Monday, January 16, 2017

Bio-Inspired Artificial Pancreas, with Jedi Master Yoda on Board

http://type2diabetestreatment.net/diabetes-mellitus/bio-inspired-artificial-pancreas-with-jedi-master-yoda-on-board/

If Yoda from Star Wars can use a closed loop system to manage diabetes, then anyone can become a “Jedi-like master” of their D-health, right?

Believe it or not, that’s the pitch for a new Artificial Pancreas system being developed in England. Of all the similar projects worldwide we"ve heard of so far, this one certainly seems to be the most unique and creatively marketed...

Say hello to the BiAP (short for bio-inspired artificial pancreas), being developed by a research team in London that"s using Yoda as an outreach tool to show off the closed loop technology in an interactive, fan-friendly way.

It’s at least a couple years out from coming to market in Europe, but it would be the first of its kind using a mini silicon microchip with Bluetooth Low Energy integrated into a handheld device that serves as the system"s brain. It can work with any Bluetooth-enabled device, and so far it"s been connected to the Roche Accu-Chek Spirit Combo pump and the internationally-sold CellNovo patch pump.

To get the details, we talked by phone recently with Dr. Pantelis Georgiou, one of the research leads at the Centre for Bio-Inspired Technology, Circuits and Systems along with Dr. Chris Toumazou, the primary investor -- based at the Imperial College in London. (You can find them on Twitter at @Imperial_BiAP.)

How Does BiAP Work?

  • Instead of being weaved into a smartphone app like many other closed loop systems, this will be a distinct handheld medical device that talks to a separate insulin pump and CGM.
  • The small five-by-five microchip dubbed the “silicon beta cell” is where the algorithms are housed to mimic the function of healthy beta cells.
  • It uses Dexcom CGM tech (currently the G5) and will be paired with various Bluetooth-enabled insulin pumps.
  • Like other closed loop systems, BG monitoring and insulin dosing will be automated, and users will enter food info into the system.
  • To simplify that, it has a "meal announcement" feature where users can push a simple button to choose from a “Small, Medium, or Large” meal depending on what"s being eaten.
  • The system will have a built-in way to gauge pump and CGM reliability, allowing the patient to take over control or change protocols if need be.
  • To being use, the patient just enters their insulin sensitivity/correction factor to personalize it and determine dosing.

BiAP has been in the works for roughly a decade, we"re told, but it’s been making more media headlines recently after a three-day event in April at the Science Museum in London. The research team doesn’t have any specific diabetes connections, but this all stems from work developing bio-microchips (like those used in computers and phones) for medical purposes like restoring hearing for kids born deaf. Dr. Georgious is an electronic engineering expert who has focused on diabetes since getting his PhD in 2004.

At first, the team was using the Medtronic CGM sensor but changed to Dexcom because of its better accuracy, Georgious says. The first prototypes had cables connected to the MedT device, but they’ve since changed to the Dexcom G5 that is Bluetooth-enabled and is wireless.

“It can work with any pump and sensor, as long as they have Bluetooth,” he says. “We are insulin pump agnostic, and really just want to use the best and most accurate CGM available on the market.”

Georgious also says they’ve tested the BiAP using dual hormones (insulin and glucagon), similar to what"s being done with the iLET bionic pancreas. But moving forward -- especially since there is not a commercially-available stable glucagon on the market yet -- they find it less complex to use the single-hormone approach.

A Jedi Master and Diabetes

More recently, the team adopted Yoda as their mascot of sorts, to engage the public and kids with diabetes in explaining how the system works.

We"re not sure if they have sought rights from the Star Wars franchise, but they"ve been showing an interactive Yoda figure wearing the device and connecting wirelessly to a laptop nearby, where a silicon model of Yoda shown on the screen illustrates how his blood sugar levels are going. The system also lets enthusiasts feed Yoda meals, and view how various glucose and insulin profiles work.

“I thought was a great idea to present (the system) with someone we all know and love, and would be a fun way to talk about this,” Georgious says. “If our system can help offer better control for a 900-year old Jedi Master, then it can do that for anyone.”

Yoda is not an official spokesman, of course, due to concerns about trademark infringement, but they hope to avoid any of those challenges while using Yoda for the good of the cause.

“We also thought about animating Yoda with different mood swings, so you could see how blood sugars correlate to emotional states – if normal he’s happy, if high he gets grumpy, if low he starts to sweat. But with copyright issues, we probably can’t do that unless we get permission,” Georgious says.

Commercialization Plans?

Since 2009, the BiAP team has stacked up 1,000 hours of closed loop use through 65 clinical studies to date. They are now moving into outpatient trials, with a three-month hospital-based human trial involving 30 people with type 1 between ages 18-75. The study ranges from fasting, overnight control, mealtimes, and even an ambulatory test.

Bio-inspired artificial pancreasTo date, these efforts have been funded by the global Wellcome Trust based in the UK and have not received funding from JDRF or other diabetes-specific groups, but that"s something Georgious hopes to change as they approach final clinical research, regulatory review, and ultimately commercialization.

Georgious hopes to have a pivotal trial for CE Mark approval and eventually the FDA all within 2017. The hope is to actually come to market within the next two or three years, he tells us.

And within five years, Georgious says they hope to have the BiAP microchip weaved into a fully integrated device with insulin pump, CGM, and the algorithms to have closed loop control all in one single device.

We certainly like the idea of BiAP, although it does still seem a bit behind the curve when compared to other integrated AP systems under development like the iLet, Bigfoot Biomedical tech, TypeZero’s InControl system and even the Medtronic hybrid closed loop that be available within a year or so. Still, any research and progress on artificial pancreas systems is good in our book -- because options are critical!

Here’s to wishing the BiAP team well as they move forward on this. May the diabetes closed loop force be with you!

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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