3 ways Tidepool has made change happen in diabetes

Since our founding in 2013, Tidepool has been at the forefront of championing regulatory change and intra-industry collaboration. We believe we’ve meaningfully impacted how diabetes and other healthcare innovations are developed and regulated today.

1. Bringing industry together in collaboration for people with diabetes

In 2014, just after our founding, our goal of taking data from many devices and unifying it in one dynamic, sleek online interface was called “ambitious.”

Tidepool did it though. We successfully convinced every major diabetes device maker to partner with us. Today, our platform supports over 50 unique devices and diabetes apps. We serve tens of thousands of users, with a record 150% growth in the last year with the launch of our telemedicine resources during a global pandemic.

"The vision is about creating an ecosystem, where you get to choose what's right for you as a person with diabetes. This pushes everyone forward in thinking about interoperability and interchangeability, and that makes for a better world for people with diabetes." — Howard Look, Tidepool CEO

2. Working closely with the US FDA to create new regulatory pathways

In 2018, Tidepool was one of only nine companies accepted into the FDA’s Digital Health Software Pre-Certification Program, alongside Google’s Verily, Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, and Samsung. The program’s stated goal was to bring together companies demonstrating “a robust culture of quality and organizational excellence” in order to help FDA develop future regulatory models for “more streamlined and efficient regulatory oversight of software-based medical devices.”

As Tidepool has championed interoperability and the breakdown of industry silos, US FDA has moved to incentivize the development of new, interoperable devices (devices designed to work together across platforms and companies) by creating new pathways to market for insulin pumps, CGMs, and automated controllers. Tidepool has been a part of those discussions with FDA from the very beginning. With Tidepool Loop, we hope to be the first company to bring to market an interoperable automated controller app for iPhone through this new pathway.

3. Taking DIY community-led innovation through official regulatory channels

Perhaps the boldest step that Tidepool has taken is volunteering to take patient-built software and take responsibility for guiding it through a federal regulatory agency’s rigorous and thorough review.

When we can finally realize our vision of launching Tidepool Loop in the App Store, we hope to have demonstrated that patient-led innovation — tried and tested among do-it-yourselfers — can be safe and effective enough for a wider audience. We believe that FDA clearance of Tidepool Loop would have the potential to broaden access and put cutting edge technologies into the hands of those who cannot build it themselves.

Support us on this pathway?

What can you do as a member of our community to champion our calls for change and support bringing our vision to life? We’d like to humbly ask you to please consider a gift of support to Tidepool. We are the only nonprofit 501(c)(3) organization in diabetes with a commitment to bringing you continuous innovation.

We believe that our nonprofit status gives us the courage to do all that we’ve done to date and all that we intend to keep doing for you and your families. But the truth is that we could not do this work we do for our community without your support.