Bigfoot Scores FDA Clearance for Diabetes Management System

Bigfoot Biomedical is a company that MD+DI readers should be quite familiar with by now. In 2017, the diabetes company was selected as the readers' choice for Medtech Company of the Year. The company is developing products to optimize insulin dosing and provide automated insulin delivery for people with insulin-requiring diabetes.

Just this week, FDA cleared 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 are designed to 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 Milpitas, CA-based company says 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 healthcare providers.

The Bigfoot Unity System is the only solution for people with either type of diabetes on MDI therapy that 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 connected smart cap (pictured below) for the person's disposable insulin pens without the need to manually input glucose data on a separate device. Cleared for ages 12 and up, Bigfoot says its 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.”

How the Bigfoot Unity Diabetes Management System Works

The Bigfoot Unity System has three primary components — smart pen caps for both rapid- and long-acting insulin, mobile app, and integrated FreeStyle Libre 2 iCGM sensor.

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 healthcare provider’s suggested meal insulin doses with the correction dose. In just a few steps, the system is designed to give 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 healthcare provider also can view this patient data through a secure web portal, the Bigfoot Clinic Hub.

The Bigfoot Unity System is included as part of a more comprehensive program offering, focused on helping healthcare 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 was designed to focus on the key aspects of insulin management for patients struggling with glycemic control, insulin dosing, or those experiencing hypoglycemic unawareness (A complication of diabetes in which the patient is unaware of a deep drop in blood sugar because it fails to trigger the secretion of epinephrine which generates the characteristic symptoms of hypoglycemia).

“For healthcare providers the Bigfoot Unity diabetes management program could be a game changer by connecting them to data that can provide better insight into what their patients are actually doing,” said 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.”