Your Diabetes May Vary

#TwoBits - Scare Tactics, Altered Images and Diabetes Ads

2012-01-27T10:42:00.001-05:00

Riva Greenburg has a wonderful piece (first of two pieces) up on the Huffington Post about Agriculture and Health. I found fascinating the idea of linking farm policy and health. I thought the idea that incentives for health based agricultural goal vs demonizing was a fascinating way of approaching the issues. It’s kinda like the idea of positive emotional behavior as motivation vs scare tactics and shame to get individuals to deal with the diet health and relationship in their individual lives.

Speaking of scare tactics, there is an ad running by NYC that shown an amputee than links diabetes, soda and amputations. In an interesting twist to the scary ad in question - it is photoshopped. Boston.com reports that photo is digitally altered and not of an amputee or even diabetic. The poll in the Boston.com piece is running in favor of the altered ad. Apparently photoshopping images to make models skinny on magazine covers is bad but faking amputations is OK.

What is your view of digital manipulation to make a point? How about scare tactics - think they work?

Sysy has a piece up on The Girls’d Guid to Diabetes about scare tactics and this ad. Riva also has some great words about the campaign in her back issues.

The Brits Crack Me Up.

2012-01-16T12:15:00.000-05:00

The diabetes/time continuum

http://www.shootuporputup.co.uk/2012/01/the-diabetestime-contiuum/

#TwoBits A Great #DSMA Live Replay and #TuDiabetes Live

2012-01-16T11:32:00.000-05:00

Here’s a quick #TwoBits* around the DOC this week.

Replay the DSMA Live show from week guest Lane Desborough. Lane shares his career, passion & glimpse inside of his life as a Parent of a child w/ diabetes. In addition to being a T1D Dad Lane is a key part of the Medtronic brain trust helping shape T1D care. I have met the guy and listening to him is a great investment of time. http://dsmalive.com/2012/01/13/after-thoughts-lane-desborough/

Friday January 20, Join the TuDiabetes for a live video chat with C.C. King, Ph.D., Associate Research Scientist at the UC, San Diego Pediatric Diabetes Research Center. Dr. King will begin by presenting a brief overview of his research into stem cell therapy for type 1 diabetes, followed by a live Question & Answer session with the TuDiabetes community!

Time:
* 1/20/12 1 pm Pacific Standard Time (GMT -8)
* 1/20/12 4 pm Eastern Standard Time (GMT -5)

http://www.tudiabetes.org/events/video-chat-stem-cell-therapy-for-type-1-diabetes-the-work-of-dr-c

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

Stem Cell Reports and Asking questions.

2012-01-14T11:45:00.000-05:00

There are a number of headlines about stem cells as a cure for type 1 that have been written in the past few days. They are based on a study out of China the reports to have reeducated lymphocytes aka T cells. I read this article and am left with far more questions than I am comfortable with. Josh Levy has a sound write up, I recommend his write up.

In part here why I have questions. In other news this week identified CD8 T cells as the source of the autoimmune response that causes type 1.1 There is a quote from ViaCyte on Diabetes Mine that spoke to the difficulty of getting stem cells to differentiate into beta cells.2 For that I presume that getting a stem cell to differentiate into any specific cell is an involved proposition.

The lymphocytes reportedly reprogramed in the China study are already differentiated cells. If the autoimmune process is stopped it is due to a modification or reeducation of these CD8 T cells. There are a myriad of CD8 cells and they are created in the lymph nodes to recognize specific antigens on the cells the are programmed to kill.

Differentiated means a stem cell became a specific cell in the body. That is they started off as a stem cell and became a specific type of t cell. Very loosely hematopoietic stem cel in bone marrow become a common lymphoid projenitor that becomes a T cell.

This study suggests that exposure to stem cells changes the existing antigen receptors. If that is true then why don’t the stem cell that become to the lymphocytes in our bone marrow have the same effect? I also fail to see a mechanism to explain how this erase the memory of the adaptive immune system. Why is it the type 1 autoimmune T cells that are reeducated and not say the one that provide immunity to chickenpox.

All that said I would love to see a cure. I get excited by headlines just like everyone else. I hope this is repeatable. I have come to be suspicious of reports of apparatus that seem to good to be true.

I would hope that the news agencies that report this kind of study know enough to ask some basic questions. Among them should be how does it work, is it peer reviewed and has the study been repeated?

1 La Jolla Institute researchers identify pivotal immune cell in Type 1 diabetes in humans, http://www.eurekalert.org/pub_releases/2012-01/ljif-lji011112.php

2 http://www.diabetesmine.com/2012/01/whats-up-with-diabetes-stem-cell-research-firm-viacyte.html

#TwoBits on Cure Research. One Guy: Joshua Levy

2012-01-13T09:00:00.002-05:00

Here’s a quick #TwoBits* from around the DOC.

We of us living with T1D want a cure. A lot of us also want an easy way to keep track of progress towards cure. My Go To Guy is Joshua Levy. In late December he wrote two essays well worth reading for those looking for cures.

http://cureresearch4type1diabetes.blogspot.com/2011/12/two-essays-on-progress.html

Of Mice and Men: Joshua also started a new blog. One dedicated to all the NOD Mice that get cured. The freaking mice get cured all the time and each time starts a cycle of a cure is coming headlines. It is nice then to have a resource that knows the difference between curing mice and people while still keeping an informed eye on what is going one with the rodents.

http://t1dcuredinmice.blogspot.com

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

#TwoBits Diabetes Sisters & Stem Cells at the Mine.

2012-01-12T12:35:00.000-05:00

Here’s a quick #TwoBits* from around the DOC.

1: Registration for Diabetes Sisters annual conference open January 1^st. I hear they are already about half way booked. For more information see: http://www.diabetessisters.org/events/nationalconference

2: Diabetes Mine has an interesting piece on encapsulated stem cells research. An outstanding read. http://www.diabetesmine.com/2012/01/whats-up-with-diabetes-stem-cell-research-firm-viacyte.html

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

Of Fantasy Diabetes Devices, Sheldon & Dewy

2012-01-11T12:38:00.000-05:00

Victoria’s Secrets holiday runway special has past, football is winding down so maybe we need some new fantasy league to talk about. How about insulin pumps?

I had a fascinating conversation with Greg from Medtronic at CWD’s Friends For Life last summer on the topic of what would be my fantasy pump. A plausible device, that is one based on current technology, insulins etc.. I would say that a full artificial pancreas is beyond that scope but only a little.

Yes it takes a particular lack of a real life to have fascinating conversations about fantasy pumps. You can call me Sheldon if you must. It turns out for me the fantasy isn’t a pump, and so the talk expanded out to a fantasy diabetes management system. Greg asked if I thought FDA would approve my fantasy devices. I allowed as how they probably wouldn’t but industry would probably wouldn't make it either.

Meet DEWY, he's a winner.

I think the tools to available to manage diabetes are fairly good. I think there is a significant opportunity for better diabetes care through breaking down the technological towers of Babble that separate devices from each other and our lives. My fantasy device would be a common collection point for diabetes information in a way that would facilitate managing lives with diabetes not just adjusting parts of those lives.

Our meters, pumps, CGMs need to talk together and work through a common Diabetes User Interface. A D.U.I.

WAIT! We can’t call it D.U.I.! That’s been used.

How about DEWY for ah.. um.. er.. Diabetes Equipment Works for You.

Dewy’s job is to listen for information from devices and lives. Then to integrate that into a possible responses. Dewy should work for us, patients, in our lives. Dewy should try to accommodate our individual life styles not define them.

Dewy should help out with the basics. If we are low or high Dewy needs the wizard logic already in pumps to help calculate corrections or carbs based on our particular insulin and carb sensitivity. Dewy should have access to food databases with the ability to create a meal list in a way that approaches the ease of use of making play lists in iTunes. Drop and drag foods into a meal, easily adjust quantities of food in a meal, calculate carbs and even make note of fat, fiber and protein. Parents will want to be able to store these 'cause kids eat the same meal over and over again, by choice. Dewy should be able to help adjust boluses based on all of that but like any good friend of a diabetic not be too pushy about it.

Dewy could even help out tracking trends. He could gently mention times of the day that he sees spikes. He could pay attention to our post workout BGs and see if there are trends worthy of note. Along the same lines Dewy could even try to pay attention to two hour post meal BGs and make suggestions about I:C rates. He could look for between bolus times when basals are responsible for what happening with BG and point out trends.

Dewy would scream bloody murder if he ever sees serious overnight lows. He would turn off basals and wake up everyone and anyone we say with phone calls and text messages and keep at it until we tell him it is OK. That is just the kinda guy Dewy is.

Some folks like patch pumps, some traditional pumps and some folks like shots. To accommodate those life styles choices Dewy should be independent of device manufacturers. That is Dewy should be able to accommodate what ever meter, pump or cgm an individual chooses. Dewy should be smart and tag along with us patients wher we do our living so he will need to reside on the smart phone of our choice.

Dewy isn’t an artificial pancreas, not that he wouldn't be willing to work with one. An AP tries to be a pancreas. AP wouldn't care what you ate or if you worked out. Dewy being a really good diabetes assistant would, if we wanted him to, track what we eat or how our workouts impact our lives.

Dewy would talk wirelessly to devices; pumps, meters, CGMs. He would do this securely and let us know if he is in touch or lost connection to devices. He would be the universal remote to the show that is our diabetes lives. When we change to a device that woks better in our life, Dewy could cope. He would have simple friendly ways to enter shots, exercise, and daily, weekly and monthly cycles. He would let us invent variables of our own because, well, our diabetes many vary.

Until there are artificial pancreases, smart insulins, encapsulated implantable functioning beta cells and the cure that reverses the autoimmune glitch that causes type 1 diabetes families will need to manage diabetes. Managing diabetes will requires multiple devices to measure and adjust blood glucose but wouldn’t be cool if they all played nice?

Well that’s my crazed fantasy pump. This got me wondering what others would see as a fantasy diabetes device? What is yours?

Accu-Chek Nano FDA Approved.

2012-01-11T12:36:00.001-05:00

Roche announced that they have FDA approval for the NANO in the US.

Innovative, small, no code device will be available to people with diabetes in the U.S. in first half of 2012
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Accu-Chek® Nano SmartView blood glucose monitoring system. The new Accu-Chek Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, pre- and postmeal markers and average glucose calculation. The Accu-Chek Nano meter uses Accu-Chek® SmartView test strips and will be available to customers in the first half of 2012.

Our pals across the pond did a review of the Nano a while back: http://www.shootuporputup.co.uk/2009/06/review-roche-accu-chek-aviva-nano/

Required Reading - JDRF on GRI in Countdown

2012-01-10T11:30:00.000-05:00

Back in September JDRF Launched a prize to encourage people outside of diabetes research to join the hunt for a Glucose Responsive Insulin (GRI.) I wrote briefly about it in the post Know a Smart Chemist? JDRF's current edition of Countdown, their online magazine has a great story with more information about GRI and the JDRF initiative.

This is a fascinating approach to living with type 1. It is not a cure in the pure sense but if they can find ways to make Glucose Responsive Insulin work it is a Game Changer. In fact The Game Changer is the title of the piece and because of that potential, years down the way, the articles gets my vote for this weeks reading assignment.

The Game Changer: Treating type 1 diabetes with glucose-responsive insulins.
http://countdown.jdrf.org/Features.aspx?id=8589934727

JDRF IDDP with KalVista Pharmaceuticals

2012-01-09T11:09:00.002-05:00

From the News Wire:

KalVista Pharmaceuticals and JDRF form research partnership focused on novel approach for treating diabetic eye disease

Southampton, UK and New York, USA 09 January 2012 - KalVista Pharmaceuticals ("KalVista") and JDRF have formed a research partnership focused on a novel approach being developed by KalVista to preserve vision and slow the progression of diabetic eye disease. Diabetic eye disease is one of the most common and most serious complications in people with type 1 diabetes (T1D). JDRF will provide up to $2.2 million in milestone-based financial support and research expertise to KalVista. The goal of this partnership is to advance KalVista's lead pre-clinical candidate, a plasma kallikrein inhibitor, into human proof-of-concept clinical trials and to generate clinical data that would highlight its potential as an entirely new approach to treat diabetic macular edema (DME). DME is a leading cause of visual loss for people with T1D that involves swelling of the retina, which can lead to blurred vision and blindness. More: http://www.jdrf.org/index.cfm?page_id=116775

#DSMA Makeover & an Easy Resloution #TwoBits

2012-01-09T10:12:00.003-05:00

Here is a quick #TwoBits* from around the DOC.

#DSMA’s New Years New Look: The web site has been overhauled and sports a more user friendly interface. Included in the more friendly part is a menu link to the weekly Wednesday night party that is #dsma chat. More on how to join that party can be found in this post.

Carey Potash my favorite blogger at dLife writes about the Medtronic mySentry, its costs and dreaming of a lost poodle. If Carey isn’t in your RSS feed adding him is a great New Years resolution. You will thank me I’m sure.

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

#dsma Makeover & an Easy resloution #TwoBits

2012-01-09T10:05:00.000-05:00

Here is a quick #TwoBits* from around the DOC.

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

Happy New Lancet and Butterfly Pod People #TwoBits

2012-01-07T12:25:00.000-05:00

Here is a quick #TwoBits* from around the DOC.

First Happy New Lancet form our pals across the pond at Shoot Up or Put Up who say;

"Happy New Lancet to all our readers, Please join us in cracking open a brand new shiny lancet in celebration of the new year."

Leighann has a post reporting that Butterfly strips are now approved for the OmniPod so Happy New Strips to the Pod People.

*If you see an interesting pair of posts around the Diabetes Online Community (DOC) how about sharing them with the rest of us with the hash tag #TwoBits in case others missed them?

Of Diabetes, The Lion King and Paying It Forward

2012-01-04T14:38:00.001-05:00

At our most recent Children's Hospital of Philadelphia (CHOP) Parent Network meeting there was a newly diagnosed mom having a tough time. Diabetes is hard. Having a child diagnosed is devastating. Truth be told at every meeting, everywhere, there is almost always a family in the emotional deluge of a recent diagnosis.

Why us, why now, we don’t know what to do.

Our family has been there. Twice. The second diagnosiwas no easier even with the skills to manage it. Maybe because we had the skills and experience and knew more clearly what a diagnosis meant.

That’s the deal with a diagnosis like diabetes. As I become closer to people living with other chronic conditions I learn that the flood of emotions associated with diabetes isn’t unique. A lot of my e-patient friends with other conditions to manage share similar stories. Many also share the value they have found in patent communities. There is a common theme of receiving much needed support from communities and ultimately providing.

So climb up on Pride Rock and queue the music, that is part of the circle of support. Sometimes I wonder who is doing more for who in that process. Sure the newbie needs a shoulder to cry on. Still I think there are those with experience also have a deep need to offer that shoulder. The truly gifted turn the circle a little farther. The make their chronic condition valuable and see it as an ability.

I read this on the Facebook page of Glu*, It was written by Jen Block, “I consider diabetes to be an asset. Its presence in my life has brought many challenges, but with each challenge I face, I emerge a little stronger.” She is a 15 year veteran so she isn’t all pollyanna and goes on to add, “Don’t get me wrong this is a challenging disease and I have no idea of the challenges you face in managing diabetes; but I do know you are all incredible people.”

In there is a rock solid answer to, why us, why now, we don’t know what to do. Because you can be better for all the challenges you will face. You can be a little stronger and that is incredible.

*Glu (myglu.org) is a T1D community launching this spring. I have been having fun with the beta.

Medtronic Remote CGM Monitor Approved

2012-01-04T09:48:00.003-05:00

Medtronic announced that the FDA has approved the mySentry(TM) remote CGM monitor. It is a second screen that allows a parent to remotely see CGM data. Here's a picture from the Medtronic Blog where you can also find more information about the thing. The full press release is here.

Version of something like this have been seen and talked about for years. It is great to see that Medtronic and the FDA managed to find a way to make patient information more available. For parents this has significant value. Particularly over night. Imagine checking BG without getting out of bed.

Here's a Youtube bit by Medtronic about it:

Happy New Year.

#TwoBits - A List and Lyrical Word @Ninjabetic @DMomBlog

2012-01-02T11:39:00.000-05:00

Leighann over at D-Mom has a list of words for 2012. While I am a fan of the last item on her list as the word for diabetes in 2012. I think the one I’ll vote for in the DOC caucus this January is one not in the list but in her introduction, Second. It also is part of teh title of her upcoming book Kids First, Diabetes Second.

Meanwhile George is Looking Somewhere and offers up a lyrical reelection on 2011 and anticipation of 2012. The Ninja is should be the DOC's poet laureate.

Nothing is Easy

2011-12-30T14:29:00.002-05:00

Some of my T1D friends in the DOC (Diabetes Online Community) have said that they think it is more difficult to be the parent of a T1D child than to be diabetic. Maybe. I doubt it but I do think being a parent bring with it a different set of stresses.

As a parent our kid's lives are more dear to us than our own. I have yet to meet a parent who wouldn’t trade places and take the diabetes to free their kid of it if they could. That just the way parenting works. No news there.

I think one of the bigger stresses that parents face is in due course letting the diabetes be their kid’s. That in part means separating our worry about diabetes from our love of our kids and letting them get on with figuring out how to manage it, in their lives, as their diabetes.

A big part of this is trying, and we all will fail at this trying, to appreciate that nobody is a perfect diabetic and so when our kids diabetes varies our job is to not freak out or worse project judgment.

That ain’t as easy to do as it is to write. Here is one way to help, find other parents and commiserate. Vent your diabetes frustration with them not at your kids and when you do that venting no blaming the kids just vent your emotions.

Nothing about diabetes is easy. Not having it. Not being a parent. The truth is the medical professionals who teach diabetes care, teach us management techniques and processes. Few teach the emotional side of living with diabetes, that is tough on everyone. So find an outlet.

This is part of what what the Diabetes Online Community community is here for. It is part of why CDW or TuDiabetes are great online destinations. I hope it is part of why you read YDMV.

Consider Jonah’s comment on this post.

If you're going to ask about blood sugar readings and the kid's a teenager, be really careful about how you ask. From my parents, I'd probably hear that as a judgment part of the time, especially if it's a high or low that they ask about, and especially because they don't do my diabetes care.

Nothing is Easy.

#TwoBits - Sorry @CharlieKimball, Thanks @MrMikeLawson

2011-12-26T12:10:00.002-05:00

Here's two quick bits. I spoke at a parents support group last week. There were two boys playing quietly in the back. I gave them each a Charlie Kimball car and showed them this:

http://thebetesnow.com/?p=110

Needless to say they enthusiastically reenacted the event. The moms and dads were concerned about the noise. I couldn't have been happier. Sorry Charlie, your die cast effigies got trashed in the service of making small boys happy.

How to eat dinner with a diabetic:

http://youtu.be/fYQcBgYm9V4

Good stuff. My advice; Play with your toys and eat with enthusiasm.

Prom King!

2011-12-15T15:47:00.002-05:00

So I'm sitting here heavily marinated in caffein studying for a bio exam in my masters program. I am particularly focused improving my knowledge of the endocrine system of all things. You would think that a guy involved with the diabetes online community would do at least OK in the endo section.

You would be wrong. It seems my interest in the field and what is on the test diverge. Significantly.

So, I'm sitting here sucking back coffee trying to memorize what gland, makes what hormone, to do what, to some fictitious patent named Sam, when I get a Facebook notification: I was appointed Prom King by one of my classmates. Here is the proof:

I found it hysterical. You may ask how is that possible? Simple. Bribery. I make printable documents of our online lectures to study and I share them with who ever may want a copy. Now if I can only bribe my way into King of DProm....

... and remember all this non D endo. stuff for tomorrows exam.

Schooling to Think Like a Pancreas - Free

2011-12-15T13:11:00.000-05:00

Gary Scheiner, CDE, author of Think Like a Pancreas and all around good guy is offering his Type 1 University online classes FREE in January. I think this is a GREAT deal for anyone who is looking to kick their diabetes management up a notch, particularly if doing so is part of resolution making for the New Year.

Classes on the schedule for January are:
- Mastering Pump Therapy
- Blood Glucose Control During Sports & Exercise
- Advanced Carb Counting
- Getting the Most from Your Continuous Glucose Monitor
- Weight Loss for Insulin Users
- Hypoglycemia Prevention & Management
- Strike the Spike: After-Meal Glucose Control
- Managing Pregnancy with Type-1 Diabetes
Practical Pramlintide – Making Effective Use of Symlin

Curious but not ready to commit to a full one hour class?

Think Pizza.

Gary has a short class on pizza with type 1. It runs about 10 minutes. Maybe start there and if that seems effective take another class or two in January for free.

Here is a little promo for the Pizza class:

For more visit http://type1university.com.

Full disclosure: I shot and edited these, and another, short ads for Gary. There were no fees involved but Gary did buy lunch.

@JDRF New Research #TwoBits

2011-12-13T12:18:00.002-05:00

JDRF announced two research initiatives today. The first is a study of seeking to Reduce Cardiovascular Risk in Adults with Type 1 Diabetes. From the release:

New York, NY, December 13, 2011-JDRF-funded researchers have begun enrolling adult patients with type 1 diabetes (T1D) in the REMOVAL study, to test whether metformin-a drug commonly used to treat type 2 diabetes-could help prevent or reduce the risk of cardiovascular complications in people with T1D.

The REMOVAL study (Reducing with MetfOrmin Vascular Adverse Lesions in T1D) is a multi-center, international trial that will study 500 patients with T1D aged 40 or older, a patient group known to be at higher risk for cardiovascular disease, one of the leading causes of death associated with diabetes. A study from the United Kingdom has shown that people with T1D aged over 40 are at much higher risk for cardiovascular disease, including heart attack and stroke.

The second is in conjunction with the firm ViaCyte and looks at Encapsulated Beta Cell Replacement Therapy for Diabetes. (This look like an IDDP but my reading of the release is not clear. I will see if I can get confirmation.) Yes it is in fact an IDDP* From the Release:

Existing cell therapies such as islet and pancreas transplantation have the potential to cure T1D by restoring normal islet function and normalizing blood glucose levels in people with T1D. Because the number of cadaveric human donors for pancreatic islets is limited, ViaCyte’s program will provide a replenishable supply of functional insulin-producing cells. Furthermore, packaging the cells in a device (“encapsulation”) creates a physical barrier around the cells and has the potential to protect the transplanted cells from immune rejection, and may eliminate the need for chronic immunosuppressive drugs. The ultimate goal of this partnership is to help patients with T1D restore their ability to regulate blood glucose, thereby reducing or eliminating the need for constant self-management and administration of insulin.
The three-year series of preclinical studies being co-funded by JDRF will help ViaCyte prepare the information necessary to apply for regulatory approvals to study the system for safety and efficacy in people with T1D.

For more see JDRF's New Room online.

Why these matter:

Most folks living with type 1 are adults. Our first goal as parents of T1D kids is to have the grow to be T1D adults pursuing their lives interest. I have heard the figure tossed around that 85% of T1Ds are adults, seems about right. So it only makes sense to study how to keep T1D adults health.

Cure can mean a lot of different things to different people. To me, in the broadest sense it is to return the biological production of insulin. That may or may not include turing off the autoimmune response that killed off the beta cells in the first place and from the little (very little) I know of how immunity works that is no small think. Encapsulation get around that problem with magic star tech like shields that protect the Starship Insulin-producing-cell from attack by evil T cells. ... or something like that. Getting beta cells is no easy matter either. This project addresses both the shield and production of beta cells form stem cells. May the Force be with you, wait wrong sci-fi flick but you get the point and the point is Live Long and Prosper.

*For some background on IDDP you can see earlier post in YDMV.
http://www.ydmv.net/2007/07/over-last-few-months-i-have-seen-number.html
http://www.ydmv.net/2007/10/apparently-somebody-does-know-how-this.html
http://www.ydmv.net/2007/10/5-easy-pieces.html

iBGStar Blood Glucose Meter for iPhone Now Approved in U.S.

2011-12-13T09:26:00.003-05:00

From the News Wire:

iBGStar blood glucometer attachment for the iPhone, developed by AgaMatrix and commercialized by Sanofi, has received FDA approval. The iBGStar uses the iPhone as a beautiful visualization tool to keep track of glucose readings, food and insulin intake, and exercise.http://medgadget.com/2011/12/ibgstar-blood-glucose-meter-for-iphone-now-approved-in-u-s.html

Sanofi Press Release

Prior YDMV posts on iBGStar:
http://www.ydmv.net/search?q=ibgstar

YDMV Nominated at WEGO

2011-12-12T13:45:00.000-05:00

Award: Advocate for Another (http://info.wegohealth.com/advocate-2011)

Link: http://www.ydmv.net/

Reason: Bennet is a father of two type 1 diabetics and has been an exceptionally active member of the DOC since he started blogging back in 2007. He's got advocacy credentials - fundraising for the ADA and JDRF, attending social media summits for Roche and Medtronic, meeting with politicians on a state and federal level - but more than that he offers the perspective of a dad trying to help his kids become well rounded people for whom diabetes is only a small part of their lives. Despite all his work, he consistently flies under the radar - which I'm sure is by design. He never conflates his experience as a caregiver with that of his Type 1 children. His humor, passion and intelligence as - for both his family and the DOC at large - part of the invisible support structure that provides individuals with a safe space to learn and grow.

Congrats! We hope you’ll join in the excitement and take a moment to nominate your own favorite Health Activists for any of the 10 Awards and share the program with your online community.

Learn more:

Check out all the awards (and nominate others!): http://info.wegohealth.com/awards-2011/

Download our quick sharing templates: http://info.wegohealth.com/awards-sharing/

Want to help pick the winners? Apply to be part of our Judging Panel:http://info.wegohealth.com/awards-jury/

Merry Christmas and Happy Campers in the New Year

2011-12-09T08:48:00.003-05:00

Delaney loves Setebaid. Setebaid, diabetes spelled backwards, is her diabetes camp. There is no longer Abby Normal. She is loud, crazy, loud happy, loud, one of the crowd, loud, normal.

Held in the farm country of central Pennsylvania it is about a two hour drive from home. On the way out she is excited and has been know to make “are we there yet?” comments. On the trip home the first thirty minutes is crazy excited and happily recounts camp adventures, typically involving much riotous and loud carrying ons. She then falls asleep, exhausted from the week of being a normal kid with other normal kids, all of whom just happen to also be type 1.

Part of camp stays with her year around. More than just texting other campers, it pop up in conversations as a touch stone. "At camp my friends and I ...." Some of those conversations now are about wanting to be a counselor in the not too distant future when she is old enough to be one. Because their influence lasts, diabetes camps matters.

Camp has been a Christmas present from the grandparents some years. If you know a grandparent of type 1 who is looking for an outside the box holiday gift maybe a week at camp fits the bill. If not and money is tight many camps also have financial assistance.

Camps fill up. Now is the time to think about next summer.

If diabetes camp isn’t right for the type 1 child in your life, maybe Children With Diabetes Friends for Life convention is. Either way, or both, finding a place to be the normal one is a wonderful experiance for a kid with diabetes.

I would love to hear about your diabetes camp and why it matters. Post a comment here, link your camp blog post or share the URL of your camp. Diabetes camps are wonderful. Now as the air gets cold, it is a great time start thinking about camp next summer and to share their glory.

Need some help finding a camp near you? Here’s a few links. I welcome more such links as comments.

The Diabetes Education and Camping Association

http://www.diabetescamps.org/

Or on Facebook at

http://www.facebook.com/diabetescamps

Children With Diabetes Camp Page

http://www.childrenwithdiabetes.com/camps/

ADA Find a Camp
http://www.diabetesarchive.net/diabetes-camp/find-a-camp.jsp

Camps mentioned in comments below:
http://www.campnejeda.org, Northern NJ
http://www.campsweetlife.org, "Near" Mankato, MN
Camp Needle Point, Hudson, WI

.

Love Ya / Mean It Robin

2011-12-06T11:56:00.001-05:00

Joy is a wonderful thing. Mostly it is a choice. First to choose to be joyful and second then, maybe, to choose to share it.

It may even be more than choosing, perhaps joy is something one creates. I love joyful creative people. Nobody embodies that more than the woman who coined a phrase I have joyfully cribbed - Love Ya / Mean It.

We are not talking blind love here, Love Ya / Mean It means something far more significant. LY/MI is loving past foibles and idiosyncrasies. Loving not in spite of them. It is more that the things that our loved ones do to make us crazy are the very things that make them the unique individuals we love.

It is a spectacular thing to simply love people for who they are. I try to open my heart that way. For me it is a process that requires a conscious effort. For years I would watch Robin and marvel that she was able to do it with an inborn grace.

I got to know Robin through Disney fan sites on the internet. She wrote loving, hysterical stories of trips to Disney, warts and all. I love those stories and I love Robin.

I made some pins once with LY/MI on them. The plan was to sell them and raise a few bucks to help her have another Disney vacation, so she would write stories and we could all share in the joy laugh. At the time Robin was delivering Pizzas in frozen Maine to make ends meet and maybe save a little for a trip. When I told her the plan she simply said that she wanted them money to go to diabetes care. Delaney had just been diagnosed and she felt that was more important. So Robin.

Robin left this world yesterday. I am confident that she left it a better place for her care, her humor, and her ability to find and share joy. I pray for comfort to all the hearts she touched that will be broken by her passing, her magically blended family, her friends, maybe even the odd grasshopper that terrified her. We are all better for how Robin touched our lives.

If you would like a look into the joy Robin found and shared and maybe get a real feel for LY/MI some of her stories are on BadShoe. (Some of the links out and photos no longer work but Robin's Magic is still just as strong as ever.) In the beginning of one of her 2004 collection of stories she wrote, “Because that is all life really is, a series of great adventures.”

Thanks again for sharing your adventures Robin,

Wonka with Type 1

2011-12-04T16:59:00.000-05:00

Connor played Willy Wonka this weekend in the school fall play. We are still trying to figure out how many carbs are in a chocolate river. One of the first consumes where I didn't see the pump cording. What really matters is that he is focused on what he loves, performing.

Of the ER, the Web and Perfection

2011-12-04T12:05:00.001-05:00

A very dear friend is embroiled is some online nastiness over her blog, diabetes and a trip to the ER. It illustrates one of the sad things about reaching out and sharing as an e-patient, some folks thrive on being superior, and thrive on negativity.

I don’t know what it is that motivates them. I don’t much care. I do know that there is a difference between pettiness and being constructive. I know that an am fiercely loyal to my friends and I make no claim of being un-biased in my regard for them.

I have twice been to the ER with a child experiencing serious abdominal pain. The kid in question being type 1. As a result of that insulin production inability, there was extensive conversation between the physician and us about diabetes care. This included, at the doctor’s request, detailed information about A1C. I don’t know how it was relevant but apparently it was. I therefor presume that if I had not had those number handy they would have drawn blood to calculate them since they ran a bunch of other far more costly, timely and intrusive test.

One of the very many mind tricks diabetes does is inventing new variations on the game of This is Your Fault. Diabetes is diabolically adept at this. I haven’t met a person or parent living with type 1 who hasn’t been sucked into the vortex of this game.

When you are in the ER and someone in scrubs asks about control, diabetes takes the game to a whole other level. It makes a great NFL two minute drill look lethargic. Diabetes covers the whole field in two second.

So when the Doc asked about A1C, and even though I knew the numbers were good, had been good for a long time and I know diabetes rat bastard mind games, I went straight to the guilt over not being a better parent, as measured by A1C. I felt my shortcomings with diabetes, particularly my willingness to the let the teen self manage put him in the ER.

In those seconds, diabetes covered all 100 yards, scored a touch down, two point conversion, took a penalty for excessive celebration and even while winning big, kicked onside, recovered for another TD before the clock ran out. It brought game and crushed. The game was simple, it was my failure to be a perfect diabetes parent that put my kid in the ER in excruciating pain.

On the second trip, when they did take out his appendix, we refused to let the hospital manage his diabetes. Specifically: no change in insulin, no change in delivery method, no steroids, no kidding. The folks in the pressed lab coats with embroidered names were not happy and I had to sign a bunch of papers as a result of their displeasure.

I am leaving out details but feel free to post comments and criticize based on your assumptions and partial knowledge of the situation. I will read them and may respond just don’t expect me to care too much about your presumptions.

The point here is diabetes plays the Perfect Number Drill as part of the This is Your Fault game. It defines perfect quantifiably and is often supported by a medical industrial process that behaves as if it believes in a numeric definition of perfection is actually and perfunctorily obtainable.

It isn’t and it isn’t what the goal is anyway.

The goal of being diabetic is to do what one can, to be someone who finds and shares motivation to keep doing what they can. They know that perfect numbers are not possible even while they get sucked into the Two Second Drill. Sure diabetics may get sucked into diabetes mind games. Hopefully they know how to come out of it with only a few dozen points run up in the process. The are human, they feel the emotions but they bounce back and in part they do that by sharing. They know that others are there for them and that in turn they will be there for others.

The perfect diabetic would be one who shares imperfections as the reality of diabetes while being focused on the joy of life outside the diabetes game. Perfect doesn’t exist but there are some who play the game very admirably.

Then there are arm chair quarterbacks. They have no skin in the game but they think they have something to say, that's fine, but why the {obscenities deleted} listen to them?

PS: to the DOC and Kerri in particular. Love Ya / Mean It

FDA Guidelines on AP

2011-12-01T13:42:00.001-05:00

Thanks Scott Strumello for the email tip that the FDA has issued Guideline for Artificial Pancreas. I will be giving them a good reading and if you are so inclined here are some links:

Reuters: FDA: Diabetes device plan may help patients faster

FDA: Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems

FDA: Press Release

Three great Guys in #Two Bits

2011-12-01T11:31:00.001-05:00

Time for two bits I liked from around the DOC. Both are about great guys and one is written by a great guy making three great guys in two bits.

First up Scott Johnson tells the story of Medtronic's Lane Desborough. Like Scott I met Lane at the Medtronic Diabetes Advocates Forum and like Scott I was very impressed. Scott does a spectacular job of explaining why.

http://scottsdiabetes.com/2011/12/lane-desborough-chemical-engineering-diabetes

Today's second bit is me being a few days late: Novo Nordisk has extended sponsorship of Charlie Kimball's ride in Indy Car No.83. I am looking forward to seeing Charlie in the New 2012 Indy Car. Hopefully he will share a little about as he get some time in it.

http://www.indycar.com/news/show/55-izod-indycar-series/50981-novo-nordisk-extends-kimball-team-deal/

Here is to Lane, Scott & Charlie.

Medtronic iPro®2 CGM Approved by FDA

2011-11-23T09:48:00.001-05:00

From the News Wire:

MINNEAPOLIS – November 22, 2011 – Medtronic, Inc. (NYSE:MDT) today announced the Food and Drug Administration (FDA) approval of iPro®2, a next generation Professional continuous glucose monitoring (CGM) system and the latest in a series of recent diabetes technology approvals and innovations from the company. iPro2 simplifies Professional CGM and enables healthcare providers to obtain a more complete picture of glucose control for the patients they treat. Professional CGM is used by healthcare providers to reveal low (hypoglycemia) and high (hyperglycemia) glucose excursions that can lead to the dangerous health complications of diabetes. These excursions often go unnoticed with traditional A1C tests and standard glucose meter measurements.

Glooko, the Grail and Audrey Hepburn

2011-11-22T11:29:00.000-05:00

Glooko was kind enough to give me a cable to review, no string attached as it were. I’lI get to that review in the upcoming weeks because this is more an editorial Grail Quest than review.

I have been been on this search for the diabetes management version of the Holy Grail for a while. Back in 2007 I wrote “my quests is for a diabetes management software application that is worth using. I would like the cure and the Holy Grail while I am at it too - they seem just about as likely.”

The thing about Grails is that your definition of it tends to grow while you are looking for it. Data standards became part of my Grail Quest because I want all the data, that comes from different machines, to play nice together in the diabetes sandbox. I wrote about this back a then too but what I have forgotten in my quest is that a UN translator is almost as good as data standards. If you don’t think a UN translator can be sexy, go watch Audrey Hepburn in Charade. (I am sure it will be more interesting than the rest of this post.)

Glooko may be such a UN translator, if not as classically lovely as Ms. Hepbrun. It looks like a step in the direction from a different nations of the diabetes globe talking together perspective

It is also a shift in the center of the diabetes data management universe. Glooko is a cable that connects a meter to an iPhone. I think data in your smart phone instead of your computer is a move closer to where folks with diabetes live their lives.

You maybe thinking, where have I seen this before? Probably the presentation of introducing the iPhone 3 back in 2009. Apple had J&J dummy up an cable and and app for the big unveiling. It never saw the light of day - well maybe until now.

Glooko is a cable that can connect meters, from a variety of manufacturers, to an iPhone, iPod, or iPad. The application does the translation of the data from Bayer, Abbott or OneTouch’s data format and fill in the log book. That mix of brands is part of the path to the grail. To me it is significant that Glooko plays the roll of Audrey Hepburn and translates data from different meters into one log. You can email that log right out of the device.

That is not the only step towards the chalice. I see shifting from computer based applications to a mobile device as moving data collection, and hopefully use, closer to people with diabetes' lives. A more mobile logbook and translations of data are steps towards the grail even if they are not the goblet itself.

Back in my UN inspired post I suggested that the makers of meters would come out ahead if they joined in a common app and data development effort. I wrote, some what flippantly, “Just think, all the manufacturers could all reduce the cost of R&D spent on the machine that listens to the Machine that goes PING if they didn’t each have to invent a new language in the process. Hey guys in expensive suits! Lower expenses means more profits and bigger bonuses for the guys in expensive suits or they could then invest that saved R&D money into better design, clearer user interfaces and compete on usability! Yeah I think it would go to bonuses too.”

The logbook is Glooko first step. They say they want to make better tools for diabetes management. Time will tell what that means. More meters and more mobile devices showing up at the UN, probably. More functionality than a basic log book, maybe - but that is an FDA regulation issue and why we all should care about mobile apps. I would love to see devices other than meters talk to the app, not that I am directly lobbying Glooko or anything. OK maybe I am.

I still define the grail like I did back in 2007 as software that would help families adapt to varying diabetes by:

Tracking for reporting all the data users create in their daily diabetes care without creating a lot more sets of family tasks. We have diabetes – that has enough tasks as it is.

All the BG data, including CGM info. All the basal data. All the carbs entered into the pump to calculate all the bolus data. Any user defined flags on those carbs like pizza. User defined variables that could be things like heavy exercise, set pulled off, ketones, freaky weather, stress, menstrual cycle, weekday, weekend and what ever else people dream up. The key here is being user definable.

Then we need reporting ability and the ability to include or exclude data based on those use defined fields. Build reports that average the midnight to 6 am BD data from meters or CGM for nights following a day with hard exercise. There you have info for tailoring basals for a post activity dip in BG.

How about sorting the data for a school girl’s weekdays, excluding days with PE class to build a normal school day profile and one only for PE days?

To that I would add that grail should ultimately connect to devices wirelessly and store information in a cloud accessible with any modern browser. Which is fairly sophisticated and outside the mindset of the FDA. - All of which is what makes it a Grail.

Tandem t:slim™ FDA Approval

2011-11-17T10:02:00.000-05:00

From the News Wire:

Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System
Smallest Insulin Pump System and First-Ever with a Touch ScreenSummary: Tandem Diabetes Care, Inc. today announced that the U.S. Food and Drug Administration has granted the Company clearance to market the t:slim™ Insulin Delivery System.

SAN DIEGO, November 16, 2011—TandemDiabetes Care, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.
“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.” More

Of Stem Cell and Cures:

2011-11-16T12:47:00.001-05:00

Diabetes and the stem cell promise

The search for a cure, or even a less-complicated treatment, is still on a long road to its goal.

By Eryn Brown, Los Angeles Times
November 7, 2011

Ever since scientists started talking about the medical potential of embryonic stem cells, curing Type 1 diabetes has been one of the dearest dreams.
When researchers announced in 1998 that they had derived stem cells from human embryos, their landmark report flagged juvenile-onset diabetes as a disease that might be treated by stem cell transplants.

In the run-up to the 2004 vote on California's Proposition 71, diabetes was repeatedly mentioned as a target by scientists campaigning to form a state-backed stem cell agency.

Years later, the promise remains. But success has been elusive. MORE

Spoiler alert: The last line of this article is the the most telling and why better treatments matter as well as cure research: "Next century, when you look back at it, two decades won't seem like much. But for those affected right now, every month is too long."

http://www.latimes.com/health/la-he-diabetes-stem-cells-20111107,0,5759144.story

Legislators push for faster FDA device review

2011-11-10T11:54:00.000-05:00

MASSDEVICE ON CALL — Minnesota legislators penned a letter to FDA head Margaret Hamburg pushing for a faster and simpler review process for medical devices.Sens. Amy Klobuchar (D) and Al Franken (D) were joined by Reps. Erik Paulsen (R), Betty McCollumn (D), John Kline (R) and Michelle Bachman (R) in raising concerns over "increased review times, inconsistent expectations, and poor communication from the FDA."

http://www.massdevice.com/news/minnesota-pushes-faster-device-review-massdevicecom-call

CGM Sensor Trials

2011-11-09T12:32:00.000-05:00

Most folks in the diabetes online community recognize a need for better CGM sensors. Part of getting them to market is testing them in clinical trials. Medtronic has news today about a CGM trial:

MINNEAPOLIS – Nov. 9, 2011 – Medtronic, Inc. (NYSE: MDT) today announced a new United States investigational device exemption study to evaluate the accuracy of six-day use in adults with diabetes of its Enlite™ Sensor, the company’s latest innovation in continuous glucose monitoring (CGM) technology for people with diabetes. The study will evaluate Enlite, a glucose sensor for CGM designed to offer improved hypoglycemic detection and comfort compared to current CGM sensors. CGM provides a more complete picture of glucose control because it can reveal high and low glucose levels that periodic fingerstick testing might miss.

The first two patients in the study were enrolled at Rainier Clinical Research Center in Seattle, Wash., and at AMCR Institute in San Diego, Calif., by the sites’ principal investigators (PI), Ronald Brazg, M.D., and Timothy Bailey, M.D., respectively.

Full press release info here

Trials may or may not be your thing. Full consideration is needed for joining any study, but if you are interested in participating see: http://clinicaltrials.gov/ct2/show/NCT01464346

This is not the only CGM trial of interest. For more on other CGM studies is also available at clinicaltrials.gov: http://clinicaltrials.gov/ct2/results?term=CGM

One in Twenty / Twenty to One

2011-11-07T08:25:00.004-05:00

Another diabetes dad sent an email asking about the JDRF New York Times Ad. Specifically if anyone knew the source of the 1:20 number it cites. I replied that I had traded emails with Aaron Kowalski and Jeffery Brewer at JDRF about the ad.

Of the people I know in the diabetes community, and I know a lot of y'all there is nobody among us who is more passionate about with people with T1D living long, happy, well managed lives than Aaron and Jeffery, certainly including my craziness.

Hypoglycemia can kill. Should we be less motivated to address hypos if the life time mortality risk is 1:40, 1:60 1:100? Shouldn't be just be motivated to make less of a risk, until it is not a factor at all?

The data for the ad is the based on various articles by Philip E. Cryer, MD. Significant in that is a piece in the American Journal of Medicine, Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. http://www.amjmed.com/article/S0002-9343(11)00687-5/fulltext

That article in turn references:

The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Long-term effect of diabetes and its treatment on cognitive function. N Engl J Med. 2007;356:1842–1852
http://www.nejm.org/doi/full/10.1056/NEJMoa066397

Feltbower RG, Bodansky HJ, Patterson CC, et al. Acute complications and drug misuse are important causes of death for children and young adults with type 1 diabetes. Diabetes Care. 2008;31:922–926 - http://care.diabetesjournals.org/content/31/5/922

Skrivarhaug T, Bangstad H-J, Stene LC, Sandvik L, Hanssen KF, Joner G. Long-term mortality in a nationwide cohort of childhood-onset type 1 diabetic patients in Norway. Diabetologia. 2006;49:298–305 -
http://www.springerlink.com/content/f932481234766352/

All of which I have printed and am in the process of re-re-reading and formulating thoughts on. Here is a readers digest of where I am so far.

The ad is not for the diabetes community. Period.

In the diabetes community we know that insulin has risk and that those risk involve the possibility of death from excessive insulin. I often hear those who live with diabetes and "Get It" wish that the general population understood type 1 better. The non-diabetes world doesn't have a frame of reference for diabetes management risks and this ad puts that into stark terms.

Mark Twain has a famous comments on numbers, "Figures often beguile me," he wrote, "particularly when I have the arranging of them myself; in which case the remark attributed to Disraeli would often apply with justice and force: 'There are three kinds of lies: lies, damned lies, and statistics.'" There is little reason to think Disraeli actually said that, but there is history, humor and Mark Twain. Think: The Daily Show.

The effect of the ad statistic on some people with, and more significantly maybe some parents of T1D kids, is an increase in fear. I am not sure that is productive. (Please see ad is not for the diabetes community above.) I know a young woman who was so scared by dead in bed she disconnected her pump every night. Her parents were at a total loss as to why her night time BGs were so bad. It may not be a surprise folks who "Get It" that her A1C were through the roof. This was before blue candles and 1:20 ads in the paper. Fear is real.

Hunter S Thompson wites of "The Fear" in Fear and Loathing in Las Vegas. "The Fear" in my mind is a character in the book. A book I found hysterical. I don't find diabetes fear so amusing. It can lead to actions, as was the case with the young woman who was disconnecting, that are dangerous.

Many in the Diabetes On-line Community write about the phycological aspects of diabetes care. Many say the mind game is as difficult as physiological management effort. In that context feeding the fear is a bad thing. Also turning those people (PWDs) to thinking about the statistics and motivating them into discussions about the numbers instead of discussions about doing stuff to move the ball forward on solutions is contrary to the goal of better living with T1D.

All that said I have issues with simplifying the underlying papers to 1 in 20. Dr. Cryer writes about T2D as much or more than about T1D in Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. He cites ACCORD, ADVANCE and VADT studies all of which appear to be T2D studies. In T2D there may be means of managing health other than insulin. In ACCORD the goal was A1C under 6% and the trial was stopped due to harm to T2D patients of that aggressive goal.

It also appears that the good Dr. Cryer's article was a response to another in the same journal issue that seemed to say that hypoglycemia was a comorbidity of other causes of death, seemingly downplaying hypos. So maybe he was saying, Hey you idiots hypos are dangerous in and of themselves... well he probably wouldn't say idiots, in fact I don't see that word used anyplace in his article. Maybe Mark Twain or Disraeli who used the "I" word.

Cryer writes "Older estimates were that 2%-4% of patients with type 1 diabetes die from hypoglycemia. [16], [17] and [18] More recent estimates are that 6%,[19] 7%,[20] or 10%[21] of those with type 1 diabetes die from hypoglycemia."

Notes 19, 20 and 21 are the ones I shared above. 20 and 21 are studies form the UK and Norway, started in 1978 and 1973 respectively. Both are T1D studies. I have concerns that studies starting then will have significant data from pre DCCT, pre Lantus and pre Pump care regimes. Who is on NPH?

One can argue that pre DCCT was typically less aggressive care and that means less hypos so these may understate the risk. - Or - One can argue that the lack of stable basal insulin, pumps modern meters ect. made hypos more frequent due more peaky nature of the tools available. I don't know. I suggest there is grounds to wonder if the fruits of the studies is all apples. Maybe there are some oranges involved.

We hold these truths to be self evident: the risk of fatal hypos is a lot higher if one takes insulin than if one does not. Even so that is not the only source of stress in a T1D household.

1:20 is not an annual rate but a life time projection. Looking at the reciprocal, when they die, 19 of 20 people with T1D will not die of hypos related issues. That is a lot better than the 100% that died of DKA in pre insulin days.

Diabetes care is about balance.

That and I hope that in my kids lives they each have 20 non-diabeteic people people in their 'get' fottaly tine.

To me that 20 to 1 is more important than 1 in 20.

I maybe wrong, I often am.

.

A Request from Spain

2011-11-07T07:59:00.000-05:00

My friend Mike from DiabetesInSpain.com sent this request and I am happy join in and to pass it on.

I appreciate their are many things taking place regards to Diabetes this month, but I hope that this project will capture your imagination.

On November 11th (11.11.11), across the planet, documentary filmmakers, students, and other inspired citizens will record the human experience over a 24-hour period and contribute their voice to the second annual global day of media creation called One Day on Earth. Together, we will create a shared archive and a film.

Imagine being able to capture the world on the same day, each giving their unique perspective on Diabetes around the globe! Anything goes! It just has to have something related to Diabetes. Please share and pass on to friends, family and anyone else you may know.

I would like to invite everyone from the DOC both online and offline to take part if possible by taking a Diabetes related image on 11.11.11 and submit them either via a Flickr group, via twitter with the #diabetes111111 hashtag or directly on my website site.

1. Grab your camera – take your Photo/Video – 11.11.11
2. Submit Photo via Flickr, Twitter or this website.
3. Enjoy the photos as they appear on this site, twitter and flickr from Friday the 11th November.

Please join me and share! - http://diabetes111111.com

Links:
http://www.flickr.com/groups/diabetes111111/
http://twitter.com/#!/search/realtime/%23diabetes111111
http://diabetes111111.com/upload/

Saludos

Mike

Mice Again

2011-11-03T21:40:00.000-04:00

Molecule That Prevents Type 1 Diabetes in Mice Discovered; Has Similar Effect On Human Cells
ScienceDaily (Nov. 1, 2011) — Researchers at the University of Colorado School of Medicine have found a specific molecule that can prevent the development of type 1 diabetes in mice and has a similar effect on human cells from diabetic patients.

More

JDRF & Helmsley Trust Collaboration

2011-11-02T14:34:00.002-04:00

From the News Wire:

JDRF and the Helmsley Charitable Trust Form a Collaboration to Accelerate Innovative Type 1 Diabetes Research and Development:
NEW YORK, Nov. 2, 2011 /PRNewswire-USNewswire/ -- JDRF and The Leona M. and Harry B. Helmsley Charitable Trust, two of the largest non-government funders of type 1 diabetes (T1D) programs, announced today that they have formalized a collaboration that will foster a new level of cooperation between the organizations. The goal of the collaboration is to accelerate the pace of research and development to deliver better treatments, devices, and diagnostics for improving the lives of people with T1D. The first two co-funded grants as part of the collaboration were also announced today. More

This is good news. I know some great dads of kids with diabetes at both places. They share the passion for better lives for all kids living with diabetes that maybe unique to parents. Both organizations are substantial investors in researches to create better lives. By comparing notes and goals is more than great way to avoid re-inventing the wheel, it is a powerful way align interests.

Thanks to all the dads, moms, people with diabetes, their friends and families that are doing what they can to help innovate type 1 diabetes (T1D) care.

Diaversary and our #T1Din3- "Bolus for Candy"

2011-11-01T10:07:00.000-04:00

Halloween is our (first of two) diaversary. Spell check is having a hard time with the combination of diabetes and anniversary. That is OK spell check I know how you feel.

We have felt strange about it too, every year. I have found writing about it helps.

We haven'e always the same way about diagnosis anniversaries. It is like our diabetes has varied. At first we were still a little raw and then shortly after that first diaversary we got a second diagnosis and it was as raw as the first. By now we are so far into the "new normal" that it is fairly close to simply normal.

Still Halloween is our day and Halloween brings out different responses in type 1 families. Some don't trick or treat, some fret about it, some buy back candy and then there is us. We eat the stuff. On nurses orders.

JDRF has a hash tag fest going on on Twitter, #T1Din 3. The idea is to share a T1 thought in three words. There is even a "Flat Stanley" thing to give diabetes the finger. We are all fairly sure it is "the wrong finger." (Not to telegraph one of our #T1Din3 offerings or anything.)

So anyway in honor of Connor getting sprung from CHOP our three words are, "Bolus for Candy."

We had great support at that first diagnosis. Here is a link to the story of Connor's diagnosis and the great care we received from our nurse at CHOP. She is the one who sprung him a day early so he could trick or treat and gave him instructions to eat the candy (as part of his meal plan.)

A Halloween Re-Run: Eat the Candy.

2011-10-29T12:08:00.001-04:00

Here is a YDMV bit from the YDMV WABAC machine. If you remember the reference you are both my hero and old like me. As Halloween approaches I once again offer my feelings about carb based holidays and kids with type 1: Make the joy of bing a kid first.

Kerri vblogged about Halloween candy, mostly snickers bars. It was like she has some kind of a Snickers obsession. Almost as if she was scared for life by having Snicker withheld from her in her formative years.

At the risk of further damaging my good reputation (I know you’re thinking “What reputation?” As if I could say anything else to make myself out to be more of a total boob.) I want to talk about Halloween candy.

Candy didn’t cause our kids to be type 1.

Candy isn’t going away because they are.

I needed to learn this but it is a lesson I learned early. I didn’t know much about diabetes; OK I didn’t know jack squat about type 1 diabetes before Connor was diagnosed other than there were some parents who had to give there kids shots every day and I thanked god I wasn’t one of them.

I hated needles. I still do.

I know a lot more now than I did then. Mostly I know not to spell out my fears for Murphy’s Law by being thankful for not having needles in my life. It is a sure fire ticket to Needleville.

Before he was released from Children’s Hospital of Philadelphia I learned the lesson that candy didn’t cause Connor diabetes and his having it wouldn’t make candy go away. They were very clear - Kids with diabetes are kids and so are entitled to the joys of being a kid.

Candy on holidays is part of being a kid.

Candy based holidays are important and among the many things CHOP taught us were these two: He is trick or treating. He is eating his candy (as part of his scheduled carb intake.) They released him a day early on the morning of Halloween with solemn and serious instructions to trick or treat that night.

So I am here to say don't let your kid grow up and become some kind of a scared by Snickers bar Halloween freak like some vbloggers I know. Let them eat cake! Or in this case the candy! For Kerri I recommend the both in the form of a Crumbs' Snickers cupcake.

Be a kid with diabetes.

Kid first, diabetes second - deal with the diabetes so they can be kids.

News on LGS

2011-10-28T14:23:00.000-04:00

Medtronic Receives IDE Approval to Conduct Aspire In-Home Study of First Insulin Pump with Low Glucose Suspend for US Market

"People Who Get It" and TEDx #TwoBits

2011-10-28T10:56:00.000-04:00

Over at humaBLOG there is a post about having someone around who "get it" (it being diabetes.) I like that mom caught onto dueling hypos, but more I like the idea that we rely on each other in families and online communities.

Speaking of relying on communities, we rely on the scientific community to make living with diabetes better. TEDx DelMar shared a lot of what that community is up to. ASweetLife has a glorious two part tour of the presentations, here and here.

AP by Any Other Name & Experts on CGM #TwoBits

2011-10-27T10:59:00.000-04:00

Two Bits form around the DOC:

Thanks to Scott Strumello for alerting me to this article with this great definition of

Artificial Pancreas: "To merge three key aspects of type 1 diabetes management - human behavior, physiology, and technology." Way to include human behavior! Also way shorter than by post.

Another bit:

Apparently experts have caught up to what most PWD knew innately:
Experts Find Continuous Glucose Monitoring Beneficial in Maintaining Target Blood Glucose Levels, Now would someone please tell Scott's insurance?

CWD Technology Conference in Philly!

2011-10-27T10:00:00.000-04:00

What Penny Said:

CWD Technology Conference in Philly!

The Children with Diabetes Focus on Technology Conference

is coming to Philadelphia in February 2012!

If you are even remotely close to Philly, I urge you to come!

Not only for the learning, but for me to meet you, o' faithful reader!

You can read about the conference here.

You can register for it here.

Come!

YDMV Interviewed as an e-Patient

2011-10-26T12:13:00.001-04:00

I was happy to participate in a Medsider.com conversation about e-Patients. I am still not sure what an e-Patient is but I jumped in with Scott Nelson moderating e-Patient DavdeBronkart and Hugo Campos none the less.

I think that we in the Diabetes Online Community share issues with other online patient communities. In this case the issue we talked about was access to our individual medical data.

I think it is everyone mutual benefit if we take the time to learn about the issues others face and honor their struggles without offering trite solutions. Finding areas where we share concerns present opportunities to share insights on how to work to common goals.

I hope I did the DOC proud. The full round table conversation is on Medsider.com

More Art Than Science

2011-10-26T09:45:00.000-04:00

Support the diabetes arts: http://main.diabetes.org/goto/theBetesNow

More Art than....

2011-10-25T18:53:00.004-04:00

... Science

New Video on theBetesNOW.com

More Art Than Science

Pump Hack II

2011-10-25T15:45:00.001-04:00

From the news wire: Pump hacked by sniffing serial number.

http://www.cso.com.au/article/404909/lethal_medical_device_hack_taken_next_level

I get that hacking is seen as a noble endeavor, particularly by the practitioners. My gripe is that while there are significant computing shills involved the communications leave me cold.

Consider these headlines:

Lethal medical device hack taken to next level
Attacker sniffs insulin pump ID, delivers fatal dose

To me these articles project a cavalier attitude of, 'We play games with devices that keep people alive.'

There is an FDA process for reporting device flaws. That seems more useful and a nobel a channel of communications than general media. If reason for the hacks is to motivate change then the FDA is in a position to see that it happens.

Artificial Pancreas and Egg Baskets

2011-10-19T09:52:00.001-04:00

A friends asked this about the artificial pancreas (AP):

I have noticed over the past few days a lot of interest in the Artificial Pancreas project, the FDA and an online petition.

I know nothing of the project beyond the controversy it caused when the JDRF supported it and people felt that money was better spent on a cure rather than technology.

From what I have seen, and again, I need to do a lot more research, this will be a tool-a more advanced pump if you will. If this is correct, are we looking at a tool that will only be available to those that can afford it or will it be looked upon as similar to a pacemaker for a heart patient?

In Canada, we are still fighting to have insulin pumps covered in all provinces for all ages. Very few have coverage for CGM. How will the masses therefore afford to have access to another device...unless this is something for the masses again like an artificial limb or pacemaker.

Please feel free to email me direct if you can help me to better understand this rather than clog up the list. I don't mind standing behind something if I feel it will make a real difference. At the moment, I am just not sure I understand the planned way forward with this.

This was my response:

There are a number of approaches to AP. Some use just insulin others, I think a study at Boston University uses something to raise BG as well as provide insulin. If you get the chance, go to a JDRF technology meeting. The Capital Chapter ran a great one last year. You will see AP is part, but by no means all of the story of making living with diabetes better.

You are correct about the tools involved - CGM and pumps. There is wide appreciation that improvement is needed in both sensing and insulin delivery. Faster insulins and better pumps sets. The benefits of those would also improve care outside of AP. Faster insulin would be good for everyone, better sets and sensors would benefit those who use pumps and CGM without AP.

AP then is an set of algorithms, or an application if you will, that manages BG with the pump as measured buy the sensor. It certainly will be costly to develop and more so to get approved, particularly as there are currently not guidelines to get it approved. (in part this relates to the recent conversations about Low Glucose Suspend (LGS) and apps.) In fact LGS is a stepping stone to AP in that it does one AP function, stopping additional insulin with low BG.

You are correct in noting AP is concerning to some. It is worth noting that JDRF's investment in AP is small compared to to their other research initiatives. I don't have the current numbers percentage numbers.

I think you are legitimately concerned about costs and reimbursement. My good friend Scott Strummello often expresses the same concern. I think that AP will need to demonstrate effectiveness before insurance will cover it. To do that it will need to be approved by the FDA and tested, to be approved it
needs to be invented and go through trials. That is a lot of steps.

Glucose responsive insulin (GRI) would make AP mute. I think GRI may be even more distant down the same path of discovery and approval as AP. Still one could argue that GRI is a better solution than AP and that it should be the focus. Others can rightly point out neither is a cure or a sure bet.

I believe that better is better and perfect should not be the enemy of good.
So I am all for advances in type 1 diabetes care that may fit into individual's life styles in a Your Diabetes May Vary kind of way. AP may work for some while GRI works better for others. I fairly sure none of it will make diabetes care easy but it may be less hard and that's better.

I support a diversified approach to making life better. There is a fable about putting eggs in more than one basket that explains modern portfolio theory better than most finance professors. Any one approach to making diabetes life better may fail. Most pharma development projects start with promise but don't make it to the market. So to make life better for people with diabetes a lot of different approaches need to be tried. It is in that context that I think JDRF GRI x-prize like initiative is a good idea even after the support they have put into and the promise that is still expected from SmartCell's Smart Insulin that Merk bought.

Let me know if this helped any.

You can learn more at the JFDR AP website: http://www.artificialpancreasproject.com/

Share you support for the AP initiative at this online petition.

Bennet

The Provider will Teach Your Now

2011-10-13T14:07:00.000-04:00

In the last day or so I have seen a a few pieces on the role of phyicians, and patients or providers and consumers. On was a New England Journal of Medicine piece (who would think that I read that rag? - certainly not me) by Hartzband and Groopman titled, "The New Language of Medicine" (1).

It was a good article. I like this part particularly:

"The word “patient” comes from patiens, meaning suffering or bearing an affliction. Doctor is derived from docere, meaning to teach, and nurse from nutrire, to nurture. These terms have been used for more than three centuries."

So to me this suggest that maybe when doctors move away from teaching to a detached paternalistic approach, that projects a perception that they are 'the expert telling the patient what to do' they may have changed the historic relationship. In all fairness, this may be a function of the pressure to see patients and quickly, diagnose and treat before moving on the the next bearer of ill news. I notice there isn't any teaching the sufferer in that little process.

Teaching, it seems to me implies there is a need to for the bearer of an affliction to understand what is going on. Even more it seems to appreciate there is some autonomy in the patient's selection of what to do after said bearer has learned from the teacher.

From my experiences as the father of type 1 diabetic teens, the biggest contributor to managing their wellness are great teachers. Some have physicians. Some CDEs. Many have been others who are carrying the same load of daily diabetes care. We have found many of that later group at Children With Diabetes Friends for Life. I am looking at folks like Joe, Paul, Jim and Natalie.

So while Hartzband and Groopman worry about language that demeans the professions of doctors and nurses it seems to me that those professions should also pay attention to the role to teach and nurture and the fact that others outside of the professional ranks help in that process.

(1) N Engl J Med 2011; 365:1372-1373October 13, 2011

Dear FDA It is Me Again, Again.

2011-10-13T11:43:00.000-04:00

If you scroll down a few post you will see my two bits on FDA regulation of mobile apps. Here is another form letter you can feel free to edit and use to comment. It runs a bit over the 2000 character limit on the FDA site so edit away.

Thank you for the opportunity to comment on Mobile Medical Applications. I live with type 1 diabetes (or "my child lives with type 1 diabetes"). I try to live a useful life not limited by diabetes. To that extent, mobile medical applications can be a great help. Through guidance, the FDA can help improve our lives by facilitating a robust mobile device ecosystem.

I and others like me use many portable medical devices to manage type 1 diabetes; insulin pumps, glucose meters and continuous glucose sensors. Each as its own software. None of those systems are capable of sharing the diabetes information with systems made by others.

Diabetes care is all about balancing blood glucose with insulin, food and activity. The Diabetes Control and Complications Trial (DCCT) showed that tighter control leads to healthier lives. Applications can combine data from multiple devices to help give insight into the whole of diabetes care. Mobile apps offer the promise of accurately combining the information from different diabetes management tools, the correct formulas and analysis from the care textbooks into wizards that can help manage diabetes to the standards of DCCT.

Recent articles in the New England Journal of Medicine call for “Balancing Regulation and Innovation” (Curfman and Redberg, 9/15/2011) and the need for “Creating a New Regulatory Framework for Moderate-Risk Devices” (Challoner and Vodra 9/15/2011) As a patient whose life depends on devices I am frustrated to learn that innovative US designed and manufactured products are available overseas but not here. "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and Implications for Reform" shows that three quarters of the firms bringing innovation to heath devices do so out outside the US first. (Linehan, Ph.D. Northwestern). As the FDA considers guidance for mobile applications I encourage the adoption of regulatory models used in the EU that balance regulation with improving heath care.

Thank you for taking into consideration this comment. They are made with the hope to improve the lives of people with diabetes.

medGadget on Echo Therapeutics

2011-10-11T14:41:00.002-04:00

From the News Wire: medGadget has an article on Echo Therapeutics CGM.
http://medgadget.com/2011/10/more-positive-results-for-transdermal-continuous-glucose-monitoring.html

Hi FDA, It's me again.

2011-10-05T11:59:00.000-04:00

The FDA has another open docket that I would encourage anyone with an interest in medical apps and ePatient rights to use as an opportunity to share your views with the good folks at the FDA. My pal Bernard tweeted me with this link to Draft Guidance for Mobile Medical Applications.

You can read the Draft here: http://ow.ly/6M9lJ

You can comment here:http://www.regulations.gov/#!submitComment;D=FDA-2011-D-0530-0002

This what I sent:

Thank you for the opportunity to comment on Mobile Medical Applications. My wife and I have two teens with type 1 diabetes. Our hope is that they develop and pursue dreams and aspirations not limited by diabetes. Mobile applications can help that. The FDA through guidance can help facilitate dreams by facilitating a robust mobile device ecosystem.

We use many portable medical devices to manage type 1, insulin pumps, glucose meters and continuous glucose sensors. Each as its own desktop software. None of those systems are capable of sharing the diabetes information with other systems. Diabetes care is all about balancing blood glucose with insulin, food and activity.

The Diabetes Control and Complications Trial (DCCT) showed that tighter control leads to healthier lives. W. Polonsky, PhD, of the Behavioral Diabetes Institutes says, “Well-controlled diabetes is the leading cause of nothing.” Our goal is to control diabetes and pursue dreams.

Applications can combine data from multiple devices to help give insight into the whole of diabetes care. Mobile devices can facilitate that insight in real time, in real lives, bringing the vision of DTTC into practice.

The FDA can facilitate this future with regulations that take an approach that sees patients’ information as something they have an ethical right to have.

FDR add value through safety review. This should be expeditious to prevent delay becoming a veto of innovation. This means the FDA will need a process to quickly re-approve apps to keep apps current with advances in mobile operating systems.

Most significantly the FDA can ease the review process and facilitate app development through open data standards. Common data standards and database tools will make it easier for the FDA to insure safety while simultaneously providing a common framework for application development that will lower the development cost for innovators.

#dsma Oct 5

2011-10-05T10:04:00.001-04:00

Fire up Twitter for #dsma - 9:00pm eastern time

More on JDRF GRI Prize

2011-09-28T15:29:00.001-04:00

In the post Know a Smart Chemist? I wrote about JDRF's Glucose Responsive Insulin (GRI) prize. Here's more on the plan from JDRV:
Streaming by Ustream

Tonight on #dsma

2011-09-28T13:48:00.003-04:00

Join in #dsma.

Need to know more? See : http://diabetessocmed.com

Finding Support in an e-Patient World

2011-09-26T15:40:00.000-04:00

Mark S. King has a video about e-Patients on his blog My Fabulous Disease. In it Mark shares patient values across heath concerns. I hope in doing so he helps all see beyond our unique conditions to shared roles as patients. Maybe it is gifts are what make us unique not our heath.

Enjoy the video and read his post.

Review of iBGStar on DiabetesMine

2011-09-26T12:16:00.002-04:00

Amy has a review of the iBGStar up. Interesting reading.

http://www.diabetesmine.com/2011/09/testing-out-the-ibgstar-first-plug-in-glucose-meter-for-the-iphone.html/comment-page-1#comment-536516

A Song About Health Data

2011-09-21T13:17:00.003-04:00

Seriously. A song!

I may have ranted a bit at times about diabetes data. My new pal e-Patient Dave sent me this little link. It aint just us diabetes folks who want our data and this is a lot more fun than reading my stuff.

ePatients: A Hopeful Happy Handful

2011-09-20T16:29:00.000-04:00

I was part of a conversation on e-patient rights sponsored by Klick Pharma (from who I swiped the photo), HealthCentral and the Digital Health Coalition. About two dozen patient social media writers with diverse histories with a variety of conditions shared experiences and hopes about health. I think we were trying to talk about digital health issues but just as often spoke about empowered patient concerns. I am still not sure what e-patient means but I found the conversation fascinating non the less for a number of reasons.

While we were, at least in on the basis of the invitation, talking about an e-patients bill of rights I think Mark King made a particularly good point about our responsibilities, not that I think he meant it that way. He said he was hopeful, happy and a handful. I found that particularly good as a guiding principal for a social media writer.

I want help make life better so I should try to be hopeful. Happiness is a choice that can be made over anger and it probably facilitates hopeful participation. I sometime fail to find happiness and I think that is probably a shortcoming I can work on. Finally I as a social media writer I need to be a handful. I need to become informed, share and motivate from my individual perspectives and at times, happily and hopefully pursue interests in cases where patient health perspectives need a voice. Thanks for that Mark.

Kelly Young made maybe the most profound comment of the day regarding the device and medication trials and approval process. She simply said that nobody asked her what she as patient wants. From that flows a similar observation about what the patient’s definition of successful treatment is. Maybe asking the patient is success should be part of the larger process. Thanks for that Kelly.

As we got down to conversations about digital medical issues I found that my new friends, with a variety of medical problems, shared similar concerns with what I hear from my old online friends in diabetes community. Notably, patients want access to the information about their condition, the data. We would like to have access to our information in a not too overly clumsy way, preferably electronically.

This leads to the cold fact there there is no simple, not too overly clumsy, standardized electronic means of patients accessing their own medical information. So as a health consumers I should advocate for patient input into the creation of such standards. I should do so hopefully and happily. I know that nobody is asking what patients want so I may need to be a handful to the health industrial complex in offering up my two cents.

Photos credit to "©2011, http://klickpharma.com. All rights reserved."
Imagethink boards credit to "Graphic recording by www.imagethink.net"

Know a Smart Chemist?

2011-09-20T11:15:00.001-04:00

JDRF is looking for some. They would like to get into conversations about innovative ways of making insulin respond to blood glucose levels. They have a hundred Gs for really good ideas.

Some smart YDMV readers may ask, “Hey isn’t that what SmartCell’s SmartInsulin does?”

Yes, yes it is.

So you may wonder why JDRF would be looking for chemist to reinvent the proverbial wheel. I know I did. Particularly in light of JDRF funding SmartCells via an IDDP.

Scott Strummelo and I joined JDRF on a conference call on that very issue. JDRF’s reply, as I understood it, was that while they have confidence in SmartInsulin other means of achieving the same end would be great for a variety of reasons. Different glucose responsive insulins would provide patients options to see which works best for their them - your diabetes may vary and so might your response to an ‘intelligent’ insulin. Competition in the market place can have an effect on price that is good for consumers. The drug approval process is a long and risky process, given the potential value of a glucose responsive insulin, more “at bats.” is a good thing.

Better is better and I am all for seeing if some smart chemist can bring their skills to solving the science of another way to prevent infused insulin from causing hypos.

Honestly, looking in the light of blue candles, I can't think of much that is more important.

Not Enough

2011-09-17T13:54:00.002-04:00

Blue candles.

I hate seeing blue candles.

I loathe the very reason they exist.

I pray to never see another.

Blue candle are a small tribute to a young life lost to type 1 diabetes,

lost to overnight lows.

They are condolences beyond the words fail to express our feelings.

Like words they fall short in sharing them.

I am angered that better means of detecting, alerting and treating overnight lows is possible,

but lack a clear paths, through regulatory approval, insurers red tape and into homes.

I grieved that better care is not more available.

I am numbed at the sight of blue candles.

I am numb at the the increasing frequency of seeing them.

I grieve for losses, unknown to those who would share,

ineloquent words and

insufficient blue candles.

I appreciate researcher who advance type 1 care.

I admire those who make basic diabetes care more available around the world.

I love the champions and advocates of families living with diabetes.

I celebrate the actions beyond blue candles.

Blue candles are not enough.

A Grievance

2011-09-02T14:00:00.000-04:00

I have a Grievance with the FDA

It take them too darn long to approve better stuff for diabetes care. Someone should do something about that...

... and there is an opportunity to do something right now. The FDA docket on Low Glucose Suspend (LGS) is open for just a few more weeks. Take advantage of this chance to share your views with the regulators and congress.

You can click here to comment.

You may feel that you are not qualified. You may fear that you do not know all the ins and outs of medical studies and that is what this seems to be about.

I think this is about more than ins and outs of studies. This is about timely approval of devices that can help manage diabetes. You may not use a CGM, you may not pump, you may have doubts about artificial pancreas but if you live with diabetes regulatory delay puts you at risk.

I think we should have an expectation that the FDA will preform their regulatory duties with alacrity. That doesn’t seem to be the case with LGS. Here is a product that is in use in 40 different countries and the FDA still doesn’t have a process for considering applications to approve it here. That is more than a little late to the party.

If nothing else the FDA should hear from people with diabetes saying that devices should not come to the US market years after they are approve else where. The FDA needs to do its thing in a timely, citizen friendly and focused manner.

I think LGS can save lives. Particularly lives lost to sever overnight lows. I

That could mean fewer blue candles on Facebook. There are few things I hate seeing more than that symbol of grief and remembrance of a life lost to diabetes. Further delay moving forward on devices to that may keep kids alive is unacceptable.

LGS is not a magic bullet. It is no cure.

It does offer a means of lowering potentially tragic risks. What there is NOT is a means of the FDA will considering these and other pump / sensor advances as they are created.

Please comment on the Docket. I view it is one way of avoiding blue candles. I hope it is only ONE of MANY ways of avoiding blue candles. We need all the ways we can get to keep them out. The FDA should be our ally not an impediment in those efforts.

Comment to the FDA and share those thoughts with your member of Congress. Be someone who does something. As it says in the first amendment, “petition the government for a redress of grievances.”

Diabetes Art Day

2011-09-01T10:08:00.004-04:00

Part of the art of diabetes is knowing what to say to who. We think Fotaly Tine is great place to start.

Fotally Tine from thebetes now on Vimeo.

See the gallery and join Diabetes Art Day.

Abbott Bails

2011-08-31T22:35:00.001-04:00

The FreeStyle Navigator is dead, long live CGM.

The best line in this is, "When we bring a product to market, it is our responsibility to consistently provide the product to customers."

Abbott didn't live up to their self defined responsibilities and they should be ashamed.

http://www.abbottdiabetescare.com/adc_dotcom/url/content/en_US/general_content/General_Content_0000422.html

(Thanks Ellen for the link)

#TwoBits

2011-08-31T10:02:00.000-04:00

Two great pieces from around the Diabetes Online Community for August 31, 2011:

GlucaPen: The Way Glucagon Ought To Be
Karmel Allison offers a look at a better way to deliver Glucagon. She points out that while there is a better device it isn't yet available.

Tomorrow is Diabetes Art Day
I am a fan. A fan of diabetes art, the reasons for making it, the people who make it and the great woman who connects us with creativity. Join in. Create.

Aug 29, 11 #TwoBits

2011-08-29T20:54:00.000-04:00

Two Bits from around the DOC.

Both brought to my attention by good friend Ellen Ullman on her Google+ page. She's great at finding news on type 1 and a more importantly a lovely lady. Here's today's Two Bits:

The pancreas as we’ve never seen it before

Professor Ulf Ahlgren and associates at Umea University in Sweden are a leading research team in the world in the development of optical projection tomography. With the aid of this imaging technology, they have now described aspects of how the pancreas develops during embryonic development and how the so-called islets of Langerhans are distributed in the adult organ. The findings are important for the interpretation of modeling systems for diabetes.

TEDx - PREVENTING AND CURING TYPE 1 DIABETES
OCTOBER 15, 2011

TEDxDelMar will offer a full day of talks by the country’s leading researchers and clinicians addressing the cause, the most advanced treatments and ultimately a cure for Diabetes.

Eighteen minute talks by 15-20 speakers will be simultaneously broadcast live on the web. A global audience of over 400,000 viewers is expected to hear the live talks interspersed with feature videos.

Man would I love to attend that! Oh wait I can it will be online! Yea Internet!

Ford Has My Back

2011-08-28T21:18:00.000-04:00

I Want Their Voice.

Back in May, Ford reached to out some members of the Diabetes Online Community asking them to participate in an online chat about research to connect CGM data into their SYNC® system. I was not one of the folks their PR contractor emailed. (I assume that shows good judgement on their part.) Too bad for them, a friend shared their email with me and I got myself invited into the chat.

Who would think I would butt my way into a conversation? (OK anyone who has ever met me would think that.)

They were very nice about my butting in.

You can read the story about Ford’s research and see the chat transcript here.

Many of us who participated, myself included, came away with the impression that Ford didn’t “get it” when it comes to diabetes and diabetes social media in particular. I know I felt that the chat was a vehicle for Ford to generate positive PR about addressing diabetes health concerns with out actually doing any actual addressing.

They seemed to be ignorant of basic realities managing diabetes. I found this comment particularly difficult to take, “Our plan is to go with open standards, so we align with the healthcare industry.” As a self appointed leader of the where are the data standards for diabetes committee, I know there are no industry standards open or otherwise.

I and others worried that Ford’s PR efforts would create a bunch of stories that will be seen by people who don’t live with diabetes. Those folks will have a positive impression of Ford marketing something useful to diabetics. The reality is there is no real product, only slickly packaged remote possibilities. These false impressions could add to the existing list of multitude of misconceptions about living with diabetes. I can just imagine comments, “It must be so easy now that your car monitors your blood and tells you what to do to manage your diabetes.”

Given the way Bloomberg picked up and spun the story, the fear that Ford was in it for the buzz seemed to have merit. They wrote of Ford seeing a sales surge from such devices.

Ford’s folks were kind enough to maintain a follow up conversation with me on twitter. That lead to a phone call with the research and PR team working on the project. That call cleared up some of the questions I had about the research. Ford tried to clarify their communication approach too.

From a research perspective, this project is the investigation of possibilities that they know are way down the road. There is no product expected any time soon. They do have to start someplace and this is that start. I appreciated the candor that said that with.

Given that this research is not likely to provide actual capability in a Ford anytime soon, I questioned a communications strategy that seems to position this as more of a coming attraction than candidly remote possibility. Ford’s communication person strongly objected. He insisted that Ford’s communication made it clear this was research. In all fairness, technically, it does.

Still, Ford’s PR efforts created a number of articles in a variety of media outlets about SYNC® and health. As the whisper down the lane process evolved the far far away research aspect kind wore off. The result appears to be a vehicle for Ford to generate positive PR about addressing health concerns with out actually doing it. At least until an undefined remote future.

The last thing diabetes needs is media now about a remote undefined future. That where a a lot of better living with diabetes and even the cure lives - the undefined future. The place is crowded.

To me this raises an interesting question about how business use of social media. Many experts say the first rule for businesses using social media is to listen. There’s even books about it.

I think Ford could stand to be seen listening a little more attentively on this. Ford reached out to diabetes social media writers with a story to tell. I am not aware of them listening or joining into conversations before hand. The came in with an ad campaign and a call to support it.

The result was that in the #DSMA chat at the time, Fords PR efforts around the SYMC/CGM connection was called a “Gimmick.” Another participant said “Ford's In-Dash CGM” would be a used by, “Slime Salesman (to push a) ‘diabetic upgrade.’”

About the same time as Ford’s CGM SYNC® press releases Charlie Kimball became the first driver to race the Indy 500 with diabetes. He as Dexcom CGM mounted to the steering wheel of his car. Charlie clearly demonstrates the value of CGM information and driving.

He is a great guy with a great story: Type 1 Racer dosen’t let diabetes slow him down. His autographed picture is on my daughter’s wall. We watch Indy Car races to see him. Charlie is a role model. To be clear we should leave the 200+ mph stuff to him but we also should encourage every diabetic kid to chase their dreams just as aggressively as Charlie drives.

Sadly I don’t think in car CGM information is going anyplace other than the receiver in the cup holder or like Charlie’s attached to the steering wheel. FDA scrutiny on devices is tough. CGM data on that remote display may be seen as clinically significant information making the display a medical device. I don’t see Ford applying to the FDA for approval of each different car model configured with SYNC®.

It would be easy to be pissed at Ford for what kinda appears to be exploitive use of the diabetes community to generate PR. I don’t think that is entirely fair.

I think Ford has the diabetes community's back. - Literally.

I wear a lot of JDRF walk T shirts. You may too. Mine all have a Ford logo on the back. Ford is a big supporter.

The Ford SYNC® researcher I spoke with about the CGM/SYNC® has type 1 in the family. Type 1 impacts the lives of Ford employees across the spectrum from rank and file to executive management, just like it impacts lives across the world. I think this personal connection is the root of Ford’s research desire to make diabetes management in the car easier.

I think where they may have dropped the ball was in communicating. The impression that CGM and SYNC® will work together in the foreseeable future not a realistic expectation. It is a worthwhile effort. Ford has demonstrated they can do it - so it is not a technical issue. I suggest that sharing CGM data to other means of display is a regulatory hurdle. One that will take a lot of voices to overcome

If Ford’s goal was simply to manufacture a vehicle to generate positive PR about addressing health concerns with out actually doing any actual addressing then they have succeeded. Google can find a lot of stories about it. If Ford really want to be part of the diabetes social media that serves the families of their employees and customers living with type 1 then I think they need to be part of the dialog.

I think Ford gets diabetes because they have coworkers who live with it. Bloomburg may, or may not, be right about a sales surge from SYNC® displaying health information. I think the real motivation is a desire to contribute to better lives through their products. It is what they do. The fact is nothing can happen in an environment that restricts information from regulated health devices from being shard in innovative, useful ways.

I would love to see Ford communicate, through their lobbing team, and share their interest in making driving safer with elected officials. More and more powerful voices can only help.

I would love to be part of that conversation.

Please follow Jeffrey Brewer @JDRFceo

2011-08-22T19:04:00.000-04:00

He is on Twitter at @JDRFceo CEO of JDRF, the largest charitable funder and advocate of type 1 diabetes science worldwide.
http://www.jdrf.org or on Facebook at http://www.facebook.com/brewerjeffrey

Pie is Important

2011-08-22T14:57:00.001-04:00

Right now very important.

- Posted using BlogPress from my iPhone

prescient |ˈpreSH(ē)ənt, adjective

2011-08-22T13:31:00.004-04:00

prescient |ˈpreSH(ē)ənt, ˈprē-|

adjective

having or showing knowledge of events before they take place: a prescient warning.

It takes no prescience to guess my topic, sorry about that. I will learn a new tune, soon. There are times in life when tunes are prescient. Consider the Talking Heads Rock Movie, Stop Making Sense and insulin pump hacking. How can a 30 year old rock and roll album show knowledge of insulin pump hacking well before insulin pumps and hacking were commonly used terms? Read on my friends YDMV is going pop culture.

Jay “Pump Hack” Radcliffe wrote on Facebook that he thought this war was over. Jay didn’t seem to expect that as the hack story lives on and in that others (a word that here means me) would continue to put forward the idea that there are other risks associated with insulin pumping that are as, or more, pressing than hacking. That is Life During Wartime Jay

But I do not see myself as at War with Jay. In my first post on the issues I offered up the fact that I kinda hacked a pump way back when when we first started using them. I hope I am all about the idea that pumps need to evolve and become better. Better should be prioritized in terms of advancements in improving lives and not simply be a function of what scare get the most press play.

I do not see Jay as a Psycho Killer. On the contrary he brings up legitimate issues. Doing so, I think he is responsible to offer up suggestions on how to address the issues he found. I see him as anxious to do that. I do worry that the media attention given the hack story will suck all the oxygen out of the room and things like low glucose suspend, faster insulins, smart insulin and the glucose meter shuffle will choke for lack of attention.

I think we would be Burning Down the House if hacking were to become the only or even primary concern around innovative diabetes care. So I speak up. I would hate to see the meter that has bolus wizards for the multiple daily injection community be kept off the market out of fear of hacking. I can’t see how the color screen on a remote is regulatory issues in any issue in any but the most minor way what so ever but it is available in Canada and not here. I look forward to seeing the Dexcom integration with Animas and Omnipod but both are in regulatory purgatory. LGS is a small first step towards automating insulin delivery and blood glucose sensing. All the laypeople in the world think that is what a pump does now but we know it does not. Further delay keeping that innovation from the market may cost lives.

Are the media Slippery People for publishing a compelling story without putting it into put into a wider context? No. Their job seem to me to be focusing on the next edition's Once in a Lifetime story that will sell banner advertising. For the mews media every day is Shark Week.

I fear an isolated and exaggerated risk myopia may be responsible for Burning Down the House of better diabetes care. So on second thought maybe we should focus on what really matters and Start Making Sense:

There is no war: Pumps communications should be secure. LGS matters. We all need to talk about risk in the context of life with diabetes.

Get Serious: Industry with the FCC and FDA need to figure out secure protocols for medical devices. Regulators should make these protocols easily approved as changes for device manufacturers to implement. This should be in the form of standards to spread the cost of the changes widely and efficiently. Each manufacturer should not be required to reinvent the secure communication wheel. Each consumer and insurer should not have to pay for new and different processes for each device.

Remember Who’s Air It Is: Secure communications over the public radio spectrum should NOT be proprietary. That is no firm should have the proprietary advantage of excluding others from the spectrum's use for safe secure health care device communications. The air belongs to us all.

Make it Work: The FDA should make it very clear how to implement secure communications and make it easy to get such communications approved into existing devices.

Risk is not absolute: The lack of such security protocols should be balanced with the benefit of innovation. Advances such as LGS need to come to market while the FDA and FCC figure out what they will require.

Shouldn't Better Diabetes Devices Be BIGGER News?

2011-08-22T10:56:00.002-04:00

Pump-hack-gate, yes I am officially going with the gating of the event to signify its significance, continues to get print and now more media attention for the congress members who wrote a letter about it.

Here is the thing that bugs me. Do these same folks have the same interest in keeping people with diabetes healthy? Do they invest a similar concern that Low Glucose Suspend is available in 40 countries around the world but not here in the USA where it was engineered? Do they cover advances that can save the lives of kids with the same attention that they cover the very unique and isolated hacking of a pump.

No. It doesn't seem so.

I though I was used to the rest of the world not appreciating the real risks of type 1 diabetes. The food police and the ignorant are one thing. One ignorant person at a time. This wholesale stuff with media that are selling their banner ads with stories about what are very marginal risks would do well to learn what the real balancing acts of diabetes are and what the risk associated with them mean in daily life.

http://abcnews.go.com/Technology/wireStory?id=14344300

Congress & Pump Hacking, Who Didn't See This Coming

2011-08-20T11:53:00.006-04:00

So it begins:

Aug 15, 2011: Eshoo, Markey Ask GAO to Study Safety, Reliability of Wireless Healthcare Tech
Senior Committee members Anna G. Eshoo (D-CA) and Edward J. Markey (D-MA) sent a letter to the Government Accountability Office (GAO) early this week calling on them to look into whether the new devices are "safe, reliable and secure. " The issue stems from a hack shown at the popular Las Vegas conference where researcher Jerome Radcliffe -- diagnosed with Diabetes 11 years ago -- demonstrated how he could tweak the dosage levels on his pump remotely.

Dear Congresswoman Eshoo and Congressman Markley

I read the press release about your letter concerning wireless health technology. I have a personal interest in insulin pumps. I am a social media writer and participant in the diabetes community online as I am the father of two teenage type 1 diabetics who lives depend on insulin pumps. I know that diabetes management is a balancing act. Insulin and activity balance with food to maintain blood sugar. It is never a perfect balance of risks but it is what families living with diabetes strive to manage.

I hope that in your efforts to publicize your letter you are aware of the relative risks involved with insulin pumping. The community of families living with type 1 diabetes has been shocked with the deaths of a number of adolescents in the past year form hypoglycemia, excessively low blood sugar. You may know the condition better as insulin shock and it can result even when people believe that have balanced all the inputs just right.

Insulin absorption is affected by a number of variables. Physical activity can present diabetics with increased insulin efficiency as well as changes when in insulin impacts blood sugar. It is possible that healthy, active kids see blood sugars fall overnight as a result of daytime physical exertion. In those cases reducing or stoping the delivery of insulin, even normal amounts that have previously been fine, can help prevent dangerous low blood sugars.

The US Government has tightened regulation of insulin pumps to the point where innovations that are available around the world are not available for use here. Continuos glucose monitoring systems (CGM) integrated with pump systems are sold in Europe. These insulin pump systems are made by US companies. The more advanced systems can shut off insulin to people having a low glucose episode. This innovation, while made in the USA, is not available for sale here, yet it is available around the world.

These devices have the potential to save lives. They give people living with diabetes in Europe more choices to consider with their physicians than we have in the US. Sadly the FDA does not even have guidelines for considering how to approve low glucose suspend.

Let me be clear. I am not suggesting that wireless security is unimportant. The devices should be secure. Device makers should be allowed to bring more secure devices to market without a significant regulatory delay.

I am urging you to reflect on the life saving capabilities of innovations like CGM integration and low glucose suspend with the security risk. To date there has been no reported case of any health impact from the possibility of hacking an insulin pump. Zero.

There have been and continue to be tragic cases of severe hypoglycemia that cost young American lives. The particularly sad loss of adolescents with type 1 diabetes highlights where LGS may have prevented the unfortunate loss of life. Unlike pump hacking, the lives of American children are been lost to hypoglycemia. Pump hacking, considered outside of the balance of risks facing insulin dependent diabetics, may increase the regulatory delay of life saving technology reaching American families.

The cumbersome FDA regulatory process for inulin pumps slows innovation to US families. Your letter uses the word proliferation. Typically politicians use the word with a negative context. We need a wider rapid adoption of life saving innovation to help keep American teens alive not the proliferation of government studies that prevent US patients from using the innovations of American companies to live healthy lives.

How can you as senior members of the House Energy and Commerce Committee speed up not only the safety of devices but the availability of life saving tools?

Repeat After Mike: Dear FDA...

2011-08-18T08:15:00.000-04:00

Mike Ratrie left a new comment on the post "Repeat After Me: Dear FDA..." that I think is so good it should be a stand alone post. He wrote:

Bennet,

Here is a copy of the what I posted on the FDA comments link you provided. I also sent it along to my Congressperson (Mica) and Senators (Nelson, Rubio).

Cheers,
Mike

"Having read the draft guidance regarding Investigational Device Exemption (IDE) and Pre-Market Approval Applications (PMA) for Low Glucose Suspend (LGS) Device Systems, there are at least two areas that stand out for me.

The first and most obvious one is why is the FDA putting together this lengthy and dense type document when these devices have been approved in over 40 countries AND have been in use for over three years. Surely in this time of near instantaneous communication of results, the companies who market these devices have already answered most if not all of the questions and concerns raised by the FDA. If not, the remaining questions and concerns should be relatively minor and not worth the time and expense of undergoing full-blown trials.

Note that by time and expense, I refer to not only the time and expense for both the FDA and the LGS manufacturers, but also the time and expense to the patient community that would benefit by having these devices immediately available. Indeed, delays like this strike at the heart of the public's confidence in the FDA's ability to follow its mandate.

The second issue that stands out is the HB1AC guideline for a successful trial. It seems to me that the FDA is being overly technical here and is missing the bigger picture - the avoidance of hypoglycemic events. In other words, a T1DM patient who has a 0.4% lower HB1AC without using a LGS system, doesn't just have a lower "number" without meaning to their quality of life, and in all likelihood they are not "healthier", because this lower number means they are spending more time with blood glucose levels that are too low. I urge the FDA to revisit this parameter of trial success, with a more expanded, less technical view.

There are other minor issues with the draft such as spelling and grammar, inappropriate links (there is one that literally links the reader to the very next paragraph) and language that just cannot be followed."

Statement from Bayer on Contour Strip Recall

2011-08-17T19:39:00.001-04:00

I just received this statement form Bayer:

BAYER HEALTHCARE RECALLS 10-COUNT and 25-COUNT VIALS OF BLOOD GLUCOSE TEST STRIPS IN UNITED STATES

US Action Follows Stop-Ship That Began in June

Tarrytown, NY --Bayer HealthCare confirmed today that it is recalling all 10- and 25- count Contour strips and 10-count Contour TS test strips from US retail stocks, retail distribution channels and offices of US healthcare professionals. The FDA is aware of this action.

These actions are not taken as a result of any adverse events reported to Bayer. Instead, Bayer is taking this action out of an abundance of caution to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing. In the FDA’s view, this deviation from US-approved specifications constituted a technical violation that required a field corrective action under US regulations.

50-count vials of Contour test strips are not affected, and strips used with Bayer’s Breeze™2 blood glucose meters are not affected.

This action follows Bayer’s decision in late June to stop new shipments of products containing the small-count vials of these test strips world-wide. And with no new shipments of small count vials into the market since that time, we believe remaining unused quantities of potentially affected product in the market are likely very small.

While it resolves this issue, Bayer has increased its stocks of 50-count vials and is using these to fulfill new orders to ensure continued, uninterrupted market access to unaffected strips.

Contact:

Susan Yarin
Bayer HealthCare
(914) 366-1738
susan.yarin@bayer.com

Possible Bayer Contour Test Strips Issue

2011-08-17T16:02:00.002-04:00

Amy at Diabetes Mine tweeted information about Bayer test strips false low readings. She wrote:

Quality issue w/ BAYER CONTOUR TEST STRIPS 4 #diabetes - some batches create falsely low #bgnow readings cot.ag/qui8Mc

Thanks Amy for brining up the issue.

I wanted more than a tweets worth of information so I called Bayer communications team. There are some possible issues strips that come in cans that shipped with small strip counts. For example: the ten count cans that came with a new meter.

This is my less than expert understanding: The issues apparently stems from shipping the low count cans and the amount of gas in the can vs strips. It seems the fewer strips and more gas can alter the chemistry of the strips slightly. This creates the possibility of reading slightly lower than they should. For you error grid fans (and there can't be anyone who is an error grid fan) Bayer told me the possible errors are in the non clinically significant error grid ranges.

My conjecture is that the issue also involves time in the cans before being opened as well but that is pure speculation on my part.

Bayer said they have stopped shipping the low count cans.

Bayer says the 50 count cans are OK. They suggest if you have any concerns to talk with you health care team or call their Bayer support number. That number as far as my search engine knows is 1-800-348-8100.

1) Don't stop testing.
2) If you have Bayer strips in cans that came with less than 50 strips call Bayer or your health care team.
3) See #1 above.

Aug 17, 11 #TwoBits

2011-08-17T13:19:00.001-04:00

Here are two bits from around the DOC on stuff that isn't currently available, at least here in the US.

Shoot Up or Put Up has a bit on the OneTouch® Verio®Pro. Pay no attention to the part where they call it an Accu-Check, I think Dave may have been low.

http://www.shootuporputup.co.uk/2011/08/review-accu-chek-onetouch-verio-pro/

Over at Corengi.com there is a post about Mankind and inhaled insulin trials. Is inhaled insulin something you would want or not so much?

http://blog.corengi.com/2011/08/interview-with-mannkind-corporation-about-new-afrezza-inhalable-insulin-trial/

Blue Candlelight

2011-08-11T14:47:00.000-04:00

Our dear friend George puts words together to express the emotions behind blue candles.

I can not equal his words to express how the Diabetes Community feels when we lose one of our own.

Please take a moment and read his.
http://www.ninjabetic.com/thebadblog/2011/8/11/blue-candlelight.html

Aug 11, 11 #TwoBits

2011-08-11T13:27:00.001-04:00

Here are two great bits from around the DOC today:

Bob on being an advocate life.
http://tminustwo.net/2011/08/10/making-room-for-advocacy/

Caroline Sweeney's letter to the editor is a great role model post for a comment to the FDA:
http://www.pressherald.com/opinion/council-should-extend-petition-limit_2011-08-11.html?pageType=mobile&id=4
(scroll down to "Keep on making progress toward artificial pancreas")

Shark Week in the DOC

2011-08-07T11:11:00.002-04:00

It is Shark Week. - A week devoted to stoking the fear of real big fish that can eat you. Not only can sharks eat you - they wants to eat you, they will eat you. Detailed research by John Beluchi illustrates they ARE coming to your door to deliver a candy-gram.

One of the staples of shark week are shows by marine biologists who like to get close to big sharks. Seemingly idiotic to us viewers, they study the predators. They try to explain how sharks are beautiful animals and not a real risk to humans. To prove this they get in a cage and provoke a shark to attack said cage. Still some information about the reality of sharks get out.

We love to be scared of things that are fairly unlikely. Sharkattackfile.info list 2 fatal USA shark attacks in 2010. At that rate injury from fights over the remote, while watching shark week, are probably just as serious a risk as an being eaten in a shark attack, land sharks not withstanding.

Media is about story telling. From the classic camp story about the convict who escaped and is hiding in these woods NOW, to sharks, scary stories sell. There is a word for this. It is sensationalism. It is a noun meaning (esp. in journalism) the use of exciting or shocking stories or language at the expense of accuracy, in order to provoke public interest or excitement.

This week, in addition to shows about sharks, the media is writing about insulin pump hacking. From what I have seen the stories don’t much understand living with a pump and the associated risk of diabetes. The media do show good imagination in creating shock and exciting language to provoke public interest.

Let be honest the public is not otherwise NOT interested in insulin pumps or living with diabetes. We hold theses truths to be self evident. Hell we’ll raise a bowl of ice cream in to honor the idea. Maybe we need to take a page from the sharks and use our week to share some of the stories about really living with diabetes.

Let’s view the hacker as the marine biologist in a cage. He is gonna see some teeth. But there are steel bars between the teeth and the camera. The hack is possible but unlikely.

The reality is diabetes is not tame. It is a real big fish that can eat you. Not only can eat you - it wants to eat you, it will eat you, unless you are constantly vigilant. (Yes I know I just mixed references to Jaws and Mad Eye from Harry Potter)

Those of us who live with diabetes have an opportunity to focus on the real risks we live not sharks.

Repeat After Me: Dear FDA...

2011-08-06T11:56:00.001-04:00

The FDA is seeking comments on how to evaluate diabetes related innovations, specifically, Low Glucose Suspend. In the simplest language that is stoping an insulin pump from delivering insulin into a person that is hypo. This is a step towards and artificial pancreas.

You can read the proposed guidnace (it run 55 pages) at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdf

Here is my four point, overly short, version of what the FDA is seeking comments on:

The FDA is proposing guidelines to consider approving low glucose suspend.
Low glucose suspend can stoping delivery of insulin to people who have had too much already.
The FDA is considering a lot of things including the risk of raising A1C with such a system.
The FDA are open to considering studies for people under age 18 but they are not there yet.

My feelings is the FDA is way behind the times. Systems designed and made in the USA are on sale around the world but not here. In part because the FDA doesn’t know how to approve it.

We deserve better.

There are a lot of reasons why we all should comment. If you care about artificial pancreas you should comment. If you don’t care about artificial pancreas you should still comment.

I think the most important reason for us all to comment is so that the FDA sees the diabetes community as a group that is capable of, and willing to, hold the FDA’s feet to the fire. The DOC should be the FDA's squeaky wheel.

People living with diabetes needs are different than virtually all other medical conditions. This is due to the extremely high level of self-management we do daily. The FDA should come to expect the DOC to comment on diabetes issues from artificial pancreas, faster insulin, smarter insulin, encapsulation of islets, and my pet peeve device interoperability through data sharing. Our voices should be part of the regulatory process. By commenting on as many diabetes issues as the FDA opens dockets for we can exercise such a voice.

The more - the better.

The issue at hand is low glucose suspend. Given the tragic cases of young lives lost to severe lows, providing tools that can help minimize and prevent such lows is important.

I of beg you, please do three things

Learn about the FDA’s proposal.
Comment on it
Send a copy of your comment to your Congressperson

The comment space is 2000 characters. Think of it as one big-ass tweet.

I encourage you to share what you write the FDA with the DOC - let others to use it as a template or help for their own comments. I welcome anyone willing to post what they write to the FDA as a link or comment here for others to use as inspiration and or a cheat sheet.

To post to the FDR public docket go here: http://www.regulations.gov/#!submitComment;D=FDA-2011-D-0464-0001

Please also copy your comment into a email to your elected officials in DC. (I did mention squeaky and the more the better right?)

The following are a few sample comments that I offer up to be copied, edited and abused as form letters. Each are well under the 2000 character limit giving you room to expand, personalize and otherwise riff on the theme.

A Comment on Live Lost to Hypos:

I am a parent of a child with type 1 Diabetes. Type 1 is extensively managed in the home by families. Yes we have a medical team of physicians, nurses, educators and more but day to day actions and decisions are made in the home by parents and teens living with diabetes.

Diabetes is difficult and stressful to manage. Diabetes varies based on a vide variety of things. The biggest risk we face and the biggest fear we have as parents is a severe hypo that results from the variety of things that impact diabetes.

This is particularly stressful at night. As you consider low glucose suspend and it non inferiority based on A1C please keep in mind that a number of young people in the type 1 diabetes community have passed away due to over night hypos recently. Being alive with a A1C that increase due to low glucose suspend would be vastly superior than another fatality from a sever night time low.

A Comment on Pediatric Approval and A1C Varibility:

Our family lives with type 1 diabetes. Day to day we are the primary managers of this chronic condition guided by our doctor and nurse educator.

As the FDA considers low glucose suspend I urge you to fast track the pediatric approval of such a device. Younger, smaller people are more sensitive to insulin as either basal or bolus injections. As such they tend to vary more than older people. Also kids face hormonal issues with growing that significantly impact and change insulin needs. Significant dose needs can change as rapidly as a few weeks.

With the higher insulin sensitivity and more variable insulin needs due to growth, children are likely to see a wide variability in blood sugar numbers expressed as A1C. This proposal suggest non inferiority based on glycemic control as quantified by A1C. As you evaluate pediatric use please consider that kids’ glycemic control is a wider range of variability that adults.

This higher variability means kids may see more and more severe hypos than adults. As a result they are more at risk and are more in need of low glucose suspend.

Please move to establish guidance for pediatric approval of low glucose suspend that recognized both the more pressing need to keep children safe and the higher variability in their glucose control.

A Comment on FDA Proactivity:

As you consider guidelines for low glucose suspend, I urge the FDA to move from being behind the ball to being proactive. Low glucose suspend is already approved and available for patients across the world. It has been coming for some time yet the FDA seems to have been unprepared for it.

The FDA should consider developing guidelines for the more advance possibilities of an artificial pancreas. This would include the low glucose suspend now under consideration, possibly systems that introduce means glucagon for severe lows as well has high glucose insulin bolusing. Beyond the artificial pancreas the FDA should be preparing guidance for the approval of faster insulins, smart insulins, better infusion sets and data processing tools that facilitate better manual and automated glucose management.

A Comment on Hacking and Distractions.

In the time since the FDA has opened this docket to consider devices to better manage type 1 diabetes through low glucose suspend, provided by multiple devices that communicate wirelessly, there have news reports about ‘hacking’ diabetes device wireless communications.

The possibility of such interference is an appropriate issue for the FDA and device manufacturers to consider and to address in a timely manner. However such willful interference is extraordinarily unlikely. It should not be seen as a reason to prevent far more significant advances to mitigate far more significant risks.

Specifically in the case of low glucose suspend, the risk of severe hypoglycemia is a real risk that has been made all the more tangible by the untimely death of young people living with type 1 diabetes in the past year. Developing guidance for the approval of devices that may have helped prevent such tragedies should be a FDA priority. Given that such devices are approved and available in other countries suggest that the FDA guidance, under consideration here, is in fact over due.

I strongly urge the FDA to prioritize risks. Hypoglycemia is currently costing the lives of American children. Guidance on device such as low glucose suspend should not be overly delayed by esoteric communications risks.

Pump Hacking and What Really Matters.

2011-08-05T17:09:00.009-04:00

In todays news: Insulin Pumps can be hacked.

Here is one of many news links:
http://www.npr.org/templates/story/story.php?storyId=138976508

I don’t find it at all surprising that pumps and meter communications can be hacked. Nor do I have a big issue with the idea of publishing it, particularly at a hacker convention in Vegas.

There is an appropriate flow of information. I don't think legitimate hacking is an oxymoron. People find vulnerabilities. They make them know. The folks who make the products fix the issues. I am good with that.

I know that I ‘hacked’ the very first pump my we had - kinda. The organization of the food database was a mess. The first few categories of foods presented were not things my 5th grade son was interested in eating (Baby Food & Beans.) I wrote the manufacture about what I saw as a usability short coming - nothing came of it.

That food database was a mark up language. I found I could manually manipulate that markup language in a text editor to put foods into the more accessible beans and baby food categories that they didn’t belong in. Well unless Lucky Charms are baby food. I guess some would make the argument that they are intended to be kids' food and go all food police on who eats what. But the food police are not the point here, devices are.

Even with my hack the food database was not a great set up. I would love to see a convenient food database, one that built meals like an iPod makes song lists from a library of foods but that ain’t happening. I think the kind of advancements in user interface, like that, are for the most part, prohibited by the process of getting the FDA to sign off on changes. It simply costs too much to be worth while.

So I hacked the food database. I am not surprised to hear that someone else hacked pump communications. I don’t think the rest of you should be too worried - both of us are fairly harmless geeks.

Short of an elaborate Colombo episode, I don’t see much incentive to maliciously hack a pump or meter. It apparently takes skill, equipment and being reasonably close to the device in question. In day to day life how often is your pump close enough to a highly skilled geek who wants to hack your pump and has a bag full of gear handy?

I think there is a risk of unintended ‘hacking’ in households with multiple people on similar devices. Say little Jane and big brother Johnny both use brand X pumps with remotes. Those remotes are basically indistinguishable. Their baby brother craws over and pulls the remotes off the table and onto the floor. There, baby pulls them out of their cases and make a general mess. (Babies do this kinda stuff for fun and they are WAY good at it.) At dinner Jane and Johnny bolus. It seems to me that in picking them up and putting them back in their pink and black cases the remotes could easily be switched. Johnny picks up Jane’s remote thinking it is his, knows he needs 12 units and fires away, shooting his little sister a bigger bolus than she needs or can reasonably eat to cover.

I think that is a far more real risk than malicious wireless hacking. I worry that the news of the wireless vulnerability reported above will distract development and regulatory efforts from making diabetes devices more useful. Useful like say different color remotes, usable food databases, smartphone data exchange or the holy grail - data standardization.

The real risk in my mind is a paralysis based on fear of the phenomenally unlikely that prevents the eminently useful from coming to market. Now you may think I am nuts. Many will agree with that. I don’t have much I can put up to defend myself from claims of craziness. I will however offer this:

Fear of adverse reactions, including raising A1Cs some undefined but magical amount, and a feeling that studying those fears is critical, is keeping advance diabetes management tools from people living with diabetes in the USA. Consider the auto suspend pump based on CGM data - it is available in a lot of countries other than these United States. The FDA doesn’t even have rules in place to consider approving it.

They are afraid of the wrong thing.

This is a year where a number of young people have passed away from overnight hypos. It seems to me that the fears around incremental changes in A1C from low glucose suspend systems are preventing tools, that may have saved lives, from getting into the homes that need them. I fear that kind of mistaken priority. I fear this hacking news could make such priority errors more common.

There are real risks involved with living with diabetes. We know that. We manage the fear associated with that and diabetes together. We need to focus on the real issues, not unlikely ones. The risk of insulin pumps being hacked is not anywhere near as news worthy as the fact that US access to technology is behind the rest of the world's. That devices that are designed and manufactured here, are only sold overseas, is a real issues.

I submit that the cost and delays involved with the FDA regulatory process are more harmful than a hacker in Vegas. What happens in Vegas stays in stories that don't stay in Vegas. What doesn’t happen in Washington costs lives across America.

Please read my good friend Kerri's post on this same subject at:
http://sixuntilme.com/blog2/2011/08/hacked_jay_radcliffe_insulin_p.html

Or Scott Hanselman's (Of Scott's Airplane Analogy in my side bar) at:
http://www.hanselman.com/blog/HackersCanKillDiabeticsWithInsulinPumpsFromAHalfMileAwayUmNoFactsVsJournalisticFearMongering.aspx

Kelly Booth:

http://kellywpa.wordpress.com/2011/08/07/pump-hackers-revisited/#comment-2184

Mike Hoskins
http://www.thediabeticscornerbooth.com/2011/08/hacking-into-real-concerns.html

Sara Nick's
http://momentsofwonderful.com/2011/08/08/insulin-pump-hackers-do-not-care-about-me/

Matt McGuire
http://type1online.com/hacking-insulin-pump-47.html

Medtronic response on TuDiabetes
http://www.tudiabetes.org/forum/topics/pump-hack-q-and-a-posts

Animas response on TuDiabetes
http://www.tudiabetes.org/forum/topics/statement-from-animas-about-pump-hack

K2
http://diabetesaliciousness.blogspot.com/2011/08/im-not-afraid-of-my-pump-being-hacked.html

Coco

2011-07-06T15:13:00.001-04:00

- Posted using BlogPress from my iPhone

Lilly and Disney at FFL and Beyond

2011-07-06T13:20:00.002-04:00

Lilly is connecting with Disney to help families live with diabetes. I was one of a few bloggers who received a little sneak preview of some of their early steps this morning.

Type 1 care is more than tests and shots and I think both Lilly and Disney are taking real steps on a path that I hope evolves into a broad spectrum of support for living with t1 with hope and optimism.

Here is a quick overview: Lilly and Disney showed a kids book with Goofy (my non d son's favorite when he was little) and a new type 1 character. The story line helps break down some misconceptions and gives kids with t1 a Disney character of their own. They also announced an official guide to the parks for type 1 visitors. It is a start that I hope leads to better type 1 awareness in the parks. My dated unofficial guide is at http://DisneyWithDiabetes.com.

They also announced a new website at

http://family.go.com/parenting/pkg-type-1-diabetes/

I played with it on their iPad. It is a great start for newly dx families. I look forward to seeing this site and the other parts of the relationship grow. Chapter books for Tweens, cooks books for me and more. I applaud the idea that type 1 care is more than drugs. It is a whole person thing.

There is some official legal gibberish that I am meant to include that says I went to an educational event. What is important is that they did NOT give me an iPad or anything else cool. (I considered trying to swipe the iPad but I was badly out numbered) In all fairness, what I get wrong about this cool start to a future of Lilly and Disney working together is my fault not theirs. I will attach that legal stuff when I get the official copy but for now this is posting from my phone in the hallway.

FTNW: Data Standards

2011-06-21T09:06:00.000-04:00

Here are a few quick links that help make the case for data standards, not just for diabetes management but in the larger health context. I particularly like this little comment about standards as "a path out of high-cost, locked proprietary systems in the end-to-end ecosystem."

http://www.cmio.net/index.php?option=com_articles&article=27860&publication=56&view=portals

http://www.technewsdaily.com/biometric-sensor-networks-health-2711/

Thank for the Father's Day Shoutout

2011-06-14T09:50:00.000-04:00

I was thrilled to be asked by Sanofi's Discuss Diabetes to join in their fathers day series of blog posts. I am privileged be there with some other guys who I an happy to call friends to share a few thoughts on being a diabetes dad.

Knowing the many great dads in the diabetes online community it is an honor to be asked to be one of the guys representing all of us this week. Yesterday they featured my good friend Manny Hernandez. No spoilers other than to say some other great dads are coming later in the week. I know I look forward to hearing from them.

I am sure all of us featured and all the diabetes community dads agree that the real privilege isn't about a day, it is the joy of the 24/7 lifetime fatherhood gig.

Thanks Laura for the invitation to represent the brotherhood of diabetes dads. I hope I do us all proud.

Pennsylvanians: Oppertunity to Support of Safe at School Legislation

2011-06-03T11:46:00.001-04:00

Pennsylvanians: Safe at School legislation for diabetes is pending and we have an opportunity to be supportive of it to our legislators.

The ADA has a quick and easy way to reach out. I also suggest sending and individualized communication if possible. Here is a link to ADA's information on the issue. As always vote early and often.

Here is what I wrote:

Students with diabetes most typically are type 1 diabetics. That is the form of diabetes that is an autoimmune disease. They require insulin injections and management, not as the result of life styles but as a result of their bodies no longer making insulin. Injected insulin is a balancing act. Many of the daily school events from physical education to the stress of academic work can and do impact that insulin balance. Kid may need help maintaining that balance.

With two insulin dependent type 1 students, I know first hand that this is a challenge. The clarity of this legislation will make life easier for schools, parents and mostly kids.

Safety for Pennsylvania students with diabetes means making sure schools understand diabetes and create safe environments for students to learn. More than anything schools, all schools public and private need guidance on how to create that safe environment. This legislation provides even handed, wise guidance.

Often schools officials see significant problems in creating that safe environment. The bill you are considering helps create that environment in a cost effective way. It provides for schools to train adults in the school to safely respond to an emergency when a nurse is not available.

In the current time of budget constraints safe at school programs that train adults to respond can help maintain a safe learning environment in a medically, educationally and fiscally sound manner.

FTNW: Animas/Dexcom Vibe gets CE Mark

2011-06-02T09:35:00.000-04:00

From the News Wire: Animas Dexcom CGM combo get approved in Europe. Here are the highlights and a link:

Animas® Vibe™, the First Integrated Offering from Animas Corporation and Dexcom, Inc., Receives European CE Mark Approval:

WEST CHESTER, PA, June 2, 2011 /PRNewswire/ — Animas Corporation announced today the receipt of CE Mark approval for Animas® Vibe™, the first and only continuous glucose monitoring (CGM)-enabled insulin pump system with Dexcom G4™ CGM technology. Animas® Vibe™ brings together the unique features of an Animas® insulin pump and the convenience of Dexcom CGM, which is the only sensor approved for up to seven days of wear. More here.

Thanking a Brilliant Star

2011-06-01T11:12:00.000-04:00

There is a nice article on Boston.com about people who have lived with type 1 diabetes for a log time. Like half to three quarters of a century. The story is about the things that made them thrive not just survive.

I think that thriving is a great plan. It takes other people to make thrive happen. I encourage you to read the article with an eye towards seeing how others help you thrive. I think about that in the context of this line from the piece, “With the right constellation of proactive activity, you can manage it.’’

Managing it, thriving, require a constellation. A whole bunch of stars. Stars do a lot. They inspire, they can be a point to navigate by and sometimes they just sparkle. They can’t be seen in the bright light of daily activity, they come back out in the quiet of the night.

Certainly individual stars shine bright, moms are key in this article and in most diabetic kid’s lives, yet they are not alone. There is a constellation.

I like to think of all of you as part of our constellation. You are all stars in my eyes and if our respective daily activity prevents me from seeing you shine today, I know calm clear nights are coming to help me see you all.

Thank to each of you for sharing your individual brilliance.

Oh and and bacon too. You know who you are and you are a star.

LY/MI

FTNW: Continua

2011-05-27T12:12:00.000-04:00

FTNW for those who don't know but may care, and that is a small small group I am sure, is From The News Wire. My short hand for stuff that may be of interest.

This one is about the Continua Heath Alliance. It is something I keep an eye on as it may be a source of data standardization.

So for my few fellow geeks, here is a link to the latest state of the Alliance bit from Continua.

Vote Jen

2011-05-26T18:55:00.000-04:00

The DOC's own Jen Hanson (See Crazy Cool Canucks) has been selected as a finalist in 2011's Explore Magazine Top 30 Under 30 Outdoor Adventurer Contest!

The winner will be announced next week, and chosen based on the finalist with the most number of votes (facebook likes). Here how to show Jen some of that DOC Love Ya / Mean It vibe:

1. First, 'LIKE' the Explore Facebook Page (found here: www.facebook.com/exploremag)
2. Click on, and 'LIKE' Jen photo (by following this link: http://on.fb.me/jVr5ye )

Do your DOC thing. Vote Jen.

FTNW: Interoperablity

2011-05-25T13:54:00.000-04:00

Ran into this blog post today:

Lack of Interoperability Limits Personal Health Solutions

One of the key recommendations is that the buyers of personal health solutions need to understand and value interoperability, and demand it from vendors.

“The project partners share the belief that if Europe wants to reap the full benefit of personal health systems, health stakeholders must understand the benefits of interoperability, and be empowered to demand those systems from vendors”, says Veli Stroetmann, researcher at Empirica. “Only if there are buyers who demand interoperable systems, vendors will bring them to market.”

I would to have the option of demanding systems instead of systems being demanded by type 1. Veli, I don't think you get it, that kind of influence exists in discretionary markets, where folks can choose not to use products. Type 1 diabetics don't have the option of not choosing a glucose meter.

FTNW: Medtronic Research

2011-05-24T13:14:00.000-04:00

When Medtronic held their social media summit in April one of the topic of conversation was the wealth of data that the CareLink system creates. An obvious question is how is that data studied and is it open to folks outside the big M.?

Today Medtronic with ADA announced such studies. These are anonymous, hippa compliant uses. You can read more at the ADAlink:
http://www.diabetes.org/for-media/2011/Medtronic-Research-Grant-Release-2011.html

FTNW: Pearl Insulin Pump 510k Cleared

2011-05-17T20:23:00.000-04:00

New Pump gets 510(k) clearance. From their web site: http://www.asantesolutions.com

Pearl Insulin Pump. It’s designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump -- or are considering it. The small and sleek Pearl is the only pump that uses a pre-filled 300-unit insulin cartridge. That’s right . . . no more reservoir filling. No need to handle syringes to fill our pump. No battling pesky air bubbles from filling reservoirs. It’s a simple yet elegant pump solution – Asante Solutions.

I Was Wrong.

2011-05-17T19:18:00.004-04:00

I know! Who would think I could be wrong?

(That should get a long list of comments consisting of “Me” and let me just say hi to Tim who will be prominent on that list.)

In addition to all the playing nice in the sand box with JDRF that I reported about in yesterday’s recounting of Scott and Bennet’s excellent JDRF IDDP adventure, we did have some specific questions. I know one of mine was about Amylin and leptin analogs.

As an aside I was not only wrong but also daft, I just finished a class, for which I memorized stuff about leptin but somehow couldn’t associate metreleptin with leptin but enough of my digression about being daft. (Which I am also sure Tim will appreciate.)

Leptin, is hormone produced in fat tissue that plays a key role in regulating metabolism. My text book says it does this "by affecting hunger. As your fat stores increase, leptin signals the brain to decrease your level of hunger and food intake." (Joan Blake, Nutrition and You, 2012, Benjamin Cummings, one hundred bucks but I am not bitter about the price)

Anyway, I made note of JDRF entering into an IDDP project with Amylin last November for a study of metreleptin. I know that I was confused when Amylin and Takeda announced a suspension of trials of pramlintide/metreleptin. (Pramlintide is marketed by Amylin as SYMLIN® just in case there isn't enough name confusion.) I was very confused, particularly when I found a JDRF newsletter in the mail that had an article on Amylin a few weeks later.

So here is the straight story. These are two different studies of the same analog, in different groups, for different reasons. The JDRF IDDP is still on.

Let me quote JDRF:

... to follow up on our conversation from last week about the recently halted metreleptin study, which you had asked about. As we discussed, Amylin and Takeda Pharmaceutical Companies recently suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of an investigational combination therapy using pramlintide and metreleptin for the treatment of obesity. This is a separate trial from the metreleptin study JDRF and Amylin are collaborating on.

They go on to say:

As for the metreleptin study that JDRF and Amylin Pharmaceuticals are partnering on, we, along with The University of Texas Southwestern in Dallas (the institution where the trial is taking place) will continue to monitor trial participants in accordance with the team’s diligent safety monitoring strategy, which has been approved by the university’s Institutional Review Board and FDA. Additionally, in light of the recent findings with metreleptin in the above-mentioned obesity trial, the team has consulted with the FDA and will continue to as the study proceeds.

So there you have it folk, I was wrong when I thought they were the same investigation. I don't think I wrote anything here about that confusion but I am sure I was confusing none the less. On the plus side, I now know how to get fast answers to questions like, “Hey was that the Amylin study JDRF did an IDDP with?“ when I am reading the news.

There you have it, YDMV - fairly accurate-ish.

p.s. I don't think either of these is the May 10th IDDP on mixing insulin and SYMLIN®.... maybe I better check.

Scott and Bennet’s JDRF Adventure

2011-05-16T13:20:00.002-04:00

I have written periodically about JDRF’s IDDP program. Occasionally I have had conversations either via email exchanges on on the phone with JDRF’s communications staff about IDDP. For those less interested in alphabet soup, IDDP stands for Industrial Discovery and Development Partnerships. This is a smaller portion of JDRF’s activities as measured in dollar terms, maybe 10% of their funding budget. The goal of IDDP is to help transition discoveries from the lab to therapeutic options in the clinic.

I think the IDDP program is valuable. I am added a link in my sidebar with the Newbie link and Teens that can help anyone interested find more about what I have said about IDDP. (I realize that is probably a very small group.) In time I’ll ad a post that includes other good pieces on the projects.

There is a wide series of gaps between the discoveries we read about in laboratories and the options our care team can prescribe. Each gap being another step along a regulatory process from lab to pharmacy. This path will be followed by better care options and it will be true of any incremental steps to a cure.

Here is what those gaps cumulatively look like. Bringing a pharmaceutical treatment to market is estimated in one research study cost $1.3 billion, yes with a “B” and take 7.9 years.¹

IDDP helps bridge gaps at strategic points. These may be points where industry is less inclined to do take some of the steps along that 1.3 billion dollar process or possibly steps where a type 1 application for a product is not seen by a pharmaceutical company. You can think of it as JDRF helping to push the processes along at key sticking points.

Even representing a fraction of JDRF’s funding budget the amounts involved are substantial. So I believe there is a need for clear communications on what these partnerships entail. I think this is one way that bloggers can serve our community. (This post is about Scott and Bennet's excellent JDRF adventure, for a primer on IDDP here is a link.)

Last week Scott Strumello and I had the opportunity to to meet with JDRF in their New York offices for an extended conversation on IDDP. I was anxious to have Scott participate. He and I share an interest in writing about the business side of diabetes. We have both written about the IDDP process.

I think he writes in deeper detail while I write try to translate business writing into a more common vernacular. Somewhere in there, between the two of us, I hope folks get an insight they may not otherwise have. I respect and admire Scott’s writing. I consider him a friends and am proud to join him in writing about IDDP. In fact I would not have scheduled a meeting at JDRF without him as every Andy Sipowicz needs a Bobby Simone. I am not sure who is which.

Scott and I with Rachel Steingardt, Joana Casas and Gary Feit of JRFD’s communications team first. We talked about social media and more transparent means of JDRF sharing information in general and the IDDP program specifically.

We were then joined by Richard Insel, MD, JDRF’s Chief Scientific Officer and Karin Hehenberger, MD, Ph.D. Senior Vice President of Strategic Alliances. Jeffery Brewer JDRF’s CEO was going to join us but he was ill. (Insert your joke about me making people sick here.) Jeffery has since followed up with an email which was very gracious. I greatly appreciate that as sign of his openness. My good friend Kelly Kunik speaks well of him and that is high praise in my book.

I had scores of questions going in but the question that troubled me the most was this; how could I approach JDRF with detailed and potentially tough questions about IDDP projects and be seen as an advocate of people living with type 1 and not simply a critic? In fact that I think was the real goal. To open lines of communications that could facilitate better communications about these projects. To be able to learn on an ongoing basis share what we learn with the diabetes online community. I think Scott and I were received with respect and developed a level of rapport that will facilitate our future writing on IDDP.

I will close with one point that Dr. Hehenberger made very clear in our conversations. The IDDP program isn’t just about financial investments in specific projects with for profit businesses. More significantly is a sharing and networking of JDRF contacts in a wide variety of labs with a similarly wide set of contacts in industry to help bring the two together to get promising research out of the lab.

Hopefully our meeting was a similar opportunity to bring transparency to IDDP efforts. I hope we can help those of us who Walk with JDRF for a Cure to see IDDP projects as a positive step in the mix of efforts JDRF facilitates.

¹ Kaitin K, Clinical Pharmacology & Therapeutics (2010) 87 3, 356–361. doi:10.1038/clpt.2009.293