May 29, 2008

From the News Wire: CHOP Pitts, JDRF Awards and Finland

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Miscellaneous T1 News:

New vaccine approach prevents/reverses diabetes in lab study at Children's Hospital of Pittsburgh
Results of study are published in Diabetes, a journal of the American Diabetes Association
Microspheres carrying targeted nucleic acid molecules fabricated in the laboratory have been shown to prevent and even reverse new-onset cases of type 1 diabetes in animal models. The results of these studies were reported by diabetes researchers at the John G. Rangos Sr. Research Center at Children’s Hospital of Pittsburgh of UPMC and Baxter Healthcare Corporation.

In a research study at Children’s Hospital, the scientists injected the microspheres under the skin near the pancreas of mice with autoimmune diabetes. The microspheres were then captured by white blood cells known as dendritic cells which released the nucleic acid molecules within the dendritic cells. The released molecules reprogrammed these cells, and then migrated to the pancreas. There, they turned off the immune system attack on insulin-producing beta cells. Within weeks, the diabetic mice were producing insulin again with reduced blood glucose levels.

http://www.eurekalert.org/pub_releases/2008-05/chop-nva052808.php

JDRF announces 2008 Spring Research Review Award
Researchers Brownlee, German and Sander chosen as winners
The Juvenile Diabetes Research Foundation recently awarded its top honors to three noted scientists. The awards were presented at the 2008 Spring Research Review Awards Dinner.
http://www.eurekalert.org/pub_releases/2008-05/jdrf-ja2052208.php

Surge in insulin-dependent diabetes among Finnish children
Levels of type 1 (insulin dependent) diabetes among Finnish children have more than doubled in the past 25 years, with the increase set to continue. A combination of genetic and lifestyle factors are the likely cause, conclude authors of an Article in this weeks Diabetes Special Issue of The Lancet.

A steady increase in the incidence of type 1 diabetes has been reported worldwide, with the trend most pronounced in children aged four years and younger. The average increase per year has been 2.5 -- 3.0% worldwide, but with a huge variation between individual countries.
http://www.eurekalert.org/pub_releases/2008-05/l-sii052108.php

May 28, 2008

Prior Planning Prevents ...

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Today Delaney's pump needed to be swapped out for maintenance. The light didn't come on. I don't know if it was the button or what. Don't care why. At 3:00 am I need a light in the pump.

Animas is very cool about swapping about a pump. I call and drive down and pick one up. It is not that bad a drive. I like the guy at the front desk. We talk cars. He has red VW GTi. It's sweet. It's his baby.

Back home a new pump need programing. That means either using EZmanager to upload and reload setting or doing it manually. I think I'll go manual. EZmanager is a dinosaur. So much so it didn't get reloaded into my computer after a hard drive crash last year.

I have felt this way for a while. In fact here is a letter vintage '06 I wrote the then incoming president of Animas. Much is about EZmanager. Some of this is posted elsewhere on YDMV. I edited the letter slightly due to my particularly bad spelling and a generally strange sentence or two.

He did write back. He said he wore a pump for a bit. Thanks for the input an all that.

Almost two years later, EZmanager is still a dysfunctional Access database application. You other Animas pumpers out there what do you think of it?

For that matter I see J&J IP addresses in the blog log regularly, so J&J what are you doing about it?

Mr. Mike Rechtiene
Animas Corporation
200 Lawrence Drive
West Chester, PA 19380


July 16, 2006

Dear Mike,


Congratulations on becoming Animas’ President. I wish I had a few more Animas shares in my IRA but hind sight is 20/20. As the father of two kids using Animas pumps I am rooting for Animas’ continued innovation and success, which is worth more to me than the portfolio anyway. In that vein I offer some user wish list suggestions for you all to ponder in your process of innovating more and better solutions for diabetic kids.

I read your bio in “Sweet Talk” the Animas pumpers magazine. I didn’t see anything in your background relating to Type 1 diabetes. To better understand your clients I hope you will take pump training class and wear a pump for a week pumping saline to get a feel for how your product is an integral part of your customers lives and how even minor changes can have a significant positive impact on their daily routines

The pumps are great. We have seen dramatic improvement in A1Cs that are a result of the better control the pumps offer. As good as they are they could be a lot better, mostly through information processing.

Remember…
I feel the single biggest pump issue that could lead to better results is more pump memory. Enough memory for it to store everything that is entered into it, BG, carbs., times etc..

Yeah that is a lot of data points. Yes the meter does capture some of it. In theory they can be synchronized, in practice sync is a poor mix.

With the coming of continuous BG metering that is potentially a lot more data. Some may say that the pump is not the place to capture it, maybe, but the pump is where the insulin comes from. It is the place where users make and input choices. It is where the data needs to be considered before the pump is used so in my mind it is the logical repository of the information.

With continuous metering I would think the standard for recording data, including BG would be the basal increment, every 3 minutes. Yeah it is a ton of data, fortunately microprocessor memory is very small. All of the data should sync out of the pump to the desk top or PDA management system.


2Ks
The ezManager desktop application needs an update. It isn’t particularly stable. It acts like an application stuck in a prior decade. It doesn’t conform to windows standards. It doesn’t like USB devices. You have users swapping cables into the computer’s serial port. As a result it doesn’t get used.

It would be great to be able to define or edit pump set up in the desktop application without the pump. We all had the coach some time, “Prior planning prevents pi** poor performance.” The problem is you can’t prior plan the pump with out connecting it via I.R..

Once the set up is configured it could be uploaded into the pump. As it is now the pump must be present to open the setup function, even recalling a setup configuration that is saved on the PC! That makes editing setup excessively cumbersome.

The 24 hour log in ezManager is a nice report. Unfortunately the basal insulin delivery on that report is at best misleading if not downright dangerous. As I understand it basal insulin is reported in totality for periods of time. Speciffically my understanding is the basal insulin for a few hours is totaled and reported in the last of those hours. So you have no basal for a while and a ton in one period. As it is the report is nicely designed but unfortunately unusable as it is reports information dead wrong.

If this report detailed the actual basal insulin delivered by hour, including changes as a result of a temp basal, and that could be matched up with BG then it would be a useful tool for managing basal rates. It would be even better if the pump remembered the time of bolus and carbs and that was reported too.

iPod!
The pump user interface is cumbersome. Scrolling is at times strange and the whole thing needs an infusion of customization and simplification for users. Give the designers an iPod, there is and easy to use and customizable interface.

The food database is a great idea but we hardly ever use it. It is too much of a pain.

Do you eat a lot of Baby Foods? How about Beans? There they are the 2nd and 3rd groups of food items listed on the first screen of the food database. Two of the first six, 33% of the best screen real estate. You know what they say the three most important things about real estate are, Location, Location, Location.

Try thinking of the food groups like play lists on an iPod. Users should have that degree of customization of what food is in a food group and what to call the group. We should be able to put any food in any group, call the group what works for our lifestyles and have as many for few as we need to manage our diabetes. One size doesn’t fit all and one set of food groups doesn’t either, your diabetes may vary.

On the subject of that food database, top food items work great in the pump. How about cutting a deal with the supplier to get the PDA application for pump customers so we have the rest of the food items handy too? Handy is a word that here means in the smart phone (Treo, Blackberry, Q, iPhone etc) of our choice. .

Further customization of the pump would be great. Let the user define what the Audio Bolus Button does. Let them pick one screen the pump jumps to when it is pushed, if it isn’t in Audio Bolus mode. Ours would be set to carb smart.

Why is it harder for two?
Animas has a systematic bias against multiple pumps households. You send out email reminders it time to order. I have two kids and I never know which kid an email reminder from Animas is for. Maybe you could put the client name in the email instead of assuming there is only one pumper in the household?

You have an estore but it is a one client per email deal. Only client one can be linked to my email and estore account. I want to be able to place one order for stuff for both kids not two orders with one vendor. Nope I would need two emails to do that.

Most business have an affinity process where by clients who bring more business to a relationship are rewarded for it. Animas has the reverse. You make it harder, annoyingly harder, to bring more business to the relationship. The estore is a case in point.

Another is your upgrade practice. The longer we have been a client, supplying you with an annuity for supplies the higher the upgrade costs when a new product comes out. That supply annuity adds up. We get two days out of a set. So that's 15 sets a month. Set changes need reservoir changes so tack them on there too. IV Prep, yeah we need that. What's that worth 4-5 grand a year? So a guy buys a pump (or two in our case) and over a few years sends another ten plus grand your way for supplies for each pump and what is your reward for that customer loyalty? Higher upgrade fees if they want to upgrade to a newer pump.

Thanks for reading this. Don’t mistake all the ideas for improvement as dissatisfaction. We are convinced our pumps have made significant improvements in our lives.

Enjoy wearing the saline pump.

May 27, 2008

I know one of your fears.

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My Fellow Type 1 Parents… I know one of your fears.

It’s are the other kids going to get type 1 too?

Probably not.

Should you be testing them?

Yes and No.

Yes. When they are old enough to understand, they need to do a test so they know what their sibling is going through. It doesn’t take more than one or two finger sticks for them to get the idea. (I almost wrote get the point! LOL) They need to know how it feels. When it is age appropriate they need to know how to test, in case they need to test the D kid when you’re not there. Age appropriate, like diabetes varies.

No. You don’t need to test to see if they are getting it too. You have probably noticed for the first time in a long time, possibly their lives, that they drink water. If you’re feeling the need to test them, that falls into the category of your stuff. As in you need to deal with your stuff. Testing without seeing a couple of the symptoms will just ad to your and more importantly their anxiety. Neither of you need it. They don’t deserve you putting your anxiety on them.

Getting diabetes too has probably crossed the other kids’ minds. That thought doesn’t need encouragement. Diabetes puts enough stress on a family.

If there is a second case in your family, you will know what to do. If it’s going to happen, it’s going to happen. You may miss the signs for a while but you will pick up on it faster the second time.

Trust me. I know. I have been there.

If it does happen, when you test, the meter will say HI! As in How You Doing? You will be suddenly doing very crappy. You will have been there, you’ll know the road, and it will still suck.

Don’t go looking for trouble.

May 21, 2008

From the News Wire: U.S. Patent on Islet Progenitor

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From their web site:

Guildford, UK, 21 May 2008: ReNeuron Group plc (LSE: RENE.L) today announced that it has received a notification of grant from the US Patent and Trademark Office concerning a key patent covering the culturing and isolation of islet progenitor cells for use in its ReN002 programme focused on a cell therapy treatment for Type 1 diabetes.

The patent, "CD56 Positive Human Adult Pancreatic Endocrine Progenitor Cells" (No. 7,371,576), contains broad claims directed to methods of culturing and identifying living islet progenitor cells by way of expression of the CD56 cell surface marker. The cells produced by this invention can be further proliferated in culture to increase cell number and then allowed to form islet cell clusters suitable for subsequent transplantation. In its ReN002 programme, ReNeuron is currently researching a potential islet cell therapy for Type 1 diabetes patients, utilising expanded islet cells which are then enclosed in clinically-tested, immunoprotective capsules prior to transplantation.

ReNeuron has broad patent coverage across all of its stem cell technologies and products, having written or exclusively licensed over 55 issued patents and over 70 further patent applications. Of these, over 30 patents have issued in the key European and US territories.

May 19, 2008

Unrealistic CGM Expectations

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Med Student with Diabetes Cautions Against Unrealistic Expectations for Continuous Glucose Systems

Zachariah Kramer a med student, class of 2010, says the media coverage of the value of a CGM without equal reporting to the down side is a problem. “I believe this will lead to unrealistic hopes among diabetics eagerly searching for more effective ways to manage their disease.”

http://www.diabeteshealth.com/read/2008/05/16/5757.html

The good some-day-to-be-a doctor however wears a pump and CGM. Some how he understands but we don’t.

Is the message here do as I say not as I do?

The information a CGM provides he says is valuable. I have to wonder if the implication of the articles isn’t that the value is there only because he’s a medical student and we the unwashed masses shouldn’t expect trending information to be valuable because we aren't doctors (or doctors in training.)

Now me, I think it is an unrealistic expectation that the Medical Community, including soon to be newbie doctors, will manage our day to day diabetes care. I am willing to bet that author knows more about diabetes care form ten years of experience practicing type 1 care than from med school. Practice makes perfect, even medical practice.

Are CGMs a panacea, a cure? Heck No. Would the information be valuable for managing basal rates in growing kids? Heck Yeah! (Probably more so than in managing BS in an adult medical student who isn’t going through growth spurts and puberty.)

CGMs have issues. We hold these truths to be self evident. We also know that to secure Life, Liberty and the pursuit of Happiness we, not our physicians are the front line of diabetes care.

May 18, 2008

Pappa

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I’m a T1 parent. I blog. So do a lot of other T1 parents, some of who are T1 themselves. Of course we all know and love the T1 bloggers.

How about the wisdom of the ages – a T1 grandparent’s blog?

Well now there is that too. For a starter on the wisdom path how is this little gem?

In order to have a normal, helpful and caring relationship with a T1 child, extended family and friends MUST accept the seriousness of this disease at face value… They must also examine themselves and the distinction between being afraid of the child and being afraid for the child. A little knowledge and education will go a long way toward understanding that you can help keep that child safe and secure and lessen your own fears.

Enjoy

http://dotinggrandparents.blogspot.com/

The Artificial Pancreas, Unteathered.

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The Artificial Pancreas making you loopy?

Lots of folks are working hard to close the loop of Pump, CGM and Software to make an artificial pancreas. JDRF has made it a high profile mission. NIH and FDA have a workshop coming up.

It is interesting to read about people who have a different perspective. Outside the loop as it were. A University of Akron professor is teaming up with the Northeastern Ohio Universities College of Medicine to taking a biological approach. His group is, if you will forgive the over simplification, making a small tube with holes in it that may do the job.

So if you missed it here is an article on their work:
http://pubs.acs.org/cen/science/86/8618sci4.html

May 17, 2008

It is your turn to walk the CGM.

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There is a great article about a Diabetes Dog in the Argus Courier, from scenic Petaluma, California. I had absolutely no clue where Petaluma California may be but Google maps did. It is north of San Francisco, south of Santa Rosa. I assume it is scenic.

It was you typical hypo dog story - which is to say very cool. Who needs a CGM if Muttly can sniff out problems? Well OK I can see value in CGM for basal testing but a smart hypo dog would be cool none the less.

Our beagle has occasionally woken us up when Delaney was low. Not that she is reliable at it. The only thing our dogs are reliable at are eating and barking when one of the neighbors walk by with their dogs. We have a lot of neighbors with dogs. Ours reliably bark a lot. We have the K9 equivalent of morons.

Anyway the thing that really got me interested in this article is the family has THREE kids with type 1. I thought we had it tough with two. Actually I think anyone with a toddler with type 1 has it tougher than we do. At least our kids can talk.

Anyway back in scenic Petaluma, the dog, Lawton, can sniff out lows in all the kids and like a groovy new CGM can predict lows and know to get help. That is way cool. That is smarter about diabetes than a lot of people I know.


Quote:

With three young boys to monitor, Lawton has been a life-saver for the Schumacher family. “He’s a super hero,” said (Meri) Schumacher. “He’s the greatest thing. He even wakes me up at night when the kids levels are low. I used to not be able to sleep at night because I was so worried about them. Now I can go to sleep and Lawton will come lick my face to wake me up if something changes. He really is our miracle.”

I tried reading the story to my beagles. They were not impressed but they barked when the Lab from down the street walked by.

Morons – Yeah I know that moron is synonymous with beagle and for that matter when it comes to Type 1 a lot of the people I know too. Not that I want a lot of people licking my face...

May 14, 2008

From the News Wire: Omni Pod Earnings Call

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Insulet Corporation Q1 2008 Earnings Call Transcript is on line at :
http://seekingalpha.com/article/77146-insulet-corporation-q1-2008-earnings-call-transcript?source=homepage_transcripts_sidebar&page=1

Ten pages, mostly business stuff relating to sales, sales taskforce, volumes income etc… Go read it if you are into that stuff. I pulled out a few parts that were potentially of interest to families dealing with type 1

On CGM integration:

Mimi Pham - JMP Securities
Can you talk about the time line for the Abbott or DexCom integration? Last week, DexCom had mentioned December 2009 time frame for seven to be integrated with your J&Js pump?

Duane DeSisto
Our goal with both partners is basically to be into the FDA in the first half of 2009. Then both of our partners are significantly more familiar with that whole regulatory path, but our goal with both partners is in the first half of ’09 to be into the FDA.


On Quality Control and service:

Benjamin Andrew - William Blair & Company
Somebody asked before about product quality issues and you talked about seeing a little bit of a bump in issues. Are you catching those at the manufacturing level or are those coming back out of the field?

Duane DeSisto
I’d love to tell you we catch them all at the manufacturing, but we have seen a slight blip of probably 1% to 2% out in the field in terms of phone calls. We’ve reacted to them. I think our customer service is doing a great job, I think it gets pretty high marks when people talk to them and I think what we’ve seen we’ve been able to deal with so far.

Benjamin Andrew - William Blair & Company
Do you credit back a Pod or two and try to make nice to the patient, or do you lose people from that? Has it become recurring with any individual?

Duane DeSisto
It is. I would tell you it takes a lot of time and effort to get the patients, so we will do whatever it takes to keep the patient.


On using the Omni pod for something other than insulin:

William Plovanic - Canaccord Adams, Inc.
You had previously mentioned on other calls that you would be partnering with a pharmaceutical company. Is the Micromet portion of the press release is that the partnership you had mentioned, or is there something else?
Duane DeSisto
That is not the partnership that we are alluding to, no.
William Plovanic - Canaccord Adams, Inc.
Are you still expecting something by the end of the year?
Duane DeSisto
We would be disappointed if we don’t get something by the end of the year, correct.

May 8, 2008

Scott's a Good Read

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Scott has an interesting interview / conversation with Dr. Norma Sue Kenyon on his blog. The good doc is both a professor of surgery, medicine, microbiology and immunology at the University of Miami and the mom of a T1 daughter. This makes for an interesting set of skills IMHO. Scott's writing is informative and approachable. Hop over if you haven't seen it yet.

http://sstrumello.blogspot.com/2008/05/interview-with-immunologist.html

May 7, 2008

Lather Rinse Repeat

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One online forum post asked How Do You Basal Test? The lovely and talented Mrs. YDMV responded saying; “For over night testing we try to test every 2 hours. And if we are feeling really up for being sleep deprived we test multiple nights 12, 2, 4, 6.”

To which I added: “Then I go to Starbucks and soak my head in coffee." (Mrs. YDMV is not cursed with the coffee addiction. The Coca-cola shareholders are grateful.) Well after the coffee, I noticed that the spikes in our kids' BG is about an hour to an hour and a half after they fall asleep. I figure that is the growth hormones are kicking in.

Keeping blood sugars in range over night seems to be the key to a good A1C in our house. Your kids may be better about this but ours have a nasty habit of growing. Growing means basal changes.

We try not to make changes on any one hard day’s night’s numbers, (see above: multiple nights and soak head in coffee and/or Coke) Once changes are made, the expected results need to be verified with more multiple nights and coffee soaking.

It is actually a lot tougher to test day time basal rates. Try controlling eating, activity, weather and school work for a few days. Those and other factors combine to make it more of a wing and a prayer than measurable science.

Our strategy is to work out the over nights, try to figure out the morning on weekends and wing the rest by kind of moving rates proportionally. Once the basal rates are tuned up, we look up the correction and I:C based on tables in Pumping Insulin based on TDD.

We once got a few months out of a set of basal programs. They didn't grow much those months. Typically it last about six weeks. Then two weeks of testing, reprogramming and verifying.

Lather Rinse Repeat.

From the News Wire: Novel Combination Treatment for Type 1 Diabetes

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I haven't had time yet to read this with care - first read is very interesting:

DiaKine Therapeutics and Kinexum Metabolics to Develop Novel Combination Treatment to Type 1 Diabetes

Lisofylline and INGAP Peptide Combo Therapy Set for Phase 2 Clinical
Trial

CHARLOTTESVILLE, Va. & HARPER'S FERRY, W. Va.--(BUSINESS WIRE)--DiaKine Therapeutics, Inc. and Kinexum Metabolics, Inc. today announced an agreement to jointly develop a new combination therapy that has shown, in preclinical studies, to cause type 1 diabetes to go into remission by protecting and promoting the growth of new insulin-producing cells.

A Phase 2 human clinical trial with the new combination therapy, consisting of DiaKine’s Lisofylline (LSF) and Kinexum’s INGAP peptide, is expected to begin in late 2008. The trial will be unique in that patients who are beyond the ‘newly diagnosed’ period will be included in the study. Current trials seeking to treat people with type 1 diabetes do not include those with established disease.



Full story here

May 5, 2008

From the News Wire: Oral Insulin Special Access

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From Seeking Alpha

Generex Biotechnology (GNBT) quietly released an 8K SEC filing on May 1st. In this "Current Report" they note:

Generex Biotechnology Corporation (the "Company") has received Special
Access Programme authorization from the Therapeutic Products Directorate of
Health Canada for a patient-specific, physician-supervised treatment of Type-1
Diabetes Mellitus with Generex Oral-lyn™, the Company's proprietary oral insulin
spray product. Health Canada's Special Access Programme [SAP] provides access to
non-marketed drugs for practitioners treating patients with serious or
life-threatening conditions when conventional therapies have failed, are
unsuitable, or unavailable.

The filing states that a Type 1 patient will be allowed access to
Oral-lyn. Her Doctor will record her therapuetic response to Oral-lyn and alert
the Director. Investors in Generex hope that positve results may lead to an
expansion of the program.

May 1, 2008

Amy wrote another great blog post.

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No shock there right?

Well two actually this one and this other one, not to mention the rest of her blog.

So anyway one of the comments on this other one struck me as particularly interesting. I responded by didn't bother to use actual English. In my defense, I was too excited by the whole conversation.

It was about data.

Oh my lord I am in getting excited about data, I am in fact a total geek! Possibly a Trekkie but then I didn't capitalize 'data.'

Anyway I encourage y'all to go read Amy's latest design challenge. For those of you who are not product designers and who understand databases and stuff (and so are even more of a geek than me, but I mean that in a nice way, honest) maybe you can design data standards for diabetes devices the designers design. After all iPods look cool and work intuitively.

After reading the good stuff at Amy's, my prior blog entries on the subject are:

...and I would like a side order of Holy Grail while I am at it too

Swimming in the Data Stream Looking for the UN.