Tandem Diabetes Care Announces FDA Clearance for the t:slim X2 Insulin Pump to Bolus Using the t:connect Mobile App

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, announces that the U.S. Food and Drug Administration (FDA) clearance of bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app. This represents the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems. The updated t:connect mobile app is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through the convenience of their compatible smartphone.

In addition to the t:connect mobile app being the first to receive FDA clearance on both iOS and Android operating systems to deliver insulin from a personal smartphone, Tandem was also the first to receive an interoperable automated glycemic controller designation with Control-IQ technology in December 2019, the first to receive an alternate controller-enabled infusion pump classification in February 2019, and the first insulin pump designated as compatible with integrated continuous glucose monitoring devices in June 2018.

The Tandem Diabetes t:connect Mobile App

The t:connect mobile app gives you access to patient data during office visits without having to plug in a device. When released, this new feature will be offered in the United States for no additional cost to new t:slim X2 insulin pump customers and to in-warranty customers through a remote software update for the t:slim X2 insulin pump and the updated t:connect mobile app.

Tandem Diabetes plans to roll out the mobile bolus feature update throughout the spring in a series of limited launch groups, followed by an expanded launch later this summer. Limited launch participants have already been selected.

The t:connect mobile app is a secure, user-friendly mobile application that, when paired with a t:slim X2 insulin pump, discreetly displays the user’s pump information on their smartphone. In addition to the newly cleared bolus feature, the mobile app displays the last 24 hours of glucose trends, pump status changes, and insulin therapy data, including basal and bolus deliveries and suspensions of insulin delivery. The app also displays pump alerts and alarms, and it securely uploads data into the cloud-based t:connect web application wirelessly. Tandem Diabetes Care believes this new feature removes a barrier to adoption, meaning that more people will hopefully take advantage of this life-changing technology.

Easily Manage Your Diabetes with the t:slim X2 Insulin Pump and t:connect Mobile App

Notably, the t:slim X2 insulin pump functions independently from the t:connect mobile app, therefore a user always retains the freedom to view pump therapy data, program requests and cancel bolus insulin requests from their pump. That increased flexibility decreases how often you need to interact with your pump.

Benefits of the t:connect mobile app

For Users

• A discreet secondary display for their pump.
• Enable push notifications for their pump messages and alerts^†
• Wirelessly upload their pump and therapy data

For Providers

• Shorter, streamlined office visits
• Authorized providers have access to recent therapy data
• No more searching for the right cable or waiting on a pump upload

Explore the features of the Tandem Diabetes t:connect Mobile App

Patients must download the app on their phone and then pair the app with their insulin pump. Here are the steps to follow:

1. Download Free Mobile App
   • Visit Google Play or the App Store, search for “Tandem Diabetes” and select “t:connect mobile” from the results.
2. Turn on Mobile Connection
   • Unlock the pump, tap OPTIONS, Device Settings, and then select Bluetooth® Settings. Tap the toggle to turn on the Mobile Connection and enable Bluetooth.
3. Login to Mobile App
   • Use a t:connect web application username and password (or create a login and password in the t:connect mobile app).
4. Pair Insulin Pump to Mobile App
   • Follow the prompts to pair the pump with a phone. For detailed pairing instructions, visit our Quick Reference guide. Only one device can be paired with the t:connect mobile app at a time.

The Healthcare Consumer Experience

Change has long been a constant in healthcare, but it has dramatically accelerated in recent years. Digital health tools that facilitate innovative methods and modalities to improve care, enable lifestyle change, and create efficiencies are progressing quickly. The digitalization of healthcare provides a better healthcare delivery experience for both patients and clinicians. Before the COVID-19 pandemic, consumer interest in using digital solutions to engage with their healthcare team rose. People with T1D need better tools if they’re going to do better—that means achieving an optimal HbA1c, increased time-in-range, and more. Tandem Diabetes knows that this clearance makes the t:slim X2™ a better tool.

As digital technologies become more of the norm in healthcare, there’s an opportunity to rethink how to do healthcare by embedding the changes that have worked well during the pandemic. In this era of empowered healthcare, consumers expect easy and streamlined access to care. The key to successful behavior change is developing habits that make change more accessible. As digital consumerism in healthcare accelerates, expectations for the patient experience continue to evolve equally. The patient experience can no longer be defined alone by the clinical care setting. Today, the patient experience encompasses every step of the healthcare journey, including navigating the web, scheduling, billing, insurance, and beyond. The digital behaviors that gained momentum in recent years have been hard-coded into the patient journey. 

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem’s flagship product, the t:slim X2 insulin pump, is capable of remote software updates using a personal computer, and features integrated continuous glucose monitoring. Tandem is based in San Diego, California.

Tandem Diabetes Care, Control-IQ, and t:connect are trademarks registered in the U.S. and/or other countries and t:slim X2 is a trademark of Tandem Diabetes Care, Inc.

Forward-Looking Statements:

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 availability of the new features in the t:connect mobile app, the compatibility of the mobile app with smartphone hardware and operating systems and our ability to offer the related pump software update for current t:slim X2 pump users. These forward-looking statements are subject to numerous risks and uncertainties, including risks associated with the research and development process generally, such as the completion of final testing and validation of products and related systems in compliance with applicable quality system requirements, our ability to operate and maintain a system to facilitate online training and prescription handling for existing t:slim X2 pump customers upgrading their existing devices, and the risk that we may encounter other challenges that may delay the commercial launch of new features, as well as other risks identified in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and other documents that we file 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. 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.