Bigfoot Unity Diabetes Management System Cleared by FDA

The FDA has granted 510(k) clearance for 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 provide on-demand, insulin dose decision support to minimize guesswork and enable patients to follow their doctor’s instructions in a convenient, simple way. This 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.
 
The Bigfoot Unity System 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 proprietary, connected smart cap for the person’s disposable insulin pens without the need to manually input glucose data on a separate device. Cleared for use by individuals aged 12 and up, the system is designed to clearly, and in real-time, help answer the question, “How much insulin would my doctor recommend I take right now?”
 
“Diabetes management is incredibly hard because insulin has no 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,” said Jeffrey Brewer, CEO of Bigfoot Biomedical. “At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimizing the anxious guesswork involved with insulin dosing in a convenient, simple way.”
 
The Bigfoot Unity System can:
 

• Display physician recommended dose at point-of-therapy using current iCGM data right on the pen cap
• Seamlessly integrate with Abbott’s FreeStyleLibre 2 system, the leading sensor-based glucose monitoring system in the U.S. and worldwide4
• Compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens—including those produced by Eli Lilly and Company, Novo Nordisk and Sanofi
• Upload iCGM and dose-time data without manual intervention from the patient or the health care provider to enable ongoing, proactive patient care through remote physiologic monitoring

 
“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,” commented Jared Watkin, senior vice president, Diabetes Care, Abbott. “Through Abbott’s collaboration with Bigfoot Biomedical, we’re integrating our revolutionary, easy-to-use FreeStyle Libre 2 technology with the Bigfoot Unity System to provide automated information for personalized diabetes management.”
 
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 avery 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.
 
Benefits for Health Care Providers
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.  
 
“For health care providers the Bigfoot Unity diabetes management program could be a gamechanger by connecting them to data that can provide better insight into what their patients are actually doing,” explained diabetologist Jim Malone MD, chief medical officer for Bigfoot Biomedical. “By replacing guesswork and complexity with connectivity and simplicity, the Bigfoot Unity program is truly serving as that real-time partner for both patients and providers when it comes to dose decision support and overall diabetes management.”
 
The Bigfoot Unity program will be available through select diabetes clinics beginning in spring 2021.