Bigfoot is taking a big step towards getting its artificial pancreas to market, announcing that it has gained approval to enroll up to 50 participants in a trial of its pump system.
Bigfoot Biomedical has obtained the FDA’s blessing to conduct a clinically-supervised test of an algorithm designed to translate readings from a Dexcom CGM into insulin-delivery instructions for a pump. On June 29th, the FDA granted Bigfoot an investigational device exemption (IDE), a form of relaxation of certain FDA requirements for premarket clinical trialing, to test the company’s pump-controlling software. Bigfoot will be proceeding with a feasibility study limited to 50 participants and five clinical facilities.
This round of trials is an extra regulatory layer artificial pancreas makers must navigate, as such a system is considered both new and high-risk by FDA regulators. This will be the first of three steps towards submitting an application for premarket clearance approval for the device. Bigfoot has a one-year window to complete this step and report findings back to regulators. The next step would be a hotel study where participants will use Bigfoot’s system under less constant supervision. Then in early 2017 there would be a three-month study that will more closely resemble a traditional clinical trial for a new model of an existing medical device. If everything goes as planned, Bigfoot could submit its premarket clearance application to the FDA by the end of 2017.
There has been a lot of discussion in medical news outlets about handicapping the race to get the artificial pancreas to market. If it is a race, then Medtronic might have a clear advantage as sources believe the company could begin selling an artificial pancreas as soon as this year. However, Bigfoot officials rejected this notion, saying in a July 25 Facebook post, “Getting it right isn’t a race. It’s the reason we exist.”
The company has grown to about 40 members since it was conceived by computer scientist and mathematician Bryan Mazlish. Mazlish had been battling sleep deprivation since 2011 to check his son’s nighttime glucose, and he hoped to devise a way to use a smartphone and the cloud to get remote access to CGM readings. He got down to cracking device code to see if he could make it work, and then to see if he could use a remote to operate a pump. Working outside of the FDA’s radar, he enlisted another diabetes dad, former JDRF CEO Jeffrey Brewer, who brought tech startup and regulatory experience to the venture. Diabetes dad and Nightscout developer Lane Desborough then came over from Medtronic as chief engineer. By summer 2015, Bigfoot had a development agreement with Dexcom.
Jon Brilliant, former senior advisor to the Merck Global Health Innovation Fund, became Bigfoot’s chief financial officer in 2015. He helped raise enough private capital to acquire Asante’s pump technology when that company ceased operations of the Snap pump in May 2015.
Bigfoot designers changed the interface of the Snap pump, but not the pump body itself. The company’s guiding principle is that a pump is only as good as its algorithm and the service provided by the company, according to Bigfoot’s community relations director Melissa Lee.
“We don’t consider ourselves a device company. We’re a software company, with a device, and we’re a service company,” Lee said in a telephone interview. “We’re in the automated insulin delivery business, and we want to offer complete diabetes solutions, not deliver a commodity.”
Bigfoot-affiliated researchers are beginning to recruit juveniles (age 7 or older) and adults who have been diagnosed with Type 1 diabetes for at least a year and have an A1C score of 10 or lower. The study’s two primary outcomes will be to evaluate and graph performance of the Bigfoot algorithm to command insulin delivery in response to signals from a CGM over a 48-hour period, and to assess safety outcomes of using the pump system. Secondarily, the study will measure real-time glycemic control with the pump’s use. The study will be conducted at the Barbara Davis Center at the University of Colorado, the Sansum Diabetes Research Institute in Santa Barbara, and Stanford University School of Medicine in Stanford.
To see if you are qualified to take part, click here.
8/14/2016 – This story was corrected to give the spokesperson for Bigfoot the correct first name of Melissa, not Michelle, as was previously published. A Twitter follower correctly pointed out the error a few days earlier…and then the editor completely spaced on making the correction. Apologies.
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