Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system.
Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors.
The company announced collaborations in the past that include pumps from Insulet and Medtronic. However, it has not yet announced its initial launch device partners. It currently has a development partnership with Dexcom and additional yet-to-be-named medical device companies.
In a blog post on the company’s website last month, Howard Look, Tidepool’s founder, president and CEO, confirmed the FDA clearance.
“What we submitted was different from other [AID] solutions on the market, because our submission did not depend on proprietary insulin pump or continuous glucose monitoring hardware that we develop or control,” Look wrote. “Instead, we submitted Tidepool Loop as a fully interoperable solution for diabetes management. Giving people living with diabetes the freedom and flexibility to collaborate with their healthcare providers, to select the interoperable hardware components, and to establish the settings configurations that work best for their particular situation is part of our bigger goal. FDA clearance is a critical milestone in that roadmap.”
More about Tidepool Loop
Tidepool designed Tidepool Loop for the management of type 1 diabetes in people with diabetes six years of age or older. It has compatibility with the Apple Watch, according to the company’s website.
According to a news release, the algorithm works with compatible integrated CGMs and alternate controller-enabled (ACE) pumps. It automatically increases, decreases and suspends delivery of basal insulin based on CGM readings and predicted glucose values. The algorithm can also recommend and deliver correction boluses when it predicts exceeded predefined thresholds.
The system can now serve as a predicate device for future interoperable AID submissions, Tidepool said. This provides a more clearly defined pathway through the regulatory process. It offers the same opportunity for CGM makers. In addition to defining the regulatory pathway, Tidepool says this creates a path for more rapid diabetes innovation, too.
Grants from JDRF, the Helmsley Charitable Trust and the Tullman foundation helped support the company’s work. Additionally, a diverse community of individual funders impacted by their experience with diabetes supported the development.
“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” Look said. “I’d also like to personally acknowledge and celebrate the contributions of the DIY community and participants in the Loop Observational Study conducted by the JAEB Center for Health Research who made this milestone possible.”