Editor’s Note: This is breaking news coverage that will be updated as more information becomes available.
The FDA authorized Tandem Diabetes’ t:slim X2 insulin pump for marketing as “interoperable”. The device itself does not change with this designation — but the future possibilities for closed-loop systems and other management technologies that include the Tandem pump have been blown wide open. In 2018, the Dexcom G6 was designated the first interoperable continuous glucose monitor by the FDA, also referred to as iCGM.
With this designation the FDA established a new category of insulin pump for regulatory purposes, deemed an “alternate controller enabled (ACE) infusion pump”. This means that the t:slim X2 will be able to be used with a range of continuous glucose monitors, opening the door for patient choice in building future closed-loop systems to meet specific needs and preferences. And CGM is only the beginning – interoperability frees the t:slim X2 up for integrations with automated insulin dosing (AID) systems, blood glucose meters, or other electronic devices or platforms used for diabetes management.
The establishment of the “ACE” designation by the FDA is perhaps even more groundbreaking. FDA Commissioner Scott Gottlieb, M.D. stated, “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.”
The ACE designation will allow future technologies to go through streamlined review processes at the FDA in order to help pump and other device innovation reach patients more quickly.
In order for the t:slim X2 to receive this designation, the FDA reviewed performance data demonstrating accuracy and reliability of insulin dosage and delivery as well as the ability of the pump to communicate with external devices taking into account reliability, cybersecurity, and fail-safe modes.
Currently, the t:slim X2 pump can be used with Tandem Diabetes’ Basal-IQ system, a low-suspend feature that integrates with the Dexcom G6. FDA approval for Control-IQ, Tandem’s hybrid closed-loop system (also using the Dexcom G6), is expected summer 2019.
Theoretically, today’s news opens the door for the t:slim X2 to integrate with additional CGM systems, algorithms, blood glucose meters, software platforms, and whatever else the future of diabetes technology holds. The ACE designation marks an exciting step towards additional pump options for the FDA-approved loop systems of the future, like those being imagined through the Tidepool Loop Project. Today’s FDA news paves the way for faster approvals and increased patient choice in next generation technology.
Read the full press release from the FDA here.