Tidepool Announces Plans to Create FDA-Regulated Loop
Editor’s Note 6/7/19: Medtronic has signed on as the second pump manufacturer to partner with Tidepool. The partnership was announced at the D-Data Exchange in San Francisco during the ADA 2019 conference.
Editor’s Note 11/2/18: Insulet has announced that they are the first pump partner for the Tidepool’s Loop Program. The companies are working together to develop an interoperable, automated insulin delivery system that allows Omnipod DASH to be controlled by the Tidepool Loop algorithm from an iphone.
On Monday, October 8, Tidepool announced plans to deliver an officially supported, FDA-regulated Loop app, available via the App Store. They’re calling it the “Tidepool Loop”. So what’s a Loop? Who is Tidepool? And what does this mean for the future of insulin pump and automated insulin delivery technology?
Right now, Loop is a DIY open source automated insulin delivery app. DIYers in the Type 1 diabetes community are using Dexcom CGM and older Medtronic pumps connected to the Loop app via a tool called RileyLink. The Loop app runs an algorithm for automated insulin delivery via the pump based on Dexcom CGM readings. The system is not FDA approved and requires a bit of “hacking” by users interested in setting it up.
Read much more about the current world of DIY Looping HERE.
Tidepool is a not-for-profit company that creates tools and platforms to liberate data from diabetes devices, supports researchers, and provides free software to people with diabetes and their care teams. Their mission is to make diabetes data more accessible and actionable. The Tidepool software available currently provides a platform for people with diabetes and their care providers to see all of their diabetes data in one place. Tidepool was also an early grantee of Beyond Type 1.
What does this mean for the future of automated insulin delivery?
Tidepool entering this ring is a big deal! Automated insulin delivery – closing the loop between CGM data and pump settings to keep blood sugars in range – is a hot frontier in diabetes technology innovation and development. The Medtronic 670G is the only FDA-approved commercially available device on the market. The Omnipod Horizon system and Tandem Control IQ system are both in development. And DIY-ers are building their own systems.
So far, closed-loop efforts have been segmented – algorithms and device compatibility has been limited by proprietary information. You can use the Medtronic system, wait for the Omnipod or Tandem systems, or hack something together yourself. Tidepool’s vision for the future cracks that model open. They want to work alongside a range of device companies – both CGMs and insulin pumps – and build a compatible app that runs on a smartphone. They’re working closely with pump vendors on their “iPump” capabilities, hoping to get a number of companies on board – putting the choice of CGM and pump more firmly in the hands of the patient. Tidepool is imagining a world where you can run a Loop insulin delivery system on your choice of medical device hardware.
A note from Tidepool on transparency: “Tidepool has always been, and always will be, a completely transparent organization. We’ve always felt that full transparency has the greatest positive impact on the diabetes community and industry. With Tidepool Loop, we will share everything we do openly, including all of interactions with the FDA, our quality system, our source code and our project plans. We hope that this will help other companies and projects going forward.”
Tidepool has hired DIY Loop leaders Pete Schwamb and Katie DiSimone full-time to help with this effort. They are putting safety first, partnering with the Jaeb Center for Health Research to conduct an observational study to show the safety and efficacy of the Loop system, funded by the Helmsley Charitable Trust. As always, code, designs, and intellectual property that Tidepool produces will be released.
Learn much more and get all of your questions answered over on the Tidepool Blog. Stay tuned for updates about the Tidepool Loop project. We’re looking forward to following along with you.