NEWSFLASH: Bigfoot to Kick Off Closed Loop Clinical Trial!

http://type2diabetestreatment.net/diabetes-mellitus/newsflash-bigfoot-to-kick-off-closed-loop-clinical-trial/

Big news in the world of closed loop research is being announced today.

OK, make that "Bigfoot" news... as in Bigfoot Biomedical, the closed loop (aka artificial pancreas system) startup based in Milpitas, CA, led by the D-Dad trio of former JDRF leader Jeffrey Brewer, former Medtronic chief engineer Lane Desborough, and financial whiz Bryan Mazlish (Mr. "Bigfoot" himself) -- along with many others well-known in the Diabetes Community.

On June 29, the FDA gave Bigfoot the green light to move forward on its Investigational Device Exemption (IDE) submission, allowing the first clinical study for its "smartloop" system to begin. This three-month clinical study will take place at three sites across the U.S., gathering data that will move the needle on getting this ready for FDA submission in 2017 and hopefully commercialization in 2018!

We"ve reported on Bigfoot since their #WeAreNotWaiting efforts began taking shape in late 2014, from sharing the story of how Bigfoot came to be to our latest closed loop tech update in February 2016.

For those not familiar with this project, here"s a quick refresher on the Bigfoot system in development:

• "Bigfoot Brain" - containing the pre-filled insulin cartridge and tubing (this is the part based on former Asante Snap pump technology that Bigfoot acquired in mid-2015). This is where the smart algorithm is housed, which does all the calculations for food, insulin delivery, etc.
• Mobile App - acts as the controller and user interface
• Dexcom G5 CGM - and eventually, future continuous glucose monitor generations

Bigfoot will be using the disposable Snap insulin pump body, maintaining use of a pre-filled pen cartridge and the auto-priming function that Asante users liked so well. The so-called "Bigfoot Brain" will have a slick cover, with a microprocessor housed inside that contains all the smarts for controlling and calculating insulin dosing and other diabetes decision-making. A Bluetooth chip will allow it to talk to the smartphone, BG monitor, and Dexcom CGM.

"The device itself won’t have a screen or any buttons, as that will all be done on the phone that becomes the interface," says Jeffrey Brewer. "That’s where you’ll enter meals, or keep track of how the system is doing, or where you"ll see announcements for glucose warnings, infusion set and CGM changes, calibrations, etc."

The Bigfoot app will display your current CGM value and also a projected CGM reading for the next half hour.

Very exciting, indeed!

This is certainly not the only closed loop tech in the works, and we definitely have our eye on many of the roughly 20+ systems being developed across the globe. Bigfoot is one of the more exciting ones making rapid progress, along with the Boston-based team at Beta Bionics developing the iLET bionic pancreas that will use glucagon and insulin. These are both grassroots efforts that embody the #WeAreNotWaiting mantra.

Also in the news today is the inControl AP, which startup TypeZero Technologies announced today is partnering with Tandem Diabetes to help develop, get through regulatory review and eventually commercialize. That system"s been in the works for several years at the University of Virginia, and the hope is to have that AP ready in 2017 for submission to the FDA.

Of course, it"s worth noting that Medtronic in late June filed its Minimed 670G hybrid closed loop system with the FDA, and assuming it"s approved by this time next year, that should be the first closed loop system to hit the U.S. market.

We asked Bigfoot what distinguishes it from competitor closed loop systems in development, and spokesperson Melissa Lee -- a fellow type 1 and D-advocate whose husband Kevin is part of Bigfoot"s software engineering team -- tells us this:

"Bigfoot is approaching T1D from many angles -- the complexity of therapy tools in terms of adoption, usability, and training, the hundreds of hoops a provider has to jump through to prescribe pump therapy, and especially the overall costs to patients, providers, and payers in using these tools. Automating insulin delivery with a system that personalizes your therapy is a key piece to reducing the burdens of managing insulin-dependent diabetes, but it"s not the only piece of the puzzle. A large number of our team has a direct connection to diabetes and we understand the many ways in which T1D can be a headache. We care about the details and we"re going to get them right. We have to."

Bigfoot likely won"t be first to market, but it"s highly anticipated based on these close connections to patient needs and desires.

And while we don"t report on all clinical research that"s just starting up, the news that Bigfoot"s moving forward with key human trials research is an exciting step forward -- and also a great answer to common question among D-peeps: "How can I get involved?" Volunteering for this study is a great way to participate, if you"re interested!

The three sites will be:

• Stanford University School of Medicine, in coordination with Lucille Packard Children"s Hospital Stanford / Stanford Children"s Health in Palo Alto, CA
• William Sansum Diabetes Center in Santa Barbara, CA
• Barbara Davis Center for Diabetes at the University of Colorado School of Medicine in Aurora, CO

As many as 50 people will be enrolled in this Phase 1 trial, which will be a so-called Clinical Research Center (CRC) study -- meaning participants will spend 48 hours consecutively in the hospital while testing the system. Each of the three locations has a rolling enrollment period, so start dates will vary at each spot. You can check out details and get contact info on the federal clinical study hub, ClinicalTrials.gov.

Official timelines for Phase 2 research are still TBD, but the Bigfoot team had said it plans to get that rolling that by year"s end. It will be an off-site study in which patients will stay in a hotel, but will have ready access to help with the system if needed.

Aside from this clinical study news, Melissa tells that Bigfoot is growing fast and now has 40 employees!

"Expect us to be disruptive, expect us to deliver on what we"re promising, and please believe that we want simple, safe, effective, affordable solutions for ourselves and our families, too," she says, adding that they"ve also recently redesigned their Bigfoot Biomedical website and they often share news updates on the Bigfoot Facebook page.

All great news, Team Bigfoot! We"re excited to watch your progress, and are thrilled to know that you (along with many others in the closed loop tech space) are pushing ahead to bring us these awesome, unprecedented options in next-gen diabetes care!

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

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