Bigfoot Unity® Demonstrates Strong Glycemic Control Among People with Type 2 Diabetes in Real-World Retrospective Analysis

Bigfoot Biomedical, a mission-driven company dedicated to supporting better health outcomes for people with insulin-requiring diabetes, presented real-world data from its late-breaking abstract presented at the American Diabetes Association 82nd Annual Scientific Sessions. Data from the real-world retrospective analysis suggests that, for people on multiple daily injections (MDI) of insulin, using the Bigfoot Unity System has the potential for rapid and durable improvement in glycemic control.

"Millions of Americans have Type 2 diabetes, yet the population is largely underserved with solutions for managing insulin ? and many who use a continuous glucose monitor (CGM) don't get the full benefit because they have to calculate their insulin dose manually. We also see limitations because providers are resistant to instruct correction dosing due to fears of miscalculations and insulin stacking," said Bantwal S. Baliga, MD, East Alabama Endocrinology, PC, lead author of the analysis.

"The First Real-World Experience with Bigfoot Unity® A 3-Month Retrospective Analysis" analyzed 49 people with diabetes with an average age of 60.3 years. 81.6% were Type 2, and 71.7% used CGM previously but were new to smart pens and diabetes apps. A minimum of 50% CGM data within the first two weeks and the third month were required to be part of the analysis.

The study found strong glucose control at three months of use of Bigfoot Unity. The mean Glucose Management Indicator (GMI), calculated from CGM readings, was 7.5% from a baseline mean HbA1c of 8.5%. In 26 patients whose baseline HbA1c was >8% (mean HbA1c 9.5%), the mean GMI at three months was 7.5%. Time spent with low glucose and very low glucose (1.5% and 0.2%, respectively) was below established medical guidelines and mean post-prandial glucose was < 180 mg/dL.

Engagement with the system was promising, with more than 70% of patients following through with a long-acting insulin dose within two hours of receiving an alert. 95.9% of the individuals were still actively using Bigfoot Unity after 6 months. Outcomes associated with Bigfoot Unity usage were immediate and durable, with GMI reductions occurring within the first two weeks and continuing through the three-month analysis period.

"Our analysis demonstrates that, by using CGM data and smart technology to provide dose recommendations, Bigfoot Unity can support a therapeutic dosing regimen that can be easily adhered to ? both short and long term. This is promising because when we see consistent adherence and effective insulin management, we see an improvement in overall glycemic control," said Dr. Baliga.

Bigfoot Unity is the first and only FDA-cleared dose decision support system based upon CGM data, offering a simple tool for managing MDI therapy for people with diabetes.

About Bigfoot Biomedical, Inc.

Bigfoot Biomedical was founded by a team of people with personal connections to Type 1 and Type 2 diabetes. We seek to change the paradigm of care for diabetes. Bigfoot is an unconventional company taking an unconventional approach. Unlike others, we're looking at insulin therapy holistically and utilizing services, support, and novel business models. We're partnering with healthcare professionals to deliver simple, connected, and comprehensive solutions for the large number of people who have been overlooked by diabetes innovation. Learn more on our website and by following us on LinkedIn, Twitter, Instagram, and Facebook.

PR-400106 Rev A June 2022