All About the Bigfoot Unity, a Smart Dosing System for Multiple Daily Injections

There’s some new technology that people with diabetes who use multiple daily injections (MDI) of insulin may want to learn about: the Bigfoot Unity Diabetes Management System.

The Bigfoot Unity is a “dose decision support system” that uses smart insulin pen caps and a continuous glucose monitor (CGM) to keep track of your blood sugar levels and recommend insulin doses.

I spoke with Ian Hanson, Bigfoot Biomedical’s chief operating officer. Hanson explained that Bigfoot, a “mission-driven” business, is striving to simplify diabetes:

“We’re really trying to make things simpler. We’re trying to reduce the burdens any way we can.”

The Unity is intended to be a truly all-in-one system, offering both comprehensive management technology and streamlined diabetes supply ordering.

The Dose Decision Support System

It all starts with the integrated smart pen cap system. Here’s how Bigfoot Unity works:

You attach Bigfoot’s smart digital pen caps to your insulin pens, both basal and rapid.
The pen caps communicate with a FreeStyle Libre 2 CGM sensor. If you wave your pen cap over the sensor, it will learn your blood sugar level.
The pen caps have digital displays that recommend doses for meals and corrections, based on your current blood sugar level and your customized ratios.
All of the data — your blood sugar measurements and insulin usage history — is collected in the Bigfoot Unity smartphone app.

The system remembers how much insulin you’ve used and when you used it. It keeps track of insulin “on board,” and won’t let you stack insulin unnecessarily. You can configure meal-time dosing to work several ways, with exact carb counts for every meal or with broader categories like small/medium/large or breakfast/lunch/dinner.

Smart insulin pen caps can help people with diabetes use insulin more precisely, but that’s not the only benefit, Hanson said. The Bigfoot Unity system aims to “decrease the burdens and steps.”

The Bigfoot app is intended to be the only app you need. Though the Unity employs a FreeStyle Libre 2 CGM, there’s no need to use the official FreeStyle Libre app. The CGM sensor will pair directly with the Bigfoot Unity app, which will track and display all of your blood sugar data. Even low blood sugar alerts will be delivered through the Bigfoot app. “You don’t have to have multiple apps,” Hanson explained. “It’s all integrated into Bigfoot Unity.”

Streamlined Ordering

You also won’t need to order FreeStyle Libre sensors from a pharmacy or durable medical equipment supplier: Bigfoot will send new sensors to you as you need them.

In fact, Bigfoot wants to take care of all of your ordering for you. Pen tips, test strips, alcohol swabs, lancets? Bigfoot will send them all directly to Unity users. “It’s all set up to ship automatically,” says Hanson, with easily-adjustable automatic monthly orders. No more calling the pharmacy to fill multiple prescriptions for all of these individual supplies every month.

The app also packages all of your data for your clinician, easing their ability to give you advice on your diabetes management. “We’re trying to integrate information that isn’t integrated easily, and make it available to the clinicians.” Users may adjust their correction factors and meal ratios by themselves, or with the help of their healthcare providers.

Compatibility

Bigfoot claims that the Unity is “the only [U.S. Food and Drug Administration] FDA-cleared system to support all major brands of both long-acting (basal) and rapid-acting (bolus) disposable insulin pens.” The Bigfoot Unity’s smart pen caps are compatible with a broad array of different insulins, and the companies just announced that it now works with lower-cost options from Eli Lilly and Novo Nordisk. That flexibility gives it a big advantage over competing smart pen cap systems from the big insulin manufacturers, which are intended to work only with their own insulins. The Unity system is also compatible with more insulins than Medtronic’s InPen, perhaps the most popular smart pen system on the market.

For now, the Bigfoot Unity works only with the FreeStyle Libre 2 CGM. Hanson told me that they are “in discussions” to incorporate the newer FreeStyle Libre 3. No word on whether or not Bigfoot will eventually make a pact with Dexcom.

The system is now available for sale in the United States, with a doctor’s prescription. If you’re interested, the first step is to speak to your doctor. Bigfoot is expanding rapidly but may not yet be available through your insurance provider.

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