Bigfoot Biomedical® Receives FDA Clearance for New Diabetes Management System
Bigfoot Biomedical® Receives FDA Clearance for Bigfoot Unity™ Diabetes Management System, Featuring First-of-its-Kind Smart Pen Caps for Insulin Pens used to Treat Type 1 and Type 2 Diabetes
The Bigfoot Unity System includes a smart pen for both short and long-acting insulin, a mobile app, and the FreeStyle Libre 2 Continuous Glucose Monitor (CGM). Usually, the Libre 2 required a device that would scan the libre that is attached to your skin, but with the Bigfoot system, the bolus (rapid acting insulin) pen cap scans the Libre. This Smart Pen Cap will take the current blood sugar and tell the patient much insulin to inject based on your insulin to blood glucose ratio from their doctor.
The system includes a sensor so that everything is connected, as opposed to using a pen and a separate CGM. Users can scan their blood glucose and find out how much insulin to use right on the pen cap, without having to enter their blood glucose on their device, like with the InPen. The Bigfoot Unity app notifies the patient if their blood sugar is low, along with if they missed their basal (long-acting insulin) dose.
Jared Watson, the senior vice president of Diabetes Care at Abbott said, ‘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.’
The goal of the Bigfoot Unity System is to provide simplicity for patients who are using MDI to manage their diabetes. They also provide training and an onboarding process for those who are less comfortable with a CGM, or any aspect of the system.
There is no information about how this system offers any help with carb counting and insulin to carb ratios to calculate insulin doses. Considering this is a major part of diabetes management, this could majorly discount the proclaimed “simplicity” of the system.
Integrated Diabetes Services is the worldwide leader in one-on-one consulting for people who use insulin. Diabetes “coaching” services are available in-person and remotely via phone and the internet for children and adults.