Tidepool Announces Completion of Tidepool Loop Human Factors Validation Study
Summary
PALO ALTO, Calif.--(BUSINESS WIRE)--Tidepool, a 501(c)3 nonprofit committed to providing free software for the diabetes community, today announced the completion of its summative human factors validation study for Tidepool Loop, an automated insulin dosing app in development intended for the management of Type 1 diabetes. 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. Participants simulated completion of certain critical tasks related to the delivery of insulin, configuration of settings, and the entry of data via the apps user interface. “I could not be prouder of our team and how we quickly adapted to the challenges of conducting a remote study during a pandemic,” said Howard Look, CEO and co-founder of Tidepool. “Our next step is to submit Tidepool Loop for review to FDA in the hopes of seeing our software cleared and available in the App Store.
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