FFL

I keep hearing the AT&T 'you have a text' jingle. 'Lanes is texting her FFL buddies.

She is looking forward to Disney. We are Disney people. www.DisneyWithDiabetes.com is us. This time she is looking forward to seeing her FFL friends maybe more than playing in the parks.

I underestimated the value of being with other people with diabetes. Delaney has never been alone with diabetes. She has always been in a club with at least her brother. He's cool. Not as cool as friends.

FFL is a gift. Give it to the T1 in your life.

-- Post From My iPhone

Continua Health Alliance

I have written (OK ranted) about standards for diabetes data. In short I want all the tools we use to manage type 1 to play nice together.

Alert YDMV reader KoHo wrote “There is an industry group out called continua connected health that does exactly what you all want.”

Really?

Well yes, really, except it is called Continua Health Alliance.

Since KoHo left that message I have been digging around learning about Continua. It will take a few post to share what I have picked up. Lets start with what they say about themselves:

(Continua is) a non-profit, open industry alliance of the finest healthcare and technology companies in the world joining together in collaboration to improve the quality of personal healthcare.

Our Mission is to establish an eco-system of interoperable personal health systems that empower people & organizations to better manage their health and wellness.

Who are these “finest healthcare and technology companies?” Way too many to list here you can get a get a feel by follow this link. Members of the type 1 community will recognize some of our key vendors including Medtronic, Roche, LifeScan, and Bayer Diabetes Care.

The Association board has members form Intel, Partners Healthcare, Kaiser Permanente, Roche, Cisco Systems, Medtronic, Panasonic, Philips, Samsung, Sharp, Welch Allyn and tallying the Academy’s votes and tabulating the Oscar winners Price Waterhouse Coopers. Ok I was kidding about the Oscars. These companies are some economic big dogs. Good news for YDMV readers, the Roche board dude is from their diabetes care group.

The point I they make plain and I’m getting loud and clear is that these are serious corporate players. Here’s hoping that if the suits play nice, we’ll get tools that do too.

So much for who, how about ‘What are they gonna do for me?’ As I understand it they do a couple of things. First they establish standards on how devices for all kinds of things talk and aggregated information into common data sets. Manufacturer’s will make devices following the standards and submit them for the Continua version of the ‘Good Housekeeping Seal of Approval.’ Their efforts are then bifurcated. (Continua’s dude there actually used the word when I spoke with him. I had to stop to go figure out what he was talking about. Apparently is a cool word for split in two I should have known.) Anyway Continua spits its efforts between government and private payers to try to help them see that common standards and preventative tools are a good investment in avoiding more expensive conditions down the road.

How is it gonna work? Imagine having all kinds of devices in your house reporting on your health. Of course if you’re a type 1 household you don’t need to imagine devices they are probably on the coffee table right now. Imagine those meters, CGM, pumps, etc, talking to a central data hub. That hub then share the data in common combined reports.

That sounds really cool.

When is it going to happen? Continua would like you to see that it is happening now. Well OK - there are devices that have earned Continua certification. Exactly two. Both are Nonin Oximeters one is USB the other wireless.

No diabetes toys yet. They can’t say when. Continua does say that they expect additional certifications in the coming weeks and months. Or in other works - stay tuned.

From The News Wire: FDA PMA Upates May

The FDA released May PMA Approvals
The following maybe reliant to YDMV readers, DexCom software revisions, Abbott Navigator modifications to the inserter and Mini Med's sensor base and software.

P050012/S018 5/5/09 Real-Time
DexCom Seven Systems
DexCom, Inc.San Diego, CA92121
Approval for design revisions to the accessory software program to provide additional supplementary information to users on glucose trends and patterns downloaded to the program. The software program, as modified, will be marketed under the trade name DexCom Data Manager 3 (DM3) and is indicated for use by consumers to allow for the transfer of glucose data stored by the DexCom STS or Seven Systems into a personal computer (PC). The software modifications included several new features as identified in the submission.

P050020/S012 5/8/09 Real-Time
FreeStyle Navigator Continuous Glucose Monitoring System
Abbott Diabetes Care, Inc.Alameda, CA94502
Approval for modifications to the Inserter component housing of the FreeStyle CGMS, to reduce the overall thickness in the shelves of the housing and a change to the manufacturing equipment used to mold the housing components.

P980022/S054 5/22/09
SOF-SENSOR Glucose Sensor
Medtronic MiniMedNorthridge, CA91325
Changes to the sensor base and the needle/hub components.

P980022/S052 5/22/09 Real-Time
CareLink Pro PC Software
Medtronic MiniMedNorthridge, CA91325
Approval for a modification to the CareLink Pro PC Software (Version 1.3A, MMT-7335) to correct two identified problems.

Ellen LYMI (Good News about CVS Caremark)

I just read a post from Ellen at CWD

I just received information from an organization that I'm not at liberty to name, that CVS Caremark informed them that CVS Caremark "recently changed their protocol to include a cold pack with ALL shipped insulin. This is in response to customer reaction." Dated June 9, 2009.

Can a Caremark customer please confirm this? I'd also like to know where this is in writing on the Caremark website but I'm not a customer. Thank you.

So I got on the phone....
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I am on the phone (on hold) with Michel now.
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still holding
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I could use some Cheereos

(little inside joke for Ellen)
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Still on hold
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'OK Sir, According to our recordw we have no change but let me get you into Pharmacy they may have more recent information...'
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Back to hold
(No elevator music. I have to say no music is better than bad music.)
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‘Sir I have Michel from Pharmcay on the line there have been some updates and she can tell you about them.’

‘Me - wait aren't you Michel too? I am so easily confuse, thanks Michel and hello Michell.’

‘Sir I am going to put you on hold for a pharmisist.’

‘OK’
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This time we have some classical music - not one particularly inspiring.
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‘OK Sir? I just wanted to let you know we are waiting for a pharmacist. OK?’ Michel

‘OK’ - Me

‘OK’- Michel

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‘Mr. Dunlap? Thank you for patiently waiting. I have Dale a pharmacist at CVS / Caremark on the line.’ - Michel

Me - ‘Thank you Michel. Hi Dale.’

‘I understand you are interested in our shipping policy for (mumble)log diabetes products.’ Dale

‘Yes all insulin. I stopped being a CVS Caremark client when you stopped shipping it cold. I understand you may have changed your policy recently so I may need to consider coming back as a client.’ - YDMV

‘Yes as of June 5th we will now include a cold pack with every shipment of insulin. The only change is if the expected temperature at the receiving destination is expected to be over 85 degrees we will then ship next day.’

‘Thanks! That is great news!’

Ellen - That LY/MI on the post-it. Means Love Ya/Mean It

OK Campers - Lets all give Ellen a big

LY/MI

Around the Neighborhood: Diabetes Power Show

Talking a walk around the neighborhood is a healthy habit. One I need to do more of both in ‘real life’ and virtually on-line. I’ll take the dogs for a stroll later when Delaney can go with me - she enjoys it and I like her company. In the mean time let’s get ready to take a quick stroll to another part of the diabetes community online.

Having a child diagnosed as Type 1 stressful time. We know we have been there twice. It is time of fear and intense focus. Sadly those two - fear and focus - tend to push away humor when you need it most.

One of the things that ads to the stress are the lows that happen as the initial insulin resistance wears off. You face two uncertainties the fear of lows, ‘cause you have been told lows are something to take seriously and WTF maybe the doctor was wrong about this diagnosis ‘cause we are using next to no insulin.

The Diabetes Power Show has a great podcast on this and a bunch of other stuff. Here is why I think it is so great, the warning at the beginning is hysterical and important. Now I intend to go on and say why I think this is so important BUT SPOILER ALERT if you are the kind of person who really has to experience thing first hand with no preconceptions go there now and listen now.

What I find so great here is their good humor and relaxed attitude with the fact that blood sugars are crashing like model buildings in a Godzilla movie. Yeah they do what they gotta do about it but it is clear that their minds aren’t so clear. I think this is hugely important. It is a great demonstration of the diminished capacity that can come with lows. The lows are taken seriously but they are not even remotely solemn about it. I listened in the car on my iPod and was literally laughing out loud not just moderately amused little lol.

They talk about diabetes as an ability. The ability to function when low and have a sense of normalcy and humor about it is a great case in point. Panic never helps anything.

I have gone back and linked this pod cast in my Newbie Advice on Insulin Resistance. I hope it will help someone someplace deal with the stress of a new diagnosis.

From the News Wire: iPhone Apple and FDA

From MobiHealthNews.com

Apple puts onus of FDA clearance on iPhone developers

The U.S. Food and Drug Administration has indicated in the past that under certain circumstances the iPhone may be considered a medical device and therefore regulated as one, however, as of February the FDA still hadn’t figured out exactly which circumstances those might be.

Turns out Apple isn’t waiting around for the FDA. iPhone application developer and GraniteKey COO Mike Ahmadi wrote in to point out that Apple’s iPhone developer agreement includes a special section that puts the regulatory onus, in particular the duty of ensuring FDA compliance, on the developers themselves.

Obviously this section of the agreement has become increasingly important since Apple began promoting connected peripheral devices and medical apps like LifeScan’s glucometer and AirStrip’s cardiac monitoring application at the company’s iPhone 3.0 and World Wide Developer Conference events.

From The News Wire: Artificial Pancreas Used in T1s

Hi there YDMV fans. This one sounds interesting. Dexcom & Omni Pod used in closed loop:

NEW ORLEANS, June 8 /PRNewswire/ -- UC Santa Barbara and SansumDiabetes Research Institute scientists have demonstrated for the firsttime that an automated artificial pancreas system (APS) can safely andeffectively maintain desired blood glucose levels in patients with type1 diabetes. The clinical study results will be presented today in alate-breaking poster session(1) at the American Diabetes Association's69th Scientific Sessions in New Orleans.

The UCSB and Sansum researchers, working with the Schneider Children'sMedical Center of Israel, tested an automated insulin delivery systemcomprising the OmniPod(R) System and the DexCom STS7(R) continuousglucose monitor, linked and controlled through UCSB's artificialpancreas software. The software's insulin delivery algorithm, optimizedfor each patient, includes a unique safety feature, based on clinicalparameters, which prevents insulin-induced low blood glucose levels(hypoglycemia).

Read the full story here:

http://www.itnewsonline.com/showprnstory.php?storyid=50113

Clearly there is a lot of work going on and lots more to come. PWD are not going to see these at there next endo visit. It does get me wondering, how would you feel about using a closed loop?

There are so many non-insulin delivery variables in the YDMV equation that I am kinda sceptical. (I know me being skeptical who would have thought it?) How does it know there is exercise coming up? How does it account for stress?

From the ADA Daily: Sunday Patch Pumps

http://www.nxtbook.com/nxtbooks/tristar/ada09-2/#/6

From the ADA Daily: T1 Research & CGM Stuff

The big ADA Scientific Sessions are underway in New Orleans. Other than having access to some outstanding places to eat it would be fun to be there to hears some way over my head science. There is a daily newspaper of goings on and I have a fun time reading it. (I'll cook up some nice spicy food and pretend I'm there.)

So in case any of y'all want to have a sneak peak here's the paper's link:
http://www.nxtbook.com/nxtbooks/tristar/ada09-1/index.php?startid=1

Page 1 has a quick summary of possible treatments. Page 8 has an article on CGMs. My standard rant about who the caregivers are applies to the CGM bit where the data stream is too much for doctors to look at but what the heck as my buddy Mark says - We are the primary care teAM.

From the News Wire: Medtronic's CGM Move

As Previously Advertised: Medtronic had diabetes announcements at their annual investor meeting.

MINNEAPOLIS - (Business Wire) Medtronic, Inc. (NYSE: MDT) announced today
at its annual institutional investor and analyst meeting that the company
purchased substantially all glucose monitoring assets from PreciSense A/S, a
Denmark-based development company focused on continuous glucose monitoring (CGM)
technology. Specific terms of the acquisition were not disclosed.

“This strategic acquisition is an effort to expand Medtronic’s already
robust continuous glucose monitoring pipeline, and to develop a new CGM platform
to aid development of our ‘closed-loop’ system,” said Diabetes business unit
president and senior vice president at Medtronic, Chris O’Connell. “This
potentially disruptive technology could significantly broaden the use of CGM,
and help improve diabetes care for more patients.”

From PreciSense’s web page:

Non.invasive Glucose Reading
The PreciSense System includes a microcapsule
placement unit and a light detecting non-invasive reader unit. The microcapsule
placement unit poses the right dose of glucose-responding microcapsules in the
upper layer of the skin, painlessly. The glucose assay components in the
microcapsules generate a fluorescence signal that corresponds to the glucose
level. The non-invasive reader unit monitors this glucose binding event through
FRET, Fluorescence Resonance Energy Transfer, which is directly related to the
concentration of glucose.

I am officially not holding my breath for non invasive (or semi non invasive since this sound like you invasively plant a microcapsule but read it non invasively) blood readings. Still this sounds like a promising line of pursuit and all the best to tem if they can be the first people to make some form of non invasive work.