Tidepool Loop (closed loop app) submitted to FDA

Tidepool, an open-source diabetes non-profit company has submitted its automated insulin dosing app – called Tidepool Loop — for iPhone to the American Federal Drugs Administration (FDA) for review for the management of Type 1 diabetes. This is being presented as an interoperable automated glycaemic controller (iAGC). If cleared, Tidepool Loop could become the first app for iOS cleared for the automatic dosing of insulin. Built on 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 so that they can choose compatible components to which they either have the best access (e.g. is approved by their healthcare provider) or with which they are most familiar or comfortable using in order manage their diabetes self-care. Basically, it’s about choice and making things easier for those living with T1D.

Howard Look, CEO and co-founder of Tidepool says of the submission, “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, 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 the 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 Dexcom, Insulet (Omnipod) and Medtronic as well as donations from a diverse community of individual funders impacted by their experience with diabetes. 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 app itself.



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