MILPITAS, California – (BUSINESS WIRE) – Bigfoot Biomedical announced today that its innovative Bigfoot Unity ™ diabetes management program is now available to diabetes clinics and endocrinology practices in select markets in the US that rely on insulin therapy with multiple daily injections. Rather than infrequently reviewing patient data and making episodic therapy adjustments, the program provides clinicians with tools, support services, and access to data for their Bigfoot Unity patients to monitor adherence, analyze data, and make any necessary proactive therapy adjustments. It also enables clinicians to provide remote physiological monitoring to these patients in a scalable and efficient manner.
“As an industry, we need to fix the broken cycle of treatment for diabetes so that both patients and clinicians can successfully achieve better outcomes,” said Jeffrey Brewer, CEO of Bigfoot Biomedical and former CEO of JDRF. “With these innovative, connected technologies, we can address many of the challenges clinicians face. Our Bigfoot Unity program is designed to act as a real-time partner in diabetes management so clinicians can focus on what matters most. ”
Doctors treating diabetes face unique Challenges not only in helping patients perform their insulin therapies, but also in dealing with new technologies and the vast amounts of patient data they generate. “As noted in the new AACE guidance, with the advent of new technology, it is critical that clinicians have the support, training, and infrastructure to use and manage these tools as we work to achieve better outcomes for ours Patients, ”said George Grunberger, MD, of the Grunberger Diabetes Institute and co-chair of the AACE Task Force. “Bigfoot’s holistic approach looks at the entire treatment ecosystem to help both clinicians and patients be successful.”
The patient-centric component of the Bigfoot Unity program is the recently FDA-cleared Bigfoot Unity system with the first intelligent pen caps of its kind and integration with Abbott’s FreeStyle® Libre 2 iCGM sensor. The system is the first and only solution that converts continuously monitored glucose data into on-demand insulin dose recommendations based on instructions from the doctor and displayed right on the pen cap screen for ease of use.
For clinicians, the innovative approach of the Bigfoot Unity program focuses on the Bigfoot Clinic Hub ™, a secure, cloud-based platform. Data from their patients using the Bigfoot Unity System and a FreeStyle Libre 2 sensor is passively collected and uploaded from the system’s smart pen caps to the Clinic Hub when a WiFi or cellular signal is present that one Provides on-demand access.
The Bigfoot Clinic Hub enables providers to make informed, timely therapy adjustments and address potential issues between doctor visits – before they become critical. Patient reports with integrated glucose and insulin data help doctors recognize patterns and make it clear that the patient is adhering to the prescribed therapy. Through the hub, clinics can track their Bigfoot Unity patient population and sort them easily as needed, for example by patients who have frequent low or high glucose values.
It is this interaction with passively collected patient data that enables the Bigfoot Unity program to support an integral component of telemedicine – Remote Physiologic Monitoring (RPM). “This innovative approach redefines the traditional treatment cycle and enables clinicians like me to effectively scale therapies to a broad patient population and have the patient and clinical tools to reimburse the delivery of proactive remote care,” said Grunberger.
Bigfoot Biomedical is introducing a very different commercial model by partnering with contracted endocrinology practices and diabetes clinics. The program is offered as a bundle of devices, consumables and services and is provided as a convenient 30-day subscription to avoid upfront costs. The Bigfoot Unity program is insured and should generally be covered by insurance, although co-payments may vary. The Bigfoot Unity program is supported by a dedicated team of Bigfoot specialists to help clinicians integrate the tools into their existing workflows. Bigfoot Certified Diabetes Care and Education Specialists onboard and train patients through a 1: 1 platform.
“Technological advancement is fast and requires a radical change in diabetes care,” said Brewer. “It’s long overdue, especially for those who need multiple daily insulin injections and their doctors.”
The Bigfoot Unity program is now available in California, Texas, Florida, Pennsylvania, Ohio, New York, New Jersey, Massachusetts, and other states of New England. Availability will be extended to other markets in 2021 and 2022.
About Bigfoot Biomedical, Inc.
Bigfoot Biomedical was founded by a team of people with personal connections to type 1 and type 2 diabetes. We want 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.
Important Safety Information for the Bigfoot Unity Diabetes Management System
The Bigfoot Unity System is indicated for the treatment of diabetes in individuals 12 years of age and older. Bigfoot Unity provides glucose measurement data through the Abbott FreeStyle Libre 2 Flash glucose measurement sensor. The system has real-time alarms and is designed to replace blood glucose tests when making decisions about diabetes treatment, unless otherwise stated. The device is designed to provide insulin dose information using available glucose data to assist individuals with diabetes mellitus who use disposable pen injectors to self-inject insulin in implementing insulin dose schedules recommended by healthcare providers. The system is not intended for use with automated insulin dosing systems (AID), including closed loop and insulin delivery systems.
The Bigfoot Unity System requires a prescription. A healthcare provider must provide appropriate settings for the device based on user-specific criteria. It is not intended for use by those administering insulin in 1/2 unit increments, taking multiple daily doses of long-acting insulin, or taking high doses of vitamin C (greater than 500 mg per day).
The system gives dose recommendations; However, the final decision on when and how to dose rests with the individual user. Failure to use the system in accordance with the instructions for use could result in the failure of a serious high or low blood sugar event and / or a treatment decision to be made that could result in injury.
For complete information about the system and its components, including warnings, contraindications, and precautions, see the Bigfoot Unity User Guide.
The circular shape of the sensor housing, FreeStyle, Libre, and associated trademarks are trademarks of Abbott and are used with permission.
