Artificial Pancreas News: DIYP, Bigfoot and Medtronic

#WeAreNotWaiting has become very well know in the diabetes data space. As I read about it, the next steps are slowly starting to come tantalizingly into view. Some even have hastags and Facebook pages. Others come from the usual suspects.

#DIYPS

Do It Yourself Pancreas System the fascinating collaboration of Dana Lewis & Scott Leibrand. A lovely couple if there ever was one. Their story is outlined at Median.com (1).  What is clear is their DIYPS is doable. Some folks wonder why hack your diabetes? Dana's 2¢ is, "I have to make about 300 decisions per day on average. It’s really fatiguing." Brilliantly understated Dana.

Having had the great pleasure of talking with them over the past year, doable was never in doubt.  It was more about about when. So my big question after reading the Median piece was simply, are they moving up the wedding date? Read it and see why.

Another piece that makes the connections from Nightscout to AP in Wired. (2) It goes from Nightscout to #DIYPS and then on to tease about Bigfoot.

There is a Bigfoot?

Bigfootbiomedical (3) is on Facebook where former JDRF leader Jeffrey Brewer is listed as CEO.  Some other very interesting folks, who are less public about it, are said to be working there as well. I trust they will confirm those rumors in their own good time. In the meanwhile Jeffery is playing a fun game of cat and mouse with Bigfoot on his Facebook timeline today.

Medtronic

It isn't only the home brew and startup crowd that are making strides. Medtronic has launched a next step with the MiniMed 640G (4). This new device shuts off insulin predictively. While that is an incremental step, it is a step. OK step / stride? You say potato..., it is somewhere in there. What is significant to me is progress. Medtronic will be sharing more about their next step their Hybrid Closed Loop system soon (do two steps make a stride?) It will be presented at the upcoming Advanced Technologies and Treatments for Diabetes (ATTD) 8th Annual Meeting being held at CNIT Paris La Defense from February 18-21, 2015 (5) At the last #MedtronicDAF, they said they were going to speed up bringing things to market. Seems they are. 

YDMV

All these are great news IMHO. Before somebody starts complaining about FDA, lets remember FDA approved the Medtronic 530G under their Artificial Pancreas guidance. Lots of folks complained that it wasn't an AP. OK you AP may vary - but FDA approved it as AP and that tells me they are looking to do just that. Well, OK. Also FDA flat to say they are looking to approve innovations under AP guidance. It may be a tad short of them saying, "Bring it on!" - So maybe the 530G is, as the saying goes, proof in the pudding.

To me this all matters because of Eggs and Baskets (6) in which I wrote:

I believe that better is better and perfect should not be the enemy of good. 

So I am all for advances in type 1 diabetes care that may fit into individual's life styles in a Your Diabetes May Vary kind of way. AP may work for some while GRI works better for others. I am fairly sure none of it will make diabetes care easy but it may be less hard and that's better.  

I support a diversified approach to making life better. There is a fable about putting eggs in more than one basket that explains modern portfolio theory better than most finance professors. 

YDMV, so should your AP options.



In case the links break:
(1) https://medium.com/access-matters/do-it-yourself-diabetes-bd1ea1adf034
(2) http://www.wired.com/2014/12/diabetes-patients-hacking-together-diy-bionic-pancreases/
(3) https://www.facebook.com/bigfootbiomed
(4) https://www.medtronic-diabetes.com.au/insulin-pumps/640g
(5) http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2017567
(6) http://www.ydmv.net/2011/10/artificial-pancreas-and-egg-baskets.html

Sexy new AP from Medtronic.

That get you attention? Good.

Medtronic is starting to roll out their next step to AP in Australia, and it's got a new look

What's new other than the good looks? Predictive suspend aka it stops delivery of insulin when thinks you are gonna go low. Very groovy. Medtronic calls this "SmartGuard™." I call it another step along the path to better care. 

When the 530G rolled out with Low Glucose Suspend, there was a lot of chatter about calling it AP. A Rose by another name is still progress in my book, and I am excited to see both a new pump form factor and another step to AP come to market. 

Speaking of Roses: Spare A Rose is coming up soon. We all need to join in and help kids around the world who need a hand. Show some love this Valentines Day. 

source: http://multimediacapsule.thomsonone.com/medtronic/medtronic-launches-minimed-640g-system--breakthrough-in-artificial-pancreas-technology-outside-the-us

Medtronic Safety Information

From Medtronic:

http://www.medtronicdiabetes.com/support/product-updates

IMPORTANT MEDICAL DEVICE SAFETY INFORMATION
Date 4-1-2013 

Download important safety information for Paradigm^® pumps Download > 

At Medtronic, we are committed to continuing to improve our products and services to enable people to manage diabetes. We recently sent a letter to notify U.S. Paradigm users and their healthcare professionals of two potential issues relating to Paradigm insulin pumps. 

We are informing our customers of the potential for a loose drive support cap. In rare cases, the cap may stick out from the side of the insulin pump as a result of impact(s) with a hard surface. The letter also reminds our customers of the existing User Guide instructions that exposure to water can damage the insulin pump's internal electronics.

#TwoBits from Industry. Glucagon Training App and Bayer Meter Talks to Medtronic Pump.

#TwoBits of news today. I use to call this stuff From the News Wire!

Bayer / Medtronic 

Bayer and Medtronic have a press release out today announcing the Contour Next Link.  Think Bayer USB that connects to a Medtronic meter - except this is charcoal grey not black. It uses new, improved and more accurate strips. I hope to read up on the more accurate part at a later date. I will be back when I do. Mean time read Riva.  

Groovy Photo from: http://diabetesselfcare.blogspot.com/

Review of the meter:  http://diabetesselfcare.blogspot.com/2012/04/medtronic-trial-bayer-contour-next-link.html

From the Press Advisory: 

Medtronic, Inc. (NYSE: MDT) and Bayer HealthCare today announced that Bayer’s CONTOUR^® NEXT LINK, a new blood glucose meter, is now available in the U.S. with Medtronic’s compatible integrated diabetes management systems. 
Bayer’s new meter provides exceptional accuracy utilizing high-performance CONTOUR^® NEXT test strips, helping optimize insulin delivery through wireless communication with the MiniMed^® Paradigm™ REAL-Time Revel™ insulin pump and the MiniMed^® Paradigm™ REAL-Time insulin pump. People with diabetes can have greater confidence that seamless integration with Medtronic’s Bolus Wizard^® makes bolus calculations quick and easy, eliminating inaccuracies due to manual entry errors.

This will be available to new Medtronic pump users starting now. The expectation is that existing customers can get it over the "next few months." I think you should look for the Bat Signal or a message from Medtronic in January. 

OK Bat Signal aside - here is the real text from the release:

Starting today, new Medtronic customers will receive CONTOUR^® NEXT LINK with any new pump order. Existing customers will be contacted by Medtronic and provided with new meters over time, beginning in January of 2013.

More from Medtronic:
http://www.loop-blog.com/blog/Update-on-Linking-Blood-Glucose-Meters-for-Medtronic-Insulin-Pumps

Lilly

Lilly Diabetes today announced the release of a new mobile application designed for caregivers and healthcare providers who support people with type 1 diabetes. The Lilly Glucagon Mobile App is a tool to teach how to use Glucagon for Injection, through simulated practice. 

The app is here:

http://itunes.apple.com/us/app/glucagon/id553314007?mt=8

More information is available from the Lilly press release here: 

https://investor.lilly.com/releaseDetail.cfm?ReleaseID=704061

Medtronic Remote CGM Monitor Approved

Medtronic announced that the FDA has approved the mySentry(TM) remote CGM monitor. It is a second screen that allows a parent to remotely see CGM data. Here's a picture from the Medtronic Blog where you can also find more information about the thing. The full press release is here.

Version of something like this have been seen and talked about for years. It is great to see that Medtronic and the FDA managed to find a way to make patient information more available. For parents this has significant value. Particularly over night. Imagine checking BG without getting out of bed. 

Here's a Youtube bit by Medtronic about it:

Happy New Year.  

FTNW: Medtronic Research

When Medtronic held their social media summit in April one of the topic of conversation was the wealth of data that the CareLink system creates. An obvious question is how is that data studied and is it open to folks outside the big M.?

Today Medtronic with ADA announced such studies. These are anonymous, hippa compliant uses. You can read more at the ADAlink:
http://www.diabetes.org/for-media/2011/Medtronic-Research-Grant-Release-2011.html

Tea and Crumpets News Network: Minimed Enlite

News and comments on diabetes products from Europe is getting to be a regular staple of YDMV. On one hand it is good that new products are coming to market.  On the other it is less than awesome that these things are not available here. It  speaks volumes about the state of regulatory affairs that innovations for better care are happening in Ye Olde Countries and not in the the Colonies of the New World.

Our good friends at Shoot Up have a post up on the new MM Enlite sensor. Sort version of the story; smaller, less harpoon like inserter, six day life. The folks at Shoot Up are doing there best to get'm to try'm. Stay tuned to the Tea and Crumpets News Network (TCNN) for a review. Click over to the other side of the Atlantic and read up:
http://www.shootuporputup.co.uk/2011/04/the-age-of-enlite-enment/
http://www.shootuporputup.co.uk/2011/04/let-there-be-enlite/ 


Editors Note: It may be wise to click out now. All that follows is a pointless and silly rant.


Somehow the brain trust in Regulatory Prohibitions on Communications Division (#NotIntendedToBeAFactualStatement) of the FDA doesn't quite appreciate that information is fungible.

I can hears some alert readers, who haven't had coffee yet, asking, "What the heck did he just say, fungus-able? Information has a fungus, is that like a computer virus? Honey! Do we have Norton Anti-Virus updated? "

Don't get you knickers in a knot. Fungible means easily replaced with an other identical item. Money is fungible. Any one dollar can be use just like the next. Information is easily replaced with... other information. Nothing is as exchangeable as words.

Information that is prohibited by the FDA here is easily replaced with information from other sources. So while MM can't say Jack Diddly to anyone in the U.S. of A. about a new sensor (and for the record it was actually funny to listen to the verbal gymnastics that they went through not to say anything about new products at #MdetronicDAF), we can read our friends across the pond who can say something about the new sensors. The information get fungible-ed... er... something like that.

There in lies a problem: Information isn't as fungible as money.

Now folks, far be it from me to suggest that Bloggers are possibly flawed. (Other ones. Not me, of course.) It seems that instead of having patients rely on some kind of 21st century whisper down the lane it would be better if the vendors could come out and offer comments and or corrections on the misstatement that may work there way into blog-o-sphere mishmashes.

So in an effort to sort out the mess I am making here (a mess that is kinda making my point along the way) there is not a Regulatory Prohibitions on Communications Division at the FDA as far as I know. There are new sensors and meters available in Europe that aren't through the FDA black ops process (Black Ops = #NotIntendedToBeAFactualStatement.)  More innovations including CGM enabled pumps are on the way into European markets and simultaneously US regulatory delay. I think we would all be better served if y'all didn't find out about these things solely from 'reputable' unofficial sources like say, me.

Seriously, I know better than to trust me.

All of this is not to say that I do not value the goals of the FDA or a regulatory process. I believe there is great value in safe devices (#IntendedToBeAFactualStatement). I like all parents of kids with T1 diabetes want the best for their kids. That starts with safe. I also believe that efficient markets crave information and that it is not detrimental to safety of patients or markets to have factual information responsibly shared by the people who know that information best. Best, in this case, would include the folks who make said devices.

 

Crash Test Dummy

Raise you hand if you put a car into a ditch or other immovable object off the side of the road as a teenager.

I did.

I was cut off on a highway and ran a perfectly good VW Bug into an Exxon sign pillar. The sign was fine. I popped the windshield off the car with my head and it flew 20 feet in the air, bounced and landed unbroken. The windshield did best. I went to the hospital and the Bug went to the scrap heap.

I loved that car.

It was the American dream in a old German car. It was slow. It was noisy.  The heater didn’t work very well, when it worked at all.  But it was freedom. It would go anywhere and, bonus, it fit on sidewalks. However the statute of limitations on some those sidewalk missions may still not have expired so enough said.

It would’ve been nice to miss the sign.

My T1 son is learning to drive. It would be nice for him to miss the sign too and to stay off sidewalks.

Some of all of y’all (a phrase that here means "In select cities"), can get free hands on training to miss the sign and stay off sidewalks.

Medtronic is sponsoring a free driving program for diabetic teens. It is called Test B4U Drive.

If you are skeptical, I understand. I thought “Test B4U” sounds like diabetes preachiness dressed in text messaging slang trying to be cool. I too was a tad skeptical. I mean I am an American Male and therefor endowed by the creator with certain unalienable rights like life, liberty and the pursuit of happiness.

Hello! I am sure that by that Thomas Jefferson meant driving.

Also it means that my American Maleness grants me presumed naturally superior driving abilities that I can passed on to my son both genetically and spiritually. (Your Honor. I move the testimony of the Exxon sign be excluded on the grounds that it is a sign and so has no business commenting on my natural American Maleness driving superiority.)

I mentioned the class to my son and he responded with the comment that the driving session at Friends for Life a few years back was an extremely boring lecture, where they just sat there and listened to some dude drone on. This is what I call this the Charlie Brown’s Teacher Syndrome   “Wa WAA wa Waa WaWa.” (C.B.T.S. - you know I love the four letter acronyms.)

The folks at Medtronic were kind enough to talk with me about the program today. They rolled out their big guns, Dr. Francine R. Kaufman, Chief Medical Officer and Vice President and Amanda Sheldon, Director of Public Relations. You put three people on the phone that are passionate about diabetes care and we tent to all talk at the same time. We did somehow sort out taking turns. 

I asked them straight up how they were going to avoid CBTS with an all day deal for teens? I can’t pay attention for 7 minutes how are they gonna get teens to pay attention for 7 hours?

(I can hear regular YDMV readers saying, “Hey Bennet the T1 teens are probably more mature than you are!” Probably that Kerri chick and her pal Christel. Those two are trouble with a capital T of course that's why I love'm.)

I digress. Back to Test B4U Drive. First of all driving is a topic near and dear to the teenage heart so that should help get attention. (How else can you explain the American Dream in a German car above.) Next while there is some diabetes stuff and there will be an actual endo at each session the organizers get that the day is about cars. So they will also have professional diving instructors at each session. Instructors - plural. One instructor to three teens. 1:3.

The day will be mostly driving and only some classroom. They said it is like six hours playing and one hour of classroom time and it sounds like there is fun stuff to do in the cars. Hard breaking, avoidance maneuvering and my personal favorite skidding! (but not into an Exxon sign - avoiding now there is a concept... )

Medtronic is in the program with the Juvenile Diabetes No Limits Foundation, who I had never heard of. The good folks at Medtronic explained it a group based in Minnesota lat is supports T1 kids living full lives. Cool. I think they said something about the founder being a car racer. Even more coolness.

Test B4U Drive is being offered to teens with diabetes at these select locations, none near me, in 2010, 15 kids to a class:

• July 19-21, The Forum, Los Angeles
• July 26-28, Dick’s Sporting Goods Park, Commerce City, Colo. (Denver area)
• August 2-4, KCI Expo Center, Kansas City, Mo.
• August 9-11, Standard Bank Stadium, Crestwood, Ill. (Chicago area)

Yeah they may mention diabetes care and some of Medtronic’s products and/or services but they are also gonna let you go beat up err.. play no wrong word again... learn in a rental car. That’s a fair deal.

For more information see: http://www.medtronicdiabetes.com/testb4udrive/