技术与治疗。2023；25（5）：329-342。

Messer LH, Breton M. Diabetes Technol Ther. 2023;25(12):877-882.

梅瑟 LH，布雷顿 M. 糖尿病技术与治疗. 2023;25(12):877-882.

Breton MD, Kovatchev BP. Diabetes Technol Ther. 2021;23(9):601-608.

布列塔尼 MD，科瓦切夫 BP。糖尿病技术治疗。2021；23（9）：601-608。

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 availability of the Tandem Mobi Android mobile application as well as our ability to provide the Tandem Mobi Android mobile application on the Google Play Store.

本新闻稿包含根据修订后的《1933年证券法》第27A条和修订后的《1934年证券交易法》第21E条所定义的“前瞻性声明”。这些前瞻性声明涉及，除其他事项外，Tandem Mobi安卓移动应用程序预计可用的时间，以及我们能否在Google Play商店提供该应用程序。

These statements are subject to numerous risks and uncertainties, including the timing of, and our ability to continue to offer, the Tandem Mobi mobile application on the Google Play Store. 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.

这些声明受到诸多风险和不确定因素的影响，包括我们能否以及何时可以继续在 Google Play 商店提供 Tandem Mobi 移动应用程序。这些风险以及其他风险在我们最近的年度报告 Form 10-K、季度报告 Form 10-Q 以及提交给证券交易委员会的其他文件的“风险因素”部分中有更详细的识别和描述。

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. 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..

读者应注意不要对这些前瞻性声明施加过度依赖，这些声明仅截至本发布日期有效。实际结果可能与前瞻性声明中预期或预测的结果存在重大差异。由于新信息、未来事件或其他因素，Tandem不承担更新或审查本新闻稿中任何前瞻性声明的义务。

Important Safety Information: RX ONLY. The Tandem Mobi insulin pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. Tandem Mobi system: The Tandem Mobi 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.

重要的安全信息：仅凭处方使用。Tandem Mobi胰岛素泵采用互操作技术（该泵）和Control-IQ+技术（Control-IQ+），仅供单个患者使用。该泵和Control-IQ+适用于与NovoLog或Humalog U-100胰岛素配合使用。Tandem Mobi系统：Tandem Mobi胰岛素泵旨在通过皮下输送设定和可变速率的胰岛素，用于需要胰岛素的糖尿病患者的管理。

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 persons 2 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.

该泵能够可靠且安全地与兼容的数字连接设备进行通信，包括自动胰岛素剂量软件，以接收、执行和确认来自这些设备的指令。该泵适用于2岁及以上的人群。Control-IQ+ 技术：Control-IQ+ 技术旨在与兼容的集成连续葡萄糖监测仪（iCGM，单独出售）和替代控制器启用（ACE）泵配合使用，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..

它还可以在血糖值预计超过预定义阈值时提供校正追加剂量。

WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely..

警告：Control-IQ+ 技术不应用于 2 岁以下的 1 型糖尿病患者或 18 岁以下的 2 型糖尿病患者。同时，也不应使用于每日总胰岛素剂量少于 5 个单位或体重低于 20 磅（9 公斤）的患者，因为这些是 Control-IQ+ 安全运行所需的最低要求值。

Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

泵和Control-IQ+的用户必须：按照各自的使用说明使用胰岛素泵、iCGM及所有其他系统组件。未能遵循这些使用说明可能导致胰岛素输送过多或过少，从而引发低血糖（低BG）或高血糖（高BG）事件。

Visit tandemdiabetes.com/safetyinfo for additional important safety information..

访问 tandemdiabetes.com/safetyinfo 获取更多重要的安全信息。

© 2025 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ+, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Android and Google Play are trademarks of Google LLC. All third-party marks are the property of their respective owners..

© 2025 Tandem Diabetes Care, Inc. 保留所有权利。Tandem Diabetes Care、Tandem 徽标、Control-IQ+ 和 Tandem Mobi 是 Tandem Diabetes Care, Inc. 在美国和/或其他国家的注册商标或商标。Android 和 Google Play 是 Google LLC 的商标。所有第三方标志均为其各自所有者的财产。

Contacts

联系人

Media Contact:

媒体联系人：

858-366-6900

858-366-6900

[email protected]

电子邮件地址

Investor Contact:

投资者联系人：

858-366-6900

858-366-6900

[email protected]

电子邮件地址

Source: businesswire.com

来源：businesswire.com