Tidepool Completes Its Summative Human Factors Validation Stud for Tidepool Loop: Open Source Diabetes Nonprofit Down to Final Steps in Preparation for FDA Submission

November 12, 2020

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.

Tidepool notes: 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. Tidepool is partnered with device makers Insulet (PODD), Dexcom (DXCM), Medtronic (MDT), and two additional yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform in development.

Tidepool’s validation study, announced on the company’s blog in September, included over 50 participants. Cohorts included adults with type 1 diabetes, caregivers of people with type 1 diabetes, independent pediatric participants with type 1 diabetes, and pediatric participants with type 1 diabetes paired with their caregivers. Each participated in the remote study using Apple iPhones and Apple Watches preloaded with software by Tidepool. Participants simulated completion of certain critical tasks related to the delivery of insulin, configuration of settings, and the entry of data via the app’s user interface. Tidepool was supported in the study conduct by Core Human Factors, Inc in Pennsylvania, with remote conduct of the Tidepool study arms made possible through remote user research software by Lookback.

The final report from the study will be included with Tidepool’s upcoming medical device submission to US FDA. All submission documents will be published and available at tidepool.org.

The human factors study comes on the heels of a broader Loop Observational Study conducted by JAEB Center for Health Research that studied the algorithm as it’s employed in the Loop mobile application developed in the do-it-yourself diabetes community. Tidepool has implemented this algorithm in Tidepool Loop and will submit study data from the Loop Observational Study in support of its submission.

“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. We couldn’t do this work without the community — who stepped up to volunteer for the study and who continue to support our mission through our Pave It Forward fundraising campaign.”

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

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