8 June 2022 - - US-based Bigfoot Biomedical, a company focused on 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, the company said.

Data from the real-world retrospective analysis suggests that, for people on multiple daily injections of insulin, using the Bigfoot Unity System has the potential for rapid and durable improvement in glycemic control.

The study found strong glucose control at three months of use of Bigfoot Unity. The mean Glucose Management Indicator, 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 six 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.

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.

Bigfoot Biomedical was founded by a team of people with personal connections to Type 1 and Type 2 diabetes.

Bigfoot is looking at insulin therapy holistically and utilizing services, support, and novel business models.

The company said it partnering with healthcare professionals to deliver simple, connected, and comprehensive solutions for the large number of people who have been overlooked by diabetes innovation.