Bigfoot Biomedical steps up diabetes tech with acquisition of auto-adjusting insulin dosing algorithm

Bigfoot Biomedical is doing its part to ensure that the possibility of building a smarter diabetes management system is more than just an urban legend.

The tech maker has purchased a new algorithm designed to observe how people with diabetes respond to various insulin dose that then uses information to generate future dosing suggestions. Bigfoot acquired the algorithm from developers at McGill University, it announced Thursday, though the company didn’t disclose the financial terms.

Bigfoot CEO Jeffrey Brewer suggested in the release that the algorithm could ultimately be added to the existing Bigfoot Unity system. The FDA-cleared diabetes management tech revolves around “smart” caps that can be attached to virtually any commercially available insulin pen and wirelessly connects to a user’s continuous glucose monitor.

Though the Unity system does already provide insulin dosing recommendations, they don’t take a user’s direct response to the medication into account. Instead, the caps currently offer suggestions throughout the day based on real-time readings from the user's CGM and guidelines from their doctor that have been preprogrammed in an accompanying app.

“We look forward to the responsibility of taking the necessary next steps to bring their innovation to the diabetes community, including research and development to incorporate the algorithm into the Bigfoot Unity platform and collaborating with the FDA on the appropriate regulatory pathway,” Brewer said.

In a retrospective study of the algorithm, according to Bigfoot’s release, McGill researchers analyzed blood sugar readings and insulin dosing data collected from 20 users of the Bigfoot Unity system and found that the algorithm’s resulting recommendations lined up with the actual dosing adjustments made by the users’ healthcare providers.

In addition to offering real-time suggestions, the algorithm has also been programmed to get “smarter” the longer it’s used—keeping track of users’ responses to their insulin doses to help make even more accurate recommendations over time.

Bigfoot’s acquisition of the algorithm comes amid a flurry of other plans to expand the company’s footprint—despite shedding some patents related to automated insulin delivery in a $25 million sale to Insulet last month. Earlier this month, it announced an expanded FDA clearance for the Unity system allowing the app to run on Android smartphones; the original iPhone-exclusive clearance arrived in 2021.

Plus, in addition to rolling out the system for Android users, Bigfoot also noted in this week’s release that it’ll be following a recent trend among other diabetes tech makers to begin offering the Unity system through the pharmacy channel. Allowing users to purchase diabetes devices from pharmacies rather than durable medical equipment providers not only can lower their overall costs—thanks to insurance-backed pharmacy benefits—but also typically gives them the option of a pay-as-you-go plan for CGMs and other devices that rely on single-use components.