MILPITAS, California – (BUSINESS WIRE) – Bigfoot Biomedical, a company committed to improving health outcomes for people with insulin-dependent diabetes, announced today that the FDA has granted 510 (k) clearance for the unique Bigfoot Unity ™ diabetes management system of its kind, Smart Connected Pen caps that recommend insulin doses for people using Multiple Daily Injection (MDI) therapy. Bigfoot Unity’s smart pen caps provide assistance in deciding insulin doses when needed, to minimize the guesswork and allow patients to follow their doctor’s instructions in a convenient and easy way. The Bigfoot Unity System is at the heart of the larger Bigfoot Unity program, which takes a holistic approach to simplifying and connecting important aspects of insulin management for patients and healthcare providers.
The Bigfoot Unity System is the first and only solution for people with Type 1 or Type 2 diabetes on MDI therapy that uses data directly from the Integrated Continuous Glucose Monitoring System (iCGM) from Abbott’s FreeStyle Libre 2 System to provide an insulin dose recommendation based thereon on the advice of a doctor. The dose is displayed directly on a proprietary, attached smart cap for the person’s single-use insulin pens without the need to manually enter the glucose data on a separate device. The system has been approved for people aged 12 and over and is intended to answer the question “How much insulin would my doctor recommend if I take it now?” In real time, clearly and in real time.
“Diabetes management is incredibly difficult because insulin doesn’t have a fixed dose or timing. As a result, individuals must constantly determine their doses and configure devices as they make several critical decisions each day about how much insulin to take,” said Jeffrey Brewer, CEO of Bigfoot Biomedical. “At Bigfoot, we want to relieve the burden of diabetes on people who take insulin by taking the fearful guesswork out of insulin dosing in a convenient and easy way.”
The Bigfoot Unity System is the only FDA cleared connected solution for:
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View the doctor’s recommended dose at the time of therapy using the current iCGM data directly on the pen cap
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Seamless integration with Abbott’s FreeStyle Libre 2 System, the leading sensor-based glucose monitoring system in the US and worldwide4
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Compatible with all major U.S. brands of fast and long-acting disposable insulin pens – including those manufactured by Eli Lilly and Company, Novo Nordisk, and Sanofi
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Upload iCGM and dose-time data without manual patient or healthcare provider intervention for ongoing, proactive patient care through remote physiological monitoring
“People with diabetes can be overwhelmed with the amount of data they receive from multiple devices, so it is important to develop connected technologies that simplify the experience,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “Through Abbott’s collaboration with Bigfoot Biomedical, we are 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 consists of three main components – proprietary fast and long-acting insulin smart pen caps, mobile app, and built-in FreeStyle Libre 2 iCGM sensor – that fit seamlessly into the person’s dose decision process if they need it throughout the day .
Bigfoot Unity’s fast-acting insulin smart pen cap allows the user to scan the FreeStyle Libre 2 sensor to see the user’s current glucose level, trend arrow and recommended corrective dose. The smart pen cap also directly displays the healthcare provider recommended insulin doses for meals with the correction dose. In just a few steps, the system supports the person with diabetes in deciding on treatment in real time.
While the Bigfoot Unity system’s dose recommendations are requested from the user as needed, the system also provides ongoing assistance with important reminders and warnings. The Bigfoot Unity System will notify the person when they may have missed their usual long-acting insulin dose. The Bigfoot Unity app also offers a very low glucose alarm if the person’s glucose drops below 55 mg / dL, as well as an optional low glucose alarm if the person’s glucose drops below 70 mg / dL.
Data from the iCGM and dispense time data from the Bigfoot Unity pen caps are automatically captured and uploaded to the cloud when WiFi or a cellular signal is available. This replaces the tedious manual protocols normally kept by those on MDI therapy. The person’s healthcare provider can also view this patient information through a secure web portal called the Bigfoot Clinic Hub.
Healthcare providers gain real-time partners to support patients
The FDA-cleared Bigfoot Unity System is part of a broader range of programs designed to help healthcare providers provide personalized and proactive care to their patients with insulin-dependent diabetes. The Bigfoot Unity program supports the treatment of a wide variety of patients on MDI therapy, from those with type 1 diabetes who are not receiving insulin pumps to those with type 2 diabetes who need to add insulin therapy. The holistic approach of the program focuses on the key aspects of insulin management in patients struggling with glycemic control, insulin dosing, or hypoglycemic ignorance.
“For healthcare providers, the Bigfoot Unity ™ diabetes management program could be a game changer by linking them to data that provides better insight into what their patients are actually doing,” said Jim Malone, MD, diabetologist, chief medical officer of Bigfoot Biomedical. “By replacing the guesswork and complexity with connectivity and simplicity, the Bigfoot Unity program truly serves as a real-time partner for patients and providers in assisting dose decisions and overall diabetes management.”
Key Benefits of the Bigfoot Unity Program for Healthcare Providers:
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Allows providers to remotely deliver customized, proactive care and easily track their entire population of MDI patients
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Introduced a simple, accessible system for patients with Bigfoot that provides onboarding, training, and ongoing customer care
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Ensures first-time patients a smooth entry into CGM technology and helps patients make safe and personalized decisions about insulin dosing
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Automatically collects data to aid physician remote physiological monitoring
“There are more than 7 million people in the US on insulin therapy, and many use insulin injections several times a day. However, little progress has been made in this extremely underserved market,” Brewer said. “Bigfoot Unity was specifically designed to be simple and accessible – regardless of the person’s technical expertise – and to remove a major barrier to health equality. We know that people with diabetes want their insulin therapy to be successful, and it is often a complex and expensive technology that gets in the way. ”
The Bigfoot Unity program will be available in select diabetes clinics from spring 2021. Vendors who want additional information should contact www.bigfootbiomedical.com.
About Bigfoot Biomedical, Inc.
Bigfoot Biomedical was founded by a team of people with personal relationships with Type 1 and Type 2 diabetes. We are trying to change the paradigm of diabetes care. Bigfoot is an unconventional company that takes an unconventional approach. In contrast to others, we take a holistic view of insulin therapy and use services, support and new business models. We partner with healthcare providers to provide simple, connected, and comprehensive solutions to the large numbers of people who have been overlooked by diabetes innovations. Learn more at www.bigfootbiomedical.com. Follow us on Twitter @BigfootBiomed, Instagram and Facebook.
About Jeffrey Brewer, CEO of Bigfoot Biomedical
Jeffrey Brewer is the founder and CEO of Bigfoot Biomedical. Since his son was diagnosed with type 1 diabetes in 2002, Jeffrey has been a thought leader and catalyst in the diabetes community, first as a philanthropist who co-funded and launched the Artificial Pancreas Project with JDRF International, and then as CEO of JDRF where he forged partnerships to drive this innovation for medical devices. Jeffrey was previously an entrepreneur and founded and ran very successful dotcom start-ups such as CitySearch and Overture / GoTo.com.
Indications and important safety information
The Bigfoot Unity Diabetes Management System is indicated for the treatment of diabetes in people 12 years of age and older. The Bigfoot Unity System provides glucose monitoring data through Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring system. The system has real-time alarm functions and replaces blood glucose tests for diabetes treatment decisions, unless otherwise stated. The device is designed to provide insulin dose information using available glucose data to help people with diabetes mellitus who use disposable pen injectors to self-inject insulin in implementing health care provider recommended insulin dose schedules. The device is intended for single patient use only and requires a prescription. The Bigfoot Unity system is also designed to autonomously communicate with digitally connected medical devices where the patient manually controls therapy sessions.
A healthcare professional must make appropriate settings for the device based on user-specific criteria. It is not intended for people who dose insulin in increments of ½ units, take multiple daily doses of long-acting insulin, or take high doses of vitamin C (more than 500 mg per day).
[1] Based on products available in the US as of May 2021
[2] Table 6.4 – Classification of Hypoglycemia. American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care for Diabetes – d2021. Diabetes Care 2021; 44 (Suppl. 1): S73 – S84. https://doi.org/10.2337/dc21-S006
[3] To receive alerts, Notifications and Critical Alerts must be turned on, and the sensor must be within 20 feet of the phone with the Bigfoot Unity mobile app activated. Notifications only available on the phone. Compatible phones can be found at www.bigfootbiomedical.com/compatible
[4] Data in file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading sensor-based personal glucose monitoring systems.
