September 29, 2008

46 Degrees of Separation

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My good friends at Caremark had a Pharmacist call back to explain that their insulin shipping practices are tip top. There was a fairly impressive amount of smoke blow up my skirt and I was less than impressed. He promised to have someone else call back to explain why I should trust them. Given that I can barely breathe from all the smoke, I am not holding my breath. It has been more than a week. I don’t think they are calling back.

The gist is they are just all over it and I shouldn’t be worried because they are just brilliant. Sure. Then why did you’re their own pharmacist decide to re-ship not once but twice? He did let the cat out of the bag and told me they were looking into considering the weather when they ship going forward. Ya Think?

I called Lilly. They wanted me to know I could refuse a shipment. Not that they have a vested interest or anything.

I asked at what temperature can I be confident that the stuff is OK? In short if I take my trusty instant read thermometer and check the stuff what is the safe range to store the stuff?

36 to 46 degrees.

Get a thermometer. Check your insulin. If your shipment is in that range you are cool, literally as well as figuratively. Simple no guessing.

No need to thank me, adding more numbers to check into the daily lives of families with type 1 is thanks enough.

September 23, 2008

Food for the Shrink.

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Eating issues are a very common problem with kids. Here I'll prove it - Who's kid eats veggies?

Nobody's.
See what I mean.

When kids are under stress one of the very few things they can control is what they do or do not eat. As parents of type 1 diabetic kids we need to be aware that the eating and emotional link does not disappear with the beta cells.

No. In fact all diabetes does is add to the complexity.

We parents take new eating rules kind of matter of fact -  this is the diet plan. That is it. For us the stakes are too high to not follow the plan. We are talking about our kids lives, that's enough for us - we are following the plan.

The problem is that message doesn't really get through to the kids. They may hear it. Can probably recite it. But they just don't buy it like we do.

Guess what? (This may be hard to believe) The kids are stressed by diabetes. (I know it came as a big shock to me too...)

We need to be aware of food not only as carbs but as a possible indicator of distress. OK maybe we should just settle for not letting food make thing worse.

The New York times recently ran an article about the 6 Food Mistakes Parents Make. One for the six was about forbidden fruit. They say:
Keeping ‘good stuff’ out of reach
Parents worry that children will binge on treats, so they often put them out of sight or on a high shelf. But a large body of research shows that if a parent restricts a food, children just want it more.

In another Penn State study, researchers experimented to determine whether forbidden foods were more desirable. Children were seated at tables and given unlimited access to plates of apple or peach cookie bars — two foods the youngsters had rated as “just O.K.” in earlier taste tests. With another group, some bars were served on plates, while some were placed in a clear cookie jar in the middle of the table. The children were told that after 10 minutes, they could snack on cookies from the jar.

The researchers found that restricting the cookies had a profound effect: consumption more than tripled compared with when the cookies were served on plates.

Other studies show that children whose food is highly restricted at home are far more likely to binge when they have access to forbidden foods.
With the strict eating schedules of some insulin regimes (cough, NPH, cough, cough) some type 1 diets make almost everything forbidden fruit. As a result kids want - more of everything! This can lead to a cycle of escalating parental control and child rebelling with eating off schedule and covering with insulin or not. It really goes off the rails when folks talk about eating in negative terms like sneaking or  cheating.

High from uncovered or off plan eating is tough enough. Not eating for insulin already in the kids is end tougher. Hear of hypos are why a lot of parents do not pre bolus kids for meals. It is just too hard to predict what they may eat. And if they don't what do we do about the lows.

If we parents becoming more controlling and more critical of what we see as a lack of the kid's efforts we are just asking for more trouble. Here is a nice little paragraph on that from our friends at Wikipedia:
Research from a family systems perspective indicates that eating disorders stem from both the adolescent's difficulty in separating from over-controlling parents, and disturbed patterns of communication. When parents are critical and unaffectionate, their children are more prone to becoming self-destructive and self-critical, and have difficulty developing the skills to engage in self-care giving behaviors. Such developmental failures in early relationships with others, particularly maternal empathy, impairs the development of an internal sense of self and leads to an over-dependence on the environment. When coping strategies have not been developed in the family system, food and drugs serve as a substitute.
Let see... Diabetes care takes a lot of controlling (and IHMO it real easy to become over controlling) and that potentially feeds (get it feeds?) into eating disorders. Forbidden food becomes more desirable food... and diabetes forbids food all over the place. Catch 22 anyone?

I don't know what the solution is.

For us it is in part pumps that allow for a more flexible eating regime. Another big but very hard part is to see numbers as numbers without attaching value judgments to them. For me in particular not attaching positive feed back to 'good' numbers. I need to go to the next step and ask about the behaviors that result in numbers and provide positive feed back for good behaviors - what ever the number is. Stuff like; 'What did you do about it?' 'How did you get there?' 'Why do you think you got there?' Followed by. 'That was good thinking on your part.'

Come to think of it, at times the 'good stuff' we tend to keep out of reach isn't food. It is the non judgmental loving positive feed back. Only makes the kids want it more.

September 19, 2008

From The News Wire: "Of course, years of additional studies"

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Scientists Turn Human Skin Cells Into Insulin-producing Cells

ScienceDaily (Sep. 18, 2008) — Researchers at the University of North Carolina at Chapel Hill School of Medicine have transformed cells from human skin into cells that produce insulin, the hormone used to treat
diabetes.

The breakthrough may one day lead to new treatments or even a cure for the millions of people affected by the disease, researchers say.

The approach involves reprogramming skin cells into pluripotent stem cells, or cells that can give rise to any other fetal or adult cell type, and then inducing them to differentiate, or transform, into cells that perform a particular function – in this case, secreting insulin.


University of North Carolina School of Medicine (2008, September 18). Scientists Turn Human Skin Cells Into Insulin-producing Cells. ScienceDaily. Retrieved September 19, 2008, from http://www.sciencedaily.com/releases/2008/09/080917175042.htm

September 17, 2008

Parenting P Words That Aren't Punish.

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I was reading an online conversation about punishing kids for sneaking food. Regular YDMV readers know I am not a fan of calling it sneaking or cheating. What I found particularly useful in one of the replies was a positive way to manage it. Here is what my friend Kristin had to say about punishing for sneaking;


We do not. But that is only our situation. I realize each child is different. At one point we used to make a joke. I told my son that if he was going to "sneak" food that he was to come to me and tell me he was sneaking food with a wink. Of course the agreement is that I can't say anything but ok and wink back and he would of course bolus himself! He did this once or twice and that was the end of it. He doesn't sneak any food. I also try not to limit food for d reasons. I will for health reasons but not for d. Like I said this just worked for us.

Here is what I find particularly helpful. First it is an ‘I’ statement as in I do this. Not you should do something but I do this. Next she is right up front with the idea that situations differ. Yeah YDMV! OK Y Parenting MV

Now comes the real brilliance - Joke about it. Wink and a nod support for breaking rules. Making it kind of fun to do what is the long term goal. Specifically know that it is OK and FUN to eat and bolus.

Kristin flips confrontation potential into a positive parenting practice pre positioning proper independent performance. That is 8 parenting P words that aren’t punish!

Perfect!

September 16, 2008

Sports Got no Life

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I was surfing around this evening and read this gem. I almost signed up for the sports fan site to tell the guy he doesn’t know jack about diabetes.

But what is to be gained? So some sports dude with a grudge against McDs wants to blame it on Jay Culter. I could point out that as an NFL quarterback I bet he gets his fair share of exercise every week, maybe extra on Sundays. That T1 is not T2 and yatta yatta yatta

But so what? I wish the world was more aware of diabetes and the distinction of the two types and all that. It isn’t. So Jay gets a bum rap from this clown and got away with a bum call on Sunday. So what?

It just doesn’t matter. What matters is that I do something positive with what I know. So I am going to work on encouraging the diabetics here to focus on the life part of their lives. Today that means being enthusiastic about Delaney starting field hockey and Connor getting to playing Bob Cratchit. Then I should go walk on the treadmill so I don’t get type 2. That is real life.

Dude on the sports site should get one.

September 12, 2008

Third Time, Hold the Charm

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There will be NO frustrated sarcasm in this post at all, Honest! (Well maybe that was some right there, a little... OK it will get thick.)



Caremark managed to get insulin to us. 3rd delivery wasn't cooked. yeah!

Even delivered it over night. Just like they said they would. They just didn't say over what night.

They gave us a tracking number. It didn't show up in UPS's system. That was because the number is assigned when they pack it. They packed it held it a day and then shipped it over night. They claim they have cold storage at shipping.

Forgive me if I am a wee bit concerned. They have not been real credible.

So when they gave me a tracking number, it didn't track because UPS hadn't scanned it in. Sure that just peachy with me. When the tracking number did work, it showed it wasn't on the truck for delivery. But it was.

That all works out in their minds. Somehow.

It came. While the ice was almost totally melted but this time it was still cold. And it was packed tight. I was impressed, well no I wasn't. I was sceptical and put my insta-read thermometer on it.

So the third batch came, a day late. $4,000 give or take worth of insulin cooked to get it here.

Apparently others have had the same problem. At least that is what they said when I talked with them, but this has only been like 5 people and only recently since they stopped shipping over night.

Lets see 5 people time 4k each is 20 grand. I was an executive complaint guy for a while. (Job sucked.) My experience was that only a small number of people really speak up. In fact we counted on it. Well less than 10% have the nerve work through the concentric rings of telephone protection to get to a supervisor let a lone the complaint department. Let say it is 10% then that $20 grand is really $200,000.00. Oh and it is a quarterly shipment... so they could easily be running at a burn rate of $800,000 of cooked insulin on an annual basis.

I wouldn't really care if it were a free market. Caremark could go out of business, I'm good. If my pharmacy screws up I can go to the one across the street.

BUT Caremark is not in the free market business. They are in the business of being a monopolist. I don't have the choice across the street or down the internet. I am locked into them as the provider under my insurance plan. A plan that I have no say in choosing. (Maybe they take the insurance guy golfing... in the Bahamas... for most of February.)

There is a very vocal voice that rail against 'limiting the free market' in our medical care system. Where is there a free market? Show it to me. We have 'Managed Care' a phrase that means a group of businesses that work together to limit the fundamental market forces of consumers selecting service providers based on service and value.

Caremark wanted me to know it is their cost to eat the 4k. Sure it is. Their cost go up, they pass the cost on to the insurance company and my share of the insurance costs go up.

The office of the Caremark President called. They said the presidents name was Tom Ryan. In July's earnings report Tom said, "We delivered solid improvement in sales and gross margins and continued to exercise disciplined expense control."

Sure thing there Tommy, Can you explain how pissing away 4 grand worth of insulin constitutes disciplined expense control? Yeah your shipping cost went down a few bucks. BUT You increased your return costs significantly and it not a isolated case. One middle level complaint person has seen a number of cases. Extrapolate that (Tip: use the same math you use to figure out your pay package.)


Have fun golfing in the Bahamas, we'll be here trying to manage our kids blood glucose. We don't mind that you wasted more than the cost of CGMs for our kids. Honest we don't. Pay no attention to the voodoo doll that looks like you we are using old syringes on. It mean nothing... Honest.


I am all for free markets. Health care in the US is not one.

I don't expect the service providers to work at their jobs as hard as families with Type 1 work at diabetes care. We are on 24 7 365.25. It is only a job for them, an honest 40 hours a week would be great. Real market forces would be good too.

September 10, 2008

Caremark "Saves" Money

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Saves is a word that here means pisses away.




I'll let the lovely Mrs YDMV tells us about it:

The story goes like this.

On Wednesday I order our 3 months of supplies
for both kids. On Friday18 vials of insulin arrive. It was delivered 2 day UPS
(did I mention it the 90 drgree plus days?) When opened the ice pack was warm and so was everything else including the insulin.

I called and spoke to the CS rep, then the Pharm tech and finally the pharmacist... They were going to overnight me another 18 vials of insulin.

By monday afternoon nothing had arrived so I called. Yes it was sent Sunday it should be there by Tuesday. WTH???? It was supposed to be overnighted.

Tuesday afternoon UPS arrives with the box labeled GROUND - I spoke to UPS in between and was told it had no special delivery time attached or slow boat to China except speed. We are 3 hrs from the Warehouse so it only took 2 days.

Opened today insulin and it is almost cold. Ice pack is melted and just cool, boxes are sort of cool (compared to a 90 drree day.) The insulin bottles against my cheek are coldish (but then so is any peice of glass.)

I decided to call Caremark. I finally get to the Pharmacist after the CS rep and Pharmacy tech. He decides that we do indeed need more insulin. That the last batch should have been overnighted and the frozen packs were frozen when they left the warehouse. So, we now have $4000 worth of insulin that will only be good for a month and the promise that another 18 vials will be overnighted.

I hope that the cost saving measure with regards to not shipping over night insulin any more is worth what they have lost on insulin to our house alone. But then overnght shipping doesn't run 4k per order does it?

My theory is they usually just sent one kid's bottles out so, one mid size freezer pack works just fine keeping the stuff refrigeration temp for 2 days. Unfortunately nobody is doing the calculations with how much extra cold they will need to provide to keep 18 vials of insulin cold for 2 (hot) days... So, they keep sending it two day with one frozen pack which warms up with all the bottles of insulin in the package.

So we are shipping back 'a little insulin' (a word that means 'just' the insulin in the photo above) so we don't get stuck paying for it. To keep anyone else for paying for the mistake we are going to take a sharpie to the boxes. That way the stuff doesn't end up in some other kid.

Oh and wouldn't that insurance money have been better, a word that hear means help keep BG in control, spent on a CGM?


September 9, 2008

Ya Wanna Bet?

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Silly football bet time here at YDMV.

Gotta go with the guy in the pool:

Yahoo is reporting Braylon Edwards bet Michael Phelps he would score twice as manty TDs as Phelps won golds. Good luck with that.

One more reason to love a good sacking:

AP is carrying the story of Jared Allen.

EDEN PRAIRIE, Minn. (AP) Minnesota Vikings defensive end Jared Allen is looking to sack more than quarterbacks this season.

Allen has teamed up with the Juvenile Diabetes Research Foundation to launch an initiative called "Sack Diabetes." Allen will donate $3,000 for every sack he records to the local JDRF chapter in the city he plays.

That means the Minnesota chapter will get $3,000 for every sack he records in a home game this season. Allen led the league in sacks last year with 15 1/2 despite missing two games because of a suspension.


So if he plays Denver who ya rooting for?

September 8, 2008

From The News Wire: JDRF CGM Study Significant Benifits

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JDRF Study Results Show Continuous Glucose Monitoring Provides Significant
Benefits in Management of Type 1 DiabetesMonday September 8, 9:06 am ET

ROME--(BUSINESS WIRE)--New study data presented by the Juvenile
Diabetes Research Foundation (JDRF) today at the 44th annual meeting of the
European Association for the Study of Diabetes (EASD), showed the use of
Continuous Glucose Monitoring (CGM) to be effective in the management of Type 1
Diabetes.

Highlights of the study results include:

  • Patients 25 years of age or older who used CGM showed significant
    improvement in glucose control as measured by HbA1c.
  • Most importantly, this improvement in control was observed without an
    increase in hypoglycemia (low blood sugar), which is a common concern in
    intensively managed patients trying to achieve improved glucose control.
  • In all ages, patients who used CGM at least six days a week had
    substantially improved HbA1c levels.

More

From Dexcom: http://biz.yahoo.com/bw/080908/20080908005814.html?.v=1

From MiniMed: http://www.earthtimes.org/articles/show/major-study-reinforces-the-power,530541.shtml

Kerri maybe this will help with the insurance company.

From The News Wire: Biodel Preliminary Results

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Wall Street isn't happy:
http://www.reuters.com/article/marketsNews/idINL803245020080908?rpc=44

Biodel Announces Preliminary Results of Pivotal Phase III Clinical Trials for VIAject(TM)

DANBURY, Conn.--(BUSINESS WIRE)--At the 44th Annual Meeting of the European
Association for the Study of Diabetes (EASD) in Rome, Biodel Inc. (Nasdaq: BIOD - News) today reported results from
its two pivotal Phase III clinical trials designed to compare the efficacy and
safety of VIAject™ to Humulin® R, a regular human insulin (RHI), in the
treatment of patients with Type 1 and Type 2 diabetes. The primary objective of
the trials was to determine if VIAject™ is non- inferior to RHI in the
management of blood glucose levels, as measured by the mean change in patients’
glycosylated hemoglobin, or HbA1c, levels from baseline. HbA1c is a measure of
average blood glucose level and an indication of how well patients are
controlling their blood glucose. Based on the initial analyses, both clinical
trials met the primary endpoint of non-inferior mean change in HbA1c over six
months of treatment.

VIAject™ is Biodel’s proprietary injectable formulation of recombinant human insulin designed to be absorbed into the blood more rapidly than currently marketed rapid-acting insulin analogs. Two posters summarizing the preliminary Phase III clinical trials results are being presented at the EASD conference and are now available on the Biodel website, http://www.biodel.com/. The first poster is entitled “Insulin VIAject™ and Regular Human Insulin in Patients with Type 2 Diabetes; Efficacy and Safety in an Open Label Multicenter Clinical Trial.” The second poster is entitled “Insulin VIAject™ and Regular Human Insulin in Patients with Type 1 Diabetes; Efficacy and Safety in



http://biz.yahoo.com/bw/080908/20080908005463.html?.v=1

So I guess the point of non inferior is it isn't any worse. Faster with less of an insulin on board tail sounds cool to me.

The usual full disclosure statement here. I have a few shares of Biodel.

September 3, 2008

Diabetes Daily has Faustman on Video

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It is very good.

Huge thanks to David, Elizabeth and Bernard for putting the good Doctor online.

Go see it if you haven't already.

http://www.diabetesdaily.com/edelman/2008/09/diabetes-cure.php

September 2, 2008

Terry's Two Bits on DexCom and Pumps

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Not much has come down the information super highway about how the DexCom CGM will work with pumps. We're told it will work with pumps and to be looking next summer / fall. There were some tidbits in the DexCom presentations to wall street. So figured what the heck why not write them a letter. Here is what I wrote and their reply:

Terry Gregg
President & CEO
DexCom, Inc.
6340 Sequence Drive
San Diego, CA 92121

Hi Terry

I have a particular interest in DexCom, in a small ways as a both a little share holder on a pure CGM play and as a diabetes blogger and in a very large way as the parent of two type 1 kids who have a very real long term interest in continuously managing their glucose.

I had the pleasure of talking to some of your team at Children With Diabetes Friends for Life conference in Orlando last month. Thanks for sending them. Maybe next year you can arrange for some trials of your device like MiniMed did this year. That would be great! A two day trial of their device dramatically changed my 14 year old son’s disinterest in wearing a CGM into a tangible interest in using one.

Since then I have read over your comments on earnings calls reported on Seeking Alpha. I have some questions that you may or may not know answers to.

In the March 11 call you talked about how DexCom and the pump folks will deliver data to us, families with diabetes. You said:

“In each case, DexCom’s CGM data will be displayed on the partner’s pump. In addition to insulin dosing information, patients will have access to glucose trend information, as well as high and low alarms, all in a single display unit.”

http://seekingalpha.com/article/68139-dexcom-incorporated-q4-2007-earnings-call-transcript?page=2


That sounds like how MiniMed is doing things now. That is good except we don’t love their pump. It is an attractive approach to CGM Pump integration as it requires less belt space on my daughter’s Batgirl like utility belt of diabetes gadgets.

I have to wonder is that ‘on the pump’ approach really going to be the case? Insulet most obviously will bring the data to their PDA like controller. For their approach to pumping the PDA is the pump interface.

Animas seems to be going down a similar path with the Ping meter/remote. Given that, do you continue to see the CMG data showing up on the partner’s pump or on will it be on another device like the remote control meter? Unlike heads to solve a problem, where two is better than one, for diabetes junk for a kid to carry one device is better than two.

Further the flexibility to choose the meter that best suits the user’s lifestyle is a feature that would be limited but using a PDA Meter as an intermediary. I would hate to be required to use the Pod or Ping meter to calibrate the CGM. But then you know recognize this value by your recent effort to get approval to us any meter to ‘Open Code’ the Seven unit.

So will it be CGM data displayed on the pump, or a meter in between?

Respectfully Yours

Bennet




Terry emailed back:

Bennet,

Thank you for your letter. Insulet will indeed display our sensor readings on their PDA. With respect to Animas, our first generation combination device will display on their pump for regulatory reasons, followed by future iterations utilizing remote programming devices (i.e., Ping). It is our goal to have these remote devices utilize an "Open Choice" format for the SMBG calibration.

We are actively pursuing a pediatric claim for our device and hope to have approval sometime next year.

Regards,
Terry