Help a Dad asking for better education.

Tom Karlya, aka Diabetes Dad reached out and asked for help getting the word out on a North Carolina diabetes education ask.

I'm happy to help share.

The effort is to help provide education about the symptoms of diabetes so that kids are not sent home entering DKA with a suspected flu or other childhood bug. Tom outlines the issue better than I. Like so many advocacy issues this popped up at the last second. All the more reason we need a strong advocacy database.

http://diabetesdad.org/2015/04/27/today-the-world-changes-but-we-must-act-by-2pm-est-please-help/

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

Of Automobiles and Insulin Delivery

I applaud the New York Times for caring to write about type 1 technology. I would encourage them to take a little more time to better understand the subject next time. I'll try to help. Since we are all Americans here, lets use a metaphor we all understand - cars. Fuel efficient small foreign cars, so maybe not something we all understand.

In the 1970s I drove a VW Beatle. It had been my mom’s. It would go anywhere, including places my friend Ric broke his jeep. One year for Christmas I got a hand full of Craftsman tools and rebuilt the engine and clutch. Bugs were easy enough to fix anyone with tools could do it.  

Coming home from college one weekend, I was cut off on a highway and skidded into a gas station sign. The car was totaled. I was nearly so too. The impact of my face cracked the steering wheel and popped the windshield out. The Glass flew across the service station and landed unbroken. I remember the gas station guys talking about seeing the glass fly and marveling that it didn’t break, from my semi conscious state waiting for the ambulance. 

I still like small cars. I have a Mini. It has a host of features my Bug lacked; anti lock breaks, a host of front and side air bags, crumple zone construction, good seat belts, power steering and much more.

I bring all this up to point out the value of current automotive technology verses 1970s technology. It would be easy to say that both the Beatle and the Mini do the same job. They get me from point A to point B in relatively the same mix of shifting, steering, breaking and being a little weary of bigger vehicles. In that context the newer car’s significantly higher cost could be seen an extravagance. 

Modern cars are significantly safer (even if they don’t go up Jeep trails like a Bug.) 

I think there is a parallel to diabetes technology. Modern diabetes technology looks like it is doing the same job as the 70s stuff. 

It isn’t.

Modern insulins allow a better if not perfect parallel of physiologic insulin. Pumps provide a better delivery system and allow delivery to be programed to daily rhythms. Continuous sensing can alert patients to changes and prevent dangerous lows and highs. 

Yes, this stuff cost more than 1970’s stuff. Cost isn’t the question, value is. Air bags are mandated because some cars are gonna crash. Antilock breaks, crumple zone construction, side impact doors, safe fuel systems etc all cost more. The value is in safer roads, lives saved. 

See where I am goin’ here? 

The story of technology is the value it brings. Computers cost more than pencils, ruled notebooks and movable type presses. The New York Times assembles the paper with computers, because they bring value. We drive safer cars for the value. People with type 1 diabetes can be more productive members of society due to the value of effective technology.

Sent via email to: Elisabeth Rosenthal NYT. (without the cool images, what can ya do.) 

ps. Neither my Bug of Mini looked the good but the colors are right. 

New Kind of Mail - With Stamps!

I just put stamps on letter to my Senators, Congresswoman and the President.

Real snail mail letters based on this Sample Letter at StripSafely.com. 

I am asking my policy leaders to send a staffer to the 9.9.13 Diabetes Technology Society meeting. That aide can help my elected officials understand that there is an issue with test strip accuracy.

You can help. You can write too (Hint: Use the sample!) BUT can you find cooler stamps than these Pixar gems?

It is Not OK.

Sometimes, I may be prescient. I know that came as a shock to me too.

Back in 2010 I wrote a piece about medical devices approved by the FDA. In it I joked about the OK Meter saying, “No pretensions of greatness at all. It is just OK.”

Maybe it isn’t so OK.

OK Biotech and Prodigy Diabetes care “Aligned Ownership.” In their announcement they were clear about opportunities with Centers for Medicare and Medicaid Services bidding.

Yesterday Prodigy Diabetes Care was disclosed as the recipient of a FDA warning letter in the FDA press release, “FDA alerts companies to stop illegal sale of treatments for diabetes.”

I strongly urge people with diabetes to read that FDA letter.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm
In part it says:

Complaint #598 describes an event in which a patient exhibited symptoms of low blood sugar levels after receiving high (260, 169, and 158 mg/dL) blood glucose results when using your firm’s device. Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL. The information included for complaint # 598 reasonably suggests that your firm’s device may have caused or contributed to a life threatening injury. An MDR should have been submitted for this complaint.

That said:
Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL - And - 

An MDR should have been submitted for this complaint.

That means one was not.

That is NOT OK.

How far below 20mg mg/dl does someone have to go to get a Medical Device Report filed? How much lower can someone go and recover?

 Thanks FDA for the letter.

One question - Does warning mean they are still selling strips to CMS?


If meter accuracy matters to you join the campaign at www.StripSafely.com

Hey DOC! Welcome Maryam #TwoBits

Hello my Diabetes Online Community friends. Meet Maryam or Myrm as my son calls her, all though I have no idea how that nick name is spelled. (Regular YDMV reades will know I have no idea how anything is actually spelled and not be surprised.)

She bring the DOC the much needed sound of young america which is actually the name of a PRI show but you get the point.   

Here is the bio for her blog: 

Maryam Elarbi is an 18-year-old freshman in college who was diagnosed with Type 1 diabetes at the age of 10. Eight months after her diagnosis, Maryam’s family began attending the “Children With Diabetes” conferences, which changed their entire view on Type 1 and how to cope with it. Over the past eight years, Maryam has been actively involved in advocating for people with Type 1 through these conferences, as well as fund-raising for diabetes research through JDRF’s annual “Walk to Cure Diabetes.” In her spare time, Maryam enjoys reading (especially works by Jane Austen and Kurt Vonnegut), writing, spending time in the beautiful city of Philadelphia, and defeating her brothers in the new “Dance Central 2″ game.

She and the brothers she thrashes at Dance Central 2, helped my son feel welcome at CDW years ago. What a great gift. You can see her almost live in theBetesNOW's fashion report form the FFL Red Carpet. So DOC welcome Maryam! Here’s two of her recent posts:

Adventures in Hypoglycemia

http://www.diabetesselfmanagement.com/Blog/Kids-And-Diabetes/adventures-in-hypoglycemia/

The Importance of Consistency

http://www.diabetesselfmanagement.com/Blog/Maryam-Elarbi/the-importance-of-consistency/

YDMV on the Goal of diabetes management and teens

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#dsma Makeover & an Easy resloution #TwoBits

Here is a quick #TwoBits* from around the DOC.

#DSMA’s New Years New Look: The web site has been overhauled and sports a more user friendly interface. Included in the more friendly part is a menu link to the weekly Wednesday night party that is #dsma chat. More on how to join that party can be found in this post.

Carey Potash my favorite blogger at dLife writes about the Medtronic mySentry, its costs and dreaming of a lost poodle. If Carey isn’t in your RSS feed adding him is a great New Years resolution. You will thank me I’m sure. 

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?