Bigfoot Biomedical is a company working on introducing an “artificial pancreas” for Type 1 diabetics who are on insulin therapy. The company has developed its own algorithms that control the delivery of insulin by a pump based on readings from a continuous glucose monitor (CGM). Now these algorithms are about to be tested in a clinical trial thanks to an FDA Investigational Device Exemption and enrollment of initial patients.
Bigfoot’s “smartloop” automated insulin delivery system relies on Dexcom’s G5 CGM, a product that last week received a positive vote from an FDA panel to be used as a replacement for traditional finger prick-based blood glucose testing. The smartloop receives readings from the G5 every five minutes and, though the company isn’t saying it, probably also takes manually inputted data from patients via a smartphone regarding diet and exercise. This is used to regularly adjust when to deliver a dose of insulin in order to keep the patient within a healthy glucose range.
Here’s an interesting note, according to the company, of the roots of Bigfoot Biomedical:
Motivated by a desire to improve the lives of their children, Jeffrey Brewer, former CEO of JDRF International, and Bryan Mazlish, the mysterious “Bigfoot” in Dan Hurley’s piece for Wired Magazine, founded Bigfoot Biomedical in November 2014. Moving with unprecedented speed in medical device development, over the past 20 months they’ve assembled a team of 40 people and are driving toward commercialization of a cutting edge approach to improving the lives of people with T1D.
Via: Bigfoot Biomedical…