ABBOTT AND TANDEM DIABETES CARE ADVANCE DEVELOPMENT OF INTEGRATED TECHNOLOGIES FOR FUTURE AUTOMATED INSULIN DELIVERY SYSTEMS
Abbott (NYSE: ABT) and Tandem Diabetes Care (NASDAQ: TNDM) announced today that they have finalized an agreement to develop and commercialize integrated diabetes solutions that combine Abbott’s world-leading1 continuous glucose monitoring (CGM) technology with Tandem’s innovative insulin delivery systems to provide more options for people to manage their diabetes. The companies first announced their intention to work together in October 2019, and this resulting agreement covers the technical development of device integration and associated commercial support activities.
“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 John Sheridan, president and CEO of Tandem Diabetes Care. “We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of release without requiring a new pump.”
The need for interoperability between diabetes devices is widely recognized. 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 in 2019. The special controls for ACE pumps allow for reliable and secure communication with compatible external devices. Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system was recently cleared by the FDA for adults and children (4 years and older). Through this collaboration, Abbott and Tandem will work to digitally connect their technologies for future automated insulin delivery systems, which will provide people with options to tailor and simplify how they manage their diabetes.2
“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 Jared Watkin, senior vice president, Diabetes Care, Abbott. “By combining our glucose sensing technology with Tandem’s proven insulin delivery systems, we will be able to create a cohesive ecosystem for people with diabetes that can fit easily into their daily lives.”
The companies will focus initial commercial activities in the U.S. and Canada with additional geographies considered in the future.
About the FreeStyle Libre 2 System
Abbott’s FreeStyle Libre 2 system was recently cleared by the U.S. Food and Drug Administration (FDA) as an integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes. It is the only iCGM system with optional real-time alarms3 that measures glucose levels every minute, meeting the highest level of accuracy standards.4 The FreeStyle Libre 2 next-generation sensor is worn on the back of the upper arm for up to 14 days and with a one-second scan using a handheld reader, users can see their glucose reading, trend arrow and eight-hour history.
As the #1 sensor-based glucose monitoring system used in the U.S. and worldwide,5 Abbott’s FreeStyle Libre portfolio has changed the lives of more than 2 million people across 50 countries by providing breakthrough technology that is accessible and affordable.6 Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 36 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S.
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.
WARNINGS/LIMITATIONS*:
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 Abbott Toll Free (855-632-8658) or visit* www.freestylelibre.us for detailed indications for use and safety information.
*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.