Bigfoot Biomedical announced data supporting the use of its Bigfoot Unity system for improving glycemic control in those with diabetes.
Data from a real-world retrospective analysis suggests that, for those on multiple daily injections (MDI) of insulin, Bigfoot Unity has the potential to provide rapid and durable glycemic control improvements.
Milpitas, California-based Bigfoot presented the real-world data from its late-breaking abstract at the American Diabetes Association (ADA) 82nd Annual Scientific Sessions in New Orleans.
“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,” Dr. Bantwal S. Baliga, East Alabama Endocrinology and lead author of the analysis said in a news release. “We also see limitations because providers are resistant to instruct correction dosing due to fears of miscalculations and insulin stacking.”
The analysis looked at 49 people with diabetes at an average age of 60.3 years old. Bigfoot said 81.6% were type 2 and 71.7% used CGM previously but were new to smart pens and diabetes app. A minimum of 50% CGM data within the first two weeks and the third month were required to be part of the analysis.
According to Bigfoot, the study observed strong glucose control at three months of use with Bigfoot unity with the mean Glucose Management Indicator (GMI), calculated from CGM readings, coming in at 7.5% from a baseline mean HbA1c of 8.5%.
In 26 patients whose baseline HbA1c was greater than 8% (mean of 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. Additionally, engagement with the system showed promise, Bigfoot said, as more than 70% of patients followed through with a long-acting insulin dose within two hours of receiving an alert.
After six months, 95.9% of the individuals were still actively using Bigfoot Unity. Outcomes associated with the use of the platform were immediate and durable, the company said, 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,” Baliga said. “This is promising because when we see consistent adherence and effective insulin management, we see an improvement in overall glycemic control.”