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Bigfoot Biomedical, a medtech company based in California, has developed the Bigfoot Unity System, a diabetes management technology for patients on multiple daily injection therapy. The system uses continuous glucose monitoring data and doctor recommendations to provide insulin dose recommendations, helping patients to avoid uncertainty.

The company argues that type 2 diabetes patients have been historically underserved by the medtech industry, in part because such patients typically tend to be older at diagnosis, and perhaps less inclined to adopt new technologies. This contrasts with type 1 “power users” who are more aware of the nuances of their disease at an early age and are better disposed to adopt new technologies to help manage it.

Bigfoot aims to provide technological solutions to help such patients to manage their disease more effectively.

Medgadget last spoke with Bigfoot Biomedical CMO Red Maxwell in March 2020. Now, we talk with Jeffrey Brewer, CEO and co-founder at Bigfoot Biomedical, to catch up on how the technology and field has progressed.

Conn Hastings, Medgadget: Please give us an overview of the challenges those with type 2 diabetes face in managing their blood glucose levels day to day.

Jeffrey Brewer, Bigfoot Biomedical: Effectively managing glucose levels is often very challenging for people with insulin-requiring diabetes, especially those with type 2 given they have fewer tools designed for them compared to those with type 1.  Checking blood glucose levels, counting carbohydrates, calculating basal (long-acting) and bolus (rapid-acting) insulin injections, doing calculations at every meal – it can all be very complex and overwhelming. Challenges and activities such as these are difficult and time-consuming for people with both type 1 and type 2 diabetes. Historically, people on multiple daily injections have had few solutions available to alleviate the burden of these challenges.

Another challenge faced is suboptimal insulin use either through missed or mistimed insulin dosing. We also see limitations in glucose management because providers are reluctant to instruct correction dosing due to fears of patient miscalculations and insulin stacking.

Over time, high glucose levels can lead to severe complications such as kidney failure, cardiovascular disease, nerve damage and blindness. People with type 2 have been facing these challenges with too few tools and resources, and have been underserved for far too long. It’s something that Bigfoot Biomedical is determined to address.

Medgadget: How are such patients underserved compared with those with type 1 diabetes? If so, why does this disparity exist?

Jeffrey Brewer: People with type 2 diabetes represent 90-95% of the total diabetes population, and subsequently drive more healthcare costs than the type 1 population.  Yet we still see an immense gap in the technological advances for people with type 2. They have been woefully underserved by the health-tech industry which has focused its innovation on “power users” with type 1.

The reason this disparity exists largely stems from the fact that people with type 1 are diagnosed as children and must thoroughly understand the seriousness of diabetes at a young age. They have a robust understanding of highs and lows, time in range, and what actions to take to keep levels where they need to be. The perceived severity of type 1 also encourages people to adopt technology that supports their insulin management. Insulin pumps for example, are almost exclusively used by people with type 1.  When you look at the type 2 population, the patient journey is vastly different. They are almost always diagnosed later in life and generally haven’t been raised with an understanding of the seriousness of diabetes, or the skills to manage it. It’s a complicated condition that is very difficult to understand and manage in a short period of time. It can be hard for people with type 2 to get into the swing of things, especially when the learning curve is paired with the unfamiliarity of complicated technology.

People with type 2 are usually 45+ years old. They are less likely to adopt technology of any kind compared to younger people with type 1, especially technology for a disease they aren’t immensely familiar with. Because of this, many medical device companies have prioritized innovation for the type 1 population, despite the higher prevalence of type 2. Disruption in diabetes tech for people with type 2 is long overdue. 75% of people with diabetes are not achieving their diabetes care goals – that’s a problem. People on multiple daily injection therapy need better access to tools that could help them better manage their diabetes.

Medgadget: How is Bigfoot Biomedical working to help correct this disparity?

Jeffrey Brewer: We’re taking an unconventional approach to delivering simple, connected, and comprehensive solutions for those who have been overlooked by diabetes innovation, and we’re doing it with our Bigfoot Unity System.

Bigfoot Unity enables, for the first time, people on multiple daily injection (MDI) therapy to get an insulin dose recommendation, on-demand, based on continuous glucose monitoring (CGM) data and their doctor’s instructions – helping to take the anxious guesswork out of daily insulin dose management.

We know that episodic, quarterly doctor visits and A1C checks can make it difficult for people with diabetes to feel “all in” and fully supported on their diabetes management journey.  With Bigfoot Unity, people have an easy-to-use solution that helps them keep on track of dose times and dose recommendations, each and every day. Just like with any big-picture plan, that’s how you achieve results – by consistently taking the small steps to get there. We’re in it with them for the long haul, because at Bigfoot, people with type 2 aren’t misunderstood and under supported.

Medgadget: Please give us an overview of the Bigfoot diabetes management system and its components.

Jeffrey Brewer: The Bigfoot Unity System, which is the centerpiece of our larger Bigfoot Unity Program, is the first and only FDA-cleared solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly integrates CGM data to provide an insulin dose recommendation. The dose, which is based upon instructions from the person’s health care provider, is displayed directly on proprietary, connected smart caps of the person’s disposable insulin pens.

 The system features smart pen caps compatible with a comprehensive list of commercially available disposable insulin pens for both long-acting and rapid-acting insulin. The pen caps integrate seamlessly with the Freestyle Libre 2 CGM sensor to provide current glucose information and insulin dose recommendations.

The CGM and dosing data is uploaded automatically to the Bigfoot Clinic Hub, a secure, cloud-based hub that enables healthcare professionals to review health data and provide proactive, personalized care to their patients.

When you combine these components, you get a comprehensive solution that is easy for people with diabetes to understand and follow.

Medgadget: How does the system help Type II patients to manage their condition?  How does it improve on ‘traditional’ approaches?

Jeffrey Brewer: Bigfoot Unity provides real-time insulin dose recommendations based on current CGM readings and physician instructions. It takes the anxious guesswork out of daily insulin management. It also provides reminders for potentially missed long-acting insulin doses, designed to increase the likelihood that users never miss a dose, and provides notifications for when a person’s glucose level is too low.

This differs from the traditional approach of manually determining insulin doses and trying to remember when you took your last dose. With Bigfoot Unity, there is no manual data entry. The smart caps seamlessly integrate the Freestyle Libre 2 CGM sensor, allowing people with diabetes to easily determine their healthcare professional’s recommendation based on their current glucose readings from their CGM or Blood Glucose Meter. Simplicity is key to adherence, and Bigfoot Unity was designed to give clear guidance on how much to take and when, so people with diabetes can get back to using their time and energy doing the things that matter most to them.  

Medgadget: Where is the system available at present?

Jeffrey Brewer: Bigfoot Unity is cleared by the FDA and available across the U.S. We’re actively working to expand access so more people with insulin-requiring diabetes can take control of their diabetes with a comprehensive, simple, and holistic solution.  

Medgadget: Where do you see diabetes management going in the future? How will Bigfoot Biomedical contribute to this?

Jeffrey Brewer: I think it’s critical that innovators focusing on diabetes management meet people where they’re at. We need to understand what their day-to-day looks like, what their challenges are and how we can support those challenges. For people with type 2, there isn’t enough simple technology to effectively help them manage their condition in a way that makes sense. I see a future where more companies see this gap, and more people with diabetes are empowered to understand and take ownership of their disease through the support of technology that removes the feeling of isolation that so often stems from diabetes management. 

Bigfoot Biomedical was built to change the paradigm of care for diabetes. Today, we’re taking unconventional approaches and making bold moves to offer holistic, integrated solutions with the goal to simplify and improve care for people with diabetes. As time goes on, our contributions will continue to broaden to fulfill our mission. We’ll never stop relentlessly striving to free people with insulin-requiring diabetes to live the lives they choose.

Link: Bigfoot Biomedical homepage…

Flashbacks: Bigfoot Biomedical for More Accurate Insulin Dosing: Interview with CMO Red Maxwell; Bigfoot Biomedical’s Diabetes Management System Going on Trial;

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