This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval (PMA) from the FDA.

The investors who participated in this round include Abbott as well as funds managed by Janus Capital Management. Other investors include the Bigfoot’s largest investor Quadrant Capital Advisors in addition to Cormorant Asset Management, Senvest Capital, Senvest Management, Visionnaire Ventures, JDRF T1D Fund, and T1D Exchange. In total the company has raised more than $90 million till date.

While insulin keeps many people with type 1 (and sometimes type 2) diabetes alive, it’s a tricky drug to manage. Too much can crater glucose levels and too little can spike them. Either mistake can be debilitating or deadly. The Milpitas, California company’s president and CEO Jeffrey Brewer almost lost his son to a dosing error. They were fortunate his wife checked on the boy at 4 am.

“The system recognized there was a problem,” said Brewer in a phone interview, “but it couldn’t reach out and tell anyone.”

That’s the kind of problem Bigfoot wants to fix. The company is trying to smarten up these devices by developing a phone app that controls both glucose monitoring and insulin injection. The idea was spawned several years ago when cofounder Bryan Mazlish hacked together a DIY system for his wife and son, both of whom have type 1 diabetes.

“The tricky thing is it’s not a fixed dose,” said Brewer. “It requires a lot of calculation based on carbohydrate consumption, exercise, time of day. All these different variables need to be factored in. It’s a lot of math, and it’s largely done in people’s heads.”

Though Brewer shies away from the term artificial pancreas – the Bigfoot platform is neither implantable nor plug-and-play – the company is  trying to create a closed-loop system. The smartphone takes the glucose readings and calculates doses. Over time, it’s designed to learn how the user responds to food, exercise, insulin, etc., and adjust accordingly.

For those who use an insulin pump, the system is quite automated. Bigfoot also supports people who use a monitor and self-inject. The system alerts users to a problem, and can contact a loved or 911, but the company wants it to be even smarter.

“If I didn’t give myself insulin for a meal,” said Brewer, “and I’m sitting in a restaurant geolocation for 30 minutes, it can send a message through the phone saying: I notice you’ve been at this restaurant for 30 minutes, and your blood glucose is rising.”

Beyond tying together monitoring and delivery, Bigfoot wants to simplify the whole process of diabetes management. Under one prescription, users could receive the infusion system (unless they choose to give their own shots), glucose monitor, the app that talks to both and various disposables – though not insulin.

“All that stuff comes from bigfoot in one package and is resupplied every month in the amounts you use,” said Brewer.

The company also wants to help people reduce their visits to the endocrinologist, creating a system designed to mostly automate that process.

“Within a week to ten days, it will be configured to understand your physiology, how your physiology changes during the day as far as insulin sensitivity and how it changes over time,” said Brewer. “The AI is self-configuring the device over time from changes in your body or changes in your lifestyle. If you decide to run a marathon, and you become more sensitive to insulin, the device will adapt with you.”

In July, the company began partnering with Abbott, which supplies them with their Freestyle Libre glucose monitor. Bigfoot looks forward to a pivotal trial in 2019 and a possible PMA submission in early 2020.

Meanwhile, other companies are also racing to create their own version of the ideal in diabetes: a closed-loop system. Medtronic’s hybrid closed loop system is the first step toward that and it got FDA approval in 2016. DexCom just got FDA approval for its G6 CGM system that could be integrated with other insulin pumps to create a closed-loop insulin delivery system.

Photo: D3Damon, Getty Images