3 Takeaways from Tandem’s FDA ipump Approval

-Craig Idlebrook

You may have heard the news that the FDA has granted Tandem the ability to market its t:Slim X2 insulin pump as an interoperable pump, also known as an alternative controller-enabled (ACE) pump.

While this sentence might be enough to make the eyes of the most tech-savvy light up, it might be helpful for every one else to break down what this announcement means in as non-technical of terms as possible.

A second FDA approval for the t:slim X2

In 2018, Tandem was granted FDA approval for the t:slim X2, a pump which has predictive technology and the ability to suspend insulin delivery if blood glucose trends downward.

This latest FDA approval allows Tandem to label the t:slim X2 an interoperable pump. As seemingly with all new diabetes tech innovation, this new label also goes by several other names – ipump and ACE pump – which will surely lead to some confusion.

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Whatever you call it, this means the pump has been cleared to hook up with interoperable CGMS (iCGMs), and still-to-be-approved interoperable automated insulin dosing (AID) systems. This allows Tandem and other companies to collectively build a closed-loop insulin pump system, or closed-loop insulin pump systems.

It’s all about the partnerships

What if you could try out insulin pump algorithms like apps on a phone?

In the future you may eventually be able to pair your insulin pump with a CGM and an AID algorithm from another company, or even opt into several different AID algorithms while still using the same pump.

Why is this important? So far, only Medtronic has had deep enough pockets to bring a pump system, a (built-in) CGM, and an AID algorithm to market in one system with its 670G. To do this, Medtronic created its own complete tech ecosystem, much as Apple did with its iPhone and its Apple Store apps.

Continuing this analogy, if Medtronic plays the role of Apple, then all the other pump and CGM companies are like Android makers. It’s in all the interests of these other companies to work together to match Medtronic’s system of innovation.

The pace of FDA approval continues to quicken

The FDA has basically given a regulatory roadmap to pump makers for how their devices should work with other companies’ diabetes tech. In 2018, the FDA gave a similar roadmap to CGM makers when it granted Dexcom the ability to market its G6 CGM as an iCGM. Now, all that’s left to complete the triad is for the FDA to lay out the rules of the road for interoperable AID algorithm technology.

This is good news for those who want more closed-loop options than just the 670G. When diabetes tech companies first wanted to program CGMs to communicate with pumps or phone apps, the FDA was slow and deliberate in its process to regulate these innovations based on the existing regulatory framework available.

Diabetes community stakeholders worked hard to change this. Diabetes tech activists began hacking devices to create their own closed-loop devices without FDA approval, and then sharing their experiences and data. In 2017, JDRF launched an open protocol initiative to help diabetes tech companies to work together and gain FDA approval. As this was happening, the FDA changed its philosophy to favor a quicker pace toward regulatory approval for novel medical tech.  

All this will likely come together to bring about a higher volume of FDA approval of diabetes tech than in the past. This, in turn, can lead to increased competition for customers and more choice for people with type 1 diabetes.

To read Tandem’s announcement about the FDA approval, click here.

To read some great in-depth coverage from Diabetes Mine about this announcement, click here.

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