Tandem Diabetes Care Announces t:slim X2™ Insulin Pump Compatibility with Abbott’s FreeStyle Libre® 3 Plus Sensor in the United States
Tandem continues to build its technology ecosystem to expand choice and personalization for people living with diabetes
“Diabetes management is not one-size-fits-all and it is critical for people living with diabetes to be able to personalize their AID systems to fit their unique healthcare and lifestyle needs,” said Dr.
The FreeStyle Libre 3 Plus sensor has an extended 15-day wear time, transmitting automatic glucose readings every minute directly to the pump. This data is also available to view on the Tandem t:slim mobile app, providing users with multiple, convenient ways to access their current glucose trend.
The t:slim X2 insulin pump is powered by Control-IQ+ technology, the latest generation of Tandem's advanced hybrid closed-loop algorithm, which adjusts insulin every 5 minutes based on predicted glucose values. It’s the only system with the unique AutoBolus™ feature that calculates and delivers a correction bolus to help with missed meal boluses.* Control-IQ+ is easy to start, use, and personalize, and this latest integration works with the FreeStyle Libre 3 Plus sensor and extends its benefits to even more people with diabetes.
“This is an exciting first step in our strategy to connect Tandem's portfolio of insulin pumps to Abbott’s FreeStyle Libre 3 Plus sensors worldwide,” said
When available, Tandem will email eligible users in the
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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, 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 3 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 3 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 the software update for current t:slim X2 pump users or the t:slim X2 pumps pre-loaded with Freestyle Libre 3 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
Important Safety Information – FreeStyle Libre Systems
Product for prescription only; for Important Safety Information, please visit FreeStyleLibre.us.
Important Safety Information –
RX ONLY. The t:slim X2 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. t:slim X2 insulin pump: The 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, 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. 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 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
WARNING: Control-IQ+ 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.
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. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
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* If glucose values are predicted to be above 180 mg/dL (or 10.0 mmol/L), Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL (or 6.1 mmol/L) and delivers 60% of that value.
† Future updates for all or some Tandem products may not be developed and may not be offered everywhere and would be subject to applicable regulatory approvals. Software updates are only available to customers who are in warranty at the time they update their pump. Additional training may be required to access certain software updates. Charges may apply. Tandem may discontinue select software and features over time at its discretion.
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Media Contact:
858-366-6900
media@tandemdiabetes.com
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858-366-6900
IR@tandemdiabetes.com
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