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.

CareLink Mac

The Mac version out:
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1301674650707&lang=en_US

I’m Not Clark Kent

... so that rules out superman too.

Clark is an ace reporter. I am not so good at the who, what, where, when, how but then come to think of it I never noticed Clark doing much actual reporting either. For actual play by play of the Medtronic social media event I think there may be more accurate recounting by the folks who were taking notes on laptops. Keep your eyes open I am sure the reports will start flowing in.

Here roughly the outline of the day. I try to add some color commentary:

• Amanda Sheldon, Director Medtronic PR opened and we got her talking and ran into the time that was allotted for:
• Katie Szyman who has been President of the diabetes business unit for a year and a half.
• Lane Desborough who’s title was Product Specialist. He is an engineer who recently joined MM from other larger industrial chemical engineering endeavors following his son’s T1 DX.
• Brad Monosmith introduced an app for that where that is diabetes and the long arm of the law keeps the device and the app from talking to each other.
• We took a picture:

• We talked more about a closed look and connectivity With Lane and Todd Robin director of CGMs.
• Dr Francine Kaufman spoke from clinical and medical research perspective and shared some research on a pump in Europe that turns off insulin with hypos. Due to certain Minister of Magic regulations we’ll just call it the Pump the Can Not Be Named.  (I’m kidding FDA, it was a Joke, no need to call out the Dementors from the IRS)
• Dr. Richard Rubin of Hopkins talked about diabetes burnout. Great stuff. One key point - Joking around about diabetes is good (that FDA as the dark arts bit was strictly medicinal I swear! Oh wait that means I need to wait years for clearance before using it...)
• There was a cool tool tour of the sensor manufacturing plant.

We interrupted and talked over everyone of these folks and led them down all kinds of digressions. Scott Johnson drank all the diet Dr Pepper.

Probably the most shocking utterance was early in the day when Lane used a dirty word:

"Control."

Yeah I know! The nerve of that guy. It sets off all kinds of emotional responses doesn’t it?  But he didn’t mean it like ‘you diabetic scum need to be compliant and be in range all the time - how hard can it be? what the heck is wrong with you.’ He used it as an engineer.

Engineers speak a different language. To them control isn’t profanity.  It is a process of transferring variability from one place to another. In the diabetes case to transfer some variability in blood glucose to variability in electrical current. Then to use that electric variation as feed back to have an impact on BG. He went on to talk about the success of that transfer in two time frames; first the moment and second over time. It was all very geeky and since I am a little geeky I thought it was all very fascinating.

More fascinating was the idea that some problems have been solved in other disciplines and those solutions can be transferred to diabetes care. Engineers transfer variability in large complex refineries to systems that manage outcomes in the moment and over time. It keeps the plants from blowing up. Possibly the algorithms, logic and processes used there can be brought to bear on the reality of your diabetes varying.

That I found this interesting is proves what I said, I am a geek at heart. So is Lane because he appreciated the need to minimize the space on a kids’ Bat Belts (and bat bellies) for all the stuff this may involve.

Somewhere in all this we got a first pass at the idea of data standardization. Since Bernard (BandYard) Farrell missed his flight to to a snow storm, the rest of us were more than happy to provide a little of the open honest feedback our Medtronic hosts were looking for. I happen to have ranted about data standards a bit, not as long as Bernard. He is the patients’ Superman of Data Standardization. I am more of the Jimmy Olsen on the beat.  When I get into trouble he saves me. Interestingly the engineers seemed to agree that data standards would be valuable and I don’t know that the business / lawyers side of the equation feels the same way. I am fairly confident Medtronic heard the standards message, more than once. It is one of the messages I was there to share.

That is a conversation worth having. We are the market. If we as the market start and keep demanding it it may happen. When there is a movement to standards, it will have to get past the whole secretive FDA dark arts process. I don’t expect them soon.