July 6, 2008

Ping or not to Ping that is the Question.

When our internet goes down, I ping a known address. When I get a reply back, I know everything is OK.

Hoping for a analogs response, I figured I would put out some queries for Ping the new Animas One Touch Pump (or is it a system?)


The Big Questions
(by big I mean without answers there is no point in even considering a 4 year commitment to Ping.)

  • When do you expect Dexcom integration?
  • Will Ping need an upgrade to talk with Dexcom, if an upgrade is required for a Dexcom why should I buy a Ping now?

It is public information that Dexcom integration is in the works. Asking for answers about how it will be handled is only a fair and proper action for an informed consumer.

Further it sadly appears that since the Johnson and Johnson acquisition of Animas the upgrade policy has changed to a practice of increasingly substantially fees. The more so the longer a user has been loyal to the Animas brand. It seems that the policy now is to create incremental product cycles to insure users pay out of pocket upgrade fees. Given that appearance, one can logically assume that Dexcom integration is at least as far down the road as to generate upgrade fees for Johnson and Johnson. Given this appearance of a J&J policy of maximizing out of pocket fees by users, why would anyone consider Ping without a commitment to know pricing for the Dexcom integration?

Here are some suggested fair and honestly acceptable answers.

At Animas we are working diligently to integrate the Dexcom CGM capability into our Ping product. We can not speculate on FDA actions and can not comment on time frames.
(That is a fair an honest answer and I would take it as such.)

Since we do not know what the FDA may require we can not commit to not needing and upgrade.
(again fair and honest answer.)

We at Animas / One Touch / Johnson and Johnson recognize that continuous glucose monitoring is of the highest importance to our pumping clients. We commit to every Ping client that if upgrades are needed to integrate CGM into the Ping system that we will make those upgrades free of charge during the normal warranty period. Users can take advantage of the wireless benefits of the Ping system now knowing they will be able to take advantage of the additional benefit of integrating the Dexcom CGM capability into the ping system with no out of pocket costs.
(That would be a fair and honest answer too.)

Now when they get those first question answered here are some more about the rest of the Ping product.

Wireless Hand Held BG meter questions:
Does hand held meter communicate BG to Dex for calibration as it communicates BG to the pump?

Can multi user households have more than one meter in house w/o confusing pumps.

How will Ping work with Dexcom?
Will Ping communicate directly with the Dexcom transmitter?
Or will users need to carry a Dexcom receiver around also?
Or will hand held meter be the intermediary or we need to carry all three?



About the Ping Pump
Can pump alarm setting be adjusted by time of day and set real loud at night?

Do menus allow for scrolling “around the horn” that is loop from top to bottom and visa versa?

Does Ping still allow for custom music on alarms so that multi pump households can tell which kid’s pump is alarming from the tone?

Has the food database interface been updated to allow for user customization or are Baby food & Beans still in the high priority spots?

Has the food database been given iPod like “Play List” user control?

Is food database customizable for user defined foods in categories?

Is food database exportable to smart phone?

How does Ping communicate to computer? – Still the IR dongle in the serial port?

How does Ping communicate with the remote meter - Infrared, rf, Bluetooth…

How will Ping communicate with Dexcom? - Infrared, rf, Bluetooth…

How Ping wireless communication effect battery life?

How much is a replacement hand held Meter?

How many events does the Ping system record?

Where are those events recorded? In the pump or in the hand held meter.

What events are recorded and is there a provision for recording memos on exercise activity.

Can the Ping talk to multiple wireless meters, for example a separate one at school?

What if you use another meter can Ping work with manual BG entry and does Ping remember the BG you enter into it for down loading?

Why is it bigger?

Does the meter come in colors so families with more than one T1 can tell whose meter is whose?

About Max
Is the ezManager Max software all new?

Is ezManager Max software stable?

Is ezManager Max built on Access?

Does ezManager Max follow win and Mac conventions?

Can users access their data and make custom reports?

Are the ezManager Max data files open source?

Do Ping / Johnson and Johnson support the idea of and commit to open source user diabetes data files?

Does Ping / ezManager Max allow users to plan changes to basal w/o connecting pump?

How does the ezManager Max software get information from the CGM?

Does ezManager Max download data from other meters and CGMs?

Does ezManager Max software anticipate families with multi pump users?

How does ezManager Max report basals rates?

Does ezManager Max have 24 hour basal, bolus, carb, insulin report? Does it correctly report basal rates in the times they were given or does it incorrectly report basals as ezManager does.

Does ezManager Max calculate and report on standard deviation.

Does ezManager Max have a multi day average basal BG report?

Does ezManager Max have a multi day graphical representation of BG like Cosmo’s.

Does ezManager Max have a report report of blood glucose vs. carbs and bolus for evaluation of meal spikes and insulin on board.

Is there a portable version of ezManager Max? Is it in the wireless meter? Can it be put in a smart phone?

July 4, 2008

An Independence Day Re-Run

Happy 4th!
(Jefferson is probably turning in his grave.)



With Diabetes, July 4, 2008
The unanimous Declaration
of the parents of someone who is no longer thirteen in the United
States of America

When in the Course of human events it becomes necessary for one people to dissolve the medical care bands which have connected them with their offspring and for those offspring to assume among the powers of the earth, the separate and equal station to which the Laws of Nature and of Nature's God entitle them, a decent respect to the opinions of mankind requires that they should declare the causes which impel them to the separation.

We hold these truths to be self-evident, that while all kids with type 1 are created equal, their diabetes may vary, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. — That to secure these rights, glucose management is instituted among them, deriving its just powers from the consent of the managed, — That whenever any Form of parental oversight becomes destructive of these ends, it is the Right of the People with Diabetes to alter and in time to abolish it, and to institute new glucose management, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness. Prudence, indeed, will dictate that glucose management long established should not be changed for light and transient causes; and accordingly all experience hath shewn that mankind are more disposed to suffer, while evils are sufferable than to right themselves by abolishing the forms to which they are accustomed. To avoid a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such glucose management, and to provide new Guards for their future security. — Such has been the patient sufferance of these kids; and such is now the necessity which constrains them to alter their former Systems of Glucose Management.

The alterations will be independence free of repeated injuries and usurpations, all having in direct object the preventing the establishment of an absolute Tyranny over those who's blood is being controled. To prove this, let Facts be submitted to a candid world.
  • Independence is for your parents to give Assent to Laws of BG control, the most wholesome and necessary for the public good.
  • Independence is you doing things in the ways that separate but equal.
  • Independence is the recognition that, in transition and after, Your Diabetes May Vary, that doesn't mean you did something wrong, in means you need to adapt and improvise.
  • Independence means it OK if you forget diabetes now and then, that is a Good Thing - it means your are in the pursuit of Life, Liberty and Happiness - fix the BG when you remember.
  • Independence means you manage the blood not us (we may check in from time to time), we still love you none the less.
This and other things which Independent Persons with Diabetes may of right do. — And for the support of this Declaration, with a firm reliance on the protection of Divine Providence, we mutually pledge to each other our Lives, our Fortunes, and our sacred Honor.

July 3, 2008

Not that Abbott

Now if you are new to diabetes or are new to online forums and blogs, my buddy Brensdad of Diabetes360 and I will try to explain all the different diabetes terms and web quirks. If you know us you know what to expect. If you don’t, think of us as the Diabetes Bloger's Abbott (Not that Abbott) and Costello.


BadShoe: Look Brensdad, if you're a regular here, you gotta know all the people posting on the blogs.

Brensdad: I certainly do.

BadShoe: Well you know I've never met the folks. So you'll have to tell me their names, and then I'll know who's on the web.

Brensdad: Oh, I'll tell you their names, but you know it seems to me web players now-a-days have very peculiar names.

BadShoe: You mean funny names?

Brensdad: Strange names, pet names...like Brensdad.

BadShoe: Your dad?

Brensdad: EmmasPapa...

BadShoe: And your French cousin?

Brensdad: French?

BadShoe: Goofè.

Brensdad: Goofè. Well, let's see, we have, Who's on NPH, What's on ‘log, I Don't Know is on lantus...

BadShoe: That's what I want to find out.

Brensdad: I say Who's on NPH, What's on ‘log, I Don't Know's on Lantus.

BadShoe: Are you on the forums?

Brensdad: Yes.

BadShoe: You gonna be a writer too?

Brensdad: Yes.

BadShoe: And you don't know the peoples’ names?

Brensdad: Well I should.

BadShoe: Well then who's on NPH?

Brensdad: Yes.

BadShoe: I mean the kid’s name.

Brensdad: Who.

BadShoe: The guy on NPH.

Brensdad: Who.

BadShoe: The NPH kid

Brensdad: Who.

BadShoe: The guy using...

Brensdad: Who is on NPH!

BadShoe: I'm asking YOU who's on NPH.

Brensdad: That's the kid’s name.

BadShoe: That's who's name?

Brensdad: Yes.

BadShoe: Well go ahead and tell me.

Brensdad: That's it.

BadShoe: That's who?

Brensdad: Yes.


BadShoe: Look, you gotta NPH user?

Brensdad: Certainly.

BadShoe: Who's using NPH?

Brensdad: That's right.

BadShoe: When insurance coverage pays off the NPH every month, who gets the money?

Brensdad: Every dollar of it.

BadShoe: All I'm trying to find out is the name of the kid on NPH.

Brensdad: Who.

BadShoe: The guy that gets...

Brensdad: That's it.

BadShoe: Who gets the money...

Brensdad: He does, every dollar. Sometimes his mom comes down and collects it.

BadShoe: Who’s mom?

Brensdad: Yes.


Brensdad: What's wrong with that?

BadShoe: Look, all I wanna know is when you sign on the NPH user, how does he log in his name?

Brensdad: Who.

BadShoe: The guy.

Brensdad: Who.

BadShoe: How does he sign...

Brensdad: That's how he signs it.

BadShoe: Who?

Brensdad: Yes.



BadShoe: All I'm trying to find out is what's the guy's name on NPH.

Brensdad: No. What is on ‘log.

BadShoe: I'm not asking you who's on ‘log.

Brensdad: Who's on NPH.

BadShoe: One insulin at a time!

Brensdad: Well, don't change the prescriptions around.

BadShoe: I'm not changing nobody!

Brensdad: Take it easy, buddy.

BadShoe: I'm only asking you, who's the guy on NPH?

Brensdad: That's right.

BadShoe: Ok.

Brensdad: All right.


BadShoe: What's the guy's name on NPH?

Brensdad: No. What is on ‘log.

BadShoe: I'm not asking you who's on ‘log.

Brensdad: Who's on NPH.

BadShoe: I don't know.

Brensdad: He's on Lantus, we're not talking about him.

BadShoe: Now how did I get on Lantus?

Brensdad: Why you mentioned his name.

BadShoe: If I mentioned the Lantus kid’s name, who did I say is using Lantus?

Brensdad: No. Who's using NPH.

BadShoe: What's on NPH?

Brensdad: What's on ‘log.

BadShoe: I don't know.

Brensdad: He's on Lantus.

BadShoe: There I go, back on Lantus again!


BadShoe: Would you just stay on Lantus and don't go off it.

Brensdad: All right, what do you want to know?

BadShoe: Now who's using Lantus ?

Brensdad: Why do you insist on putting Who on Lantus?

BadShoe: What am I putting on Lantus?

Brensdad: No. What is on ‘log.

BadShoe: You don't want who on ‘log?

Brensdad: Who is on NPH.

BadShoe: I don't know.

Brensdad: & BadShoe Together: Lantus!


BadShoe: Look, you gotta pumpers?

Brensdad: Sure.

BadShoe: The Animus pumper’s name?

Brensdad: Why.

BadShoe: I just thought I'd ask you.

Brensdad: Well, I just thought I'd tell ya.

BadShoe: Then tell me who's using Animas.

Brensdad: Who's using NPH.

BadShoe: I'm not... stay out of insulin cabinet! I want to know what's the guy's name using an Animas pump?

Brensdad: No, What is on ‘log.

BadShoe: I'm not asking you who's on ‘log.

Brensdad: Who's on NPH!

BadShoe: I don't know.

Brensdad: & BadShoe Together: Lantus!



BadShoe: The Animus pumper’s name?

Brensdad: Why.

BadShoe: Because!

Brensdad: Oh, he's using a Omni Pod.




BadShoe: Look, You gotta Cosmore user on this web site?

Brensdad: Sure.

BadShoe: The Cosmore user’s name?

Brensdad: Tomorrow.

BadShoe: You don't want to tell me today?

Brensdad: I'm telling you now.

BadShoe: Then go ahead.

Brensdad: Tomorrow!

BadShoe: What time?

Brensdad: What time what?

BadShoe: What time tomorrow are you gonna tell me who's using Cosmore?

Brensdad: Now listen. Who is not using Cosmore.

BadShoe: I'll break your arm, you say who's on NPH! I want to know what's the Cosmore user name?

Brensdad: What's on ‘log.

BadShoe: I don't know.

Brensdad: & BadShoe Together: Lantus!




BadShoe: Gotta a Mini Med user?

Brensdad: Certainly.

BadShoe: The Mini Med user name?

Brensdad: Today.

BadShoe: Today, and tomorrow's using Cosmore.

Brensdad: Now you've got it.

BadShoe: All we got is a couple of days on the team.




BadShoe: You know I'm a Mini Med user myself.

Brensdad: So they tell me.

BadShoe: I get on the forum to do some fancy posting, Tomorrow's starts a thread and a heavy writer gets up. Now the heavy writer starts a medium term insulin thread. When he starts that thread, I being a good Mini Med user, I'm the send guy over to the NPH. So I open up the thread and send a private message to respond to it to who?

Brensdad: Now that's the first thing you've said right.

BadShoe: I don't even know what I'm talking about!


Brensdad: That's all you have to do.

BadShoe: Is to PM the NPH user.

Brensdad: Yes!

BadShoe: Now who's got a Private Message?

Brensdad: Naturally.




BadShoe: Look, if I Private Message about the tread to the NPH user, somebody's gotta get it. Now who has it?

Brensdad: Naturally.

BadShoe: Who?

Brensdad: Naturally.

BadShoe: Naturally?

Brensdad: Naturally.

BadShoe: So I pick up on the tread and I PM Naturally.

Brensdad: No you don't, you PM the thread to Who.

BadShoe: Naturally.

Brensdad: That's different.

BadShoe: That's what I said.

Brensdad: You're not saying it...

BadShoe: I PM the tread to Naturally.

Brensdad: You PM to Who.

BadShoe: Naturally.

Brensdad: That's it.

BadShoe: That's what I said!

Brensdad: You ask me.

BadShoe: I PM the thread to who?

Brensdad: Naturally.

BadShoe: Now you ask me.

Brensdad: You PM the thread to Who?

BadShoe: Naturally.

Brensdad: That's it.

BadShoe: Same as you! Same as YOU! I PM the tread to who. Whoever it is drops the topic and the thread changes to ‘log. Who PMs topic to What. What throws it to I
Don't Know. I Don't Know throws it back to Tomorrow, Everyone posts. Another guy gets up and writes a thread to Because. Why? I don't know! He's on Lantus and I don't give a darn!

Brensdad: What?

BadShoe: I said I don't give a darn!

Brensdad: Oh, I don't give a dam - that's the Health Insurance Company.

From the News Wire: Boys with T1 have higher testosterone

Sex hormone-binding globulin and total testosterone were higher in individuals with childhood-onset diabetes compared with siblings without diabetes, according to results of a new study.

Researchers from the University of Chicago enrolled 48 participants diagnosed with diabetes before age 18 and 47 siblings without diabetes into the Chicago Childhood Diabetes Registry Family Study (age range, 10 to 32; 39% non-Hispanic white; 75% type 1 diabetes; 96% treated with insulin).



http://www.endocrinetoday.com/view.aspx?rid=29321

Maybe there is somthing to calling Dr Freud after all.

July 2, 2008

From The News Wire: MicroIslet Insulin Encapsulation Update

Company Invents New, Enhanced, Encapsulation Formulation

SAN DIEGO--(BUSINESS WIRE)--MicroIslet Inc. (OTCBB: MIIS, http://www.microislet.com), a biotechnology company engaged in the development and commercialization of cell therapies for diabetes, is pleased to report recent safety and efficacy data.

To date, MicroIslet has seen no adverse events attributable to MicroIslet-P™ in its animal models. The Company has tested hundreds of rodents and is currently completing a trial with nineteen non-human primates. Eighteen of the nineteen have been tested, and the last primate has received its final dose. Importantly, the primates have been subjected to one, two, or even three, separate transplant procedures, with no observed ill effects.

MicroIslet also has efficacy data demonstrating that MicroIslet-P™ can produce normoglycemia in both immune comprised and immune competent rodents. Additionally, all primates tested to date, post-implant, have demonstrated decreases in insulin requirements needed to maintain their blood glucose levels at a healthy concentration. Finally, post-implant, the primates have been primarily managed with long-acting insulin as opposed to acute insulin treatment, indicating improved glucose homeostasis (control).

MicroIslet is now in the process of patenting a new, enhanced, encapsulation formulation, which is being used in a current Good Laboratory Practices (GLP) rodent toxicity trial, and is the Company’s intended formulation for use in its planned human trial. The improved capsules appear to be not only more durable, but they also retain, and may increase, the positive functionality characteristics of previous formulations. Accordingly, MicroIslet believes that the new formulation will enable: (a) a greater decrease in insulin requirements, (b) better blood glucose control, and (c) increased capsule longevity.


http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20080702005426&newsLang=en

Flying Pigs II

I told Delaney about the new Animas Ping Pump. I expected here to ask if the Pink Pump was Pink.

She thought about the remote. It was cool she could hide the pump under a dress and use a remote but it was “something else to carry.”

That made me realize for the most part she doesn’t carry meters. We stage them in places for use, school, friend’s homes, different rooms of the house… more often than not she uses the meter that is near by.

Then she said, “You know what would be really cool?”

“No what?” I was expecting flying pigs.

“A cure.”

July 1, 2008

substantially equivalent

From the FDA site re: Animas ezManager Max

Device Description:
The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading and uploading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.

Indications for Use:
The Animas ezManager MAX Diabetes Management Software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

Predicate Device:
K063674 - Animas ezManager® Plus Diabetes Management Software (Animas Corporation)
Substantial Equivalence:
The Animas ezManager MAX is substantially equivalent to the legally marketed predicate, Animas ezManager Plus. Both devices have the same intended use and fundamental scientific technology.

http://www.fda.gov/cdrh/pdf8/K080587.pdf
http://www.fda.gov/cdrh/pdf6/K063674.pdf



I understand it is legal double speak to get an FDA blessing to market the product, but substantially equivalent isn't exactly what I want to hear. Substantially rewritten from the ground up and only similar only in name would be much better.

From The News Wire: Animas Announces "Ping"

http://www.animascorp.com/ViewAnnouncements.aspx?ID=85

Animas Corporation announced today the clearance of its OneTouch ® Ping TM Glucose Management System by the U.S. Food and Drug Administration (FDA). OneTouch Ping is the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote. Using the OneTouch Ping meter-remote, a person can calculate insulin doses and opt to wirelessly instruct the pump to deliver them without touching the pump at all, giving patients more freedom and flexibility in using their insulin pump.

“OneTouch Ping provides patients the advanced insulin pump technology from Animas plus the OneTouch blood glucose technology they trust, put together into a system that offers the discretion, convenience and option of remote insulin dosing," said Juan Frias, M.D., Chief Medical Officer and Vice President of Medical Affairs, Animas Corporation. “People using OneTouch Ping will no longer have to access their pump to deliver a bolus, ultimately making life with diabetes a little easier.”


Also and this I am sure is what they weren't talking about when I bent their ear about ezManager (anyone think they will send me a review copy? yeah me neither)

ezManager® MAX Diabetes Management Software The OneTouch Ping system will also work with the recently cleared ezManager® MAX Diabetes Management software designed to allow users to download important diabetes management data from the insulin pump and meter-remote. Integrated blood glucose data from the meter-remote and insulin dosing data may be downloaded for review, analysis and evaluation of insulin delivery and blood glucose history to better inform healthcare decision-making. The ezManager® MAX software is MAC and PC compatible.


I guess this explains the hits to YDMV I saw coming out of J&J on google searches for Animas and Ping recently.

Oh and anyone other than me a Monty Python fan? The Machine that goes "Ping!" LOL

It looks like Ping is a New Pump (see the picture on their web site) It doesn't look like a 2020.

Or look here -

From the News Wire: Medtronic Increases R&D for D Stuff.

Forbes is reporting Medtronic is investing in medical devices for diabetes.


Medtronic, the world's largest stand-alone medical device maker, is increasing its research and development spending on diabetes technology by 35 percent this year to speed development of next-generation diabetes devices that are simpler to use and more effective in managing the disease, said Chris O'Connell, president of Medtronic's diabetes division.

* New insulin pump in Europe this year would shut off insulin if low sugar detected
“an insulin pump that can automatically shut off insulin delivery if it detects blood sugar has fallen too low, a particular danger when a patient is sleeping.”

* Working on a pump in a patch. (Podlike)
"We're optimistic we'll have a patch pump on the market in fewer than two years"

* Sees continuous monitors outselling pumps one day. (Did anyone mention today is CGM Denial Day?)


I am a little shaky on how shutting of basals once you are already low isn’t locking the barn door after the cow got out. I guess it is a good idea and all but insulin is a lagging deal. If you are low now it is from insulin a few hours ago, you need glucose NOW, not just less insulin. I guess it is a step in the right way.

CGM Denied


By the power vested in blogging by Gina Capone of Diabetes Talkfest, today has been pronounce CGM denial day. We tried to get one for Delaney.


Guess What?


We got denied!


To be honest we expected it. In part we tried just so there would be one more family on the big insurance radar screen.


We would love to have one, maybe less for the ever popular hypo unawareness than for basal rate tuning. Yes Delaney at 10 is at times hypo unaware. She is particularly so in school after PE. CGM would be a great back up to trying to teach a child to manage their diabetes in school. What we really want is help with the basal tuning process of Lather Rinse Repeat.