Bigfoot Biomedical is a company that MD+DI readers should be quite familiar with by now. In 2017, the diabetes company was selected as the readers’ choice for Medtech Company of the Year. The company is developing products to optimize insulin dosing and provide automated insulin delivery for people with insulin-requiring diabetes.
Just this week, FDA cleared the Bigfoot Unity Diabetes Management System, which features connected smart pen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy. The Bigfoot Unity smart pen caps are designed to provide on-demand, insulin dose decision support to minimize guesswork and enable patients to follow their doctor’s instructions in a convenient, simple way. The Milpitas, CA-based company says the Bigfoot Unity System is the centerpiece of the larger Bigfoot Unity program that takes a holistic approach to simplify and connect key aspects of insulin management for patients and healthcare providers.
The Bigfoot Unity System is the only solution for people with either type of diabetes 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, which is based on a physician’s instructions. The dose is displayed directly on a connected smart cap (pictured below) for the person’s disposable insulin pens without the need to manually input glucose data on a separate device. Cleared for ages 12 and up, Bigfoot says its system is designed to clearly, and in real-time, help answer the question, “How much insulin would my doctor recommend I take right now?”