Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger sticks.
“It’s a tremendous demonstration that the FDA understands the value of factory calibration and making usage of a sensor simpler and easier,” Bigfoot CEO Jeffrey Brewer told Drug Delivery Business News.
Traditional blood glucose monitors, like Dexcom‘s (NSDQ:DXCM) G5 CGM, require patients to prick their fingers and provide the sensor with reference data points throughout the day. Theoretically, Brewer explained, this should make the device more accurate than one that’s factory-calibrated.
“But in the real world it doesn’t work like that. People don’t calibrate. They don’t wash their hands when they calibrate. There are all sorts of use cases, where in fact there is something on your hands, which is going to be measured by the glucometer and then that’s going to be injected into the system as an error,” Brewer explained.
Abbott’s system includes a sensor the size of two stacked quarters that’s placed on the back of the upper arm. Users can capture real-time glucose readings using a hand-held reader that picks up signals from the sensor. Users can also review eight hours of glucose history and keep an eye out for glucose level trends, monitoring fluctuations throughout the day.
This kind of passive system makes it easier for people with diabetes to live a normal life, Brewer pointed out, and that ease of use will help drive adoption.
“If you can make it easier and more pleasant, then they’re going to do it more often and they’re going to be able to take care of themselves better,” he said. “We see this as a validation of the entire approach Abbott has taken.”
Abbott’s approach is directly in line with Bigfoot Biomedical’s vision for the future of diabetes treatment, Brewer added. His Milpitas, Calif.-based company is working on developing an automated insulin delivery system, backed by artificial intelligence and data from Abbott’s CGM technology.
Almost every major player in the diabetes industry knows that they need to leverage big data to boost patient outcomes, but often that effort does very little other than overwhelm patients with a bewildering flurry of unhelpful data, according to Brewer.
“The problem with diabetes and insulin requiring diabetes specifically is there’s too much data. There’s too much testing. There are too many graphs, too many calculations, too many decisions, too much planning, too much diabetes in a person’s life. It’s a chronic disease and has a really large footprint on a person’s life,” Brewer said.
He would know – Brewer’s son has Type I diabetes and has almost died from injecting himself with too much insulin. Brewer helped start Bigfoot Biomedical in the hopes of creating a solution that would disrupt the industry and address the issues that he witnessed personally from his son’s experiences.
“People don’t want data. They want help. Data and graphs doesn’t equal help. It doesn’t make it easier. It’s just more stuff to think about, more stuff to interpret,” he said.
That’s where artificial intelligence can be of use, Brewer noted.
“The data is not for the person, the data is for a system and an artificial intelligence that is going to be able to use it to see when you’re headed to a bad place and tell you what you need to do in order to avoid going to the hospital,” he said. “This is the real opportunity with data. Everybody else is trying to take data and make it into graphs and present it to doctors so that doctors can tune complex devices and then patients can do better.”
But almost two-thirds of all diabetes patients in the U.S. are treated by primary care physicians, not endocrinologists, Brewer pointed out, and often only have 15 minutes with each patient.
“So the idea that you’re going to send the plots and trends and all this data to a primary care provider who’s going to be tuning an insulin pump is just ridiculous,” he said.
Abbott and Bigfoot Biomedical announced their partnership in July and Brewer anticipates that the result of the collaboration, an artificial pancreas system, will be ready for a pivotal trial next year.
“We’re very excited about the partnership with Abbott,” he said. “They’re a company that thinks like we do, focusing on real people, doing better and making it easier.”