#medtronicDAF Disclosure Statement

I was privilege to be invited to join the folks from Medtronic at a social media even this April Fools day in LA.  I went and I still don't know what the DAF in the hash tag stands for, Diabetes Air Force maybe?

I saw good friends from the Diabetes Online Community, some face to face for the first time. Met some new friends both from the DOC and Medtronic.

There are a couple of thing people ask me about events like this like: "Why you?" and "Are they seducing you to the dark side?" OK the second one doesn't typically get phrased with a fun movie reference but you get the idea.

I don’t know how they chose to invite who they did. It has to be hard. There are a lot of great voices in the DOC, I don't think that mine is any better than a myriad of others and we are not a Medtronic user.

I have traded emails and phone calls with the folks at Medtronic. They once asked if I would consider a post about their Lenny iPod app.  I chose not to and shared some of the reservations I had as a parent about the app. They fixed some of the things I was concerned about but I still never wrote about it. (Yes I am an ungrateful arse.)  Another time I did write about a driving program they sponsored. That is about it. I don't know why me.

I do think they are nice enough people. They have jobs and selling pumps make the pay checks happen. They seem to do those jobs very well. Except for Jonathan the sensor engineer. He was better than very good as a plant tour guide. If you have a kid who is interested in engineering, find a way to have'm spend time with that guy. He is funny, inspired by machines and process, very personable and a strong communicator. See: more evidence of the dark side, except I don't buy what he builds but man building them is a heck of a thing. 



When asked about how they chose who to invite, they said they were looking to hear a variety of voices. They read the DOC daily.  They know who's who. I know there were folks invited who couldn't make it. Medtronic did said they were looking for some honest feed back. 

I think they got it.

Still the evenet was stupid fun. I would be flat out lying if I said anything else. It was a mini diabetes camp for grownups, not that I actually acted all that grown up. It was also an exhausting three days of time away from home, two of which were spent in a coach seats on very full Airbusses and I didn't have enough episodes of Community on my iPhone to make that time pass pleasantly.

Medtronic didn’t push product. They can't talk about stuff that is into the FDA. We tried to get them to anyway. They looked tempted, but there is stuff they just will not talk about. They did say that CareLink (is that what it is called?) for Apple computers has been blessed and will be announced to the public this week. Maybe even tomorrow.  They did share some of their personal stories and connections to type 1. In many cases it is very personal. More on that in a different post.

Will Dubois (in the spirit of full disclosure I think the world of Will aka Lee) and I were laughing on the ride to Medtronic in the morning that we were both kinda surprised to be there. He has been a critic, harsh at times apparently. He has some fairly clear ideas about Luer-Lok that he shared again just in case they forgot. Anyway Will and I talked about the fact that we, as a community, need the durable medical guys. We need them to compete, to be successful and pursue profitable innovative products. Their market success means better care for pumpers. That is the trade off but we have more skin in the game than they do. It is their livelihood, it is our lives.


That we need device manufacturers to be successful and that I would hold back comments in exchange for two days in coach aren’t even anyplace near each other. Still you are free to form your own opinions about that. I hope I continue to earn your trust that: 1) I get around to saying what is on my mind and 2) the time between me saying what is on my mind and the time it gets there is typically nano seconds.

Do I hope Medtronic got good feed back? Yes. I think they did. Do I hope they will do more events like this? Yes. Do I want to go? Oh hell yeah. Did I screw that up by suggesting to one dude that comments about winning in the market place sound like Charlie Sheen? Yeah I did that too.

Why me? Well it probably because it was April Fools and they needed a fool. As for the dark side, nobody claimed to be my dad.

How I Almost Missed My Flight.

... I blame Dunkin Donuts

I had an early morning flight on Thursday to go to the Medtronic social media thing. Being a responsible driver, I stopped for coffee before I hit pre-sunrise traffic. Yes that is how thoughtful of other drivers I am, it had NOTHING to do with MY caffeine addiction.

Me, “‘morningmediumcoffeejustcreamplease”

DD makes a regular with extra sugar.

Me, “This has sugar. Can you make a just cream?”

DD, “You don’t want Sugar?”

Me, “Just cream thanks.”

DD does this a lot. I think I have discovered why. The Just cream was also very lacking in actual coffee goodness. It was the 97 pound weakling on the caffeine muscle beach. Brown warm water that tasted like half the grounds and that had been recycled. Sugar was the only thing that gave it flavor, no wonder they put it in even when you don't want it. Sadly I had hit traffic before this was abundantly clear.

I couldn’t drink it. I am fairly confident that why I missed the turn for the parking lot and ended up on south bound I95. Also I feel it was a contributing factor in misplacing my iPhone in  my briefcase. Yes I lost my own phone in my own briefcase going through security.  By which I mean that I was in a panic thinking my phone was lost when it wasn’t I was just too insufficiently caffeinated to see it where it was. 

I was also too slow to notice I was in terminal B when the big TV screen said A.

I blame Dunkin Donuts. I did my part. I stopped for coffee. They failed. None of this could possibly be MY fault. ;)

Dear Depressed In The West

Kelly Kunik aka K2 has an emotional response to a letter from a reader about diabetes worry. It a great little piece and if you haven't seen it yet go read it now. Anything I have to say, can wait.

So now that you have read it this next bit is redundant because it is my comment there:

I'll jump in with the not particularly sage observation that Diabetes is in fact a rat bastard. It likes to play mind games with the goal of keeping PWD less than they can be.

All too often diabetes care is talked about in terms of numbers and compliance. Who the hell wants to be a number? As for the compliance bit I have seen enough science fiction to know that the robot overlords from outer space want us to be compliant.

Those robots are not the only ones. Yesterday I wrote about The Good, The Bad and The Ugly. I wish I had read this first because I would have cast the idea that diabetes care is about numbers and compliance as The Bad. (MTV's casting call would still be The Ugly.) The Bad doesn't see that living with diabetes takes an emotional toll. The Bad doesn't see the whole person with diabetes. It cuts out the emotions, well except the bad stuff like guilt and depression. I think emotional support is every bit as necessary as insulin and from what I hear around the DOC so do a lot of other people who are smarter than I am.

Don't let the the rat bastard focus on The Bad and The Ugly. You are entitled to have The Good too.

Verio 510k Clearance

Anyone know anything about this meter? I was bored and started looking through the FDA 510k approvals. Yeah that bored. Anyway I came across this:

DEVICE: ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC.                    510(k) NO: K093745106(TRADITIONAL)
ATTN: LISA  MCGRATH               PHONE NO : 408 956 4446
1000 GIBRALTAR DR., MS 2C         SE DECISION MADE: 11-FEB-11
MILPITAS CA 95035 6312            510(k) SUMMARY AVAILABLE FROM FDA

I found an Australian page at: http://www.onetouch.com.au/

The Good, the Bad and the Ugly

I watched the Indy Car opener toady. Delaney was psyched to see Charlie Kimball’s car. We were all sad to see him leave the race early.

I think he is a roll model for her and a lot of other kids with type 1. I don’t expect many of those kids to have an interest in becoming Indy Car drivers.  That isn’t what a roll model is about. Charlie is a roll model because he is living his dream and bringing diabetes along kicking and screaming whether it likes it or not.

Diabetes is a rat bastard. It doesn't want kids with type 1 to dream. It wants to limit and define the lives it touches. Charlie shows that with hard work, character and a Dexcom screwed on the high tech steering wheel of life they can chase down their dream at a few hundred miles an hour. Chasing dreams is more than simply good.

At some commercial break during the race I saw a tweet that MTV is casting a reality bit with someone with diabetes. They are looking for a bad diabetic. Here in part is their casting call:

Does your diabetes hold you back from living the life the way you want? Do you have an extreme form of the disease which requires you to constantly inject yourself with insulin? Does it make you feel different from your peers? How is your situation more difficult than your friends' at school? Are you embarrassed by your diabetes?

It sure seems like they are looking to help that rat bastard diabetes limit and define lives. That my friends is just another case of the ugly.

In reality, we have a choice. We can tune into MTV and wallow in diabetes or what ever the find that limits and defins lives. On the other hand Indy Car has races trough the fall. We can watch Charlie strap the Dexcom to the steering wheel and take diabetes where no one has taken it before. Where fast matters and diabetes doesn't.

Charlie is a rookie in the professional big league of his sport. He is a dedicated, hard working and pleasant. Those traits are the reality of what makes him a roll model.

I am looking forward to the next race. I'll be watching. As for MTV well I will maintain my perfect record of tuning them out. Diabetes isn’t the only thing that wants to limit and define the lives it touches. Unlike being diagnosed with diabetes we have a choice as to what we get on TV.

Use the powers of your remote only for good.

@CharlieKimball: Go Fast Insulin

We hold theses truths to be self evident; that fast cars are cool. The type 1 community's own professional race car driver Charlie Kimball is racing in his first Indy Car even this weekend driving the Chip Ganassi Racing Levemir and NovoLog FlexPen Honda Dallara. A.K.A No. 83. This is the Big Leagues sports fans.

Here is Charlie in a video he made for theBeteNOW.


24/7 On Track Charlie Kimball from thebetes now on Vimeo.

He will be speeding around the streets of St. Petersburg in the Honda Grand Prix. There is great behavior to teach your insulin using kids to emulate... wait... maybe not so much unless the speeding around the streets is in an actual sanctioned racing event. Better for your car insurance premiums than getting a fist full of tickets - you can tune in on ABC tomorrow at 12:30 pm to watch.  Learn more on IndyCar.com.

Delaney and I are looking forward to the watching the race. She as an autographed picture of Charlie on the wall along with other type 1 athletes. He's cool. He goes fast. He is type 1. He  signs pictures for kids at Friends For Life. All that and he is crazy nice.

He is also the closest thing to the Stig we've ever met.

You can follow him on Twitter, maybe even Tweet him good luck on his first Indy Car race.
 

Rx: Kiss-a-Pig

That is official medical advice. Well in so far a doctor suggests, well actually request, it.

The doctor in question is Andreas Stuhr. He is about as nice a guy as I've met and a real good sport. He did a bit for theBetesNOW in German only come to think of it now, I have no idea what he said...

Rumor has it he's been walking around the office in a pig costumer drumming up support for this fund raising event. Nobody should get away with behavior like that without their friends mocking them on the internet. I have spies trying to get pictures and I will post them when and if I get them.

In them mean time, if you are so inclined, join me in chipping in a little.

Tolerx Phase 3 Did Not Meet End Points

From The News Wire: Disappointing news for people hoping for a suppression of the autoimmune causes of type 1. I am not a rocket scientist or expert on how any branch pf science progresses so I look forward to reading  what more capable writers have to say. I am sure good friend of the blog Scott Strummello will have enlightening comments when he has had time to get all the facts. In the mean time here is the opening of the recent press statement and a link to the full release. 

Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint

CAMBRIDGE, Mass. and LONDON, March 11, 2011 /PRNewswire/ -- Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.  

Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study. Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.

FTNW: Biodel

From the News Wire

DANBURY, Conn., Mar. 14, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates.  The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.  Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes.  This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog® each on separate occasions.  This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog®.  In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year.

for more see this link

Health News - RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients

Health News - RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients