ABBOTT PARK, Ill. and SAN DIEGO, Oct. 15, 2019 /PRNewswire/ -- Abbott (NYSE: ABT) and Tandem Diabetes Care (NASDAQ: TNDM) announced today that they intend to develop and commercialize integrated diabetes solutions that combine Abbott's world-leading1 glucose sensing technology with Tandem's innovative insulin delivery systems to provide more options for people to manage their diabetes.
"To help customers fully realize the potential of the latest advancements in diabetes technology, we're ensuring our products have interoperability, creating a cohesive ecosystem where people with diabetes can manage their condition across devices from us and other companies seamlessly," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "By bringing together Abbott's and Tandem's leadership and expertise, we can provide new ways for people to manage their diabetes that are impactful and can integrate easily into their daily lives, especially people who rely on insulin pumps."
The need for interoperability between diabetes devices is widely recognized in the industry. Tandem's t:slim X2™ insulin pump was the first to receive U.S. Food and Drug Administration (FDA) clearance in a new device category called alternate controller enabled (ACE) infusion pumps earlier this year. The special controls for ACE pumps allow for reliable and secure communication with compatible external devices like Abbott's next generation FreeStyle Libre system, which would give people with diabetes the ability to select tools and tailor their diabetes management to best meet their needs. Abbott and Tandem are currently in discussions regarding a final agreement for the technical implementation of device integration and associated commercial support activities.
"The FDA's new interoperable designations for the various components of automated insulin delivery systems are making integrations of advanced technologies more straightforward, and we are looking forward to exploring these possibilities with Abbott," said John Sheridan, president and CEO of Tandem Diabetes Care. "Our companies share a fierce dedication to helping expand the available treatment options for the diabetes community so that more people can experience the benefits of automated insulin delivery systems, using a combination of devices they feel best meets their individual needs."
This announcement reflects both Abbott's and Tandem's common goal to provide people with new ways to manage their diabetes that can integrate easily into their daily lives.
About the FreeStyle Libre System
Abbott's FreeStyle Libre, the #1 sensor-based glucose monitoring system used worldwide1, reads glucose levels through a sensor that can be worn on the back of the upper arm eliminating the need for fingersticks2. FreeStyle Libre has changed the lives of more than 1.5 million people across 46 countries3, and has secured partial or full reimbursement in 34 countries, including Canada, France, Ireland, Japan, the United Kingdom, and the U.S.
For the U.S., important safety information: https://www.freestylelibre.us/safety-information.html
About the t:slim X2 Insulin Pump
The t:slim X2 pump was the first insulin pump classified by the FDA in a new device category called alternate controller enabled (ACE) infusion pumps4 and the first system approved as compatible with interoperable continuous glucose monitoring (iCGM) devices. The system includes advanced features like a large color touchscreen, rechargeable battery, Bluetooth® wireless technology, USB connectivity and watertight construction (IPX7).5 It is capable of remote software updates using a personal computer, offering the potential for in-warranty users to access new features as they become available.6
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 103,000 colleagues serve people in more than 160 countries.
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, Calif.
Tandem Diabetes Care is a registered trademark and t:slim X2 is a trademark of Tandem Diabetes Care, Inc. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Tandem Diabetes Care, Inc. is under license.
Forward Looking Statements – Tandem Diabetes Care
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. For instance, while the parties are currently exploring a business relationship, there can be no assurance that an agreement will be reached or that any agreement will be on the terms that are currently being discussed. Other forward-looking statements relate to the ability to integrate devices and achieve interoperability between them. These statements are subject to numerous risks and uncertainties, including the risks that technical challenges, clinical or regulatory hurdles or other factors may prevent or delay integration/interoperability. These and other risks and uncertainties are identified in Tandem's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents filed by the Company 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. 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.
- Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal use, sensor-based glucose monitoring systems.
- Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
- Data on file, Abbott Diabetes Care
- U.S. Food and Drug Administration. FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices; 2019. Available at https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-insulin-pump-intended-allow-patients-customize-treatment-through.
- Tested to a depth of 3 feet for 30 minutes.
- Additional feature updates are not currently available for the t:slim X2 pump with Basal-IQ technology and are subject to future FDA approvals. A prescription and additional training may be required to access certain future software updates.