Bigfoot Biomedical expands footprint of connected diabetes system with FDA nod for Android app

Bigfoot Biomedical is aiming to leave even bigger tracks across the diabetes management tech landscape.

The Silicon Valley-area company has developed a system that combines continuous glucose monitors with “smart” caps for insulin pens to smooth out the process of calculating changing insulin doses throughout the day—all managed through a connected smartphone app. When the Unity system was first cleared by the FDA in 2021, the app was only authorized to run on iPhones, but an expanded nod from the agency now allows it to be downloaded onto Android devices, too.

The new FDA clearance will significantly expand the reach of the company’s technology, since Android users represent around 40% of smartphone owners in the U.S., according to Bigfoot’s Thursday announcement. Additionally, as CEO Jeffrey Brewer noted in the release, “Most Bigfoot Unity users live with Type 2 diabetes and are part of a demographic that is even more likely to use Android devices than the general U.S. population.”

That makes the additional regulatory nod particularly “key” to the Unity system’s planned expansion, Brewer said, adding that Bigfoot is now plotting an “enhanced commercial rollout” for later this year.

Bigfoot Biomedical Unity system
(Bigfoot Biomedical)

Bigfoot’s Unity system revolves around the company’s smart insulin pen caps, which are designed to snap onto the lid of virtually any disposable insulin pen, spanning all major U.S. brands and both fast-acting and longer-term insulins.

Once the pen cap is installed and Abbott’s FreeStyle Libre 2 glucose sensor has been placed on the back of the upper arm and activated, a user can simply tap the cap against the sensor throughout the day for real-time blood sugar data. The readings are immediately displayed both on the digital pen cap and in the connected smartphone app, giving the user a guide for their next insulin dose—helped along by therapy recommendations from their healthcare providers that can be stored in the app as well.

Additionally, between scans of the CGM device, the pen cap displays a timer showing how long it’s been since the last dose.

All of the glucose readings collected by the pen are stored in the Unity app, which is also responsible for alerting users if their blood sugar levels have left a desired range. The app automatically draws up graphs and charts of the collected data, showing trends in both glucose levels and insulin dosage times.

In study results presented last year, Bigfoot reported that after three months of using the Unity system, study participants with Type 2 diabetes saw their glucose levels drop to an average of 7.5% from a baseline of about 8.5%.

The expansion of the Unity app’s footprint comes shortly after Bigfoot narrowed its overall focus. Last month, it sold off several patents protecting technology that could be embedded into insulin pumps to automate medication delivery.

Diabetes tech giant Insulet offered up $25 million for the intellectual property rights—then followed up that purchase with an identical one a few days later for another set of automated insulin delivery patents, this time from Automated Glucose Control.