If you’re just now hearing about Tidepool Loop and want to know how we got here, this post will serve as a brief overview to catch you up to speed on what we have been up to for the past few years.
It is impossible to understand the history of Tidepool Loop without knowing a tiny bit about do-it-yourself (DIY) Loop. DIY Loop is a remarkable, patient-led effort by amazing community members that created and maintain the open source code for an iPhone app that automates insulin delivery. The app connects to insulin pumps and CGMs, and runs an insulin dosing algorithm to automatically control glucose and reduce the burden of type 1 diabetes. You can read more about the history of DIY Loop from this detailed post by our friend Nate Rackyleft, the original developer of DIY Loop. This project has been and continues to be impactful for the diabetes community, but we must stress that DIY Loop is not a Tidepool project. DIY Loop requires off-label use of the insulin pumps and CGMs it connects to, and it is NOT cleared or approved by the FDA.
In 2018, Tidepool announced the launch of the Tidepool Loop development efforts, a project dedicated to delivering an officially supported, FDA regulated version of the Loop app, making it broadly available to download via the iOS App Store. We announced that we would be the first to champion true interoperability with an app that would work with compatible ACE pumps and iCGMs, made by different manufacturers, that were cleared to work with automated insulin dosing systems.
We worked closely with commercial device manufacturers and grant-making organizations like JDRF, Helmsley Charitable Trust, the Tullman Family Foundation, the H.W. Goldsmith Foundation, and many other generous individual donors to help fund the work it would take our team to undertake this initiative.
Along with more than 1000 participants from the DIY community in the Looped Facebook group, we partnered with the Jaeb Center for Health Research to conduct an observational study. Over 850 people in the study contributed six to twelve months of clinical data, which was used, in part, to demonstrate the safety and efficacy of DIY Loop when used by people with type 1 diabetes. This incredible amount of data from the observational study represented over three times the amount of data from other AID system pivotal trials at the time… combined - an incredible testament to the willingness of the DIY community to “pay it forward.”
Tidepool also worked closely with the FDA, meeting early and often with the Agency to make sure we comprehensively demonstrated that Tidepool Loop was safe and effective for the diabetes community. The goal was not just to get a new tool in the hands of people with diabetes, but also to help pave the regulatory road for future submissions and diabetes device innovation.
In December of 2020, we announced the completion of our FDA submission of Tidepool Loop. If this is the first you are hearing about Tidepool Loop, know that there is an amazing team and community of people with diabetes that have worked long and hard to create this amazing tool. We chose to take on Tidepool Loop because we believe in patient choice and interoperability. We believe a modern approach to software development can push the diabetes industry forward by leaps and bounds. We believe in the power of community-driven, open source solutions to reduce the burden of insulin-requiring diabetes. And we believe in our community’s ability to redefine the potential of digital health technology through patient-led innovation.
If you are as excited as we are, we invite you to sign up to receive Tidepool Loop news and updates so you can stay in the loop with the rest of the Tidepool community.