Abbott Park, Ill. and San Diego, Calif. – Jan. 8, 2024 – 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. 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.
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 hyperglycemia5. When left untreated, hyperglycemia can lead to long-term diabetes complications, such as nerve and kidney damage or disease of the eyes.
"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."
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. Demonstrating proven accuracy in overall glucose readings with an 8.2% MARD6, the sensor is small, discreet7 and comfortable8 to wear.
"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. "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."
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.
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.
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.
1. Based on patient applied sensors currently on the market in the US.
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.
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.
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. Standard carrier data rates may apply.
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.
6. Data on file, Abbott Diabetes Care, Inc. FreeStyle Libre 2 User’s Manual.
7. Data on file, Abbott Diabetes Care, Inc.
8. Haak, T. Diabetes Therapy (2017): https://doi.org/10.1007/s13300-016-0223-6.
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 115,000 colleagues serve people in more than 60 countries.
About Tandem Diabetes Care
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 manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2 and #TandemDiabetes.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at 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.
Important Safety Information – FreeStyle Libre Systems
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. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or freestyle.abbott/us-en/safety-information.html for safety info.
The sensor house, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.
Responsible use of Control-IQ technology
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.
Important Safety Information – t:slim X2 Insulin Pump
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. 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. 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.
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.
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. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
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. 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. 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. 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. 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.