Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system.
Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release.
Bigfoot Unity smart pen caps offer on-demand insulin dose decision support in an effort to minimize guesswork and allow patients to follow their doctors’ instructions in a convenient, simple way while managing their type 1 or type 2 diabetes.
The company touts the Bigfoot Unity system as the first and only solution for those (12 years old and up) with type 1 and type 2 diabetes who are on MDI therapy that directly uses integrated continuous glucose monitoring system (iCGM) data from Abbott’s FreeStyle Libre 2 system to provide an insulin dose recommendation.
Doses are displayed on a proprietary connected smart pen cap for the person’s disposable insulin pens, eliminating the need to manually input glucose data on a separate device. The device is compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens, Bigfoot said. Among those brands are pens made by Eli Lilly, Novo Nordisk and Sanofi.
“Diabetes management is incredibly hard because insulin has no fixed dose or timing, leaving individuals to constantly determine their doses and configure devices as they make multiple critical decisions every day about how much insulin to take,” Bigfoot Biomedical CEO Jeffrey Brewer said in the release. “At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimizing the anxious guesswork involved with insulin dosing in a convenient, simple way.”
“People with diabetes can be overwhelmed with the amount of data they get from multiple devices, so it’s important to develop connected technologies that simplify the experience,” added Abbott SVP of diabetes care Jared Watkin. “Through Abbott’s collaboration with Bigfoot Biomedical, we’re integrating our revolutionary, easy-to-use FreeStyle Libre 2 technology with the Bigfoot Unity system to provide automated information for personalized diabetes management.”