Data Were Presented at the American Diabetes Association 82nd Scientific Sessions
MILPITAS, Calif., June 5, 2022 – 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 Unity® Diabetes Management System
Bigfoot Unity® Diabetes Management System was granted FDA 510(k) clearance in May 2021 for use by individuals ages 12 and up. The system features connected smart pen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy. The system is the first and only solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly uses integrated continuous glucose monitoring system (iCGM) data from Abbott’s FreeStyle Libre 2 system to provide an insulin dose recommendation, which is based on a physician’s instructions. The dose is displayed directly on a proprietary, connected smart cap for the person's disposable insulin pens without the need to manually input glucose data on a separate device.
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 health care providers to deliver simple, connected, and comprehensive solutions for the large number of people who have been overlooked by diabetes innovation.
Media Contact:
Jessica Stebing
T +1 260 336 6202
press@bigfootbiomedical.com
WEB-400117 Rev A June 2022
The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission. Other trademarks are the property of their respective owners.
