Tandem Diabetes Care has secured marketing approval from the US Food and Drug Administration (FDA) for its t:Slim X2 insulin pump with interoperable technology to deliver insulin under the skin for children and adults with diabetes.
The FDA has classified the t:slim X2 insulin pump as the first in a new device category known as Alternate Controller Enabled Infusion Pumps (ACE pumps).
Tandem Diabetes Care president and CEO Kim Blickenstaff said: This new classification of the t:slim X2 pump provides more flexibility for us as we make improvements to current products, create new products, and collaborate with best-in-class companies in the development of future automated insulin delivery systems.”
The new interoperable t:Slim X2 insulin pump will enable patients to customize treatment through their individual diabetes management devices.
Tandem’s new type of insulin pump, specified as an alternate controller enabled (ACE) infusion pump or ACE insulin pump, is claimed to be the first interoperable pump designed to be used with different components that make up diabetes therapy systems.
Diabetes therapy systems may include an ACE insulin pump and other compatible medical devices such as automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.
The interoperable t:Slim X2 pump is designed to deliver insulin under the skin at set or variable rates. The device can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices such as AID systems.
When not connected to other devices, the Tandem’s interoperable pump holds capacity to infuse insulin on its own. The AID systems comprise of a pump, CGM, and software to control the system
The FDA approval was based on t:Slim X2 pump performance data, which showed that the device can dose insulin accurately at the rates and volumes specified by the user.
In addition, the regulator evaluated the capacity of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.
The FDA commissioner Dr Scott Gottlieb said: “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently.”