Bigfoot Biomedical is a highly competitive player in medtech’s race to develop an artificial pancreas. The 50-person company has made rapid progress towards developing a smart, automated insulin delivery system since its beginnings in 2014. Just yesterday Bigfoot announced that it is partnering with Abbott, bringing together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin delivery platform. Medical Design & Outsourcing managing editor, Chris Newmarker, spoke with the company’s co-founder & CEO, Jeffrey Brewer, about its efforts to bring a secure, connected device to market.
Newmarker: Where are things right now with Bigfoot’s smart loop system?
Brewer: We are about three years into the journey with Bigfoot Biomedical. We have developed an automated insulin delivery system that we believe is the first class three medical device drug delivery system [for insulin]. It is a true internet-of-things secure device that uses a smartphone as an interface to the system, where you can announce a delivery of insulin from the phone and that phone is connected to the cloud. We created an entire system to simplify insulin administration, to make it as safe and as supported by data science as possible. And to make life easier, for people with Type I diabetes.
We’re going to a pivotal trial, later this year. That will be the final step of our clinical journey, prior to testing and an ambulatory real-world setting at home, for a few hundred people with Type I Diabetes. Then we’ll be onto a PMA with the FDA for the permission to market our system to the public. We’re very excited.
Newmarker: How did your initial trial go last year?
Brewer: That went very well. It was an inpatient trial to test the algorithm for automated insulin delivery. It was the first step in the articulated guidance for the clinical path via these systems. We are successfully through that step.
The first trial is designed to be a series of challenges that try and, for lack of a better word, trick the algorithm. You give it bad information. You have too much insulin, too little insulin, and then the system has to adapt and execute the person safe and ours successfully did so in ten adults adults and in ten children.
Newmarker: Are you expecting that if this does become commercial, it will be totally automated or will patients still have to make entries sometimes?
Brewer: It’s not possible to totally automate this disease. But what you can do, is you can have a feedback loop that is working in real time. If you make a mistake, or if your body isn’t consistent from day to day, then the system’s constantly tuning the amount of insulin you’re getting, and trying to keep you in a safe range. It still does need to get some information from you. For instance, when a person eats a meal, this is one of the things that today is so burdensome about Type I Diabetes. You have to be precise in terms of counting the carbohydrate intake, and then turning that into a corresponding amount of insulin, to cover the meal. The system helps you with that, because it allows you to be less precise. You literally are picking small, medium, and large meals to correspond with a certain amount of insulin, that then will be delivered in a smart way over time, to address the meal but also to keep you at a stable glucose range.
Our system is a partner to the person with this chronic disease, our system. It doesn’t replace all the responsibilities of life with it, but it does the math for you.