ABBOTT PARK, Ill. and
“We’re excited to integrate our insulin delivery systems with Abbott’s glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs,” said
The need for interoperability between diabetes devices is widely recognized. Tandem’s t:slim X2™ insulin pump was the first to receive
“Abbott is working with our partners to bring integrated technologies at an affordable price for people with diabetes who rely on using insulin pumps,” said
The companies will focus initial commercial activities in the
About the FreeStyle Libre 2 System
Abbott’s FreeStyle Libre 2 system was recently cleared by the
As the #1 sensor-based glucose monitoring system used in the
Indications and Important Safety Information – FreeStyle Libre 2 System
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact
*Please refer to www.freestylelibre.us for the indications and important safety information.
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 pumps7 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).8 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.9
Indications and Important Safety Information – t:slim X2 Insulin Pump
RX ONLY. The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that 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 six years of age and greater. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use with NovoLog or Humalog U-100 insulin. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
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 107,000 colleagues serve people in more than 160 countries.
Forward Looking Statement –
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. These forward-looking statements relate to development plans to integrate Tandem insulin delivery systems with Abbott glucose-sensing technology, create cohesive ecosystems and commercialize the products for use in automated insulin delivery systems, as well as Tandem’s ability to offer remote software updates. 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 and that the agreement between the companies could be terminated. 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 Tandem with the
1 Data on file,
2 The FreeStyle Libre 2 system is currently not indicated for use with automatic insulin delivery systems. Future uses for the FreeStyle Libre 2 System are under development and are subject to FDA clearance.
3 Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device.
4 Based on FDA iCGM special controls.
5 Data on file,
6 Based on a comparison of list prices of the FreeStyle Libre 14 day system versus competitors’ CGM systems. FreeStyle Libre 2 system will be list priced the same rate as FreeStyle Libre 14 day system. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
7 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. Accessed
8 Tested to a depth of 3 feet for 30 minutes.
9 Additional feature updates are subject to future FDA approvals. A prescription and additional training may be required to access certain future software updates.
View original content:http://www.prnewswire.com/news-releases/abbott-and-tandem-diabetes-care-advance-development-of-integrated-technologies-for-future-automated-insulin-delivery-systems-301084707.html
Abbott Media: Molly Cornbleet, email@example.com, 847-420-9540 OR Jennifer Heth, firstname.lastname@example.org, 510-749-6469 OR Abbott Financial: Mike Comilla, email@example.com, 224-668-1872; Tandem Diabetes Care Media: Steve Sabicer, firstname.lastname@example.org, 714-907-6264 OR Tandem Diabetes Care Financial: Susan Morrison, IR@tandemdiabetes.com, 858-366-6900 x7005