Gary, Think Like a Pancreas, Scheiner as a short class on diabetes and pizza as a sample of the way classes at his Type 1 University work. Pizza is a challenge for a lot of folks so why not have Gary help demystify it.
April 30, 2011
April 27, 2011
Phil Southerland - "Not Dead Yet"
In the preface to his book, “Not Dead Yet” Phil Southerland asks, “Who am I to write a memoir when I am still in my twenties?”
'Cause you’re an aggressive, competitive, sometimes cocky, heck of an inspiration. Philbert.
This is the story of an ordinary kid. A kid with some passion and personal ambition who chased a dream and found some unexpected consequences while making other plans. I am not even sure that it is extraordinary that this kid brought type 1 diabetes, literally, along for the ride.
I am a parent to two type 1 diabetics. I find the most amazing thing about kids and adults successfully living with type 1 is their ability to put diabetes in its place. Second, close, but not first. It gets attention but not the title. Diabetes comes second to living life. These folks drag diabetes, kicking and screaming, into their dreams of the future. Dreams that diabetes at first seems to deny, yet in many enables. Dreams of acting, competing, writing, parenting, contributing and yes even professional bike racing.
Phil’s is one of these story. Diabetes, his family was told, would close off personal dreams and aspirations with blindness and early death. Ultimately it facilitated greater opportunities. That the story unfolds in this book.
It is not the story of a master plan but a process of growth to a life beyond, in spite of and because of diabetes. It is a story with a positive supporting cast of halloween candy, Snickers, Oreo Blizzards, Super Big Gulps, burritos and characters that come with them. I encourage you to discover and experience them yourself. They brought me a lot of big smiles.
As a type 1 parent I was particularly interested in reading how Phil viewed his mom’s roll in his life and with diabetes. I carefully make a distinction as we have rolls as parents and in diabetes management but they aren't always the same things. I see type 1 parents’ goal as raising kids to be creative, individuals actively purse their dreams as moral, useful contributors to society bringing diabetes along. That process isn’t flipping a switch and saying “Done!” it is gradual evolution. Seeing that process unfold in Phil’s life from the child, teen and adult’s perspectives is a uniquely valuable view for parents regardless of diabetes.
Phil’s story reinforces my belief that parenting diabetic kids isn’t about numbers. It is about the values that make for creative, active, useful, participant in life. On the rare occasion that Phil’s story talks about numbers it is to make points beyond them. About self care needed to facilitate the dreams. That Phil’s journey isn’t about numbers and is about discovering and channeling passions is a wonderful affirmation of brilliant parenting.
To a dad of two type 1 kids and two kids with their own challenging opportunities Phil hits real close to home when he writes about the risk of the non diabetic siblings becoming the others. That is something the diabetes parenting community doesn’t talk enough about. I worry that I am guilty of falling down in this area but take comfort in the idea that I fall down and stand up for the diabetics too. I hope my lack of parental perfection evens itself out.
A lack of perfection is one of the false gods of diabetes. We make idols to it and pray to those idols seeking comfort in numbers. In doing so we elevate numbers to goals and risk a myopia that totally misses the idea that variation can be part of a healthy learning process. Phil ranged about seeking adventures on a bike. Numbers went along not in the pursuit of perfection but in the support of the freedom to roam.
One of my favorite lines from the book anticipates being less than perfect. It is brilliant, sage and simple advice, “A key part of being a diabetic is choosing trustworthy friends, reliable friends that you can depend on in a crisis.” I submit that is equally true if you take out ‘being a diabetic’ and insert ‘life’ but possibly more true for diabetics.
I think that a similar substitution is true of the book as a whole. It isn’t about diabetes it is about life. As such “Not Dead Yet” is great read for anyone whether they live with diabetes or not.
Through this book Phil becomes a friend. It is clear that, as a regular guy, he expresses friendship through good natured ribbing and honest, brief, airing of differences. So here friend, three hundred odd pages and other than a typo on page 272 (that is OK, I am good for a typo every sentence or two) I loved all but three words. The title.
To me type 1 isn’t about death it is about living. That I have such a different attitude from our family’s experiences than he does from his says a lot about the changes in expectations from Phil’s diagnosis in 1982 to our first twenty years later. So I affectionately recommend to Junior a better title, from last three words, of the first paragraph, on his second to last page.
“I will Live”
The problem with my suggestion is to see that title’s real value, you need to have traveled the previous three hundred and seven pages. Those pages share Phil’s story of how to really live. It is a great ride. I recommend it highly.
I was given an review copy. I intended, after reading, to raffle it off. Having finished it, I want the kids to read it. So sorry you will have to buy a copy.
I understand the book goes on sale Tuesday May 10. There is a Pre-Order link right up there in the spiffy banner the PR folks let me use.
I look forward to sharing comments and spoilers as folks get their own copies.
'Cause you’re an aggressive, competitive, sometimes cocky, heck of an inspiration. Philbert.
This is the story of an ordinary kid. A kid with some passion and personal ambition who chased a dream and found some unexpected consequences while making other plans. I am not even sure that it is extraordinary that this kid brought type 1 diabetes, literally, along for the ride.
I am a parent to two type 1 diabetics. I find the most amazing thing about kids and adults successfully living with type 1 is their ability to put diabetes in its place. Second, close, but not first. It gets attention but not the title. Diabetes comes second to living life. These folks drag diabetes, kicking and screaming, into their dreams of the future. Dreams that diabetes at first seems to deny, yet in many enables. Dreams of acting, competing, writing, parenting, contributing and yes even professional bike racing.
Phil’s is one of these story. Diabetes, his family was told, would close off personal dreams and aspirations with blindness and early death. Ultimately it facilitated greater opportunities. That the story unfolds in this book.
It is not the story of a master plan but a process of growth to a life beyond, in spite of and because of diabetes. It is a story with a positive supporting cast of halloween candy, Snickers, Oreo Blizzards, Super Big Gulps, burritos and characters that come with them. I encourage you to discover and experience them yourself. They brought me a lot of big smiles.
As a type 1 parent I was particularly interested in reading how Phil viewed his mom’s roll in his life and with diabetes. I carefully make a distinction as we have rolls as parents and in diabetes management but they aren't always the same things. I see type 1 parents’ goal as raising kids to be creative, individuals actively purse their dreams as moral, useful contributors to society bringing diabetes along. That process isn’t flipping a switch and saying “Done!” it is gradual evolution. Seeing that process unfold in Phil’s life from the child, teen and adult’s perspectives is a uniquely valuable view for parents regardless of diabetes.
Phil’s story reinforces my belief that parenting diabetic kids isn’t about numbers. It is about the values that make for creative, active, useful, participant in life. On the rare occasion that Phil’s story talks about numbers it is to make points beyond them. About self care needed to facilitate the dreams. That Phil’s journey isn’t about numbers and is about discovering and channeling passions is a wonderful affirmation of brilliant parenting.
To a dad of two type 1 kids and two kids with their own challenging opportunities Phil hits real close to home when he writes about the risk of the non diabetic siblings becoming the others. That is something the diabetes parenting community doesn’t talk enough about. I worry that I am guilty of falling down in this area but take comfort in the idea that I fall down and stand up for the diabetics too. I hope my lack of parental perfection evens itself out.
A lack of perfection is one of the false gods of diabetes. We make idols to it and pray to those idols seeking comfort in numbers. In doing so we elevate numbers to goals and risk a myopia that totally misses the idea that variation can be part of a healthy learning process. Phil ranged about seeking adventures on a bike. Numbers went along not in the pursuit of perfection but in the support of the freedom to roam.
One of my favorite lines from the book anticipates being less than perfect. It is brilliant, sage and simple advice, “A key part of being a diabetic is choosing trustworthy friends, reliable friends that you can depend on in a crisis.” I submit that is equally true if you take out ‘being a diabetic’ and insert ‘life’ but possibly more true for diabetics.
I think that a similar substitution is true of the book as a whole. It isn’t about diabetes it is about life. As such “Not Dead Yet” is great read for anyone whether they live with diabetes or not.
Through this book Phil becomes a friend. It is clear that, as a regular guy, he expresses friendship through good natured ribbing and honest, brief, airing of differences. So here friend, three hundred odd pages and other than a typo on page 272 (that is OK, I am good for a typo every sentence or two) I loved all but three words. The title.
To me type 1 isn’t about death it is about living. That I have such a different attitude from our family’s experiences than he does from his says a lot about the changes in expectations from Phil’s diagnosis in 1982 to our first twenty years later. So I affectionately recommend to Junior a better title, from last three words, of the first paragraph, on his second to last page.
“I will Live”
The problem with my suggestion is to see that title’s real value, you need to have traveled the previous three hundred and seven pages. Those pages share Phil’s story of how to really live. It is a great ride. I recommend it highly.
I was given an review copy. I intended, after reading, to raffle it off. Having finished it, I want the kids to read it. So sorry you will have to buy a copy.
I understand the book goes on sale Tuesday May 10. There is a Pre-Order link right up there in the spiffy banner the PR folks let me use.
I look forward to sharing comments and spoilers as folks get their own copies.
April 26, 2011
What's In a Number?
I just read a comment from a parent who was disappointed by an A1C, in a kids full into puberty. It had gone up a half a point to the lower 8s. The parent was upset. Here is my reply:
This is the problem with numbers. They miss the point.
If there had been no number, you may well have been pleased to hear the doctor say that you, both of you, are coping with the swings of puberty as well as your endo could expect. That you are adapting and making changes appropriately. You could take pride in hearing nobody could have managed the diabetes better. You could have felt great about an active life style, that while it adds to the challenges of blood sugar management now, is a great life style habit that most Amarican's lack and will contribute greatly to years of healthy living.
I say it all the time, our goal as parents is to raise kids to be creative, actively purse their dreams as moral, useful contributors to their communities bringing diabetes along for the ride. None of that is about any one BG or A1C number. It is all about long term focus most of which has little to do with diabetes per se. All the diabetes management is a means to an end and that end isn't numbers it is quality of life that can't be expressed in a number.
Numbers aren't the point.
Raising kids to become great young adults is the goal.
Numbers, at best, are a means along the path to that end.
Be proud of every step to the real goal. You're doing fine.
This is the problem with numbers. They miss the point.
If there had been no number, you may well have been pleased to hear the doctor say that you, both of you, are coping with the swings of puberty as well as your endo could expect. That you are adapting and making changes appropriately. You could take pride in hearing nobody could have managed the diabetes better. You could have felt great about an active life style, that while it adds to the challenges of blood sugar management now, is a great life style habit that most Amarican's lack and will contribute greatly to years of healthy living.
I say it all the time, our goal as parents is to raise kids to be creative, actively purse their dreams as moral, useful contributors to their communities bringing diabetes along for the ride. None of that is about any one BG or A1C number. It is all about long term focus most of which has little to do with diabetes per se. All the diabetes management is a means to an end and that end isn't numbers it is quality of life that can't be expressed in a number.
Numbers aren't the point.
Raising kids to become great young adults is the goal.
Numbers, at best, are a means along the path to that end.
Be proud of every step to the real goal. You're doing fine.
April 19, 2011
Type 2 Autoimmune - Say What?
A Standford / U of Toronto study suggest that type 2 may have roots in an autoimmune process.
That link is http://med.stanford.edu/ism/2011/april/engleman.html and in part it says:
The significance is that this suggest a new process for type 2, an autoimmune process. The study suggest treatments based on this autoimmune reaction that are new ways of addressing type 2, specifically an antibody called anti-CD20. This antibody is already approved for use in humans to treat some blood cancers and autoimmune diseases.
Daniel Winer, DM of Stanford says, “We are in the process of redefining one of the most common diseases in America as an autoimmune disease, rather than a purely metabolic disease.”
As regular readers may have guessed, mice were involved in the studies. How this translates to humans is an open issue. This statement warented it own paragraph in the relaease: "Despite the treatment’s effectiveness in mice, the researchers caution against assuming rituximab will work in humans with established type-2 diabetes."
More Studies are require.
YDMV.
That link is http://med.stanford.edu/ism/2011/april/engleman.html and in part it says:
Nearly all type-2 diabetes drugs marketed today are designed to control a patient’s high blood sugar levels — a symptom of the body’s inability to respond properly to insulin. However, the researchers found that anti-CD20, which targets and eliminates mature B cells, could completely head off the development of type-2 diabetes in laboratory mice prone to the disorder and restore their blood sugar levels to normal.As I understand this release, and let me be clear - I don't understand it, T cells and B cells inflame fatty tissues. This results in fat cells growing so rapidly that they exceed their blood supply and begin to die. To clean up the dieing cells the immune system creates macrophages. This process of inflammation, dieing and clean up inhibits the remaining fat cells ability to respond to insulin.
The significance is that this suggest a new process for type 2, an autoimmune process. The study suggest treatments based on this autoimmune reaction that are new ways of addressing type 2, specifically an antibody called anti-CD20. This antibody is already approved for use in humans to treat some blood cancers and autoimmune diseases.
Daniel Winer, DM of Stanford says, “We are in the process of redefining one of the most common diseases in America as an autoimmune disease, rather than a purely metabolic disease.”
As regular readers may have guessed, mice were involved in the studies. How this translates to humans is an open issue. This statement warented it own paragraph in the relaease: "Despite the treatment’s effectiveness in mice, the researchers caution against assuming rituximab will work in humans with established type-2 diabetes."
More Studies are require.
YDMV.
April 18, 2011
Tea and Crumpets News Network: Minimed Enlite
News and comments on diabetes products from Europe is getting to be a regular staple of YDMV. On one hand it is good that new products are coming to market. On the other it is less than awesome that these things are not available here. It speaks volumes about the state of regulatory affairs that innovations for better care are happening in Ye Olde Countries and not in the the Colonies of the New World.
Our good friends at Shoot Up have a post up on the new MM Enlite sensor. Sort version of the story; smaller, less harpoon like inserter, six day life. The folks at Shoot Up are doing there best to get'm to try'm. Stay tuned to the Tea and Crumpets News Network (TCNN) for a review. Click over to the other side of the Atlantic and read up:
http://www.shootuporputup.co.uk/2011/04/the-age-of-enlite-enment/
http://www.shootuporputup.co.uk/2011/04/let-there-be-enlite/
Editors Note: It may be wise to click out now. All that follows is a pointless and silly rant.
Somehow the brain trust in Regulatory Prohibitions on Communications Division (#NotIntendedToBeAFactualStatement) of the FDA doesn't quite appreciate that information is fungible.
I can hears some alert readers, who haven't had coffee yet, asking, "What the heck did he just say, fungus-able? Information has a fungus, is that like a computer virus? Honey! Do we have Norton Anti-Virus updated? "
Don't get you knickers in a knot. Fungible means easily replaced with an other identical item. Money is fungible. Any one dollar can be use just like the next. Information is easily replaced with... other information. Nothing is as exchangeable as words.
Information that is prohibited by the FDA here is easily replaced with information from other sources. So while MM can't say Jack Diddly to anyone in the U.S. of A. about a new sensor (and for the record it was actually funny to listen to the verbal gymnastics that they went through not to say anything about new products at #MdetronicDAF), we can read our friends across the pond who can say something about the new sensors. The information get fungible-ed... er... something like that.
There in lies a problem: Information isn't as fungible as money.
Now folks, far be it from me to suggest that Bloggers are possibly flawed. (Other ones. Not me, of course.) It seems that instead of having patients rely on some kind of 21st century whisper down the lane it would be better if the vendors could come out and offer comments and or corrections on the misstatement that may work there way into blog-o-sphere mishmashes.
So in an effort to sort out the mess I am making here (a mess that is kinda making my point along the way) there is not a Regulatory Prohibitions on Communications Division at the FDA as far as I know. There are new sensors and meters available in Europe that aren't through the FDA black ops process (Black Ops = #NotIntendedToBeAFactualStatement.) More innovations including CGM enabled pumps are on the way into European markets and simultaneously US regulatory delay. I think we would all be better served if y'all didn't find out about these things solely from 'reputable' unofficial sources like say, me.
Seriously, I know better than to trust me.
All of this is not to say that I do not value the goals of the FDA or a regulatory process. I believe there is great value in safe devices (#IntendedToBeAFactualStatement). I like all parents of kids with T1 diabetes want the best for their kids. That starts with safe. I also believe that efficient markets crave information and that it is not detrimental to safety of patients or markets to have factual information responsibly shared by the people who know that information best. Best, in this case, would include the folks who make said devices.
Our good friends at Shoot Up have a post up on the new MM Enlite sensor. Sort version of the story; smaller, less harpoon like inserter, six day life. The folks at Shoot Up are doing there best to get'm to try'm. Stay tuned to the Tea and Crumpets News Network (TCNN) for a review. Click over to the other side of the Atlantic and read up:
http://www.shootuporputup.co.uk/2011/04/the-age-of-enlite-enment/
http://www.shootuporputup.co.uk/2011/04/let-there-be-enlite/
Editors Note: It may be wise to click out now. All that follows is a pointless and silly rant.
Somehow the brain trust in Regulatory Prohibitions on Communications Division (#NotIntendedToBeAFactualStatement) of the FDA doesn't quite appreciate that information is fungible.
I can hears some alert readers, who haven't had coffee yet, asking, "What the heck did he just say, fungus-able? Information has a fungus, is that like a computer virus? Honey! Do we have Norton Anti-Virus updated? "
Don't get you knickers in a knot. Fungible means easily replaced with an other identical item. Money is fungible. Any one dollar can be use just like the next. Information is easily replaced with... other information. Nothing is as exchangeable as words.
Information that is prohibited by the FDA here is easily replaced with information from other sources. So while MM can't say Jack Diddly to anyone in the U.S. of A. about a new sensor (and for the record it was actually funny to listen to the verbal gymnastics that they went through not to say anything about new products at #MdetronicDAF), we can read our friends across the pond who can say something about the new sensors. The information get fungible-ed... er... something like that.
There in lies a problem: Information isn't as fungible as money.
Now folks, far be it from me to suggest that Bloggers are possibly flawed. (Other ones. Not me, of course.) It seems that instead of having patients rely on some kind of 21st century whisper down the lane it would be better if the vendors could come out and offer comments and or corrections on the misstatement that may work there way into blog-o-sphere mishmashes.
So in an effort to sort out the mess I am making here (a mess that is kinda making my point along the way) there is not a Regulatory Prohibitions on Communications Division at the FDA as far as I know. There are new sensors and meters available in Europe that aren't through the FDA black ops process (Black Ops = #NotIntendedToBeAFactualStatement.) More innovations including CGM enabled pumps are on the way into European markets and simultaneously US regulatory delay. I think we would all be better served if y'all didn't find out about these things solely from 'reputable' unofficial sources like say, me.
Seriously, I know better than to trust me.
All of this is not to say that I do not value the goals of the FDA or a regulatory process. I believe there is great value in safe devices (#IntendedToBeAFactualStatement). I like all parents of kids with T1 diabetes want the best for their kids. That starts with safe. I also believe that efficient markets crave information and that it is not detrimental to safety of patients or markets to have factual information responsibly shared by the people who know that information best. Best, in this case, would include the folks who make said devices.
April 14, 2011
Carb Counts and Beyond
Lesson From Toy Story
Pixar’s Toy Story has had a huge impact on our family. We are fans. Geeky, buy the behind the scenes book about the art of Pixar, fans.
We went to Disney World’s Halloween Party dressed as Toy Story characters. Twice. Well Kelley was Tinker Bell the first year.
That takes me to geekdom and beyond.
All those years ago Buzz Lightyear has some sound advice, to infinity and beyond. It seems like carb counting stretches out indefinitely. That’s not a bad thing. It means looking to a long healthy future and dragging diabetes along - like slink dog’s rear end. Some times it waddles along fine. Other times it come shooting up and rebounds past where you want it.
I think folks in the diabetes universe are light years ahead of most folks ‘casue we read the sides and backs of food packages. We are carb counters. So since we are reading all these labels anyway why not glance at something in addition to the carbs? Just pick one and see if you're getting what you need or too much of it.
Consider salt.
The amount we get in the diet from the shakers on the table and in the kitchen is probably less than 10% of what Joe Schmo eats. And while we worry about the carb counts of restaurant menus they are really burying us with salt too. Have a look at these dishes. WTH like we don’t have enough issues already. http://health.yahoo.net/experts/eatthis/saltiest-foods-2011
Come to think of it the movie popcorn is probably less than health food. That said, the mental health value of movies with the kids last to infinity and beyond.
Pixar’s Toy Story has had a huge impact on our family. We are fans. Geeky, buy the behind the scenes book about the art of Pixar, fans.
We went to Disney World’s Halloween Party dressed as Toy Story characters. Twice. Well Kelley was Tinker Bell the first year.
We were all Zurgs the second time. Yes I made all the costumes.
That takes me to geekdom and beyond.
All those years ago Buzz Lightyear has some sound advice, to infinity and beyond. It seems like carb counting stretches out indefinitely. That’s not a bad thing. It means looking to a long healthy future and dragging diabetes along - like slink dog’s rear end. Some times it waddles along fine. Other times it come shooting up and rebounds past where you want it.
I think folks in the diabetes universe are light years ahead of most folks ‘casue we read the sides and backs of food packages. We are carb counters. So since we are reading all these labels anyway why not glance at something in addition to the carbs? Just pick one and see if you're getting what you need or too much of it.
Consider salt.
The amount we get in the diet from the shakers on the table and in the kitchen is probably less than 10% of what Joe Schmo eats. And while we worry about the carb counts of restaurant menus they are really burying us with salt too. Have a look at these dishes. WTH like we don’t have enough issues already. http://health.yahoo.net/experts/eatthis/saltiest-foods-2011
Come to think of it the movie popcorn is probably less than health food. That said, the mental health value of movies with the kids last to infinity and beyond.
April 13, 2011
DOC, Meet Julie
I would like you all to meet Julie. She is working on a study of adult siblings of type 1s. She could use the Diabetes Online Community's help. So please consider this a very clear and direct suggestion to go to this link to learn more: http://siblingresearchstudy.blogspot.com/
Anything other than a clear and direct suggestion to that link would be bad, so I will not write any folksy self deprecating jokes that would get her fired.
Thanks for your help.
(If anyone asks say some other respectable diabetes site refereed you, it is probably better for her that way.)
Anything other than a clear and direct suggestion to that link would be bad, so I will not write any folksy self deprecating jokes that would get her fired.
Thanks for your help.
(If anyone asks say some other respectable diabetes site refereed you, it is probably better for her that way.)
Kelley Kunik Clashes With Craptacular non Kardashian Kraken
Meat Monster Marketer Mauled
Bloated Burger Burned
I was gonna write about spectacularly stupid food at restaurants. Actually I wrote a bit but friends Kelly’s blog post today is hysterical. Better than what I have in the can so go read it:
Craptacular, Craptacular: The Meat Monster Edition - RELEASE THE KRAKEN!!
Bloated Burger Burned
I was gonna write about spectacularly stupid food at restaurants. Actually I wrote a bit but friends Kelly’s blog post today is hysterical. Better than what I have in the can so go read it:
Craptacular, Craptacular: The Meat Monster Edition - RELEASE THE KRAKEN!!
April 12, 2011
Accu-Chek Aviva Expert - UK
Here is a fascinating little piece of diabetes gear, a meter with a bolus wizard for the MDI crowd. Hop on over the Shoot Up or Put Up for a review of a device I am fairly sure nobody in the US is talking about. I'm betting heavy on the FDA's rules is the reason why.
Anyway Tim's a good enough guy, except for the puns, so here's a link the the UK review, including the image Tim pinched from Roche and I took from him.
Anyway Tim's a good enough guy, except for the puns, so here's a link the the UK review, including the image Tim pinched from Roche and I took from him.
April 9, 2011
Go Watch This. Please.
It is funny.
Kelley and friends at NYU made it. They won 2nd place in a competition with it.
Now there is a who gets the most views on You Tube thing happening.
So please bump up their hit count.
Thanks.
Kelley and friends at NYU made it. They won 2nd place in a competition with it.
Now there is a who gets the most views on You Tube thing happening.
So please bump up their hit count.
Thanks.
April 8, 2011
FDA PMA 2011
FDA released the January and February PMA Approvals. Yeah I know. It is right up there with Steve Martin finding his name in the phone book, exciting just doesn't explain it, but here goes:
P980022/S090
1/7/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA 91325 Approval for a modification to the design specification of the lumen tubing used in the manufacturing process of the glucose sensor to allow for less dimensional variation in the tubing supplied by the tubing vendor.
P980022/S092
1/31/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325 Approval for a software change to the CareLink® Personal Therapy Management Software for Diabetes, MMT-7333, from version 5.3A to 5.4A.
P050020/S022
1/14/11
180-Day Freestyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care
Alameda, CA
94502 Approval for changes to the outgoing Quality Control (QC) solution testing.
P980022/S091
1/12/11 Continuous Glucose Monitoring System Medtronic, Inc. Northridge, CA 91325 Minor manufacturing changes to the Sof-Sensor™ Glucose Sensor MMT-7002.
P980022/S090
1/7/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA 91325 Approval for a modification to the design specification of the lumen tubing used in the manufacturing process of the glucose sensor to allow for less dimensional variation in the tubing supplied by the tubing vendor.
P980022/S092
1/31/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325 Approval for a software change to the CareLink® Personal Therapy Management Software for Diabetes, MMT-7333, from version 5.3A to 5.4A.
P050020/S022
1/14/11
180-Day Freestyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care
Alameda, CA
94502 Approval for changes to the outgoing Quality Control (QC) solution testing.
P980022/S091
1/12/11 Continuous Glucose Monitoring System Medtronic, Inc. Northridge, CA 91325 Minor manufacturing changes to the Sof-Sensor™ Glucose Sensor MMT-7002.
April 6, 2011
Diabetes Data Standards
I think it is well past the time for the Tower of Babel to fall.
Diabetes is managed through the use of data. That data belongs to the user, the patient. It is theirs. Managing data should not a tool to strengthen a vendors proprietary grip on patients. Sadly patient data is almost universally maintained in proprietary formats guarded for the commercial advantage of durable device manufacturers market share.
I believe this is wrong. I believe it is a detriment to better health individually and for patients as a population. I believe that proprietary data puts a burden of maintaining data management on durable device manufacturers that increases the cost of devices. I believe when heath insurance mandates specific formulary brands and those brands do not share data well the insurance company is reducing the opportunity for better diabetes management to reduce cost.
I think it is time for patients to start asking their medical device manufacturers to open data standards and work towards a common language for diabetes devices. I think in the long run manufacturers’ costs for data management in the long run be reduced by benefiting from shared standards. I would like to see their energy spend on innovative devices not maintaining proprietary data standards. I would like to see patients and their advocate organizations have a voice in data standardization.
If you agree I would love to hear from you. I would love you to share your thoughts. Let start by seeing who all is interested. Bernard has an old thread on the topic at TuDiabetes. If you are interested in some grass roots advocacy on data standards please introduce your self there, like this:
I am Bennet and I am interested in promoting standards.
Diabetes is managed through the use of data. That data belongs to the user, the patient. It is theirs. Managing data should not a tool to strengthen a vendors proprietary grip on patients. Sadly patient data is almost universally maintained in proprietary formats guarded for the commercial advantage of durable device manufacturers market share.
I believe this is wrong. I believe it is a detriment to better health individually and for patients as a population. I believe that proprietary data puts a burden of maintaining data management on durable device manufacturers that increases the cost of devices. I believe when heath insurance mandates specific formulary brands and those brands do not share data well the insurance company is reducing the opportunity for better diabetes management to reduce cost.
I think it is time for patients to start asking their medical device manufacturers to open data standards and work towards a common language for diabetes devices. I think in the long run manufacturers’ costs for data management in the long run be reduced by benefiting from shared standards. I would like to see their energy spend on innovative devices not maintaining proprietary data standards. I would like to see patients and their advocate organizations have a voice in data standardization.
If you agree I would love to hear from you. I would love you to share your thoughts. Let start by seeing who all is interested. Bernard has an old thread on the topic at TuDiabetes. If you are interested in some grass roots advocacy on data standards please introduce your self there, like this:
I am Bennet and I am interested in promoting standards.
No Experience Needed
The infamous Washington State 'No Strips For Kids' idea was the subject of a post I read today. The gist was that in part this may have been the result of a system that considers it a conflict of interest to have specialist with clinical experience in a given field participate in how that field get managed. So no endos when considering strip use for effective diabetes management. I would love to know if these assertions are accurate. If so:
WTF
That is Moronic.
Now in all fairness I read this on the Internet so there is a fair shot that it is not entirely accurate. The dude who wrote it flat out says he didn't have time to fact check it. Here is the bit from Forbes.
WTF
That is Moronic.
Now in all fairness I read this on the Internet so there is a fair shot that it is not entirely accurate. The dude who wrote it flat out says he didn't have time to fact check it. Here is the bit from Forbes.
This gets me to a recent pair of Wall Street Journal editorials on the Washington state health panel, called the Health Technology Assessment committee, which was considering denying reimbursement for test strips that help diabetic children self-monitor their blood sugar levels. (Coincidentally, last September, Leah Hole-Curry, director of HTAC, was appointed to the governing board of President Obama’s comparative effectiveness research program, the Patient-Centered Outcomes Research institute.)
The HTAC had previously suggested that there wasn’t enough evidence that self-monitoring was clinically beneficial. But this was, in part, an unfair criticism: it’s difficult to conduct a trial in which you ask diabetic children not to monitor their blood sugar levels. The idea that poorly monitoring one’s blood sugar levels is a good thing defies decades of understanding.
So why would the HTAC consider denying reimbursement for test strips? “One reason that the panel chose to prosecute this case,” suggests the WSJ, “may be that its strict conflict-of-interest rules prevent specialists from setting priorities. The 11-member Health Technology Assessement [committee], naturally, does not include an endocrinologist or any other physician with relevant clinical experience whose expertise might pollute the findings.”
I don’t have time to dig into HTAC’s conflict-of-interest rules myself to see whether or not this is the case.
April 4, 2011
CareLink Mac
The Mac version out:
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1301674650707&lang=en_US
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1301674650707&lang=en_US
I’m Not Clark Kent
... so that rules out superman too.
Clark is an ace reporter. I am not so good at the who, what, where, when, how but then come to think of it I never noticed Clark doing much actual reporting either. For actual play by play of the Medtronic social media event I think there may be more accurate recounting by the folks who were taking notes on laptops. Keep your eyes open I am sure the reports will start flowing in.
Here roughly the outline of the day. I try to add some color commentary:
We interrupted and talked over everyone of these folks and led them down all kinds of digressions. Scott Johnson drank all the diet Dr Pepper.
Probably the most shocking utterance was early in the day when Lane used a dirty word:
Yeah I know! The nerve of that guy. It sets off all kinds of emotional responses doesn’t it? But he didn’t mean it like ‘you diabetic scum need to be compliant and be in range all the time - how hard can it be? what the heck is wrong with you.’ He used it as an engineer.
Engineers speak a different language. To them control isn’t profanity. It is a process of transferring variability from one place to another. In the diabetes case to transfer some variability in blood glucose to variability in electrical current. Then to use that electric variation as feed back to have an impact on BG. He went on to talk about the success of that transfer in two time frames; first the moment and second over time. It was all very geeky and since I am a little geeky I thought it was all very fascinating.
More fascinating was the idea that some problems have been solved in other disciplines and those solutions can be transferred to diabetes care. Engineers transfer variability in large complex refineries to systems that manage outcomes in the moment and over time. It keeps the plants from blowing up. Possibly the algorithms, logic and processes used there can be brought to bear on the reality of your diabetes varying.
That I found this interesting is proves what I said, I am a geek at heart. So is Lane because he appreciated the need to minimize the space on a kids’ Bat Belts (and bat bellies) for all the stuff this may involve.
Somewhere in all this we got a first pass at the idea of data standardization. Since Bernard (BandYard) Farrell missed his flight to to a snow storm, the rest of us were more than happy to provide a little of the open honest feedback our Medtronic hosts were looking for. I happen to have ranted about data standards a bit, not as long as Bernard. He is the patients’ Superman of Data Standardization. I am more of the Jimmy Olsen on the beat. When I get into trouble he saves me. Interestingly the engineers seemed to agree that data standards would be valuable and I don’t know that the business / lawyers side of the equation feels the same way. I am fairly confident Medtronic heard the standards message, more than once. It is one of the messages I was there to share.
Clark is an ace reporter. I am not so good at the who, what, where, when, how but then come to think of it I never noticed Clark doing much actual reporting either. For actual play by play of the Medtronic social media event I think there may be more accurate recounting by the folks who were taking notes on laptops. Keep your eyes open I am sure the reports will start flowing in.
Here roughly the outline of the day. I try to add some color commentary:
- Amanda Sheldon, Director Medtronic PR opened and we got her talking and ran into the time that was allotted for:
- Katie Szyman who has been President of the diabetes business unit for a year and a half.
- Lane Desborough who’s title was Product Specialist. He is an engineer who recently joined MM from other larger industrial chemical engineering endeavors following his son’s T1 DX.
- Brad Monosmith introduced an app for that where that is diabetes and the long arm of the law keeps the device and the app from talking to each other.
- We took a picture:
- We talked more about a closed look and connectivity With Lane and Todd Robin director of CGMs.
- Dr Francine Kaufman spoke from clinical and medical research perspective and shared some research on a pump in Europe that turns off insulin with hypos. Due to certain Minister of Magic regulations we’ll just call it the Pump the Can Not Be Named. (I’m kidding FDA, it was a Joke, no need to call out the Dementors from the IRS)
- Dr. Richard Rubin of Hopkins talked about diabetes burnout. Great stuff. One key point - Joking around about diabetes is good (that FDA as the dark arts bit was strictly medicinal I swear! Oh wait that means I need to wait years for clearance before using it...)
- There was a cool tool tour of the sensor manufacturing plant.
We interrupted and talked over everyone of these folks and led them down all kinds of digressions. Scott Johnson drank all the diet Dr Pepper.
Probably the most shocking utterance was early in the day when Lane used a dirty word:
"Control."
Yeah I know! The nerve of that guy. It sets off all kinds of emotional responses doesn’t it? But he didn’t mean it like ‘you diabetic scum need to be compliant and be in range all the time - how hard can it be? what the heck is wrong with you.’ He used it as an engineer.
Engineers speak a different language. To them control isn’t profanity. It is a process of transferring variability from one place to another. In the diabetes case to transfer some variability in blood glucose to variability in electrical current. Then to use that electric variation as feed back to have an impact on BG. He went on to talk about the success of that transfer in two time frames; first the moment and second over time. It was all very geeky and since I am a little geeky I thought it was all very fascinating.
More fascinating was the idea that some problems have been solved in other disciplines and those solutions can be transferred to diabetes care. Engineers transfer variability in large complex refineries to systems that manage outcomes in the moment and over time. It keeps the plants from blowing up. Possibly the algorithms, logic and processes used there can be brought to bear on the reality of your diabetes varying.
That I found this interesting is proves what I said, I am a geek at heart. So is Lane because he appreciated the need to minimize the space on a kids’ Bat Belts (and bat bellies) for all the stuff this may involve.
Somewhere in all this we got a first pass at the idea of data standardization. Since Bernard (BandYard) Farrell missed his flight to to a snow storm, the rest of us were more than happy to provide a little of the open honest feedback our Medtronic hosts were looking for. I happen to have ranted about data standards a bit, not as long as Bernard. He is the patients’ Superman of Data Standardization. I am more of the Jimmy Olsen on the beat. When I get into trouble he saves me. Interestingly the engineers seemed to agree that data standards would be valuable and I don’t know that the business / lawyers side of the equation feels the same way. I am fairly confident Medtronic heard the standards message, more than once. It is one of the messages I was there to share.
That is a conversation worth having. We are the market. If we as the market start and keep demanding it it may happen. When there is a movement to standards, it will have to get past the whole secretive FDA dark arts process. I don’t expect them soon.
April 3, 2011
#medtronicDAF Disclosure Statement
I was privilege to be invited to join the folks from Medtronic at a social media even this April Fools day in LA. I went and I still don't know what the DAF in the hash tag stands for, Diabetes Air Force maybe?
I saw good friends from the Diabetes Online Community, some face to face for the first time. Met some new friends both from the DOC and Medtronic.
There are a couple of thing people ask me about events like this like: "Why you?" and "Are they seducing you to the dark side?" OK the second one doesn't typically get phrased with a fun movie reference but you get the idea.
I don’t know how they chose to invite who they did. It has to be hard. There are a lot of great voices in the DOC, I don't think that mine is any better than a myriad of others and we are not a Medtronic user.
I have traded emails and phone calls with the folks at Medtronic. They once asked if I would consider a post about their Lenny iPod app. I chose not to and shared some of the reservations I had as a parent about the app. They fixed some of the things I was concerned about but I still never wrote about it. (Yes I am an ungrateful arse.) Another time I did write about a driving program they sponsored. That is about it. I don't know why me.
I do think they are nice enough people. They have jobs and selling pumps make the pay checks happen. They seem to do those jobs very well. Except for Jonathan the sensor engineer. He was better than very good as a plant tour guide. If you have a kid who is interested in engineering, find a way to have'm spend time with that guy. He is funny, inspired by machines and process, very personable and a strong communicator. See: more evidence of the dark side, except I don't buy what he builds but man building them is a heck of a thing.
When asked about how they chose who to invite, they said they were looking to hear a variety of voices. They read the DOC daily. They know who's who. I know there were folks invited who couldn't make it. Medtronic did said they were looking for some honest feed back.
I think they got it.
Still the evenet was stupid fun. I would be flat out lying if I said anything else. It was a mini diabetes camp for grownups, not that I actually acted all that grown up. It was also an exhausting three days of time away from home, two of which were spent in a coach seats on very full Airbusses and I didn't have enough episodes of Community on my iPhone to make that time pass pleasantly.
Medtronic didn’t push product. They can't talk about stuff that is into the FDA. We tried to get them to anyway. They looked tempted, but there is stuff they just will not talk about. They did say that CareLink (is that what it is called?) for Apple computers has been blessed and will be announced to the public this week. Maybe even tomorrow. They did share some of their personal stories and connections to type 1. In many cases it is very personal. More on that in a different post.
Will Dubois (in the spirit of full disclosure I think the world of Will aka Lee) and I were laughing on the ride to Medtronic in the morning that we were both kinda surprised to be there. He has been a critic, harsh at times apparently. He has some fairly clear ideas about Luer-Lok that he shared again just in case they forgot. Anyway Will and I talked about the fact that we, as a community, need the durable medical guys. We need them to compete, to be successful and pursue profitable innovative products. Their market success means better care for pumpers. That is the trade off but we have more skin in the game than they do. It is their livelihood, it is our lives.
That we need device manufacturers to be successful and that I would hold back comments in exchange for two days in coach aren’t even anyplace near each other. Still you are free to form your own opinions about that. I hope I continue to earn your trust that: 1) I get around to saying what is on my mind and 2) the time between me saying what is on my mind and the time it gets there is typically nano seconds.
Do I hope Medtronic got good feed back? Yes. I think they did. Do I hope they will do more events like this? Yes. Do I want to go? Oh hell yeah. Did I screw that up by suggesting to one dude that comments about winning in the market place sound like Charlie Sheen? Yeah I did that too.
Why me? Well it probably because it was April Fools and they needed a fool. As for the dark side, nobody claimed to be my dad.
I saw good friends from the Diabetes Online Community, some face to face for the first time. Met some new friends both from the DOC and Medtronic.
There are a couple of thing people ask me about events like this like: "Why you?" and "Are they seducing you to the dark side?" OK the second one doesn't typically get phrased with a fun movie reference but you get the idea.
I don’t know how they chose to invite who they did. It has to be hard. There are a lot of great voices in the DOC, I don't think that mine is any better than a myriad of others and we are not a Medtronic user.
I have traded emails and phone calls with the folks at Medtronic. They once asked if I would consider a post about their Lenny iPod app. I chose not to and shared some of the reservations I had as a parent about the app. They fixed some of the things I was concerned about but I still never wrote about it. (Yes I am an ungrateful arse.) Another time I did write about a driving program they sponsored. That is about it. I don't know why me.
I do think they are nice enough people. They have jobs and selling pumps make the pay checks happen. They seem to do those jobs very well. Except for Jonathan the sensor engineer. He was better than very good as a plant tour guide. If you have a kid who is interested in engineering, find a way to have'm spend time with that guy. He is funny, inspired by machines and process, very personable and a strong communicator. See: more evidence of the dark side, except I don't buy what he builds but man building them is a heck of a thing.
When asked about how they chose who to invite, they said they were looking to hear a variety of voices. They read the DOC daily. They know who's who. I know there were folks invited who couldn't make it. Medtronic did said they were looking for some honest feed back.
I think they got it.
Still the evenet was stupid fun. I would be flat out lying if I said anything else. It was a mini diabetes camp for grownups, not that I actually acted all that grown up. It was also an exhausting three days of time away from home, two of which were spent in a coach seats on very full Airbusses and I didn't have enough episodes of Community on my iPhone to make that time pass pleasantly.
Medtronic didn’t push product. They can't talk about stuff that is into the FDA. We tried to get them to anyway. They looked tempted, but there is stuff they just will not talk about. They did say that CareLink (is that what it is called?) for Apple computers has been blessed and will be announced to the public this week. Maybe even tomorrow. They did share some of their personal stories and connections to type 1. In many cases it is very personal. More on that in a different post.
Will Dubois (in the spirit of full disclosure I think the world of Will aka Lee) and I were laughing on the ride to Medtronic in the morning that we were both kinda surprised to be there. He has been a critic, harsh at times apparently. He has some fairly clear ideas about Luer-Lok that he shared again just in case they forgot. Anyway Will and I talked about the fact that we, as a community, need the durable medical guys. We need them to compete, to be successful and pursue profitable innovative products. Their market success means better care for pumpers. That is the trade off but we have more skin in the game than they do. It is their livelihood, it is our lives.
That we need device manufacturers to be successful and that I would hold back comments in exchange for two days in coach aren’t even anyplace near each other. Still you are free to form your own opinions about that. I hope I continue to earn your trust that: 1) I get around to saying what is on my mind and 2) the time between me saying what is on my mind and the time it gets there is typically nano seconds.
Do I hope Medtronic got good feed back? Yes. I think they did. Do I hope they will do more events like this? Yes. Do I want to go? Oh hell yeah. Did I screw that up by suggesting to one dude that comments about winning in the market place sound like Charlie Sheen? Yeah I did that too.
Why me? Well it probably because it was April Fools and they needed a fool. As for the dark side, nobody claimed to be my dad.
How I Almost Missed My Flight.
... I blame Dunkin Donuts
I had an early morning flight on Thursday to go to the Medtronic social media thing. Being a responsible driver, I stopped for coffee before I hit pre-sunrise traffic. Yes that is how thoughtful of other drivers I am, it had NOTHING to do with MY caffeine addiction.
Me, “‘morningmediumcoffeejustcreamplease”
DD makes a regular with extra sugar.
Me, “This has sugar. Can you make a just cream?”
DD, “You don’t want Sugar?”
Me, “Just cream thanks.”
DD does this a lot. I think I have discovered why. The Just cream was also very lacking in actual coffee goodness. It was the 97 pound weakling on the caffeine muscle beach. Brown warm water that tasted like half the grounds and that had been recycled. Sugar was the only thing that gave it flavor, no wonder they put it in even when you don't want it. Sadly I had hit traffic before this was abundantly clear.
I couldn’t drink it. I am fairly confident that why I missed the turn for the parking lot and ended up on south bound I95. Also I feel it was a contributing factor in misplacing my iPhone in my briefcase. Yes I lost my own phone in my own briefcase going through security. By which I mean that I was in a panic thinking my phone was lost when it wasn’t I was just too insufficiently caffeinated to see it where it was.
I was also too slow to notice I was in terminal B when the big TV screen said A.
I blame Dunkin Donuts. I did my part. I stopped for coffee. They failed. None of this could possibly be MY fault. ;)
I had an early morning flight on Thursday to go to the Medtronic social media thing. Being a responsible driver, I stopped for coffee before I hit pre-sunrise traffic. Yes that is how thoughtful of other drivers I am, it had NOTHING to do with MY caffeine addiction.
Me, “‘morningmediumcoffeejustcreamplease”
DD makes a regular with extra sugar.
Me, “This has sugar. Can you make a just cream?”
DD, “You don’t want Sugar?”
Me, “Just cream thanks.”
DD does this a lot. I think I have discovered why. The Just cream was also very lacking in actual coffee goodness. It was the 97 pound weakling on the caffeine muscle beach. Brown warm water that tasted like half the grounds and that had been recycled. Sugar was the only thing that gave it flavor, no wonder they put it in even when you don't want it. Sadly I had hit traffic before this was abundantly clear.
I couldn’t drink it. I am fairly confident that why I missed the turn for the parking lot and ended up on south bound I95. Also I feel it was a contributing factor in misplacing my iPhone in my briefcase. Yes I lost my own phone in my own briefcase going through security. By which I mean that I was in a panic thinking my phone was lost when it wasn’t I was just too insufficiently caffeinated to see it where it was.
I was also too slow to notice I was in terminal B when the big TV screen said A.
I blame Dunkin Donuts. I did my part. I stopped for coffee. They failed. None of this could possibly be MY fault. ;)
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