Digital Media Net - Your Gateway To Digital media Creation. News and information on Digital Video, VR, Animation, Visual Effects, Mac Based media. Post Production, CAD, Sound and Music
Categories: News

Tidepool Announces Completion of Tidepool Loop Human Factors Validation Study

FacebookFacebookTwitterTwitterEmailEmailWhatsAppWhatsAppFlipboardFlipboardGmailGmailRedditRedditLinkedInLinkedInMessengerMessengerShareShare

Open Source Diabetes Nonprofit Down to Final Steps in Preparation for FDA Submission

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. 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.

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 Mobile, Tidepool Uploader, 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.

Contacts

Christopher Snider

Melissa Lee

media@tidepool.org

Staff

Recent Posts

Oclean Pocket-Sized Water Flosser Is Quietly Changing How People Floss on the Go

NEW YORK, NY / ACCESS Newswire / July 26, 2025 / As more people look…

21 hours ago

Norman Reedus Launches bigbaldhead Bourbon

bigbaldhead bourbon is here-and it's making its debut live at San Diego Comic-Con 2025. The…

21 hours ago

Home Team Luxury Rentals Surpasses $50 Million in Airbnb Bookings in Just 12 Months – Without a Single Outside Investor

One of the Only 100% Privately Owned Luxury Short-Term Rental Companies to Cross the $50M…

21 hours ago

Cypher Metaverse Inc. Announces Closing of Financing

VANCOUVER, BC / ACCESS Newswire / July 25, 2025 / Cypher Metaverse Inc. (CSE:CODE.X) ("Cypher"…

21 hours ago

BioNxt Solutions Announces Closing of First Tranche of Convertible Debenture Unit Private Placement

NOT FOR DISTRIBUTION TO UNITED STATES NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED…

21 hours ago