First Clinical Trial for Bigfoot Smartloop Automated Insulin Delivery System

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Bigfoot Biomedical, Inc. has enrolled its first patients in a clinical trial for the Bigfoot smartloop automated insulin delivery system.

Bigfoot was founded by Jeffrey Brewer, former CEO of JDRF International, and Bryan Mazlish, the mysterious “Bigfoot” in Dan Hurley’s piece for Wired Magazine, in November 2014, with the sole purpose of revolutionizing the treatment of Type 1 diabetes. Their  mission is expressed in a system of care to transform the lives of people who depend upon the daily administration of insulin, a life-giving but also dangerous drug. 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.

Bigfoot recently received approval by the FDA of its Investigational Device Exemption (IDE) submission for a first clinical study of the smartloop automated insulin delivery system. The trial is slated to take place at three sites, each of which is a global leader in closed-loop insulin delivery research. Bigfoot is collaborating with Stanford University School of Medicine in coordination with Lucile Packard Children’s Hospital Stanford and Stanford Children’s Health in Palo Alto, CA, the William Sansum Diabetes Center in Santa Barbara, CA, and the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine in Aurora, CO.

www.clinicaltrials.gov has not yet posted this information, but it should be available within the next few days

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