Tidepool to Develop an FDA-Regulated Insulin Delivery App with Support from JDRF and The Helmsley Charitable Trust

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With an influx of $6 million combined from funders JDRF and The Leona M. and Harry B. Helmsley Charitable Trust, Tidepool—a nonprofit software organization—is expanding their team to develop and support Tidepool Loop, a hybrid closed loop automated insulin delivery app. The app, which Tidepool will submit to the FDA for review, will be based on the current DIY Loop, and will enable a larger contingent of the type 1 diabetes (T1D) community to better manage their blood-glucose levels from their smartphones.

Brandon Arbiter, VP of product and business development at Tidepool, says the organization has been working with JDRF for more than five years, and this type of collaboration is a key component in creating opportunities to produce important tools like this for people with T1D. “Both JDRF and The Helmsley Charitable Trust have been major catalysts for patient choice and interoperability in diabetes devices.” Arbiter says a lot of people behind the scenes have also helped initiate this project. “Many device makers, researchers, clinicians and people with diabetes wrote letters of support to JDRF for this proposal. Like so much innovation in the diabetes world, this was and will continue to be a community-driven effort.”

Tidepool Loop is designed for interoperability, so it can be compatible with a variety of insulin pumps and continuous glucose monitors (CGMs). It will literally put glucose control at a person’s fingertips. “Interacting with your diabetes devices through a smartphone or smartwatch interface can be more intuitive than a conventional insulin-pump interface,” says Arbiter.

Aaron Kowalski, Ph.D., chief mission officer for JDRF, says that level of choice and ease is critical, as different people will want to use different devices. He also cites a need for solutions to be accessible to everybody. Tidepool Loop’s precursor DIY Loop has allowed some people to manage their diabetes in an innovative way, but there are both technical and cost barriers that keep most people from employing that solution.

Currect DIY Loop users need to purchase an older, out-of-warranty pumps for between $500-$2,500 on the gray market, compile the software code on their computer, stay up to date with new releases and purchase a wireless translator device. For those reasons, and the fact that many health care providers and people with diabetes aren’t comfortable prescribing or using a non-FDA approved product, only about 1 in every 1,000 people with T1D in the United States use DIY Loop. “We need the ability to use approved pumps, not buy them on Craigslist and Facebook, to have multiple potential solutions,” says Kowalski.

Tidepool Loop aims to reduce or remove these barriers, giving more people the opportunity to choose this technology for their diabetes management. In addition to being regulated by the FDA, Tidepool Loop will be officially supported by Tidepool. It will work with commercially supported pumps, rather than older models. Users will be able to simply download the app from the App Store, rather than compiling code themselves. And, it will connect directly to a user’s devices, so they won’t have to carry around a separate wireless translator device. “The end game is a cure, but if we can provide tools that help us make life healthy and make it easier until we get there, that’s a win,” says Kowalski.

Another major advantage to a smartphone-based controller for an automated delivery system is that softwares updates might be available more frequently that with traditional device-based systems. The user interface, algorithm, data visualization and overall user experience can be upgraded when a new version is available. “As an industry, we should be improving these products more often than every four years,” says Arbiter.

Stay up to date with the latest Tidepool Loop announcements at tidepool.org/loop.