Of Mice and Men: Pills & Genes

More mice news.

For people not familiar with the YMDV series "Of Mice and Men" the Mice bit it is a tool I use to say. "Hey if you hear about this or if a family member of friend hears about this and get all excited that there is a cure, keep in mind the mice get used in the early stages of investigation and there is a very long path from mice to men." It is good to know this stuff an important to keep it in a perspective that the mice stuff is far way from any actual treatment development and human trials. Oh and parents pediatric approval is even father down range.

That said let see what the mice are up to:

Science Daily as a bit on a possible pill for T1. Mice are involved.

The idea is that that a medication that was developed for other uses may help regulate the immune system.

http://www.sciencedaily.com/releases/2009/08/090810162013.htm

In other mice related news Science Daily also reports on studies that may identify identified a gene that may play a role in the development of type 1.

http://www.sciencedaily.com/releases/2009/08/090810122129.htm

It does say hope and might before although "a lot of ifs remain before we will know whether it could be taken to the clinic,"

What it all mean? Science is poking around type 1 and some mice may be seeing positive results. Mow many mice and how long the goodness last isn't clear.

Maybe possibly something comes of this. It good that a variety of work is getting done. People with diabetes can take comfort in the idea that there is a lot of science being done because it is going to take a lot of science to make even modest gain.

Mean while back at the ranch, it is important that we deal with type 1 now with the tools we have now and try to keep what little mental health we have left now.

Of Mice and Men: More Insulin-producing Cells, At The Flip Of A 'Switch'

Key word: Mice.

Science Daily as a story on turning on beta cells in mice and how it may lead to T1 treatments.

It didn’t say how many mice or how long the improved beta production lasted. How many and how long are always good places to go after the big it was in mice asterisk is applied.

It does say hope and might before although "a lot of ifs remain before we will know whether it could be taken to the clinic,"

That said, head on over and have a read if you are so inclined.

WaveSense iPhone App - First Impressions

My first impression was can I buy stock in this company - they get it.
Seriously.

I made a little flickr set of real bad pictures of the app. There are more picture there than here because I am not competent at uploading pictures to the blog.

This is a stand alone logbook application. As such it is just another app. Entering data sucks but this is clearly the first step. When they have Bluetooth working this is gonna be very cool and I will have to buy my kids iPod Touches. (I assume at that point the program no longer is standing alone and they have to go through the FDA. I am officially not holding my breath. Tough luck kids.)

When you open the App and accept the terms (the ones you didn't read) it starts on a little home page. Since you are new it points out two features to try right away - add information or get help. You can push the other buttons too but these two are good places to start, well who starts with help? This is America we don't do instructions. That leaves enter stuff.

You can ad a glucose reading, carbs or insulin. BG and carbs go in similar screens. Insulin has a whole different look and feel. I assume that is so you know you are entering insulin but it seems kinda like 'one of these things is not like the other.' I am sure they thought it through 'cause everything else seems like they thought it through. Go to flickr see more.

When you enter BG or carbs there is a nice big screen and a key pad. It assumes you are entering information for the current date and time but that can be changed with the typical iPod data wiz wheels. The sceen changes color if you are above or below target ranges.

They give you the option of entering a tag for the relationship to meals. Pre or Post Breakfast Lunch & Dinner. Night is also an option. WaveSense has the good sense to not assume it is pre or post meal by the time of day. It is like they get the idea you schedule may vary like your diabetes.

There is a crap load of options to enter a host of notes. There are 5 notes screens, Food, Exercise (including my most common one - Missed Exercise), Insulin, Meds and Notes. Notes includes my favorite "Dirty Finger." What a great and honest note for a test. You can ad you own notes to the predifined options - note the YDMV I added here. This is brilliant and the missing part of every log book I have seen. You want it as a note you can make it. Did I mention they get it and it as used here is a word that means YDMV.

After you cram in a bunch of data you can look at it; Log book style, charts or statistics. In the log and charts all you need to do is touch an entry and the details notes and all pop on to the screen. Hey why was that number out of range? Oh yeah the set failed, I was attacked by a key lime pie that made me miss my exercise and I under bolused but other than that I was good.

Go to flickr see more or maybe just go to the app store. It is free.

Oh and it doesn't look like a publicly traded firm so I don't have shares.


UPDATE: There's a quick video overview of this at theBetesNOW.com

From The News Wire: WaveSense App for iPhone

From the Press Release:

WaveSense Diabetes App for iPhone(TM) and iPod(R) Touch Now Available on iTunes(R)

SALEM, N.H., Aug. 4 /PRNewswire/ -- Diabetes? There's an app for that. AgaMatrix, Inc., the makers of the WaveSense(TM) line of blood glucose monitoring products, announced today the launch of their latest product, the WaveSense(TM) Diabetes Manager, an electronic diabetes logbook software application (an "app") that runs on the Apple(R) iPhone(TM) and iPod(R) Touch.

The WaveSense App is the first of its kind to be developed by a blood glucose meter manufacturer that is now available on the iTunes(R) App Store (www.itunes.com) by Apple, Inc. The app is available for download at no charge. The company says their app, in development and testing for over a year, lays the foundation for a series of products to come that will take advantage of the iPhone and other mobile technology platforms to assist people with diabetes in the management of their disease.

The WaveSense App combines the latest in user interface design, diabetes data management, and mobile technology to enable people with diabetes to better manage their disease. The app provides users with a number of cutting edge features including:

Easy-to-use data entry
Dynamic graphing of glucose data
Automatic mealtime tagging of results
Integrated food intake, activity, and medication data management
Insulin dosage management
Statistical analysis of glucose results
Integrated emailing of results
On-screen help menus
User-personalizable settings


More information on the WaveSense App is available here: www.wavesense.info/iphone

From The News Wire: OmniPod Earnigs Call

The Pod People had their earnigs call and the transcript is up at Seeking Alpha

There is a comment about CGM and here it is:

We continue to make progress with our next generation pod and with the version of our PDM which will provide integrated continuous glucose monitoring capabilities. We remain on track to be into the FDA by year end, with an integrated CGM solution.

And later in the call:

Ben Andrew – William Blair

Good. Last quick question, you mentioned you have a CGM going to the FDA by the end of the year, I assume that's with Abbott with DexCom.

Brian Roberts

Yes, one of those two.

Ben Andrew – William Blair

Are you not disclosing or…?

Brian Roberts

Yes, look at the end of the day, we have agreements in place with both and we are charging ahead with both of them.

Here is another interesting comment on Pod for non diabetes use:

We are also advancing our efforts to outside the diabetes. The request for CE Mark approval has been filed ahead of schedule for our first non-diabetes application and partnership with Ferring Pharmaceuticals. We expect to receive approval this quarter.

From The News Wire: Accu-Chek Continua Certified

MobiHealthNews.com reportes that Roche's Accu Chek Pix Device Reader earned Continua certification. Hopefully this is a step towards data standardization.

Diabetes management tools just got a step closer to medical device interoperability.

A few hours after news broke that A&D Medical’s Bluetooth-enabled blood pressure cuff and Bluetooth-enabled weight scale had received Continua Health Alliance’s stamp of interoperability, the organization announced that Roche Diagnostics’ Accu-Chek Smart Pix Device Reader, which currently interfaces with blood glucose meters and insulin pumps to transfer data from the devices to the user’s computer, gained Continua certification for USB connectivity.

The Smart Pix device connects to the computer with a USB cord but it interacts with the medical devices via infrared. Once the data transfers to the computer a report appears in the user’s default Internet browser to be saved later, printed out or simply viewed on screen. Roche says the system helps diabetics make timely and well-informed decisions about day-to-day self-care.

So what the heck is a Smart Pix? Roche's web store says:

With the ACCU-CHEK Smart Pix Device Reader, you can quickly collect data from your ACCU-CHEK blood glucose meter or insulin pump, create easy-to-understand charts to analyze your diabetes management program and act on self-care goals.
By making the most of the valuable data held within your blood glucose meter and insulin pump, you can make timely, well-informed decisions about your day-to-day self-care. These efforts can pay off today as you have more energy and feel your best, and down the road with a reduced risk of long-term diabetes complications. 1

Just set your meter or insulin pump near the reader, and the ACCU-CHEK Smart Pix system does the rest. It's truly plug and play for greater convenience and faster downloads—there's no software installation or special knowledge required. You can set personal targets, time ranges and preferred report styles, and print out reports and graphs to share with your healthcare team.

Download directly to your PC

The ACCU-CHEK Smart Pix Device Reader is compatible with:

ACCU-CHEK Compact Plus blood glucose meter
ACCU-CHEK Aviva blood glucose me
ACCU-CHEK Spirit insulin pump
ACCU-CHEK Advantage blood glucose meter
ACCU-CHEK Compact blood glucose meter
ACCU-CHEK Active blood glucose me
Disetronic D-TRONplus insulin pump
ACCU-CHEK 3600 data management system

I think that means it is a $125 dongle. What it does and what gets the "standardized data" treatment I don't know. Continua's big shot dude told me that there will not be continua standards for pumps until the Continua 2.0 release some time like next summer. So how does this costly IR to USB dongle deal with their pump and what data gets dealt with how?

I'll try to find out more.

Here is some initial things that make me go Hmmm.
- $125 for a an IR dongle. Ouch
- IR? Hello what is with the dongle in a Bluetooth world.
- PC what about MAC, hell what about iPhone.
- What are the reports coming out of a PC app a browser based app?
- What are the reports?
- - (UPDATE looks like sample reports here)

- How does the data standardization of Continua help us share data between our diabetes toys?

From The News Wire: Son of a Bong

Ok Ok that title was just fun to write.

For those more interested in toking than shooting your insulin: MannKind Corp's August 3 Earnings Call is up on Seeking Alpha. I freely admit I am not a close follower of the inhaled insulin industry.

Here is the bit that grabbed my eye:

Hakan Edstrom

Thank you, Matt, and good afternoon.

During the last quarter the most significant event was certainly the acceptance by the FDA of our NDA submission. The acceptance occurred on May 16th and we actually received our 74-day letter about 10 days early. Thus, our [inaudible] date is now January 16, 2010 and we are now at the stage of fielding questions from the agency. To date, the questions have been very straightforward and consistent with our expectations. We are encouraged by the interactions with the FDA.

We're also preparing to meet with the agency in order to discuss our development plans for the next generation device, which we recently disclosed on our website and in an interview with CNBC. We have already evaluated this next generation device known internally as Dreamboat, in two Phase I clinical studies. The first of these studies showed that the Dreamboat device is quite insensitive to inhalation technique and supported by a simple patient instruction program using a DVD. The studies have shown that inhalation of 20 insulin units with AFRESA administered with the Dreamboat device produced plasma insulin concentrations comparable to the administration of 30 units using the current Medtone device.

We plan to discuss with the FDA the definitive bioequivalent study design and to map out the approval pathway for the Dreamboat inhaler for use with AFRESA. We are very excited about this next generation device and would like to get it into the hands of patients as quickly as possible.

I did skip over to MannKind's web page and this thing looks a lot less like a bong than Exhubra did.

From The News Wire: DexCom and Animas

3-Aug-2009 - Entry into a Material Definitive Agreement, Results of Operations and Financial Condit

ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On July 30, 2009, DexCom, Inc. ("DexCom"), entered into (i) a Letter of Amendment, amending the Amended and Restated Joint Development Agreement dated January 12, 2009, and (ii) Amendment No. 1 to the Commercialization Agreements, amending the OUS Commercialization Agreement dated January 12, 2009 (collectively, the "Amendments"), each with Animas Corporation ("Animas"). Pursuant to the Amendments, DexCom will collaborate with Animas to develop a modified version of DexCom's transmitter to support a single, global CGM-enabled insulin pump launch by Animas. DexCom is entitled to receive a one-time $1 million milestone payment upon the achievement of performance qualification of a manufacturing line for the modified transmitter and is also entitled to receive an additional one-time $4 million payment upon the first regulatory body approval outside the United States for the new system. The Letter of Amendment modifies the original $5.0 million milestone payment that DexCom was entitled to receive upon receipt of a CE Mark for the first commercializable OUS product. Pursuant to Amendment No. 1 to the Commercialization Agreements the initial term of the OUS Commercialization Agreement is three years from the first commercial product launch, but no later than three years after December 31, 2010.

YDMV Full Disclosure: I own shares of Dexcom. I am also trying to get the things for my kids passed insurance approval.

Stupid Meter Tricks - The Series

Here are some games we have played with our T1 kids and their meters. I find making a game out of learning is a lot more fun and a more effective way of getting kids to learn than talking in one of their ears and seeing it fly out the other. I am of the school of thought that playing with the diabetes and diabetes stuff helps put diabetes in its place and that place is in line behind normal parent kids give and take.

The Meter Isn’t Important; The Child Is.
Show your kids that he meter is part of life and life is fun. Demystify the meter by playing with it.

Coding Games
Practice some Math to find out what coding or mis-coding your meter does to blood numbers.

Learning How You React to Stuff
Shhh don't tell'm you calculating ISF, tell'm just watching cartoons all morning.

Whack-a-Meter - Show it Who's Boss!
Hammer Time! One swing to better mental health.

D Summit - The Untrue Story Scene VI

Happy Cat Post

The face was a picture of knowing superiority, smug in is clam self confidence. The gray cat look regal too, eyes shut purring as it ears were gently scratched.

“Look at the fools, they think in a generation of Twittering Blackberries the only camera I have access to is the Hotel security?”

Tapping a few manicures fingers on the Blackberry get a quiet, “I see the prices on the NYMEX spot market are continuing to rise.” However these few key strokes meant a few less ear strokes and the cat is not happy. It slowly flicks it's tail in irritation at loosing the center of attention. “Yes, Yes, my Sausage. Don’t let cornering a commodities market interrupt your pressing schedule." Na as she reaches back to the cat she looks at her screen,"...but who is this Ms Siah?”



Somewhat shaken and stirred the Summiteers find themselves climbing into a black and silver shuttle bus. Chris is about to fire up the 455 when he notices M has slid into the driver seat.

“Oh no you don’t,” she says. “Do have any idea how high our insurance premiums have gone with you behind the wheel? Hell we are way passed the assigned risk pool.”

The van slowly moves through the mall parking lot and stops just on the other side of Nordstrom’s.

Chris thinks, ‘I would have been quicker to walk.’

They all roll out and into a fairly typical suburban mall free standing pad watering hole. The bloggers enter the grand hall and move to various gaming tables.

From Casino Royal (1954) to Quantum of Solace there have been 25 films in this series. We all know the canon.

So when the dude with the European accent says a few smooth words it is clear who is who. Chris reaches for the PPK. The assemble masses start collecting their pitchforks, torches and other angry mob supplies.

But there is a twist. Like a breath of new air in the room.

Who would think it? Bought off a by a free drink and some adequate if uninspiring catering the mob is swayed from the things they hold dear. With their Dexcom’s beeping warnings they abandon all they have ever know and felt about diabetes by a cute story about a 7th grade dance. Yeah I know I wouldn’t have believed it either but it says so on a bog on the internet so it must be true.

Dazed and confused they sheepishly file back out and into another bus for the long ride back across the parking lot. Chris, yet anothrer one of the Scott’s and BadShoe look up and see the businessman’s special hotel across the parking lot and decide to walk.

Chris seizes the opportunity to have a smoke. In earlier films this would happen in more significant scenes. These days he has a hard time feeding the habit that started as a device to make him look debonair in those earlier days. He has to walk in the rain with Stadler and Waldorf just to get his nicotine fix. As the Muppet curmudgeons argue about how to navigate 100 yards across the parking stalls, Chris notices his head clearing.

A gray commercial sausage purveyor’s delivery truck flies out of the loading dock of the restaurant. Thinking quickly Chris shove the two old farts one way and dives the other, narrowly saving all their lives. The back of the truck is open and Chris sees commercial compressed gas tanks.

“Odd sausages” 007 quips as he helps the feeble old men to their feet. Looking around he notices there is a compressed gas tank on the back of the van too. A sign proudly states the van is, “Going Green - A Natural Gas Vehicle!” Yet the line from the gray tank runs into the passenger compartment.

“What do you call that? They are trying to kill us!” says curmudgeon 1 shaking his frail old fist at the fleeing truck.

“An act of Mercy!” replies curmudgeon 2.

“N2O” say 007, “It’s a laugh.”