Bigfoot Biomedical begins first artificial pancreas trial


Bigfoot Biomedical has joined a rush of companies looking to launch the 'artificial pancreas' into mainstream type 1 diabetes treatment within the next few years.

The California-headquartered company uses smart technology to manage type 1 diabetes, and has begun enrolling participants in a clinical trial testing its smartloop Automated Insulin Delivery System.

It hopes that its technology, if proven safe and effective, could be on the market by 2018.  This would put it at the forefront of a revolution in insulin treatment, freeing patients from daily injections and monitoring of their blood sugar levels.

Recently approved by the US Food and Drug Administration (FDA), the smartloop system will now be tested in individuals across three US sites: Stanford University School of Medicine; the William Sansum Diabetes Center in Santa Barbara, California; and the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine in Aurora, California.

“Life with T1D using today’s tools is unreasonable,” said Jeffrey Brewer, founder and CEO of Bigfoot Biomedical. “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.

“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 smartloop system uses a continuous glucose monitoring (CGM) device to monitor blood glucose levels and automatically administers an appropriate dose of insulin in response to low levels of the hormone via a small patch-based device.

There are a number of other companies racing to develop and gain approval for their own artificial pancreas devices. Market-leading giant Medtronic is one such rival; its MiniMed 640G includes a CGM device, insulin delivery device linked to a MiniMed insulin pump, and blood glucose testing remote, and feeds data to a web-based platform for individuals to monitor their blood glucose history.

In February, the company received a NICE recommendation for its MiniMed Paradigm Veo system, NICE concluding that its technology could save the UK health system around £1,500 per person, per year.

Medtronic’s Guardian Connect CGM platform also recently received a CE mark which boasts complete management and monitoring of type 1 diabetes through a smartphone. The system features text message alerts and real-time blood glucose data.

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Marco Ricci

22 July, 2016