October 29, 2011

A Halloween Re-Run: Eat the Candy.

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.

October 28, 2011

News on LGS

"People Who Get It" and TEDx #TwoBits

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.

October 27, 2011

AP by Any Other Name & Experts on CGM #TwoBits

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!

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.


October 26, 2011

YDMV Interviewed as an e-Patient

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

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

October 25, 2011

More Art than....

... Science

New Video on theBetesNOW.com

More Art Than Science

Pump Hack II

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


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.

October 19, 2011

Artificial Pancreas and Egg Baskets

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


October 13, 2011

The Provider will Teach Your Now

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.

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.

October 11, 2011

medGadget on Echo Therapeutics

From the News Wire: medGadget has an article on Echo Therapeutics CGM.

October 5, 2011

Hi FDA, It's me again.

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

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