Bigfoot Unity™ Diabetes Management System Receives The Green Light From The FDA
On May 10, 2021, Bigfoot Biomedical, a medical technology company, received the green light from the U.S. Food and Drug Administration (FDA) for its Bigfoot Unity™ Diabetes Management System for individuals aged 12 and older. The system features connected smart pen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy and is the first-of-its-kind.
With the approval of the Bigfoot Biomedical’s management system, users will be able to access on-demand insulin dosing support, minimizing guessing and enabling patients to follow provider guidance on insulin dosing more seamlessly. The Bigfoot Unity System has three major components: smart pen caps, a mobile app and an integrated FreeStyle Libre 2 iCGM sensor.
The smart pen cap works in conjunction with FreeStyle Libre 2 to display current blood glucose values and recommended correction doses, and deliver rapid-acting and long-acting. The pen cap will also display the provider’s recommended meal insulin doses with the correction dose, eliminating manual input of glucose data on a separate device. Data from the iCGM and time-of-dose data of the smart pen caps are automatically uploaded to the cloud whenever cellular data or WiFi is present.
While the system provides real-time blood glucose values, the system is designed to provide continuous support by sending reminders and notifications to users for their long-acting insulin doses. The system also provides hypoglycemia alerts: If a person’s blood glucose levels fall below 3.1 mmol/L55 mg/dL and 3.9 mmol/L70 mg/dL, the app will alert the user.
“Diabetes management is incredibly hard because insulin has not 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,” Jeffrey Brewer, CEO of Bigfoot Biomedical said in a press release. Brewer added that at Bigfoot Biomedical, one of the company’s goals is to ease the burden for people who need insulin by minimizing guesswork involved with insulin dosing.
The Bigfoot Unity is the only FDA-approved system to:
- Display physician recommended dosing on the pen cap using the most recent iCGM data
- Integrates Abbott’s FreeStyleLibre 2 system, a sensor-based glucose monitoring system used in the U.S. and worldwide
- Be compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens, including Eli Lilly and Company, Novo Nordisk and Sanofi
- Upload iCGM and dose-time data without manual intervention
According to Bigfoot Biomedical, the approval of the system not only benefits people living with type 1 and type 2 diabetes, but has advantages for health care providers. The system would enable providers to deliver individualized care for their MDI patients, collect data to support remote monitoring, and allow for a more harmonious and smooth process for first-time users of continuous glucose monitor (CGM) technology.
“There are more than 7 million people in the U.S. on insulin therapy and many use insulin injections multiple times a day, yet there have been few advancements for this hugely underserved market,” said Brewer in a press release. “Bigfoot Unity is specifically designed to be simple and accessible—no matter the person’s level of technical expertise—removing a key barrier to health equity.”
With FDA approval, the Bigfoot Unity™ is set to hit select diabetes clinics this spring.