Bigfoot Biomedical starts clinical trial for artificial pancreas

Person testing insulin with test strip

Startup Bigfoot Biomedical has started a clinical trial for its artificial pancreas device in Type 1 diabetes patients. The move comes after Medtronic ($MDT) recently submitted to the FDA for an approval of its own artificial pancreas product.

The devices giant, though, has a reputation for being technologically challenged when it comes to diabetes--so the startup may have room to best it on that front. If the technology becomes accurate enough, it could eliminate both finger-stick testing for blood glucose and insulin injections and replace that with a patch-based device.

The Milpitas, CA-based startup is starting the trial to test its Bigfoot smartloop automated insulin delivery system. Artificial pancreas systems aim to both monitor blood glucose levels and automatically administer treatment via an appropriate dose of insulin.

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“Life with T1D using today’s tools is unreasonable,” Bigfoot founder and CEO Jeffrey Brewer said in a statement. “Therapies are too expensive, too complex, and require intense focus and attention with little support. Also, healthcare providers are overwhelmed, with too many hurdles blocking them from helping their patients.”

He continued, “The smartloop automated insulin delivery system has the potential to change people’s lives. It is designed to deliver better health with greater ease of use, making life simpler for both the patient and the clinicians who treat them, ultimately lowering cost of treatment.”

The trial is slated to be in three U.S. sites: 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.

All three sites specialize in artificial pancreas development. In fact, earlier this year FDA Commissioner Dr. Robert Califf and Colorado Senator Michael Bennet visited the Barbara Davis Center for Diabetes on the Anschutz Campus in Aurora, CO, to survey the site of a Medtronic trial for its artificial pancreas. The development of this sort of device is a priority for each of them.

- here is the announcement

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