World Diabetes Day Detour

We spent World Diabetes Day packing meals at a StopHungerNow.org event sponsored by New Church Live and the boys high school, the Academy of the New Church. A great time was had by all as the little clip shows. It was all about food and there is a glancing view of a pump. That counts as diabetes related right?

Of course one of the points I try to make here at YDMV is to make the diabetes management second so doing stuff like this can be first once and a while.



Thanks to the folks at NCL and ANC who organized this. I wonder how many carbs are in 30,000 meals? ...no I don't.

Remote Reply

I received a reply to my letter about One Touch Ping remotes and the possibility of confusion when two are used in close proximity.

What is important is this: Yes there is a way to put a legible name into the pump that appears on the remote that controls it. 


It is a very nice reply. They didn't call me any of the nasty names I probably deserve.

The instructions make it clear that, “Note: The custom Name appears on the Meter. It does not appear on the pump.” and it can only be 7 characters long, less than good old fashioned pre Windows 95 DOS but hey it is something.

The instructions are here: http://www.docstoc.com/docs/61132161/Ping-Meter-Customization

Sorry for the ugly ads and stuff. When I work out a better host location I'll move the link. I think it should be on an Animas / OneTouch site. It isn't, at least yet. 


Y’all can feel free to stop reading now because the rest is my very wordy commentary on customer service. YDMV errr.. YCSMV.



I don’t know if it is significant or not but the letter I sent was to One Touch but the reply came on Animas Corporation stationary. I also had the pleasure of speaking with Animas folks on the phone. Over the years I have found that I genuinely like the people I have met from Animas.  So it isn't surprising that the people I have met over the phone in this case are genuinely likable.

The letter said (I apologize for any typos and or egregious spelling, I am sure they are far more literate than I and such mistakes are my responsibility):

Thank you for contacting us about your recent experience with your children's One Touch Ping glucose management systems.

We appreciate the confidence in our company that prompted you to bring this matter to our attention. We at Animas Corporation have worked hard to meet the needs of our customers with innovative and high quality products. We believe that every letter from a customer offers useful insight into our business.

For that reason, we take every complaint and concern seriously. Your specific concerns regarding the One Touch Ping Glucose Management system have been reviewed thoroughly by the customer Support Department and escalated to the Complaint Management team. Complaints (the actual complaint numbers have been redacted because I don’t see value in putting them in the public domain.) entered (on) your children’s behalf are currently under review.

Additionally, you requested instructions to personalize your children’s meter. Those instructions have been included with this letter.

Again, we appreciate the time you have taken to contact us. It’s only through feedback like yours that we can continue to improve our products.

Sincerely,
Manager of Customer Support.

I have some experience in the craft of writing these kind of replies. I did it for a big bank for a few years. From that background I can make some semi informed comments on the letter (and realistically regular YDMV readers know that ‘semi informed’ is a significantly higher intellectual quality than most of the comments I make here.)

The response is both professionally and nicely written. For the most part it doesn’t say very much at all other than “Thanks. We got your letter. We’ll think about it.” That is actually just fine with me other than that part shouldn’t take a month.

It should be out the door the next day. In fact I’m willing to bet cash money that whole sections of the letter are boiler plate and if they aren’t the should be. Specifically the first three and last paragraphs. That fourth paragraph was the hard part.

My two cents is it would be better customer service to send the the other four paragraphs right away and a comment that the instructions will be sent as soon as they can be written and tested, with an expectation of how long that will take. But hey that is me.

I was on a time clock to reply to executive level letters within fixed time frames and those time frames were at the longest three business days, unless the letter was from a regulatory or political office holder in which case a response had to go out the day was received in kind (call for call, letter for letter etc.) and followed up by a letter in the mail the next day if the original was not a letter.

As for the instructions on how to customize the pump/meter. I haven't tried them yet they are four pages long and I need the pump and old PC running a legacy operating system like XP to do it*. I have up loaded scans of the instructions for the benefit of others who may wish to take advantage of theses instructions. I understand if nobody else is into four pages of crappy scans of instructions. I will comment on the actual experience after I try it.

I reached out to Animas and asked if they would like to provide a clean pdf file. They being a highly regulated business need to go back to the chain of command, a.k.a. Compliance, to see if that is OK.
To be precise they provided me personalized clearer instructions on cusyomizing a pump name because I pushed for them. Knowing I intend to share them with other parents, they will not provide a clean electronic copy, at least yet.  They put it in the context of wanting further review, like the sidelines tossing a red flag at an NFL game.  I have no idea how long that will take, but while the ref is under the hood,  kids still have diabetes to manage.

I am from Philly. Eagles fans boo bad calls, we even boo good calls we don't like. I'm not sure which one this is.

If, upon further review, I get a better pdf, I’ll post it.



* Insert my typical rant about diabetes devices not keeping up with computer operating systems technology aka current Windows & and Snow Leopard. I have a few readers who are even more rabid about it than I. I bow to their expertise and acknowledge their contributions through comments here at YDMV. Which is my boiler plate for “Way to keep me honest dudes.”

For Anonymous - ANC Sigma Telegrams.

Some anonymous soul (and this is YDMV, I can understand the desire NOT to associate one's name with it) commented on the Mark Fox clip about another of my videos on Vimeo. A clip of kids singing. Here's more and the back-story.



For those of my YDMV friends that aren't alumni of the Academy of the New Church and I expect that is most YDMV readers, it is a private, church (no kidding it is in the name) school in Bryn Athyn PA. It is at times a very impressive place and no time more than when the kid's clubs send each other singing telegrams. There are four clubs, two boys, two girls, one dorm kids one local kids of each. Twice a year the clubs have banquets and send each other telegrams.

That a school of maybe 200-ish kids can find four groups of kids with the ambition and talent like this year in and year out in impressive. No it is not a dedicated preforming arts school. These telegrams have been going on since way back when dinosaurs roamed the earth (and I was in high school) and even earlier. I that think speaks a lot about a culture that the creates opportunities for kids to diversify and explore interest. www.ANCSS.org

Connor joined his club's (Sigma!) telegram troupe this year. I shot some video so Kelley up at NYU could see him. Well some alert YDMV reader (and yes I consider that an oxymoron) somehow spotted that clip on theBetesNOW's Vimeo channel. I was very embarrassed, the quick post edit work was beyond pitiful but I found this and at least the kids heads aren't cut out of frame.

Reece is the Sigma President, a fine football player and sings the opening solo. Behind him is a guy with a triangle, Greg. He is the song leader and worked out the arrangements. Greg can do things with a fiddle that brings a tear to the eye. The soloist in the second song has committed to serve our nation in the military. Great kids, mine's  OK too. So there are some very diverse interest pooling their talents.

As an ANC alumni, Sigma member and dad I'm proud of these kids for a lot more reasons than you can see but all the ones you can see on the clip too.

Enjoy.

Big Blue Backstory

Manny has some of the back story on people in the Big Blue video. Good read, particularly if you have a girl interested in dance.

http://www.tudiabetes.org/profiles/b...stories-behind

Oh and just under 10k views left to go. Don't stop playing again and again.

Ya Oughta Know This

 If you live with diabetes you are the primary care giver. If you are a parent your job is to pass that  on and that is harder than taking the responsibility on the the first place.

Here is my good friend Mark, who was the hero of one of my earliest YDMV posts, with 24/7 on the matter:



The plan for d-blog day is six things I want people to know. Six is a lot. I find most folks don't have that much of an attention span. So if y'all get this Primary Care idea - I'm good with that.

Counting CGMS Before they Hatch

For OmniPod and Animas users looking for CGMs integration the news is more FDA reviews. Dexcom’s Earnings call of Nov 4 was released on Seeking Alpha on Sunday Nov 7. It is a long and nuanced call. I am sure a fair amount of that nuance sailed over my head. I recommend folks have a look for themselves if only to get a glimpse at the magnitude of the complexity of the regulatory process.

Here is a way over simplified overview of what I get: The FDA came back to Dexcom and is requesting more data. There is quite a bit of candid conversation in that call. About CGM pump integration and about the FDA looking at insulin pumps with a more heightened scrutiny.

Attempting to translate the call into the simple what does it mean for my pumper language for families living diabetes it comes down to this; CGM integration into OminPod and Animas pumping systems is at pushed back. Taking a SWAG maybe a half year, probably more. This looks to be in part about CGMs and part about tighter regulation of insulin pumps.

Insulin pump companies today are faced with the likely prospect of having their pump products regulated under a new subset of class two devices where approval standards are in a state of flux and human clinical data requirements are unclear.

the FDA is undergoing sweeping changes to its review and approval policies and procedures, and has set forth as a priority an effort to improve the level of regulatory science the agency applies to all medical devices to better assess, evaluate, and review products.

With regard to Generation 4 of the Dexcom system which is what Animas is looking to work with:

we (Dexcom) expect to complete a small additional clinical trial with the Gen4 sensor paired with our next-generation receiver and transmitter, and file an amendment to our Gen4 PMA supplement during the first half of next year. Although we cannot predict the ultimate decision or timing for a decision by the FDA, we believe this amended Gen4 submission will be incorporated into the current Gen4 180-day review cycle, give or take a few months.

OmniPod has some decisions to make about how to proceed. They were expected to launch before Animas based on using the current generation 3 Dexcom product. However the FDA seeking more information means OmniPod may want to look to Gen 4

Insulet, as you'll recall, is paired with the SEVEN Plus. The Animas product, when complete and filed, will be paired the Gen4 sensor.

The Insulet situation's a bit more difficult to describe, only from the standpoint that Insulet's got to make some decisions as to what they want to do going forward, either to move forward with the SEVEN Plus, or if they make the decision to go to Gen4

While there is additional scrutiny in the USA the EU combined Animas/Dexcom system continues to be expected in the first half of 2011.

we remain committed to filing for CE mark approval before the end of this year and expect to be in a position to launch the combination product in Europe during the first half of next year.

In closing my post, I thought this was a particularly telling comment in that I think every patient, parent and partner of a pumper is accurately aware of the seriousness of this statement:

I've long said it amazed me that the pumps were 510(k) products that carry around anywhere from 180 to 300 units of insulin, which is a potentially lethal amount of insulin.

As a parent of type 1 kids I don't take that lightly at all. We accept that as a means to a living more normal, better manages lives. The point of all this technology is to make diabetes secondary to living pseudo normal lifes and pursuing dreams.

Full disclosure: I own shares in Dexcom. I think CGM is a good idea. Dexom is a pure CGM play. Your Investments May Vary, mine sure do.

Dear Vendor

Your living depends on quality delivery of diabetes products. Our kids lives depend on them. It almost sounds the same but lest there be any confusion the difference is a quantum leap. Y'all would do well to project an understanding of that.

I was in the lobby of one of our vendors a few weeks ago and read a poster on the wall extorting the employees to achieve the 2009 goals. It being the tenth month of 2010, I wonder if they made the 2009 goals, or if the staff even sees the sign as they walk past since the poster, having been up for deep into the next year, had become invisible. In part the sign read, "deliver the highest quality diabetes products and services to our customers while ensuring compliance and profitable growth." It also talked about putting the "customer at the center." of quality and delivery.

Wouldn't it be great to be at the center of quality delivery? I would be a huge cheer leader for your profits if I felt my kids were at the center of your business behaviors.

I would think that would putting the customer at the center would include responding to or even acknowledging customer contact in a way that is useful and in kind with how customer the contact the company.

A month ago I wrote this particular vendor a letter. Neither of the executives who were recipients have made any reply. A third party support person called my cell about a week later with instructions on how to use my computer to manage the meter and pump in a work around. I was at my daughter's field hockey game. I did not have access to a computer or the meter. Getting the pump would require actually stopping the game. So I asked for an email. I like written instructions - I know it is old school, but I'm old. I was assured I would have that email the next day. It was a little late to get it out that afternoon and I didn't expect the caller to get home to his family dinner late so I figured one day was fine.

Never got'm.

I called a week or more later and after some fairly aggressive insistence about escalating on the line rather than waiting for another call back or email, I was told I that write instructions would require approval. Really? I can expect a call back in two business days that will update the status of getting a written reply. (There is a weekend in there so it four days with diabetes because diabetes doesn't take weekends off, I think weekend off would be a big improvement in diabetes care by the way.) I got that call and they said they were still 'working on it.'

I spoke to one of the recipients of my letter today. I was assured they had seen the written reply to my letter and the instruction for a work around. That nice. I haven't.

At the center of it all is we still have manage diabetes. Unlike a vendor the kids don't get to wait a month to think over how to respond to it.

So One Touch, that 2009 goal about customer at the center of quality delivery - care to grade yourself on this issue?

October 6, 2010


One Touch Ping - Compliance
200 Lawrence Drive
West Chester PA 19380

Ms X and Mr Y,
I am the parent two teenage minor children who use One Touch Ping pumps. The Ping meter remote and the insulin pump are designed to work together as a system by patients. In our cases by pediatric patients. With two Ping users in the house we have two OneTouch Ping Meter Remotes. The meters remotes are the same color, design and do not appear from the documentation to support user identification by name the remote screens via software customization. Short of the serial numbers these remotes are indistinguishable.

In a multi pump household, the indistinguishable remotes and lack of in device personalization presents a strong possibility of confusion and the very real possibility of one child entering an insulin dose that is delivered to the other’s pump. This would require that both the confused pumps and remotes be in common transmission and reception range. That happens at regular times, such as at a family meal. In fact insulin pumps are designed for use in conjunction with meals. The use of pumps (is common) at every family meal in type 1 households.
Lables, stickers and skins can be used to identify remotes but can all wear off or be removed. Customization of the home screen of the remote / meter with the user name would allow clear positive identification of who’s pump each identical remote controls.

OneTouch suggest that users check the serial number of the pump that can be displayed on the meter. Those numbers are long, not intuitive and potentially difficult for a pediatric patient to remember. The process of calculating and administering an insulin bolus involves an array of number; blood glucose, carb count, insulin to carb ratio and insulin on board to name a few. These numbers have the potential confusing the recall of the serial number.

Hyperglycemia may exacerbate the risk. Linda Gonder-Frederick, PhD et al demonstrates in the article Cognitive Function Is Disrupted by Both Hypo- and Hyperglycemia in School-AgedChildren With Type 1 Diabetes: A Field Study, Diabetes Care, June 2009, that hyperglycemia effects the cognitive function of school age children. Hyperglycemia require more insulin than would otherwise be infused as a correction bolus. However at the time more insulin is needed ability may be impaired and the potential confusing the recall of the serial number increases.

Were this confusion of remotes used to operate pumps to happen there is a very real possibility of excessive insulin delivery. Animas is aware of the risks of excessive insulin delivery. The phrase that is used repeatedly in the Ping Owner’s booklet, bolded and highlighted, is “... can result in serious injury or death.”

Section II, of the Owner’s booklet titled OneTouchPing Meter Remote, pages 107 - 126 details setting up the OneTouch Ping Meter Remote. Page 109 specifically speaks to the device home screen. Pages 114-118 address customization. In repeated readings I was unable to identify any customization of the OneTouch Ping Meter Remote that would facilitate naming or other easily understood personal identification of the user on the home screen or via customization settings.

Use of remotes for different pumping patients in the same household represents a potential serious risk as designed.

Sincerely yours,


cc: FDA

My post with a reply is here: http://www.ydmv.net/2010/11/remote-reply.html

Editors note: I removed the names of the contacts at One Touch. It seemed more fair to focus on the organizational behavior and less on individuals. - YDMV

Tame a Tiger

 Get Brilliance - Free!

The diabetes community asks for and gets a lot of support.

We walk to get support. Ask our friends to watch videos again and again to get support and we put our fool names and faces on the CURE for support.

It nice to join with the diabetes online community to help one of our own do some offering and giving. I’m here to help a friend give away his book. He wrote it to help people new to diabetes cope. Not explain it all, just cope. Coping is a brilliant first step.

He set out to sell the book but being one of the better angels on this planet he wants it to help more people than just those who have a few bucks to buy it. So he made an electronic copy and put it on line.

Free!

The book is called Taming the Tiger or Domar al Tigre if you prefer your tiger taming in spanish. You can get either or both here, free.

My friend’s name is William, Will, Liam, Lee or all of the above. He is an author.  I consider him an expert. I think if the rest of the world knew him, they would too.

Maybe they will.

Just this week Lee became an expert contributor to Dr. Oz’s new health Q&A website Sharecare.com. Check him out there. Of the answers I have seen there, in my expert opinion, his are the best. 

Free book and free expert advice. Lee, like all Super Heroes, only uses his powers for good and works cheap.

FTNW: FDA seeks more data from Dexcom

From the News Wire: Dexcom Share Down as FDA seeks Data:

http://www.reuters.com/article/idCNSGE6A409Z20101105?rpc=44

Nov 5 (Reuters) - Shares of DexCom Inc (DXCM.O) fell as much as 29 percent on Friday, a day after the company said the U.S. health regulator had asked for additional data related to four of its products awaiting approval.

"The regulatory delays will impact the timing of milestone payments from the company's strategic partners, which may result in DexCom needing to raise additional capital to fund the business," Wiliam Blair & Co analyst Ben Andrew said.

Be In Good Company, Join Us

 Be Part of the CURE.

We are on the 'E.' Lower Left side. Right next to our good friend Kerri!

Come to think of it, everyone on there is a good friend.

Thanks for being part of the CURE!

Join us. We're good company.