March 31, 2009

From the News Wire: Model Artificial Pancreas Pod w Navigator or Dexcom

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I found the OminiPod and Navigator or Dexcom interesting:

Researchers Successfully Create Computer-Simulated Model for Evaluating
Artificial Pancreas
http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/03-31-2009/0004997472&EDATE=

SANTA BARBARA, Calif., March 31 /PRNewswire/ -- A key step toward the successful development of an artificial pancreas for patients with diabetes has been achieved, according to new research published in this month's issue of Diabetes Technology & Therapeutics.

Researchers at the University of California at Santa Barbara, Sansum Diabetes Research Institute and Stanford Medical Center have effectively created a computer-simulated system for evaluating an investigational artificial pancreas comprised of the OmniPod(R) Insulin Management System--including the OmniPod insulin pump and Personal Diabetes Manager that controls it--and a continuous glucose monitor, in this case either the FreeStyle Navigator(R) or the DexCom STS7(R). The system also includes an algorithm that automates the interaction between the pump and monitor, and facilitates the running of a variety of tests and challenges to the software and component devices. The UC Santa Barbara-developed software and algorithms are also being used with a number of other pumps and monitors in developing additional systems.

More at the linked site.

March 29, 2009

Looking for PA People Again

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I Want You To Lobby Your Elected Officials


This is an update of a Post from August.

Safe at School legislation has been re-introduced into the quagmire we lovingly call Harrisburg. We need this and there is nothing like letting your elected officials know you (an actual registered voter) are paying attention. I don't see a PA Senate version yet.

It as easy as 123.

1) Identify your elected dude or dudette
2) Send them a letter
3) Send it again in a few months.


1) Go here and enter your zip code. It will give you your state representative.
2) Here is a little draft letter only minor modifications are required (edit out the wise cracks in the brackets) or grow your own.
3) If you hear back send a thank you note. If you don’t send the letter again a little closer to the first Tuesday following the first Monday in November. In fact send another one in mid October any way.


Dear (Insert the name your dude or dudette here, see 1 above.)

Please ad your sponsorship to House Bill 1113 P.N. 1309 Safe at School legislation for Children with diabetes. This legislation is desperately needed to help students with diabetes succeed.

We are the parents of (Your actual number of T1 Kids! I used two, if you have less than two actual type 1 kids please change the plural children to singular child as appropriate in the following sentences. Oh and congratulations on only having one.) children with type 1 diabetes. Type 1 is often reported in the media as the ‘more serious’ form of diabetes due to the higher levels of testing and insulin use it requires.

Type 1 is an autoimmune disease and is in no way the result of diet or exercise. All type 1 children and adults require insulin throughout the day and will continue to need it until a cure is found. Both our children use insulin pumps, manufactured in the Commonwealth, to deliver that insulin instead of 4 to 6 insulin shots a day. (LOOK It is good for the state economy! - Sucks big time for us but hey every silver lining has a cloud....)

(Ad A PERSONAL PARAGRAPH! follow with 'more work is still needed' like sample below)

While significant progress has been made many school still refuses the safe at school best practices that this bill would insure. For example many children have only been permitted to participate in school trips if a parent accompanies them and despite doctor’s specific recommendations are not permitted to carry and use their glucose monitoring equipment at all times.

This legislation is desperately needed. It is a safe and appropriate response to a chronic medical condition. I look forward to hearing you have added you sponsorship to the bill and your efforts to getting it passed. I hope to be able to share with the tens of thousands of other Delaware Valley (Or your local walk) type 1 families who support the October (Just before elections.... not that we are watching or anything... but maybe we'll follow up then) Juvenile Diabetes Research Foundation Walk for the Cure that you are working to improve the lives of type 1 kids by keeping them Safe at School. (OH YEAH DID I MENTION - THERE ARE TENS OF THOUSANDS OF REGISTERED VOTERS INVOLVED? right before Election Day? Oh I did mention that? Sorry.... Not!)

Respectfully

March 28, 2009

I dount it is this guy anymore..

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This was also part of the long ago quest for carb counts at WDW. Disney people move around all the time so I doubt tit is this dude anymore. DisneyWithDiabetes started as a blog before moving to AllEarsNet.com. This bit didn't move. I move information not advocacy (aka whining) to AllEars


This was:

Drop Mark a Letter (2006)

Connor just got out of Children's on Halloween '03 just a few weeks before a BIG Disney trip. (a Big Birthday for Zurgswife a.k.a. ZW.)

On that trip we went through some diabetes newbie experiences. Assuming we could buy a soda when we need to cover a low, instead of carrying a juice box. Loosing a meter etc.

We also found out that Disney Cast Members (employees anyplace else but Mickey calls them CMs) at the rank and file level are spectacular with diabetes assistance if you say "I need help."

Unfortunately we found out they are kind of a pain about carb counts. All you T1 families know the look that asks, "Why are you asking about carb counts? You an Atkins freak?"

Disney is GREAT at many thinks. Carb counting ain't one of them.

Since then I have been trying to get through to a 'suit' to talk about it. I am persistent and motivated. I kept at it off and on for two years.

No luck.

I had phone calls unreturned. I got high and mighty letters patronizing me about the important of them not getting it wrong and my responsibility to get it right for my kids. Oh and the ever popular (raise you hand if you have heard this one T1 families) info on a few sugar free items

50 odd thousand employees. Ya think someone would have a T1 clue.

Well after two years I finally talked to honest to Mickey disability executive.

He said he had never heard a guest asking about carb counts for a T1 kid.

No kidding! Wonder why? Unreturned phone calls and sugar free maybe

Turns out he was a very nice, if well insulated guy. He just needs to hear from more T1 families

So if anyone stumbles onto my little blog and would like to drop the guy a note here's where to send it:

Mr. Mark Jones
Walt Disney World Services for Guests with Disabilities
Box 10000
Lake Buena Vista, FL 32830

Dear Mickey

Links
This is an old Post from Disney With Diabetes before it moved to All Ears.

April 2006

Dear Mickey;

An Open Letter to Disney World

You do a great job with many disabilities. Maybe you can make the same effort for families with type 1 diabetes.

The thing we need most is counts of carbohydrates in the foods you sell so we can give our kids the amount of insulin they need. We are not crazy Atkins dieters gone wild. It is a Life Safety Issue Mickey.

I spoke with cast member Mark Jones of Walt Disney World Services for Guests with Disabilities. Mark said that he has not heard from guest that diabetes and carb counts is a concern.

Given my experience trying to surface the issue it is no surprise. It took me two years asking who is responsible for disability issues to get through to him. I expect that most folks give up in that time frame.

Here is a quick sample of comments from March 16, '06 on the American Diabetes Association parents forum:

One parent asked:
1) Has anyone visited WDW with their Type 1 child? Any tips? We are *considering* a visit this summer. But yikes, how to do with a 6 yr old with diabetes?
2) Related to question 1. How do you figure out how many carbs are in restaurant meals that you can't find listed in any of the carb guide books?


Another wrote back:
I went to Disney on February this year, 6 months after T1 diagnosis. I was extremely scared dealing with diabetes. Anyway, Disney was very stressful for me but My son loved it.

A third added:
We went to Disney over New Years. Our son is on the pump. Disney is great and very accommodating, but my biggest, really my only, complaint is that they have no carb counts for their food. You can bring in food of course, but at some point you will probably be buying Disney food.

So, on this one day, the idea of going to Disney with a type 1 child brought out the feelings of, “Yikes, Scared, Stressful, no carb counts.”

Some quick facts over 20 million children and adults have diabetes. Of that somewhere between 1 and 2 million are type 1.

One to Two million people who’s family thinks “Yikes, Scared, Stressful, no carb counts” when they consider vacationing at Disney World.

These kids typically do three to five thousand finger sticks, injections and/or infusions a year. That hurts a kid.

Just give us carb counts. It is the right thing to do and you will make more Mickey. Notice the one parent saying they carry in food so they know the carb count? You are loosing food sales Mickey my pal.

What do you say Mickey how about taking some stress, yikes and scared off these families and help make these families Disney Vacation Magic?

March 25, 2009

Who Care(s)mark IV

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We got the form letter from Caremark. They have a bad case of Uglycemia.

The letter says they don’t care what the FDA label says about storage and temperature, they are shipping insulin without cool packs. Well that is a loose translation. A translation in the spirit of uglycemia is more like: "FU. We're saving a few cents."

How hot do you think a delivery truck gets in direct sun on a few 78 degree days?

Here's copy:




In the mean time feel free to catch up on YDMV's experience with Caremark, weather and insulin shipments. Oh and these had cool packs but were on a slow truck from New Jersey. The three part Mini Series is here:

Caremark Saves You Money
Third Time Hold the Charm
46 Degrees of Separation

So here is what has got me ticked off, well other than We-Don’t-Care-Mark’s actual existence, Lilly the wonderful makers of Humalog lobby their opposition to “middlemen whose interest are making money – not patients” ie no cheaper Canadian imports. They Lilly are the ones on file with the storage requirements at the FDA. Anyone think they will stop selling to CVS/Caremark?

So what can we do? Here is what I did, please copy and paste and send it or something like it to Lilly and your Congressional Representative:

*********************
John C. Lechleiter, Ph.D, Chairman, President and Chief Executive Officer
Timothy J. Garnett, M.D, Vice President Chief Medical Officer
Eli Lilly & Co.
Lilly Corporate Center
Indianapolis, IN 46285

March 25, 2009

Dear Doctors Lechleiter and Garnett,

Thank you for helping me to keep my kids healthy. I am the parent of two Type 1 insulin dependent children. Your insulin keeps them alive. It is an understatement to say we use a lot of Eli Lilly products in our household. We buy Humalog a dozen and a half bottles at a time.

It is in the dozen and a half at a time where my concern lies. I would like your instructions on what to do if the Humalog we are receiving does not meet Lilly’s safety standards. I know what to do when it gets home; it is in the getting here that I have concern about maintaining your standards.

Like many patients in the US we receive our Humalog through Caremark, a domestic US mail order pharmacy. Our insurance requires us to use them and we are required to get 90 day supply at a given time. As you can image it is a big shipment of insulin.

Over the years I have heard major drug companies, including Eli Lilly, stress the importance of the US drug supply chain as a safety issue. You have clearly told consumers, like our family, that you the manufacturers can not assure the proper handling of product from non US sources. Your lobbyists have testified to congress that the US drug supply system must be protected from imports as a safety issue. Specifically Eli Lilly has very clearly stated that they are opposed to middlemen “…whose interests are making money – not helping patients.” Again thank you for your concern for our safety. Clearly you care about safety and by inference you can use market forces in the US to assure safety.

http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=916306&TICK=LLY&STORY=/www/story/10-18-2004/0002285118&EDATE=Oct+18,+2004

I’ll take your word for that. I must however ask you to stand behind your word. Specifically that you stand behind the safety of insulin shipped by firms like Caremark. With your public concern for the safety of the supply chain I would like to know if it is safe to presume that you are aware that Caremark insist that insulin does not need to be shipped in cooled packages. They are telling families of type 1 children that insulin does not need to be refrigerated in shipping, only for long term storage. See the attached form letter from CVS Caremark.

This seems to me to fall outside the labeling of the insulin and you filings with the FDA. Your Humalog packaging slip in PDF form on your web site states;

“How should I store Humalog?
• Store all unopened (unused) Humalog in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Do not use Humalog that has been frozen.
• Do not use after the expiration date printed on the carton and label.
• Protect Humalog from extreme heat, cold or light.”

You make a very similar statement to the FDA on the web at
http://www.fda.gov/cder/foi/label/2007/020563s065,021017s030,021018s041lbl.pdf

Storage — Unopened Humalog should be stored in a refrigerator [2° to 8°C (36° to 46°F)], but not in the freezer. Do not use Humalog if it has been frozen. Unrefrigerated [below 30°C (86°F)] vials, cartridges, and Pens must be used within 28 days or be discarded, even if they still contain Humalog. Protect from direct heat and light.

I have always understood this storage to include shipping. Shipping can take a few days and trucks get hot. Further our experience is that Caremark’s delivery firm leaves the insulin on the front step in the sun in 90 degree weather.

Lilly takes a clear stand on free markets. (http://www.lilly.com/about/public_affairs/positions/) You are for them.

So am I. The way our free market works is you freely sell to Caremark as a trusted US supplier of Humalog to US patients, like my kids. I trust that you support the supply chain safety system and practices you have specifically lobby for. Our Humalog is safe.

To be clear: This means you support the practice of shipping insulin without cooled containers by your US partner in the delivery chain because you continue to sell them product. You stand behind your product and remain responsible for its safety through the free market. You specifically use only middlemen whose interests include patient safety as well as profit.

In the absence of clear written notice to the contrary, I can trust that Lilly stands fully behind the safety of insulin shipped without any temperature controls. In this case you agree specifically that a few days shipping and storage are not the same thing.

If that is not the case, I trust you will take the free market steps necessary to assure the safety of the supply system, since you have strongly advocated for said system. Further if needed you will provide notice users with clear guidelines about shipping safety.

I know that you have gone to great length and expense to communicate what you are for to our elected officials. I am sure you will be happy to be as clear with them on this issue. I will forward a copy of this letter to my elected officials so they can be prepared to hear how you are using market forces to insure that the products you provide in the market meet the labeling you have cleared with the FDA. I will encourage my fellow type 1 parents to reach out to their elected officials as well.

Barring a clear reply to the contrary, I and these other parents of Type 1 insulin dependent children can rely on Lilly to use free markets to protect the safety of our insulin. It is after all a responsibility that you have specifically asked for.

Thanks again for helping keep the kids alive.

Very Truly Yours,

*********************

Representative Allyson Schwartz (PA–13)
423 Cannon Office Building
Washington, D.C. 20515

March 25, 2009

Dear Congresswoman Schwartz

Thank you for your service to our nation. We had the pleasure of meeting in your Jenkintown Office with a group supporting the Juvenile Diabetes Research Foundation a year or two ago.

I was impressed by your to attention and understanding of type 1 diabetes as well as your commitment to fiscal responsibility with pay as you go.

As the nation deals with economic stress and starts a process of examining our health care system I hope you can find a few minutes to ask the pharmaceutical industry to stand up for what they have been asking of you and your fellow representatives for years. Specifically to keep our domestic drug supply safe from those who would take risk to maximize profits.

You will find attached a letter to Eli Lilly executives on the safety of insulin shipped via by US based mail order pharmacies. Lilly has lobbied congress to keep the domestic drug supply free from non US “middlemen whose interests are making money – not helping patients.”

Lilly has filed specific temperature requirements for storage of their Humalog band of insulin with the FDA. Lilly’s distribution partner CVS Caremark has announced that they will not follow those guidelines when shipping insulin.

I believe that we as consumers and you as our representative have the right to expect that Lilly and Caremark will follow the requirements agreed to with the FDA and the market conditions they have lobbied for.

Sadly my experience with large companies is that they try to ignore or double talk their way out when dealing with consumers. This was certainly Caremark’s approach last summer when they shipped and subsequently took back $4,000 of insulin that was not kept cool in 90 degree weather.

I hope that you have the time to have a letter sent to Lilly and Caremark and ask them to standby the drug labeling and the market freedoms they have lobbied for. I suspect that they maybe more responsible to a member of Congress than a consumer. Sad.

Very Truly Yours,

March 24, 2009

Uglycemia Re-Defined

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I am not being sarcastic, much.

I am considering a new definition of Uglycenia. I know I just coined the term yesterday. So the way I see it, the term is still in flux and I am allowed to play with the definition.

Here’s my new diagnosis, uglycemia is the condition that causes people, who don’t know Jack about diabetes, to weigh in on Type 1 care. Uglycemia is caused by either resistance to, or a lack of, compassion.

For example, the food police have a fairly common case of uglycemia. Sadly this form of uglycemia is highly contagious and is often spread by those in the news media who have a case themselves.

This fairly benign form of uglycimia is best defined by the mind’s resistance to compassion. As a result BS (and we are not talking about blood sugar here) builds up in the brain of the individual with uglycemia and causes lapses in cognitive capabilities. Complications from prolonged periods with elevated BS can be serious and even life threatening.

A rarer but more serious form of uglycemia is when the body completely stops producing compassion, a key hormone that helps the mind use knowledge. Knowledge rapidly builds up in the blood stream as it can not enter brain cells without compassion. Lacking the compassion to use knowledge the brain burns fathead cells for energy. A byproduct of burning fathead cells is BS. This BS rapidly becomes toxic causing the condition know as Dumb-arse Kook Atosis or DKA. If untreated with an injection of compassion DKA is rapidly fatal. (If not from internal damage it is often fatal from getting punched in the mouth that excessive BS leaks out of.)

An example of this more serious form of uglycemia are school officials who resort to inventing self serving 'rules' that fly in the face of the best practices outlines in Helping Students with Diabetes Succeed.

So there you have it: uglycemia is the condition marked by the build up of BS in the mind. As we have discussed there are two types: the more common resistance to compassion and more serious total lack of it.

Stem Cells - It is all in the Motivation

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I read this and I thought that if someone was interested in motivating congressional action on stems cells all they would have to do is show at the Capital up with a needle and say, "Dudes line up and contribute cells or vote another source."


Of course, I have heard some say your average congressman doesn't have the items necessary to contribute to the cause.

ROFLOL

Human Adult Testes Cells Can Become Embryonic-like


From the News Wire: Biodel

Links
This out from Biodel:

DANBURY, Conn.--(BUSINESS WIRE)--Biodel Inc. (Nasdaq: BIOD) announced today its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of this year for approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel’s investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject® in patients with Type 1 and Type 2 diabetes.

Preliminary results from the Phase 3 studies were reported last year at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD). Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject®, which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation of VIAject® that was used in the company's pivotal Phase 3 clinical trials. Biodel believes that results from both Phase 3 studies showed that VIAject® was non-inferior to Humulin® R, the leading recombinant human insulin, in terms of blood glucose control, when measured by the mean change in patients' hemoglobin A1c levels (HbA1c). The results also demonstrated lower incidence of hypoglycemia and less weight gain in patients receiving VIAject® as compared to patients receiving Humulin® R.

At the EASD conference, Biodel reported that preliminary efficacy results from patients with Type 1 diabetes in India were not comparable to results from patients in the United States and Germany. While non-inferiority of VIAject® to Humulin® R was achieved without the data from India, it was not achieved when the data from India was included. Biodel identified probable causes for the variance in the data from India with the assistance of regulatory consultants and presented the results to the FDA in its pre-NDA briefing package. Among the causes noted in the briefing package, an identifiable subset of blood samples from patients in India was found to be compromised due to excessive heat exposure in transit to a central laboratory. When the compromised samples are removed from the efficacy analysis, non-inferiority in both the Type 1 and Type 2 trials is achieved.

After reviewing all of the data from the two pivotal Phase 3 clinical trials with regulatory consultants and meeting with FDA staff, the company has decided to proceed with the submission of its NDA under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The FDA will review any submission the company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated: “After investigating the cause of the anomalous data in India and discussing our findings with the FDA, we are now comfortable proceeding with the preparation and submission of the NDA for VIAject® in the second half of this year. This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal Phase 3 clinical trials, which we believe met the endpoint of non-inferior change in HbA1c over six months. In the meantime, we continue to collect safety data from the open-label extensions of the Phase 3 trials and are proceeding with plans to conduct additional development work this year to further differentiate VIAject® from the rapid-acting insulin analogs.”


I think I have lost money on shares of this too. See my DexCom comments about Jacques Cousteau

March 23, 2009

I Am NOT Making Fun of Amy Tenderich…

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… much.

I always pick up something from Diabetes Mine.

So there I am reading away and wondering why Amy is talking about ugly. Ugly-cemia to be exact.

I am all like - What the heck is that?

…is that when TV’s Betty has diabetes?

…is that what all the holes on you fingers are called?

…is that when the meter number is so bad you have to turn away from the screen for fear of being tuned into an Old Testament pillar of salt, well maybe sugar in this case.

I am a little dyslexic, ok I am a lot dyslexic, and somehow my brain wasn’t coming close to processing the “e” in the beginning of eUGLYcemia.

Through some miraculous process the “e” magically appeared and I was still all – What the heck is that? Amy went on to explain that is blood sugar at the goal. Like all diabetes terms this one falls into the “Did they intentionally make these words up to be confusing?” category. (Yes.)

Are not our live sufficiently messed up with type 1 care that we could just skate by with “goal” and maybe “target” in our vocabulary?

Nope.

But you have to remember that this "e u" word is brought to you by the people who.. (wow Sesame Street flash back - and what is up with Cookie Monster eating vegetables? Cookie was cool because even little kids got the irony that he was on PBS and wasn't PC.) ...coined hyperglycemia and hypoglycemia. They thought it was funny to try to teach those words to us within the first 36 hours after diagnosis when we were seriously sleep deprived.

I swear the diabetes educator and doctor went back to the break room and laughed hysterically after trying to teach me the words: "Gladis you should have seen this dad when I hit him with hyperglycemia. I thought his head was gonna explode. The timing was perfect he was trying to get a nap in that hard little chair next to his kid's bed. I don't think he has slept in days and let me tell you this one is the most needle phobic guy I have ever seen, so I whip out the needle, watch him turn a nice pasty white and bamb hit'm with the "H" words, Ha ha ha Priceless."

We need another weird word from these so called medical professionals like we need more holes in our fingers.

Delaney calls euglycemia, the Magic number. When the school nurse gave her some little stuffed animal doodad for hitting the Magic Number she, being a resourceful little twerp, diversified the portfolio of Magic numbers so as to provide more opportunities to cash in; 100, 101, 111, 123 and I think she was lobbing for 119 as the opposite of 911 too.

So anyway I nominate UGLYcemia as the word that describes all those numbers out there that aren’t magic. Those numbers that in their May Varry-ness make us need to look at the meter in the first place and wonder if our kids are going to turn into a pillar of sugar.

UGLYcemia is everything that isn’t euglycmia.

From the News Wire: Dexcom Call on Seeking Alpha

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Dexcom's earnings call transcript is on Seeking Alpha. Now I don't want to deprive anyone of the fun of reading the financial press but just in case wading though ten pages of CEO and Analyst speak isn't you idea of high times, here are the highlight with regard to CGM pump integration:

Terry Gregg Dex CEO
A quick update on our insulin pump partnerships with Animas and Insulet. In January of this year, we announced an expansion of our Animas relationship to an exclusive agreement to develop and market integrated insulin pump CGM systems in markets outside the US. In return, Animas will pay us $5 million upon receipt of a CE Mark for the first OUS commercial product that is expected either later this year or early in 2010. And in addition Animas will pay DexCom a royalty of $200 per CGM enabled pump sold in any OUS market. As parts of this agreement, Animas will also serve as a nonexclusive distributor of transmitters and sensors to purchasers of the Animas CGM enabled pumps outside the US. This exclusive arrangement has an initial term of three years.

We continue our development work on the integrated insulin pumps CGM systems with our pump partners. Our continued goal is to complete all development, clinical and regulatory efforts on these joint development projects and be positioned to launch a first product with Animas during 2009 and with Insulet sometime the following year. But as you are well aware, the timing of the regulatory process is uncertain.

There is a little more on page 9 including, "Well, I can't speak for them." Hmmm wonder if Terry got his hand slapped for saying more that the partners wanted in previous calls.

So pump fans this just ads to our what do we do about the pump that is up for a new 4 year hitch in April problem. If we re-up now we will more than likely need to pay a big fat upgrade fee in just a few months. Why sign up for a four year deal when it look like significant improvements are literally in for FDA approval?

Just to be on the up and up, I do have shares of Dexcom in my IRA. Jacques Cousteau and the team from the Calypso have sent divers looking but the portfolio is so far underwater they will need the mini sub any artifacts from it. LOL Maybe they will save the day by coming up with that huge diamond from the last scene of Titanic...

March 19, 2009

Link to the iPhone Presnetation

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I was remiss in not posting a link. In case you didn't find it on your own here it is.

The Lifescane presentation starts at about 43 minutes into the presentation.

Looks like they use a wire in the video not Bluetooth. (In fact it looks like the wire has shrink wrap on it.)

http://events.apple.com.edgesuite.net/0903lajkszg/event/index.html

Don't beleive what you read...

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This cracked me up. Look where you end up if you click Read Full Article.

http://www.octnews.org/articles/722004/newton-photonics-wins-a-nsf-sbir-grant-for-oct-glu/

More proof that you can't trust the internet. LOL

March 18, 2009

iPhone, LifeScan and My Standard Rants

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Wow nothing like mentioning iPhone in on your blog to generate some traffic. YDMV had unusually high traffic yesterday. Nice to know it is mention of a cool cell phone that the world wants to hear about and not the regular musings of a dad of T1 kids.

Very humbling. LOL

(But Hey iCan Learn! Look I have put iPhone in the title of this post!)

For those of you who are new to YDMV let me introduce my standard rants about T1 diabetes information. The data needs to be ours, as in the people managing diabetes. It needs to come in industry standard formats so that We the People can choose the data creation devices that promote our Life Liberty and Pursuit of Happiness. We need choices in the tools to analyze our data from the devices we pick and all the tools and data should play nice together.

See Swimming in the Data Stream Looking for the UN and I would Like a Side Oder of Holy Grail

Yesterday’s iPhone and LifeScan news brought these points to mind but I didn’t articulate my them (my rants) well at all. The BG data moving into an iPhone is all well and cool but if it is a proprietary J&J deal it is part of the problem rather than being an expansion of diabetes care options.

Animas used to tout the fact that their ezMannager program could download all the major meter data. While the program was something less than wonderful the idea of open architecture was great. Look at an Animas pump now and it says OneTough right there on the front face where it doesn't say Animas any more. That and there isn’t the down load options there was. Sorry J&J but that is the wrong directions.

We the People Managing Type 1 need applications that play nice with others. To get it we should use the ever popular market forces and choose the suppliers that provide open systems. OK OK there aren’t any. But we can deal with the fact that the vendors will try to tie us to their products by speaking up.

Call your pump rep.
Call your meter company.
Write actual sail mail letters. (File> Print. LOL)
Blog.
Ask for open data architectures.

Now this may mean your pump rep never calls you back, like our, but hey that tells you something doesn’t it?

March 17, 2009

How about iPod Touch, Bluetooth and Diabetes?

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Reading little more on iPhone 3.0 it sounds like iPod iTouch users will be able to upgrade to 3.0 and they get Bluetooth. So then will the BG app from LifeScan work on an iTouch?

Inquiring minds want to know!

I can see that making more dollars and sense than an iPhone for a kid with T1.


CNET Crave:
Stereo Bluetooth audio is coming to the iPod Touch, said Apple's Greg Joswiak at Tuesday's iPhone OS 3.0 preview event. The added Bluetooth functionality will come by way of the OS 3.0 upgrade, due out this summer. While iPod Touch owners clearly win from the addition of Bluetooth support (a $9.95 upgrade fee is required), they may be a little peeved to learn that the second-generation iPod Touch hardware has probably supported Bluetooth all along.

IPhone 3.0 and Life Scan

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YDMV Note. This post about Lifescane and the iPhone gets hit a lot. There is no real product at least yet. See
http://www.ydmv.net/2009/08/wavesense-iphone-app-first-impressions.html
for a manual entry log that is worth looking at.

Note II  Sept 21 2010 Sanofi/WaveSense announce iBGStar 

So according to Gizmodo, Apple showed the new iPhone 3.0 software today and showed and app from LifeScan charting BG for a week. Apparently you will be able to Bluetooth in the data or use a cable.

Gizmodo
By far the most manipulative pitch of the afternoon, LifeScan shows how new Bluetooth connection capabilities and accessory functions can help a young girl manage her diabetes. Above is a week-long chart of her glucose levels, which are good to know if you have diabetes and don't want to die. LifeScan can pull these from a test unit via Bluetooth or cable.


for a photo see: http://i.gizmodo.com/5172248/first-iphone-30-apps-show-off-new-functionality

OK that is cute in a geek kind of way but how about a One Touch that uses less blood, doesn't error 5 and is less huge?


Edit

Amy has more over at her site. There is a shock (not) Amy has the inside dish. She sites another source saying:

“The app then lets users send their readings and a message about how they’re feeling to caregivers like their parents, children or physician. The glucose reader app also includes a meal builder and insulin schedule for easy tracking by tagging readings as pre- or post-meals. The iPhone app can even estimate, based on diet, how much insulin is needed after each meal. The app also shows glucose levels in a chart form and lists each previous reading.”


OK now my kids are going to want iPhones even more.

Here is my question is the Bluetooth going to be proprietary to OneTouch or will it allow other Bluetooth meters to talk with it? I am thinking WaveSense, I like their meters.

Another edit.

This One Touch Ap was made strictly for the 3.0 presentation. It isn't really a coming attraction. More like hey here is an neat idea we could make but what the heck if we can get on the iPhone 3.o stage we'll hack something together.

Read more on how it got to the show here. Careful observers of the video will see something that looks a lot like a wire on the wireless connection, and a little shrink wrap on the wire.

March 15, 2009

Diabetes Too?

Links
I had my every few years annual physical. At my previous annual, three years ago, the good doc said my blood sugar was one-oh-something. He said that was a little high and warrant notice.

I had a pretty good laugh.

With two type 1 kids one-oh-something is the Promised Land, ground for celebration not notice.

This year my BG was officially an issue. I had to go back and get an A1C and have the BG re-checked. (Psst Doc, I can check that at home without much effort but he wanted me to go in anyway.)

I did do some checking at home and my fasting BG was in fact a little high. Here is the deal; I couldn’t be very impressed by the whole thing.

I did the A1C and it was 6.0. I had already made some changes and the fasting BG was half way back to normal.

They wanted me to see an endo and a nutritionist. Sure, I like I don’t know what they are going to say?

I am eating better as much to save money and eat tastier stuff as anything else. I started taking in home made soup or chili instead of buying lunch. I’m a lot better cook than the local sandwich shop so I am getting good eats and as a side benefit I have lost weight.

My fasting BG has come back to the 1-0-x range. I’ll keep check my blood from time to time. I’ll be more active. More time on the tread mill less blogging.

I am going to skip the endo and the nutritionist. I think it is an act of charity to others who would be in the classes they would refer me to. I would be a frighteningly disruptive influence in an intro to type 2 class. I need to keep making a small effort.

I’m still not impresses by the whole thing. It may need doing but it is nothing close what either of my T1 kids does without thinking.

There is no way I'll call what I need to do diabetes too.

March 6, 2009

Dexcom FDA approval - Question is for What?

Links
So this little gem is all over the wires today:

March 5 - DexCom Inc: Says received approval from FDA for third generation continuous glucose monitoring system on February 13 - SEC filing * Says to begin commercializing product in Q1 2009



Anyone paying close enough attention to know what this is?

**Edited to ad**

(After using Google apparently I know. It was the first hit. LOL I just don't know I know, ya know what that is like?)

http://ydmv.blogspot.com/2008/08/from-news-wire-dexcom-on-animas-and.html


I quoted Trey Gregg - Dex CEO from Seeking alpha:

We are also pleased to report that we have filed a PMA supplement for a third generation continuous glucose monitoring system with the Food and Drug Administration. Data from our approval support trial demonstrated significant improvements in system on time and improved accuracy as compared to our current product. In addition our third generation system will include twin doors to complement our turn graph and event entry capabilities such insulin intake, (inaudible) exercise as well as configurable alarms.




Diatribe put that into actual english
http://www.diatribe.us/issues/7/new-now-next.php

As we understand it, DexCom is close to a third generation sensor - it has completed the necessary clinical trials necessary for FDA approval. Advantages of this system include a 75 percent smaller sensor size - allows for a smaller insertion unit, which is potentially less painful. The other major promised improvement is in the software component of the device; this version of the software will have trend arrows; event markers for food, exercise, and medication dosing; and user-adjustable alerts with different sounds associated with hyperglycemia and hypoglycemia.