FDA Open for Comment on Wider Carb Labeling

The FDA is in the rule making process for nutrition information on Menus. If you like I feel that carbohydrate information is valuable consider submitting a comment here. Now is the time to speak up to be heard. Public comment is open to September 7.

Carb counting is a key part of living with type 1. Well of any insulin user's life Type 1 or type 2. Taking some of the guess work out of carb counts on menus is valuable information that make that balance easier.

You can read there Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010 by clicking this link.

Much of the document deals with calories but paragraph C sub section 7 does list total carbohydrate as other nutrition information.

Starting a Philly Burbs T1 Group

Connect with a new group joining together to share friendship and living with type 1 diabetes. It will be an opportunity for kids, teens and adult to, make friends and share our experiences and improve care.

Details Here:
http://thebetesnow.badshoe.com/?p=607

Smash-a-Meter

Feel like your meter needs a little lough love? theBetesNOW does.

BG and Steroids?

Hi there DOC. Anyone have experience with BG management and asthma steroids? One of the families that will be celebrating Infusion Set Awareness Week with tattoos asked me and as usual I am no help. Hopefully some of you can be.


Your comments are appreciated.

Also if you would be willing to be contacted directly by the family who needs a little help please email me at bennet(at)YDMV(dot)net and I will forward your email. Please don't post your email in a comment it may get picked by by a spam robot.

Infusion Site Temporary Tattoos

Our pals at Accu-Chek are promoting awareness of good pump site management. Infusion Sites even get their own awareness week. It is next week for those of you who haven't planned your festivities yet. I think it should be key-lime pie awesomeness week but I don't get to pick weeks. (I do have a daughter who makes KILLER key-lime pie and I am due. We shall not speak of its carb count.)

But I'm here to help with your Infusion Set Awareness Week family fun activities pie not withstanding. Families, a word that here means parents, need all the remotely positive/fun ways of promoting good type 1 care habits they can get. One habit that can stand a little positive reinforcement is set management. I will concede that this is about as exciting as tire rotation and is the same basic principal.

Accu-Chek sent me their Infusion Set Awareness Week kit! WoHoo.  I am happy to spread the wealth around, in the form of temporary tattoos. Yes nothing says Infusion Set Awareness Week like temporary tattoos. The idea is kids can mark set sites and see where they have harpooned themselves.

So readers is this sounds like a fun way to celebrate Infusion Set Awareness Week (actually there are 24 in a set so anyway you cut it that's well more than a weeks worth) in your household drop an email with your snail mail (please don't put you address in a comment - internet trolls etc....) to bennet(AT)YDMV(dot)net.

Supplies are limited. First come first serve. When they are gone they are gone. Your child may look like an over decorated pin cushion.  Your Diabetes May Vary.

theBetesNOW is at the Movies

Too Sweet Boutique

One of the glorious thing about the online community are the friends you have never met. Two of mine are folks I have the pleasure of knowing through CWD's forums. In fact I am always somewhat stunned and (I know this is difficult to believe) at a loss for words when I meet someone in real life. (Like Penny at camp.)

I has been a while but Nick but I used to try to make each other laugh over there. That is my way of saying I would stalk his posts and give him a hard time before he could do the same to me.

So I was delighted to get an email from him complaining that he couldn't figure out how to post wise-aleck comments here at YDMV. Apparently the redesign has had unintended benefits.

Anyway as much fun as it was to catch up it was more awesome to see his wife expanding her online creativity and to catch a picture of a very cute young lady modeling some cool custom pump gear. So with that as a very meandering introduction please go have a look at TooSweetBoutique.net 

FTNW: JDRF Faster Insulin

JDRF has a press release out on their support studies on faster insulin and insulin delivery methods that make for faster insulin response. It is subtitled: Key step on road to an artificial pancreas.

That may stir up the whole JDRF and Artificial Precancerous conversation. Part of JDRF mission is better ways to live with type 1 while working for cures. I feel that faster insulin is a good thing in and of itself.

Like many I think there maybe avenues to a cure but they are not going to happen soon and probably like everything else associated with T1 individual's responce to the treatments may vary.

JDRF launches research program to accelerate delivery of faster acting insulin

...

JDRF is funding investigators at leading academic institutions to test novel insulin formulations and delivery systems that may speed insulin action – making it work faster than the insulin currently used by people with diabetes around the world today. The objective is to use faster-acting insulin in an artificial pancreas system to more closely mimic a human pancreas in sensing blood sugar and secreting insulin in response.

One means to improve the speed of insulin action is to reformulate the molecule. JDRF will fund Dr. Bruce Buckingham of Stanford University to test such an insulin, Viaject, which is currently in development at Connecticut-based Biodel Inc. JDRF will also fund Dr. W. Kenneth Ward of Oregon Health Sciences University to perform artificial pancreas experiments with Viaject Insulin.

In addition to modifying the insulin molecule, another way to speed insulin action may be to improve the route of delivery. Currently, insulin is delivered subcutaneously (under the surface of the skin); this contributes to the slow action compared to insulin made in the pancreas. JDRF will provide grant funding to Dr. Howard Zisser at the Sansum Diabetes Research Institute to conduct studies there with AFREZZA®, a rapid-acting insulin being developed by California's MannKind Corporation; inhaled at mealtime, AFREZZA achieves peak insulin levels quickly.

JDRF recently announced a collaboration with BD (Becton, Dickinson and Company) to develop a microneedle-based delivery system. In addition, JDRF will provide funding to test two new devices also aimed at providing mechanical means to achieve faster insulin action. The first will support Dr. Howard Zisser at the University of California, Santa Barbara's Sansum Diabetes Research Institute testing Roche Diabetes Care's Accu-Chek® DiaPort system. The Accu-Chek DiaPort is a percutaneous port system, connected with an external pump, that delivers insulin directly to the liver, the primary site of insulin action. The second JDRF grant will support Dr. William Tamborlane of Yale University to test a unique warming device, InsuPatch, made by InsuLine Medical Ltd. Preliminary data suggests that this device, adaptable to most infusion pumps, considerably accelerates the action of insulin.

FTNW: Dexcom Earnings Call Aug '10

Dexcom's Q2 2010 Earnings Call Transcript is up on Seeking Alpha. Feel free to surf over and read the whole thing or not. My quick read was looking for information about pump integration and there was confirmation the the OmniPod/Dexcom product was into the FDA for review and that the Animas supplemental FDA filing was expected by year end.

Shifting to our insulin pump partnerships, as we mentioned on our last earning call, we have filed a PMA supplement with the Food & Drug Administration for our first generation integrated system with Insulet Corporation and we are currently awaiting feedback from the agency. Additionally, we have completed development and are in final testing with respect to a modified transmitter for use in our integrated system with Animas and we remain committed to filing a PMA supplement for the combined DexCom Animas system before the end of the year.

They also shared the information the next generation (Gen 4) was into the FDA and some of the possible features of Gen 4 that are of interest patients. May being  the operative word, these are forward looking statements:

I'm pleased to report that we have filed a PMA supplement Gen4 with the Food and Drug Administration.

... our goal with Gen4 is to bring to market a next generation sensor which will offer an unmatched level of performance and ease of use for our patients. Our Gen4 Sensor is more accurate than any of our previous sensor systems particularly in the hypoglycemia range. Gen4 will also have a one hour warm up time... We believe that performance of Gen4 may in the future allow us to submit through the FDA for an expansion of our labeled indications for use.

For example, the Gen4 sensor may permit a reduction in required calibrations points during a sensor session it may also enable us to obtain an indicated sensor light of longer than seven days. We expect to explore the requirements for obtaining these expanded indications with FDA and conduct clinical trial work later this year. Additionally, we are in the final stages of development of a new receiver form factor and a new transmitter, and we expect to file with the FDA later this year to incorporate those components into the Gen4 system.

Blessings

Thanks to all the people who bring blessings into my life. That is how blessings come. Folks bring theirs and share them.

The Diabetes Community is just bursting at the seams with blessing.  Active caring people who share their lives and experiences. Not from a sense of superiority but from humility. Not as perfect diabetics or parents but as folks who share lessons learned in the process of trying to be better themselves by reaching a hand out to others.

While the diabetes community seems to be all about, well, diabetes it is really about life. I think for the most part we all get that. Our connection is through a chronic condition and through that connection we share the lives, values and loves that are what really define each of us.

We don’t talk much about religion, I think it is avoided to be politically correct. In a lot of ways that is silly. At its core religion is about life and the life of religion is to do good. Sharing lessons learned is a good thing and we are drawn into communities by doing it.

If there is a God, and I think there is, then God is infinite. Infinite wisdom, infinite love. God shares some small parts of that wisdom and love with each of us. I think ‘a part of infinite’ is actually a very difficult thing for our minds to process. The ratio of anything to infinity is zero but life isn’t about us verses the infinite it about us learning from the infinite.  I believe wisdom is the ability to learn what is true and apply it to life.

I do think we can count our blessings. I think on the eve of its start now is a good time to reflect on the many gifts that have been brought to my life by people who open their lives to blessing from God through Ramadan.

Thanks for sharing the blessing of friendship. May you be more deeply blessed each day.