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.

 

Carb Counts and Beyond

Lesson From Toy Story

Pixar’s Toy Story has had a huge impact on our family. We are fans. Geeky, buy the behind the scenes book about the art of Pixar, fans.

We went to Disney World’s Halloween Party dressed as Toy Story characters. Twice. Well Kelley was Tinker Bell the first year.

We were all Zurgs the second time. Yes I made all the costumes.

That takes me to geekdom and beyond.

All those years ago Buzz Lightyear has some sound advice, to infinity and beyond. It seems like carb counting stretches out indefinitely. That’s not a bad thing. It means looking to a long healthy future and dragging diabetes along - like slink dog’s rear end. Some times it waddles along fine. Other times it come shooting up and rebounds past where you want it.

I think folks in the diabetes universe are light years ahead of most folks ‘casue we read the sides and backs of food packages. We are carb counters. So since we are reading all these labels anyway why not glance at something in addition to the carbs? Just pick one and see if you're getting what you need or too much of it.

Consider salt.

The amount we get in the diet from the shakers on the table and in the kitchen is probably less than 10% of what Joe Schmo eats. And while we worry about the carb counts of restaurant menus they are really burying us with salt too. Have a look at these dishes. WTH like we don’t have enough issues already. http://health.yahoo.net/experts/eatthis/saltiest-foods-2011

Come to think of it the movie popcorn is probably less than health food. That said, the mental health value of movies with the kids last to infinity and beyond.

DOC, Meet Julie

I would like you all to meet Julie. She is working on a study of adult siblings of type 1s. She could use the Diabetes Online Community's help. So please consider this a very clear and direct suggestion to go to this link to learn more: http://siblingresearchstudy.blogspot.com/

Anything other than a clear and direct suggestion to that link would be bad, so I will not write any folksy self deprecating jokes that would get her fired.

Thanks for your help.

(If anyone asks say some other respectable diabetes site refereed you, it is probably better for her that way.)

Kelley Kunik Clashes With Craptacular non Kardashian Kraken

Meat Monster Marketer Mauled
Bloated Burger Burned

I was gonna write about spectacularly stupid food at restaurants. Actually I wrote a bit but friends Kelly’s blog post today is hysterical. Better than what I have in the can so go read it:

Craptacular, Craptacular: The Meat Monster Edition - RELEASE THE KRAKEN!!

Accu-Chek Aviva Expert - UK

Here is a fascinating little piece of diabetes gear, a meter with a bolus wizard for the MDI crowd. Hop on over the Shoot Up or Put Up for a review of a device I am fairly sure nobody in the US is talking about. I'm betting heavy on the FDA's rules is the reason why.

Anyway Tim's a good enough guy, except for the puns, so here's a link the the UK review, including the  image Tim pinched from Roche and I took from him.

Go Watch This. Please.

It is funny.

Kelley and friends at NYU made it. They won 2nd place in a competition with it.

Now there is a who gets the most views on You Tube thing happening.

So please bump up their hit count.

Thanks.

FDA PMA 2011

FDA released the January and February PMA Approvals. Yeah I know. It is right up there with Steve Martin finding his name in the phone book, exciting just doesn't explain it, but here goes:

P980022/S090
1/7/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA 91325 Approval for a modification to the design specification of the lumen tubing used in the manufacturing process of the glucose sensor to allow for less dimensional variation in the tubing supplied by the tubing vendor.

P980022/S092
1/31/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325 Approval for a software change to the CareLink® Personal Therapy Management Software for Diabetes, MMT-7333, from version 5.3A to 5.4A.

P050020/S022
1/14/11
180-Day Freestyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care
Alameda, CA
94502 Approval for changes to the outgoing Quality Control (QC) solution testing.

P980022/S091
1/12/11 Continuous Glucose Monitoring System Medtronic, Inc. Northridge, CA 91325 Minor manufacturing changes to the Sof-Sensor™ Glucose Sensor MMT-7002.

I Would Like to Submit for the Courts Consideration...

... the number of Diet Dr Pepper cans in front of the defendant,
Mr. Scott Johnson.

I rest my case, Your Honor.

BwaHaHaha

Diabetes Data Standards

I think it is well past the time for the Tower of Babel to fall.

Diabetes is managed through the use of data. That data belongs to the user, the patient. It is theirs. Managing data should not a tool to strengthen a vendors proprietary grip on patients. Sadly patient data is almost universally maintained in proprietary formats guarded for the commercial advantage of durable device manufacturers market share.

I believe this is wrong. I believe it is a detriment to better health individually and for patients as a population. I believe that proprietary data puts a burden of maintaining data management on durable device manufacturers that increases the cost of devices. I believe when heath insurance mandates specific formulary brands and those brands do not share data well the insurance company is reducing the opportunity for better diabetes management to reduce cost.

I think it is time for patients to start asking their medical device manufacturers to open data standards and work towards a common language for diabetes devices. I think in the long run manufacturers’ costs for data management in the long run be reduced by benefiting from shared standards. I would like to see their energy spend on innovative devices not maintaining proprietary data standards. I would like to see patients and their advocate organizations have a voice in data standardization.

If you agree I would love to hear from you. I would love you to share your thoughts. Let start by seeing who all is interested. Bernard has an old thread on the topic at TuDiabetes. If you are interested in some grass roots advocacy on data standards please introduce your self there, like this:

I am Bennet and I am interested in promoting standards.

No Experience Needed

The infamous Washington State 'No Strips For Kids' idea was the subject of a post I read today. The gist was that in part this may have been the result of a system that considers it a conflict of interest to have specialist with clinical experience in a given field participate in how that field get managed. So no endos when considering strip use for effective diabetes management. I would love to know if these assertions are accurate. If so:

WTF

That is Moronic.

Now in all fairness I read this on the Internet so there is a fair shot that it is not entirely accurate. The dude who wrote it flat out says he didn't have time to fact check it. Here is the bit from Forbes.

This gets me to a recent pair of Wall Street Journal editorials on the Washington state health panel, called the Health Technology Assessment committee, which was considering denying reimbursement for test strips that help diabetic children self-monitor their blood sugar levels. (Coincidentally, last September, Leah Hole-Curry, director of HTAC, was appointed to the governing board of President Obama’s comparative effectiveness research program, the Patient-Centered Outcomes Research institute.)

The HTAC had previously suggested that there wasn’t enough evidence that self-monitoring was clinically beneficial. But this was, in part, an unfair criticism: it’s difficult to conduct a trial in which you ask diabetic children not to monitor their blood sugar levels. The idea that poorly monitoring one’s blood sugar levels is a good thing defies decades of understanding.

So why would the HTAC consider denying reimbursement for test strips? “One reason that the panel chose to prosecute this case,” suggests the WSJ, “may be that its strict conflict-of-interest rules prevent specialists from setting priorities. The 11-member Health Technology Assessement [committee], naturally, does not include an endocrinologist or any other physician with relevant clinical experience whose expertise might pollute the findings.”

I don’t have time to dig into HTAC’s conflict-of-interest rules myself to see whether or not this is the case.