Tidepool Loop has received FDA Clearance!

If you are new to Tidepool or Tidepool Loop, read our blog post on the origins of Tidepool Loop here.

We did it! We at Tidepool are thrilled to announce the FDA clearance of Tidepool Loop, the first ever community led innovation in the diabetes space to be FDA cleared! Not only did we get Tidepool Loop to clearance, we also did it as a 501(c)(3) nonprofit. We did it with an agile, dedicated team. And we did it during a pandemic. Phew.

But that’s not where the difference between our 510(k) submission process and the other players in the field ends. What we submitted was different from other automated insulin dosing (AID) solutions on the market, because our submission did not depend on proprietary insulin pump or continuous glucose monitoring hardware that we develop or control. Instead, we submitted Tidepool Loop as a fully interoperable solution for diabetes management. Giving people living with diabetes the freedom and flexibility to collaborate with their healthcare providers, to select the interoperable hardware components, and to establish the settings configurations that work best for their particular situation is part of our bigger goal. FDA clearance is a critical milestone in that roadmap.

What does this all mean for you? It means we did the work to allow for faster innovation and iterative development in diabetes management for all players, not just us. It means that our submission can now become a predicate device that other companies can refer to for their 510(k) submissions, leading to faster innovation in the diabetes community. It means that insulin pump partners can enter the AID market without having to develop another automated insulin delivery algorithm that needs to clear regulatory pathways. It means that additional glucose monitoring companies can do the same for their iCGM. It means that the pathway for more rapid diabetes innovation is more clearly defined.

Most importantly, it means that once a third-party interoperable ACE pump is cleared by the FDA, we can put a version of Tidepool Loop in the App Store that works with compatible ACE Pump and iCGM devices. And as more devices become available, we can update Tidepool Loop without needing to make additional regulatory submissions, as long as we follow our established and agreed upon processes with the FDA.

Tidepool Loop is one part of Tidepool’s broader mission of delivering software for the diabetes community, and doing it in a way that paves the road for others. We are focused on developing an entire ecosystem of software tools to reduce the burden of diabetes management, considering all the stakeholders in the process. Now that we have received FDA clearance for Tidepool Loop, we can continue the earnest work of collaborating with our device partners on key aspects of the commercial release of Tidepool Loop. We’re working closely with our device partners to create a fully interoperable automated insulin dosing system based on the first patient-led user experience in Tidepool Loop.

This incredible milestone simply could not have happened without you, the diabetes community. There are so many other people that made this possible. We will be sharing more about how Tidepool Loop came to be, and how members of the Tidepool team made it happen. But for today, we’d like to give special mentions to a few folks in particular:

• To Nate Racklyeft - thank you for your incredible work on Do-it-yourself (DIY) Loop [link], and for making your work freely available via open source. Your gift to the community makes all of this possible.
• To Katie DiSimone - thank you for your tireless efforts documenting DIY Loop, for helping the DIY community understand the art of the possible, and for kicking off Tidepool’s documentation and training efforts. Your energy, enthusiasm and support for the Loop community is infectious and inspiring.
• To Pete Schwamb and Jeremy Lucas - by making RileyLink available to the community, you enabled a whole new way of thinking about mobile-enabled AID systems.
• To everyone in the Looped Facebook Group, the moderators (especially Kate Farnsworth) and everyone who participated in the Observational Study of DIY Loop conducted by the JAEB Center for Health Research - thank you, we would not be here without you.
• To everyone saying “We are not waiting!” - your message is loud and clear. We want better solutions that allow us to manage our diabetes.
• To our partners at the FDA, and in particular Naomi Schwartz, Andrea Bell-Vlasov, Yiduo Wu and Deanna Bousalis - thank you for your guidance and patience with us as a first-time sponsor, and especially for your tenacity in working with us as we blazed a new train with the interoperability pathway!
• To Helmsley Charitable Trust, JDRF, the Tullman Family Foundation, the Goldsmith Foundation, and hundreds of other foundations and individual donors - thank you for believing in us and backing that up with your financial support.
• To other key folks in the DIY community that contributed to the code, including Joe Moran, Ben West, John Costik and to all of the other contributors to the DIY code - thanks for paving the way with the technology that made Loop possible, for paying it forward, and for being the giants upon whose shoulders we stand.

You can read our press release announcing our FDA clearance here, and be on the lookout for an upcoming blog series detailing what our process over the last few years has looked like. We are so excited to finally start sharing more information about Tidepool Loop and look forward to connecting with you about this next exciting chapter for Tidepool.

Cheers,

Howard Look, Founder and CEO, Tidepool

Disclaimer: Tidepool Loop is not available for use.

You can review some Frequently Asked Questions and learn more about Tidepool Loop here.

Key terms that are used throughout our blog posts discussing Tidepool Loop include:

ACE pump: “alternate controller-enabled pump”

What that means: the pump meets FDA criteria to work safely with more than one type of algorithm that adjusts insulin.

iCGM: “integrated continuous glucose monitor”

What that means: the CGM system meets FDA criteria for accuracy and safety for dosing insulin.

iAGC: “interoperable automated glycemic controller”

What that means: The algorithm (computing logic) has been designed to communicate with other compatible diabetes device components in a modular system.

This controller software might be embedded in the insulin pump itself, run from a separate handheld device, or even live inside a smartphone app.

510(k): A 510(k) is a regulatory requirement by the FDA in order to market something considered a medium-risk medical device in the United States.

What that means: A 510(k) filing contains detailed technical, safety and performance information about a medical device. It must demonstrate the device in question is “substantially equivalent” to another medical device already cleared for use by the FDA.