Bigfoot Is Real—and Received FDA Clearance
On Monday, the Bigfoot Unity™ Diabetes Management by Bigfoot Biomedical received U.S. Food and Drug Administration clearance for individuals 12 and older. For the first time, people who use multiple daily injections (MDI) to manage their diabetes will be able to integrate with a continuous glucose monitor and get personalized insulin dosing recommendations, lessening the burden of T1D.
How It Works
Bigfoot Unity™ Diabetes Management contains three parts: the Freestyle® Libre 2 CGM sensor, the Bigfoot Unity™ proprietary pen caps and a mobile app. The user scans the Freestyle® Libre 2 CGM sensor with the Bigfoot Unity™ pen cap for rapid-acting insulin, which fits onto the end of an insulin pen. The cap then displays the user’s blood glucose level along with trend lines and recommended insulin doses. The smart pen cap also provides a suggested mealtime bolus based on parameters programmed by the user’s physician.
It is compatible with pens manufactured by Eli Lilly and Company, Novo Nordisk, and Sanofi.
Bigfoot Unity™ System also provides alerts for very low glucose, which activates when the user’s blood glucose falls below 55 mg/dL, and an optional alert for low glucose, which activates when the user’s blood glucose falls below 70 mg/dl.
The Bigfoot Unity™ pen cap for long-acting insulin provides alerts for potentially missed doses of once-a-day “basal insulin” and displays the recommended dose determined by the user’s physician. Data is uploaded automatically to the cloud over WiFi, where the user’s physician can access it.
A Big Step Forward in T1D Management
Thanks to leadership of JDRF and partners in the public and private sector, this new system is a win for the entire diabetes community, both type 1 and type 2. There has been tremendous innovation over the past 15 years in diabetes technology. Continuous glucose monitors provide real time trend information and alarms enabling people with T1D to achieve better control. CGMs are connected to insulin pumps in artificial pancreas or automated insulin delivery systems providing real time insulin dosing. However, the choice to use an insulin pump or MDI to manage T1D is extremely personal. Both MDI and pump therapy have their benefits and challenges, with the majority of people with T1D using MDI as of 2019. This clearance brings the benefits of automation and connected devices to more members of the diabetes community as the first MDI system to utilize continuous glucose data to provide low glucose alerts and personalized insulin dosing recommendations.
Read JDRF’s statement celebrating the clearance of this new therapy here.
JDRF and Bigfoot
The connection between JDRF and Bigfoot Biomedical goes back over a decade. The JDRF T1D Fund made its first equity investment in Bigfoot Biomedical in 2017, as one of the Fund’s first investments. Bigfoot is led by former JDRF CEO and International Board member Jeffrey Brewer. Under Brewer’s leadership, JDRF invested in artificial pancreas technology. This includes funding research demonstrating the benefits of utilizing CGM data to make insulin dosing recommendations, supporting the development of multiple diabetes management device systems to improve diabetes management now available to the T1D community and working with the Food and Drug Administration to ensure pathways for systems such as Unity which use interoperable devices.
To learn more about Bigfoot Unity™ Diabetes Management’s availability visit https://www.bigfootbiomedical.com/.