On May 10, 2021 Bigfoot Biomedical Inc. received FDA Clearance for its Bigfoot Unity Diabetes Management System. Jeffrey Brewer is the co-founder and CEO of Bigfoot Biomedical, Inc. In this interview we learn about what drives Brewer and his team as well as more about the Bigfoot Unity System.

Q1: Provide a bit of background about your years of work in diabetes and why you established Bigfoot Biomedical?
A1: In 2002, my son was diagnosed with T1D. Like many families, we began learning about T1D, therapy options and research. As a tech entrepreneur, it was a very natural progression for me to begin pushing for smarter technologies to improve the lives of people with diabetes who require. I became involved with JDRF and worked to fund and launch the Artificial Pancreas Project. In 2010, I joined JDRF as President and CEO. I began building industry partnerships to drive medical device innovation, including a partnership with T1D Exchange that continues today.

It was during my tenure at JDRF that I met Bryan Mazlish, who was developing a breakthrough diabetes technology. In 2014, Bryan and I formed SmartLoop Labs and we were joined by Lane Desborough, former chief engineer at Medtronic and co-creator of Nightscout. In late 2014, Wired Magazine wrote about Bryan’s technology, but they did not know his identity, so he was dubbed “Bigfoot.” We loved the moniker and in 2015 formally changed our company name to Bigfoot Biomedical.

Q2: Provide a brief synopsis of how T1D Exchange has played a role in Bigfoot’s efforts?
A2: In early 2017, Bigfoot announced a collaboration with the T1D Exchange. It was the first investment from T1D Exchange’s initiative to accelerate the development and delivery of insulin delivery technology and solutions. It was so important to us to find a partner that supported our belief in the need for novel and disruptive approaches to delivering insulin. We’re incredibly grateful to partners like T1D Exchange who were early believers in Bigfoot.

Q3: Describe the elements of the Bigfoot Unity Diabetes Management System and its unique features among connected devices (and the insulins that can be used)?
A3: The FDA-cleared Bigfoot Unity System includes three primary components – two smart pen caps, a mobile app and the integrated continuous glucose monitor (iCGM) FreeStyle Libre 2 sensor (described below). Data from the Bigfoot Unity smart pen caps is automatically captured and uploaded to the cloud whenever WiFi or cellular signal is present, replacing the need for manual logs. The person’s diabetes care provider can view this data through the secure, online Bigfoot Clinic Hub.

    • Smart Pen Caps: The white cap is for the rapid-acting disposable insulin pen and a black cap for their long-acting disposable insulin pen – and they function differently. The Bigfoot Unity System’s smart pen caps are compatible with all major brands of rapid- and long-acting disposable insulin pens in the U.S.
      • The white smart pen cap allows the user to scan the FreeStyle Libre 2 sensor, displaying the user’s current glucose value, trend arrow and the diabetes care provider’s suggested meal insulin doses with the correction dose. It is then up the user to make that final decision of how much rapid-acting insulin to take, based on past or future factors like exercise, stress, illness, etc.
      • The black Bigfoot Unity smart pen cap for long-acting insulin functions a bit simpler – it displays the last time a basal dose was taken, and the recommended basal dose set by their person’s doctor. If it’s been longer than 24 hours since the person recorded a basal dose, the user receives a reminder alert on the Bigfoot mobile app.
    • iCGM FreeStyle Libre 2 sensor: The Bigfoot Unity System’s integration of Abbott’s iCGM means people who take multiple daily injections of insulin will receive on-demand dosing recommendations, based upon current CGM data. The dose recommendations are set by their healthcare provider.  [Provided as background by writer: In 2018 FDA cleared the first iCGM. An iCGM is integrated with other compatible medical devices and electronic interfaces, such as automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. With the 2018 clearance FDA began classifying this new type of device under class II.

    Bigfoot’s Welcome to Unity video shows how the process works.

    Q4: What care and management challenges is Bigfoot attempting to solve with the Bigfoot Unity System?
    Our focus is to take a holistic approach to insulin management that incorporates breakthrough technology to provide real-time dose-decision support to the person with connected data so diabetes care providers can provide proactive care at a distance. The Bigfoot Unity System aims to minimize the guesswork that comes with insulin dosing in a convenient, simple way. It may be going against the grain, but at Bigfoot we believe there is a significant community of users who need fewer, not more, features to be successful in managing their diabetes.

    It’s also a very exciting time to be part of the remote care conversation, certainly accelerated by COVID, as the Bigfoot Unity System automatically collects data to support Remote Physiologic Monitoring (RPM), also known as and used interchangeably with Remote Patient Monitoring (RPM) by a person’s diabetes care providers. Clinicians are seeing the value of proactive, remote care, and it’s important that solutions deliver the tools they need to make it effective and efficient.

    Lastly, Bigfoot Biomedical is introducing a very different approach to get the system into the hands of people and their diabetes care providers. We will enter into partnerships with contracted endocrinology practices and diabetes clinics. The program will be offered as a bundle of devices, supplies and services and delivered as a convenient 30-day subscription to eliminate any upfront costs.

    Q5: What people with diabetes do you particularly think the Bigfoot Unity system will work well for?
    The Bigfoot Unity System is indicated for the management of diabetes in people ages 12 years and older with T1D or T2D on multiple daily insulin injections (MDI). The system could be an important solution for individuals who may struggle with glycemic management, insulin dosing or those be unaware of hypoglycemia. We also think the system’s focus on simplicity, convenience, and ease of use, will help those with T2D that need to transition to mealtime insulin dosing. That is a big jump. They could benefit from the system’s dose-decision support.

    Q6: When and how will people be able to obtain the Bigfoot Unity System and how will they do so?
    The Bigfoot Unity System is not available for purchase on its own. It is part of the Bigfoot Unity Program provided through the person’s diabetes care provider.

    Q7: What are the benefits of the Bigfoot Unity System for the diabetes care providers?
    We believe that the Bigfoot Unity System could be a gamechanger by replacing guesswork and complexity with connectivity and simplicity. The key benefits can:

    • Enable clinicians to deliver individualized, proactive care remotely, and easily track the people they care for who use the Bigfoot Unity system.
    • Introduce a simple, accessible system to their patients with Bigfoot taking the responsibility to help people learn and use the system with ongoing customer support
    • Support to their patients to make confident, personalized insulin. dosing decisions and ensuring a smooth on-ramp for first-time users of CGM technology.
    • Automatically collecting data to support Remote Physiologic Monitoring by diabetes care providers.