FDA Public Workshop - Medical Device Patient Labeling - I may mention VW.

I am speaking as a "stakeholder" at FDA's Public Workshop - Medical Device Patient Labeling, September 29-30, 2015. I'm scheduled to go at 10:35, kicking of stakeholders on the 29 and a round table conversation on identifying label needs on the 30th.

Word is that it will be webcast. The site says registration is required and "All webcast registration requests should contact Susan Monahan at susan.monahan@fda.hhs.gov*"

Update: These appear to be the links and they look like they allow a Guest Login
Webcast Links for the September 29-30, 2015 Public Workshop: Below are the webcast links for the Public Workshop from an FDA email:

Medical Device Patient Labeling 

• September 29, 2015: https://collaboration.fda.gov/plpw092915/  
• September 30, 2015: https://collaboration.fda.gov/plpw093015/

Directions for mobile access to the meeting

1. Download the Adobe Connect Mobile App
2. Enter Meeting
3. Log-in as a Guest: Enter Name
4. Accept disclaimer

A key part of what I have to say will be your views shared with YDMV .

While not exactly on the topic, I will add my 2¢ that meters are like cars. YDMV is a direct copy of the Your Milage May Vary disclaimer of window sticker milage claims. Your meter may vary and just like VWs the test done for the feds may not be close to real world performance.

It is not the driving public job to know the real emissions of cars, nor the PWD's job to know if meters preform to FDA standards. Our jobs are to drive safe and in the case of diabetes is to do the self management to be safe. We need to know the devices we use are safe and that the emissions and device safety police have our backs.

I'm open to the betting odds of my be being allowed back day 2 if I say that day 1. LOL

*http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm



Here are some of the slides I will be using:

A Lovely Rant by Ira Hirsh

I started using the acronym YDMV years ago on web boards as a way of responding to individuals who aggressively pushed a single 'RIGHT WAY' of managing diabetes. Some time its was the right pump or meter. Occasionally it was shots vs pumps vs pens. Sometimes it was even this is THE I:C ratio you should use because it work for us perfectly.

I would typically agree making a general point about our family's approach to attention to care without mentioning "RIGHT WAY" and add Your Diabetes May Vary. That way when they disagreed with my way it was covered by the YDMV statement and gave others the same out if they didn't agree with the "Right Way."

I also thought it would be fun if it became a commonly used term on the boards. It did.

Part of the new care shake up in the US is grading doctors based on metrics. (For the record I HATE the word metrics. It is a buzz word typically used by people who substitute a number for thoughtful consideration.) Measures would be great if the metrics aligned with the current ADA treatment recommendation about individualization of targets based on the patient's specific situation. (1) It would be fantastic if there was a measure that identified that caregivers spend the time necessary to find the individual targets and customize goals for each patient.

That ain't how it works. (see I feelings for the word metrics above.)

The new system holds Docs to static levels of HbA1c, LDL-cholesterol, and blood pressure. So if you are the doc and you have a patient who is way out of range and you help decrease variability, lower A1C make progress on LDL and blood pressure it doesn't count. Progress is not the end static measure are. In this model success is a number not behaviors.

Hey Who ever makes this stuff up. YDMV.

All diabetes is a progressive. Succes is adapting and changing to make living with diabetes about life not about numbers.


Dr Ira Hirsch as a lovely rant about this. Have a read.

(1) American Diabetes Association: Glycemic targets. Diabetes Care 2015;38(Suppl 1):S33–S40.

HON Certified

I am happy to announce that Your Diabetes May Vary is now a HON Certified site.

I try to be trust worth and transparent, if at time a loony, patient / caregiver voice. HON creates a structure that respects and allow me to pledges to honor the following 8 principles of the HON Code of Conduct (HONcode).

1. Authoritative   
2. Complementarity   
3. Privacy   
4. Attribution   
5. Justifiability   
6. Transparency
7. Financial disclosure   
8. Advertising policy

YDMV's about section contains most of the details of how YDMV seeks to stay in compliance with these principles.

It has taken the better part of a year from application to certification. I am fine with that. I appreciated the detail of question they posed and the refinements in my about section that those questions inspired. I encourage other to seek certification too. I do respect those who choose to behave ethically and still choose not to seek HON Code certification. Certified or not, I think the principles provide a good outline of what those using the web can look for, in the online conversations about health, as a measure transference and trust.

The internet is a wild and crazy place to talk about health. Doing so to agreed upon standards helps sort out that wild and craziness a little.

Hey DOC! Welcome Maryam #TwoBits

Hello my Diabetes Online Community friends. Meet Maryam or Myrm as my son calls her, all though I have no idea how that nick name is spelled. (Regular YDMV reades will know I have no idea how anything is actually spelled and not be surprised.)

She bring the DOC the much needed sound of young america which is actually the name of a PRI show but you get the point.   

Here is the bio for her blog: 

Maryam Elarbi is an 18-year-old freshman in college who was diagnosed with Type 1 diabetes at the age of 10. Eight months after her diagnosis, Maryam’s family began attending the “Children With Diabetes” conferences, which changed their entire view on Type 1 and how to cope with it. Over the past eight years, Maryam has been actively involved in advocating for people with Type 1 through these conferences, as well as fund-raising for diabetes research through JDRF’s annual “Walk to Cure Diabetes.” In her spare time, Maryam enjoys reading (especially works by Jane Austen and Kurt Vonnegut), writing, spending time in the beautiful city of Philadelphia, and defeating her brothers in the new “Dance Central 2″ game.

She and the brothers she thrashes at Dance Central 2, helped my son feel welcome at CDW years ago. What a great gift. You can see her almost live in theBetesNOW's fashion report form the FFL Red Carpet. So DOC welcome Maryam! Here’s two of her recent posts:

Adventures in Hypoglycemia

http://www.diabetesselfmanagement.com/Blog/Kids-And-Diabetes/adventures-in-hypoglycemia/

The Importance of Consistency

http://www.diabetesselfmanagement.com/Blog/Maryam-Elarbi/the-importance-of-consistency/

YDMV on the Goal of diabetes management and teens

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We Hold TheseTruths to be Self-Evident, Except Trials are Required.

Medtronic has a press release out today that says with Low Glucose Suspend (LGS) folks spend less time in hypos. That seems kind of intuitive to me but hey the studies need to be done. It it wasn't a small difference IHMO. 19% less time in hypos.

You can read the press release here or click this graphic to see what is said in markets that aren't the USA and where people with diabetes can get a LGS pump.

YDMV has burned a fair number of electrons on and around LGS. Here is hoping this helps the FDA focus on the value this step brings living safe lives with insulin infusion.

What do yo think?
Would you like LGS?
Would you use it?

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Best Diabetes Parenting Advice - Updated

As theBetes:NOW has reposted a short video of my diabetes parenting hero.



At my first CWD Friends for Life I heard this dad simply say, "My wife and I are our daughter’s primary care team.”

Brilliant. This piece of wisdom had been updated when theBetes:NOW caught up a few years later. The new message,"She'll become her own Primary Care Giver.”



What do yo think, who is the primary care giver in your diabetes life?

Previously on YDMV: Of Independence and Angry Mobs

YDMV Nominated at WEGO

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/

LY/MI

Thanks 50 thousand times!

YDMV reached the 50k visit mark yesterday. Thanks to everyone of you who has stopped by. I did a little quick math and that is more visits than test strips on the floor in the same amount of time - Impressive because with two kids pumping, we get a hell of a lot of strips on the floor.

Is it possible for a strip to get into the trash without first hitting the floor?

YDMV started because my daughter challenged me to share my views on type 1 and parenting. Thanks Kelley for throwing down that gauntlet. Thanks for the challenges you, Blair, Connor and Delaney share with mom and I every day. Each and every new experience you guys bring us has been a joy. OK some take a little while to have the joy part come out but it always does.

By the way Kelley is responsible for the visual make over that comes with the 50k mark. Hope y'all like it.

It seems a little ironic that YDMV crosses this milestone while I have been spending a lot of effort on another creative challenge. This one I brought to Kelly - a turn about is fair play. While I may have let posting to YDMV slip a little, our focus on the DOC has not. I think y’all will really like the results of that other project. Stay tuned.

In the mean time please know you readers have given me back a lot thanks. LY/MI.