It’s official: Tidepool and Dexcom partner for Tidepool Loop

In addition to the exciting news about our collaboration with Medtronic, we’re thrilled to bring you the second of two blog posts that together highlight the huge advances our industry is making towards patient choice and interoperability.

Now the ecosystem is complete as Tidepool partners with Dexcom, adding their G6 CGM as the first integrated continuous glucose monitor (iCGM) to be supported by Tidepool Loop.

Today at the DiabetesMine DData Exchange in San Francisco, we announced that we’ve officially partnered with Dexcom to integrate their G6 interoperable continuous glucose monitoring system (iCGM) into the Tidepool Loop ecosystem. We welcome this pioneering company to our ambitious project.

“Dexcom shares Tidepool’s commitment to expanding patient choice,” said Dexcom CEO Kevin Sayer. “As the first company to earn the FDA’s iCGM designation, we’re delighted to partner with Tidepool to ensure that in the future patients and their doctors will be able to pair the G6 CGM with the pump that’s right for them.”

The news that Dexcom is on board is even more significant when considered in light of having multiple pump partners on board, including Insulet and Medtronic (and we hope more, soon!). Given this great news, I think it’s appropriate to reintroduce Tidepool Loop to all of you, and share what this means to the Tidepool team and to me.

The basics

Tidepool Loop is currently under development. The goal is to deliver an FDA-regulated iOS app that will automate insulin delivery. As we stated in our original blog post announcing this effort, we simply couldn't do this without standing on the shoulders of the giants in the #WeAreNotWaiting community who came before us.

Two pieces to this puzzle are needed to make this happen:

1. Tidepool Loop-compatible insulin pumps. At launch, people with diabetes and their doctors will be able to choose between two pumps, a future version of the Omnipod© System from Insulet, and a future Bluetooth-enabled MiniMed™ pump from Medtronic. We also hope to bring more even more pump partners on board. Let us know who you'd like to see!
2. Tidepool Loop-compatible integrated continuous glucose monitors. With the Dexcom announcement, we can now begin work to integrate the Dexcom G6 CGM.

This means the community will be able to pair the Tidepool Loop app with the Dexcom G6 AND either pump. We are especially proud to be working on a system that demonstrates the power of interoperability, and that will maximize patient choice.

The regulatory puzzle pieces

The FDA not only understands, but has been advocating the importance of interoperability and what it will mean for patient choice. They have created a framework in which our industry partners can pursue the appropriate designation:

1. iCGM. This is the classification of integrated continuous glucose monitors that the FDA has approved to work with interoperable automated insulin delivery systems.
2. ACE pump. This is the classification of insulin pumps the FDA has approved to work with interoperable automated insulin delivery systems.
3. iController (or whatever it ends up being called). This will be the control algorithm that powers an interoperable automated insulin delivery system.

So, while the Dexcom G6 is built to be compatible with multiple pumps, today there’s only one ACE pump on the market - Tandem’s t:slim X2. This means that both Insulet and Medtronic will need to file for ACE pump classification for their Omnipod system and future Bluetooth-enabled MiniMed™ pump respectively.

As we mentioned a few months ago, we’re working on our iController submission to the FDA, and we hope other companies are too. This is the final regulatory puzzle piece.

What does all this mean for Tidepool?

It means we’re making tremendous strides on our path to develop Tidepool Loop. Getting these agreements in place means our engineers can start working with the software development kits that Tidepool Loop will need to integrate with all of these devices. These agreements mean we can begin, in earnest, conversations about technical support, co-marketing, and other collaborations with each device partner. These agreements are the first step in a journey to delivering Tidepool Loop.

Most importantly, we're demonstrating our commitment to the vision of Tidepool Loop: interoperability and patient choice. There are many, many unanswered questions about Tidepool Loop that we are working hard to address, but behind all this work is the goal to provide an interoperable system that is defined by each person with diabetes choosing the components that work best for them. Our commitment is to you, the diabetes community, to take the incredible work of the #WeAreNotWaiting giants and bring this incredible technology to the masses.

There’s plenty more to do, and share with all of you as we move forward. As always, you can see the latest news on tidepool.org/loop.

Cheers,Howard LookPresident and CEO, Tidepool