99 years closer: About our FDA submission of Tidepool Loop

As a dad of a child with type 1 diabetes, I can’t help but note the significance of today’s date. On January 11, 1922—99 years ago—a 14-year-old boy with diabetes named Leonard Thompson received the very first injection of insulin. Our family has been impacted by diabetes for just a few of those years, but I am often in awe of how far diabetes management has come in almost a century.

That’s why I’m really excited to share with you today that, only two years since we announced the project, we’ve arrived at a huge milestone in getting Tidepool Loop to the FDA. The team has worked night and day to prepare Tidepool Loop, which was originally developed by this passionate, dedicated community, and make it ready for review with the goal of making it widely available in the App Store. We are one step closer to achieving that goal, as our FDA 510(k) submission of Tidepool Loop was completed in December.

This milestone belongs to you, as well. To the innovators in the DIY community, whose shoulders we proudly stand on and who embody the heart and soul of the #WeAreNotWaiting movement—thank you. To Tidepool team members past and present who wrote code, tested features, documented requirements, iterated on designs, managed usability tests, and so much more—thank you. To everyone who helped craft, edit, and finalize the pages and pages of our FDA 510(k) submission—thank you. And to our device partners, consultants, volunteers, supporters, and funders including JDRF and The Helmsley Charitable Trust who have supported us and believed in us—thank you.

Truly, this is a team effort. And we aren’t done yet.

The FDA is reviewing our submission now, and we’re responding to their questions in the hopes that we’ll hear their decision later this year. We know that the agency is slammed with COVID-related submissions right now, so we are especially appreciative of their dedication to public health and safety.

In parallel, the team’s work continues to prepare the infrastructure and commercial plans to bring Tidepool Loop to market if or when it receives clearance while continuing to deliver on the great software and extraordinary support you’ve come to expect from Tidepool.

Now we’re in the midst of that next great leap forward in diabetes: automation. We’ve seen what the DIY community and our device partners are capable of accomplishing. To know that Tidepool has the opportunity to be a part of this landmark effort in diabetes care, to think we have the potential to redefine the potential of digital health technology, and to share in this incredible milestone with all of you...

It’s equal parts humbling and invigorating.

As we work with the US FDA and our device partners to bring Tidepool Loop to market, there will continue to be updates to share with you to bring you up to speed on what you may expect with Tidepool Loop on its journey through review, and hopefully, to market. In keeping with Tidepool’s commitment to transparency, all submission documents will be published and available on our website upon completion of FDA’s review, expected for later this year.

We’re excited to update you on this progress that you’ve helped us make happen. With your continued support, we continue to pave it forward in the name of diabetes innovation.