- Integrated with Abbott’s FreeStyle® Libre 2 system, the Bigfoot Unity System is the first and only to translate continuously monitored glucose data into on-demand insulin dose recommendations displayed right on the pen-cap screen for ease of use
- First and only FDA-cleared dose decision support system with real-time hypoglycemia alerts2,3 and compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens
- Bigfoot Unity System is the centerpiece of the larger holistic program to simplify and connect key aspects of insulin management for patients and health care providers, allowing for individualized, proactive care
Bigfoot Biomedical, a company dedicated to better health outcomes for people with insulin-requiring diabetes, announced today that the FDA has granted 510(k) clearance for first-of-its-kind 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 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 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 health care providers.
How the Bigfoot Unity System Works
The Bigfoot Unity System has three primary components — proprietary smart pen caps for both rapid- and long-acting insulin, mobile app and integrated FreeStyle Libre 2 iCGM sensor — that seamlessly fit into the person’s dose decision process when they need it throughout the day.
The Bigfoot Unity smart pen cap for rapid-acting insulin allows the user to scan the FreeStyle Libre 2 sensor, displaying the user’s current glucose value, trend arrow and any recommended correction dose. The smart pen cap also directly displays the health care provider’s suggested meal insulin doses with the correction dose. In just a few steps the system gives the person with diabetes support to make a real-time treatment decision.
While the Bigfoot Unity System’s dose recommendations are on demand as needed by the user, the system also provides continuous support with important reminders and alerts. The Bigfoot Unity System notifies the person if they may have missed their usual long-acting insulin dose. The Bigfoot Unity app also provides a very low glucose alert when the person’s glucose value falls below 55 mg/dL as well as an optional low glucose alert when the glucose value falls below 70 mg/dL.
Data from the iCGM and time-of-dose data from the Bigfoot Unity pen caps are automatically captured and uploaded to the cloud whenever WiFi or cellular signal is present, replacing the onerous manual logs typically kept by people on MDI therapy. The person’s health care provider also can view this patient data through a secure web portal, the Bigfoot Clinic Hub.
Health Care Providers Gain Real-Time Partner to Help Support Patients
The FDA-cleared Bigfoot Unity System is included as part of a more comprehensive program offering, focused on helping health care providers deliver individualized and proactive care to their patients with insulin-requiring diabetes. The Bigfoot Unity program supports treatment of a broad spectrum of patients on MDI therapy from those with Type 1 diabetes not on insulin pumps to those with Type 2 diabetes needing to step up their insulin therapy. The program’s holistic approach focuses upon the key aspects of insulin management for patients struggling with glycemic control, insulin dosing or those experiencing hypoglycemic unawareness.