Tidepool Completes FDA 510(k) Submission of Tidepool Loop

PALO ALTO, Calif.--(BUSINESS WIRE)--Tidepool, a 501(c)3 nonprofit, today announced completion of its FDA submission of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes.

The nonprofit was notified on December 22, 2020, that the submission had completed FDA’s administrative acceptance review and was proceeding to substantive review as an interoperable automated glycemic controller (iAGC). If cleared, Tidepool Loop could become the first app for iOS cleared for the automatic dosing of insulin.

Built on the extraordinary foundation of the do-it-yourself diabetes community’s original Loop app, Tidepool Loop is a first-of-its-kind project to take a patient-led innovation and shepherd it through US FDA’s regulatory process with the goal to make the app more broadly accessible to people with diabetes and their clinicians. The app is designed to connect with a variety of compatible insulin pumps and continuous glucose monitoring systems (CGM) to automatically dose insulin for the treatment of insulin-requiring diabetes in an effort to keep a user’s glucose within a desired correction range. The goal of the interoperable design is to provide flexibility for users and their healthcare teams to choose the compatible components to which they have the best access or with which they are most familiar using in managing their care.

“We are standing on the shoulders of giants — people in the open source diabetes community who believe management tools should work better together and created software for themselves and their community,” said Howard Look, CEO and co-founder of Tidepool. “Just two years from kicking off the project, we’ve taken that foundation and built a system we’re proud to put in front of FDA. We’re committed to working alongside the agency and our device partners to drive progress in the areas of device interoperability and access, and we look forward to FDA’s review.”

Tidepool Loop was initially supported by grants from JDRF and The Leona M. and Harry B. Helmsley Charitable Trust, and further supported by partnerships with device makers and donations from a diverse community of individual funders impacted by their experience with diabetes. Tidepool recently drove support through the #PaveItForward community fundraising campaign to give people with diabetes the opportunity to support the Tidepool Loop development effort.

In keeping with Tidepool’s commitment to transparency, all submission documents will be published and available at tidepool.org upon completion of FDA’s review, expected for later this year.

About Tidepool

Tidepool is a 501(c)3 nonprofit organization on a mission to make diabetes data more accessible, actionable, and meaningful for people with diabetes, their care teams, and researchers. Founded in 2013, Tidepool hosts a suite of free software tools for people with diabetes and the clinics that serve them, including Tidepool Web, Tidepool Uploader, Tidepool Mobile, and, pending FDA submission, review, and clearance, Tidepool Loop. Learn more at tidepool.org. Follow us on Twitter at @Tidepool_org and on Facebook and Instagram.