Share on Pinterest
Bigfoot Biomedical’s Unity system

Bigfoot is real in the diabetes community!

Yes, it’s true. An exciting new connected insulin delivery system for people with diabetes (PWDs) who prefer injections to an insulin pump has now received regulatory approval in the United States.

Say hello to Bigfoot Unity, a new offering from Northern California–based startup Bigfoot Biomedical that is a first of its kind in the diabetes space. It includes a connected insulin pen cap that tracks both long and short-term insulin doses, and can be used to manually scan the Abbott FreeStyle Libre 2 Flash Glucose Monitor to recommend insulin doses and alert users to high and low glucose levels.

Unlike other early “Artificial Pancreas” technologies that connect a continuous glucose monitor (CGM) and insulin pump to automate dosing, the Unity system is designed for individuals on multiple daily injection therapy, known as MDI.

What’s unique here is offering the decision-support and automation advantages of a connected system to a broad swath of PWDs who aren’t hooked up to an insulin pump — which is, in fact, the great majority.

The FDA cleared Bigfoot Unity on May 7, 2021 (after 9 months of review). The startup plans to launch this connected pen system in the coming months following this regulatory approval, starting with a limited launch in select clinics around the United States before a broader launch later on.

Bigfoot plans a novel payment method for this multipart automated insulin delivery (AID) system: Users will get a monthly mail order package that includes all the supplies needed, for a regular subscription price or insurance-covered copay.

“Think of it like a service, where you’re not being forced to buy each particular part of a system separately, but all of that is bundled together with a subscription cost and is delivered to your door,” said Bigfoot CEO Jeffrey Brewer. “You’re being provided with a solution, and whatever you need to use that solution is provided on a monthly basis.”

Since its founding in early 2015, Bigfoot has aimed to create both an insulin pump version and a connected pen version of its AID system, offering PWDs a choice. They decided to prioritize the pen version as the first iteration in order “to serve a larger, yet lesser-served segment” of our diabetes community, Brewer said.

This system uses a “smart” digital pen cap as the base for its design, originally developed by Timesulin and acquired by Bigfoot in 2017. Yet, it goes beyond just tracking dosing data.

Bigfoot Unity is designed to clearly, and in real-time, help answer the question: “How much insulin would my doctor recommend I take right now?”

Here are the system basics:

  • There will be two versions of the pen cap: a black one for basal (long-acting) insulin pens, and a white one for bolus (rapid-acting) pens. Importantly, Bigfoot Unity will work with any type of insulin. The connected “smart” caps are designed to fit universally on all insulin pen models.
  • It’s approved for use by people with type 1 and type 2 diabetes ages 12 and older, though Bigfoot plans to request it approval for younger children down the road once those studies are completed.
  • Each cap has a rechargeable battery that lasts for several weeks before needing to be recharged.
  • Users will be able to scan the Bluetooth-enabled Abott Libre 2 using the Bigfoot Unity white pen cap, eliminating the need to use a separate handheld scanner or mobile app.
  • The system also offers a meal announcement for customizable “small,” “medium,” and “large” meal sizes to help make dosing decisions easier.
Share on Pinterest
Bigfoot Biomedical

Users can view all the data on the Bigfoot Unity mobile app but won’t need to pull out their phones to get dosing recommendations, as those will show up right on the pen cap. You can see the glucose reading and the glucose trend arrow on the cap itself.

The Bigfoot Unity caps are programmed to send a mandatory “very low glucose” alert when readings go below 55 mg/dL, as well as an optional low alert below 70 mg/dL. These alerts would appear on the Bigfoot Unity app, notifying the user to scan the Libre 2 sensor or do a fingerstick test for a numerical glucose reading. Notably, Bigfoot Unity does not offer any alerts for high glucose readings in order to avoid potential “device fatigue” from having too many notifications.

Share on Pinterest
Bigfoot Biomedical

Data from the Bigfoot Unity pen caps is automatically captured and uploaded to the cloud whenever WiFi or cellular signal is present, replacing manual logs often kept by people using MDI therapy. The user’s healthcare team can also view the data through a secure web portal, dubbed Bigfoot Clinic Hub.

For backup tests, Bigfoot includes a connected fingerstick meter made by AgaMatrix with its bundle, along with test strips based on the user’s desired amount of daily glucose tests. That meter also sends data directly to the Bigfoot phone app as well as the pen cap, to dose accordingly.

In future updates, Bigfoot plans to also offer an “auto titration” feature that can automatically adjust insulin dosing calculations based on the user’s actual results over time.

“The Bigfoot Unity diabetes management program could be a game-changer by connecting [healthcare professionals] to data that can provide better insight into what their patients are actually doing,” said Dr. Jim Malone, an endocrinologist who serves as Bigfoot’s chief medical officer. “By replacing guesswork and complexity with connectivity and simplicity, Bigfoot Unity is truly serving as that real-time partner for both patients and providers when it comes to dose decision support and overall diabetes management.”

This short promotional video shows more detail on Bigfoot Unity.

As of FDA-clearance time, Bigfoot wasn’t yet ready to discuss specific pricing or detailed launch plans that will begin at select diabetes clinics across the U.S. in mid-2021.

However, they confirmed that the system will not be available for purchase directly from Bigfoot itself.

Instead, after getting a prescription from a healthcare professional, users will receive Bigfoot Unity supplies shipped to them in a pay-as-you-go monthly subscription model. The Bigfoot-branded bundle package will include: test strips, lancets, alcohol swabs, and pen supplies (minus the needed insulin, which you’d still get the traditional way).

Share on Pinterest
Bigfoot Biomedical

The idea is to require just one single prescription from a doctor to obtain your Bigfoot system supplies in a sort of “one-stop shop” that would be delivered to customers’ doorsteps each month. Training and digital learning tools would also be a part of that.

Brewer told DiabetesMine that market research shows 30 percent of PWDs are forced to switch insulin at the beginning of each new year, due to insurance formulary changes. This will be easily managed since Bigfoot allows for an easy swap of the corresponding pen cap for the type of insulin they need.

As far as rolling out the product, Bigfoot plans to work directly with select diabetes clinics and healthcare professionals in targeted geographic locations across the U.S. that will be announced by Summer 2021. From there, they’ll gradually roll out the product on a broader basis for endocrinologists and primary care physicians.

Brewer said they expect it will be generally covered by most larger insurance plans and that Medicare will cover the Bigfoot Unity system.

The JDRF issued a statement about Bigfoot Unity’s approval, noting that this new system “fills a critical gap” for those on MDI and allows them to have important automation and device connectivity features that they’ve historically not had access to without an insulin pump.

Bigfoot and Abbott Diabetes Care announced an agreement in mid-2017 to integrate the Bluetooth-enabled version of the 14-day Libre sensor with Bigfoot’s AID systems. This is the Libre 2, which has been available in the United States since mid-2020.

That contract with Abbott is for the first couple years of Bigfoot’s commercialization, Brewer told DiabetesMine, and after that they’d likely collaborate with other CGM makers to offer other options to customers. One likely candidate is no doubt the Dexcom CGM. Brewer says Bigfoot is working to build a “modular system aimed at offering choice,” so it’s just a matter of time after the first generation rolls out.

The future insulin pump-based system known as Bigfoot Autonomy is built on the Asante Solutions’ Snap pump technology and design, which Bigfoot acquired when that company went out of business in May 2015.

That two-part insulin pump has a “brains” component and disposable piece that holds the insulin cartridge, which snap together.

Bigfoot is now developing a screenless pump device with fun Bigfoot “eye” symbols (derived from its company logo). A smart phone mobile app will be the main user interface, so users won’t even have to pull out their insulin pump to operate it or see data displayed.

Users will enter carb counts for meals on the phone app, which will then recommend a dose and allow delivery without having to touch the pump at all. The timeline on this remains TBD, dependent in part on fundraising for the clinical trial work after Bigfoot Unity. They’re hoping for a launch of Bigfoot Autonomy in 2023 or beyond.

Originally, Bigfoot was focused on delivering its pump-based version first.

But conversations with payers (aka insurers) and healthcare professionals pushed them to focus first on the pen version of their product. That’s because people using injections make up a majority of insulin-dependent PWDs, yet this larger group is underserved when it comes to diabetes tech options, Brewer said.

“This has popped to top of mind for insurance companies and large healthcare delivery systems that realize there must be a better way,” he said.

There is a growing need to offer the same kind of cutting-edge, data-driven treatment for all, he said. That is what Bigfoot hopes to address, using a “blue ocean strategy” to tap the vast, unmet demand of people with both type 1 and type 2 diabetes who may not be the most tech-savvy.

“The endocrinologists aren’t going to be able to support all the patients who need insulin therapy. So whatever comes, it needs to be simple and self-training, be able to lower the burden on the clinician profoundly, and be easily prescribed and be able to support itself. That’s what we are developing here,” Brewer said.

He acknowledges the importance of access and affordability.

“Removing the bottlenecks is critical: price, complexity, doctor familiarly, etc,” Brewer said.

“To us, it’s not either pen or pumps — it’s both. That is still a novel idea in the industry. I think we’re saying no one thing is the best. There needs to be choice, and it needs to encompass both injections and infusion pumps and probably patch and tethered pumps too.”

“These all have a place in the marketplace because they’re preferred by certain people, and the customer may change their mind over time for any variety of reasons,” Brewer said. “We need that flexibility.”

Don’t forget this startup is named after the Bigfoot creature that was historically so elusive — did he exist or not?

In early 2014, rumors began to spread within the diabetes community about a guy out there somewhere who had hacked into his diabetes devices to create a so-called Artificial Pancreas… but no one would publicly confirm his existence or real name.

That changed in late 2014, when this diabetes tech-savvy “Bigfoot” outed himself and finally shared his family’s story with the world.

It turned out to be D-Dad Bryan Mazlish from New York, whose wife and son live with type 1 diabetes. He had managed to crack the code on a CGM and insulin pump to create the first homemade closed loop — years before anyone else was openly doing this.

For the formation of the company Bigfoot Biomedical, Mazlish partnered with a trio of other diabetes dads also anxious to build best-in-class technology for their loved ones:

  • Brewer, known as the “Father of the Artificial Pancreas,” as he’d been CEO of the national advocacy organization JDRF for 4 years and helped pave the pathway for closed loop technology.
  • Lane Desborough, a former Medtronic chief engineer who had helped create the revolutionary homemade data-sharing system known as Nightscout. Notably, Desborough is now out on his own creating a new AID algorithm called Nudge BG.
  • Jon Brilliant, who had served as chief financial officer of WellDoc after co-founding the company years earlier.

“As a company we’re moving out of the development stage into a commercialization stage. It’s a different challenge and requires different talent,” said CEO Brewer, remarking on a number of employees who have moved on.

“It’s still as driven in the DNA by people who understand and are committed to alleviating challenges of life with insulin-requiring diabetes. Change is a function of our success in getting to this stage,” he said.

The company has struck up numerous partnerships to optimize its in-development system, including one with Pennsylvania-based Allegheny Health Network that allowed their endocrinologists and primary care doctors to help refine the provider-facing features for best-case use on the clinical side.

“We’ve chosen to turn the traditional logic on its end, not just asking if someone is ‘complying or adhering,’ but what is preventing them from doing that?” Brewer noted.

“Usually, if you look closely enough, it’s because (diabetes management) is too much a pain in the ass or requires too much attention, or there’s some aspect that is getting in the way. It’s not that people don’t want to be healthy. The fundamental design of diabetes care is flawed, and from the beginning that’s been our key insight and driving impetus in doing this,” he said.