Procrastinators Unite… Tomorrow!

1267744_87396573You still have time, you procrastinator you.

The docket that FDA has open on blood glucose test strips has been extended to May 7th. You can use the “Ain’t Got No Time For That” method that I came up with for all of us to comment and kick the number over the 400 comment goalpost. (Or more than 400? Be still, my beating heart.)

Even if you have commented, no one is telling us that you can’t comment more than once, so please bring your thoughts about generic/third party test strips.

Third party test strips are not made by the monitor manufacturer, so who’s responsible if there’s a need for adverse event reporting? Who do we call to report it?  Until there’s a clear cut ruling on this, it’s a Wild West sort of world.

Want to learn more about third party test strips and inspiration for your comment? Head on over to Stripsafely.com and read up. (There’s also a great article on this very topic and details about the companies offering generic strips at Diabetes Mine. A definite must read.)

I know that you’re not a procrastinator, but I’m sure that you know someone who might be. Can you do the 26 million people with diabetes a favor today and reach out to someone in your community (with diabetes or not) and ask them to do you a solid?

Diabetes doesn’t procrastinate. We shouldn’t either…

 

Where All The Cool Kids Will Be On Monday…

Less than a year ago, Bennet Dunlap decided that the status quo just wasn’t good enough for us.

We needed to band together as a community to talk about blood glucose meter accuracy and what it means to the 26 million people with diabetes (and growing). Better accuracy begets better control and better outcomes for those of us who rely on our blood glucose meters to give an accurate number. Better accuracy, quite frankly, wasn’t happening.

So, Bennet created the Strip Safely campaign and gave us all a voice under the Strip Safely umbrella. I’m the Robin to his Batman, mostly saying: “Holy glucose meters!” and ensuring our costumes are freshly pressed by Alfred. It’s an honor to work with him and every other person who believes in the importance of blood glucose meter accuracy.

Last summer, Strip Safely attracted the notice of those at the FDA and a relationship began to develop, one that has grown into something important for the diabetes community… and on Monday, you can see for yourself.

This is where all the cool kids will be on Monday… on a Live Chat with Bennet and Dr. Courtney Lias.

(P.S. You are a cool kid, if you were wondering.)

Here’s the details:

FDA

Talk with FDA expert Courtney Lias and Patient Advocate Bennet Dunlap about Glucose Monitors and Test Strips

Monday, March 31, 1:30–2:30 pm (EDT)

  • Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes?
  • Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?

When you participate in this friendly online chat, you will:

  • Enjoy an informal, open discussion with a fellow patient advocate, Center for Devices and Radiological Health subject-matter-expert and others in the diabetes community.
  • Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes.
  • Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.
  • Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.

Register for this event and be sure to mark your calendars and join us on March 31st, 2014.

Please let your friends in the diabetes community know about this event. While not all the cool kids will be able to make it, I hope that you’ll join us all on the chat and learn how you can help the community and FDA. We are a community and we can’t do diabetes alone.

Moo. Moo. Moo.

Shaggy Highland cows are the best. The. Best.
Shaggy Highland cows are the best. The. Best.

Cows are loud when they moo in unison. Unplugged death metal loud. I love their silly little faces and their big tongues that loll out of their mouth when they’re happily eating. (See: any cute animal.)

I miss them. I want them to come home, but until they do, I’m going to rehash the importance of mooing in unison to the FDA.

See, we only have a few cows mooing about blood glucose meter accuracy, and that makes me sad confused frustrated mooing at deafening decibels in the hopes that you will bring it home.

What the hell am I talking about? (“Is she talking about cows? Huh?”)

Last week, I brought to your attention the need for anyone who is, knows, loves, or might know in the future a person with diabetes. The Food & Drug Administration (FDA) has graciously opened its ears to let us have our say about their proposed changes to the recommendations about blood glucose accuracy.

I’m going to be blunt. (Please try to control your shock.)

Do you not care about blood glucose meter accuracy?

Some of you do. To date, 67 individuals have comments on the Over The Counter Use docket and 16 individuals have comments on the Point of Care docket. (So, besides me, 66 and 15.)

That’s bloody miserable. 

How many people with diabetes live in the United States? Over 26 million. (Even with my subpar math skills, I know that 26 million is more than 67.) Of those, more than 3 million are Type 1. (Again, that math thing. 3 million > 67…)

More than 67 people read this blog. More than 67 people read Bennet’s blog. More than 67 people read A Sweet Life.

So, what’s the deal?

Is it not important enough?

Is it not sexy enough?

Miss Manner’s little gaffe ignited a firestorm of responses and comments, but this – having a piece of technology that we rely on for treatment decisions that could send us to the ER or the morgue if it’s wrong – this isn’t something that warrants a comment?

I’m confused. Is there just not enough time in the day to copy and paste? I know, I know… The Internet is filled with very important things like cats and pictures of young James Spader (meow) and someone has to respond to a friend’s status update on Facebook. Or post a video of a cat and a dog snuggling. I get that.

Is blood glucose meter accuracy not as cute? For sure. It’s not cute. It’s not cute at all. Not like cows and kittens and doggies.

Was I not clear enough? Didn’t I explain how easy it was? Did I not speak loudly? Did I not enunciate? E-nun-ci-ate?

I’d love to understand why it doesn’t matter to everyone. Those who have diabetes who might end up on the wrong end of an inaccurate meter because it just didn’t matter enough to comment. Those who pay into the medical system and balk at the thousands of dollars needlessly spent on emergency situations because it just didn’t matter enough to comment?

Every. Comment. Matters. 

Your voice matters. Even if it’s not your own words. The more mooing to the FDA, the more important it becomes in D.C… I know.

So, once again, I’m going to moo on this until April 7th – that’s when the cows come home.

Here are the steps – it’s as simple as I can make it for every U.S. citizen. You don’t even need to leave your name on the comment. Not required.

1. Look at the clock. Then copy the info below from “Progress to Conclusion”:

Progress

I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypoglycemic range) are a huge step forward. The new emphasis on test strip lot release criteria will hopefully lead to better quality control, and the proposed requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies, and allow users to make informed choices.

Suggestions:

Clarity

The terms “over-the-counter-use” and “prescription point-of-care” use are confusing. Instead, “for patient personal use” and “for professional in clinic use” would make the distinction clearer.

Accuracy

Insulin is a very dangerous drug. Reports show insulin to be a leading cause of adverse drug reaction emergency room admissions.* Insulin is dosed based on meter readings. People with diabetes have a real need for accuracy in our lives, outside the hospital to preventing the adverse insulin reactions that cause ER admissions. Both the patent self use and the caregiver in office use meters should have the same mandated level of accuracy. Dr. David Sacks of NIH suggests the proposed professional standards may not be possible at this time.# Accuracy should be required at the highest level that is economically feasible.

*drugs.com/news/adverse-reactions-new-national-perspective-risk-1954.html

#Close Concerns. 2014-2-27

Post-Market

Currently there is no program in place to review devices to ensure they continue to maintain the accuracy for which they were approved. This allows quality to slip over time, and puts patient health at risk. There should be a post-market surveillance programwith the ability to remove unqualified meters from the market.

MDR

There is a wide discrepancy between manufacturers in the number of Medical Device Reports (MDR) that they file.* This is problematic since, as the FDA has stressed, MDRs are essential for the post-market evaluation of glucose meters; failure to comply with MDR requirements puts patient lives at risk. This guidance should require criteria for robust MDR policies, similar to the proposed lot release criteria, in order for a meter to be cleared.

* Close Concerns. 2013-5-27

Dose Insulin

The FDA stated in a December 2013 clearance document that “Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality.” It also indicated in that document that the 2003 accuracy standards (which this guidance would replace) may not be sufficient, because it required the meter in question — which met the 2003 requirements — to be sold with the following all-cap warning:  “DO NOT USE [the meter] TO CALCULATE INSULIN DOSES. DO NOT USE [it] TO CALIBRATE CONTINUOUS GLUCOSE MONITORS.”* The new guidance should make clear that only devices which meet the tighter standards can be cleared by FDA to dose insulin or calibrate continuous monitors (and thus be considered DME).

* accessdata.fda.gov/cdrh_docs/reviews/K122340.pdf

DME

The FDA must also be clear that meters that do not meet the new accuracy requirements should not be considered “durable medical equipment.”

The guidance should explicitly state that the only blood glucose meters that can be considered “durable medical equipment” by payers are those that the FDA determines can be used to “make therapy adjustments” — meaning that they’re accurate enough to calculate insulin doses or to calibrate a CGM. Any meter that does not meet the necessary level of quality (and maintain it post-market) cannot be considered DME, and therefore should not be considered eligible for Medicare/health or private insurance reimbursement as DME for diabetes. (The quoted language comes directly from CMS.)

Therapy Adjustments

The proposed labeling requirements should specifically state whether a meter has received FDA clearance to “make therapy adjustments” — a statement that could only be made if the meter and its strips met, and continued to meet, these proposed new accuracy standards. Again, this phrasing would clearly distinguish which meters should be eligible for insurance coverage, since only those that are accurate enough to be used for therapy adjustments should qualify.

Conclusion:

The proposed new standards are a positive step, but they can only be effective if they are accompanied by specific quality and labeling requirements that prevent third-party payers from limiting coverage to antiquated meters, and meter/test strip manufacturers from dragging their heels. These proposed changes, when combined with a post-market surveillance system and enforcement policy, will help ensure that I and all people with diabetes are able to safely manage our disease.

2. Click on the link below and paste the stuff you’ve just copied.

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1446-0002

3. Click on the link below and paste the stuff you’ve just copied again.

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0001

4. Look at the clock. Two minutes? Three minutes?

I’m sorry that it may have taken you away from Facebook or TMZ, but I’m glad you took a few minutes from your life to help save mine and others in the future.

Please moo with me. Please see that while this isn’t sexy or cute, it’s so very necessary. It doesn’t matter if you have diabetes. It will impact you. You know someone with diabetes. You want that person to live well, right? I’m a firm believer in the adage of “If you’re not part of the solution, you’re part of the problem…” Be a part of the solution with us.

Please…

Moo.

 

 

"Do it. Do. It. DO IT!!!"

I am quoting my daughter when she wants me to complete something for her: opening a jar, getting art supplies off the top shelf, or putting tofu and ketchup on a plate for lunch. (The Kid has some eclectic food combinations.)

But today, I’m saying this to you. Two minutes of your day can help all of those with diabetes. How?

This:

Keep Test Strips Available              View in browser
[TURN IMAGES ON: StripSafely - Accurate Diabetes Testing Matters. Please Turn Images On.]
Got two minutes to help shape the future of accurate diabetes testing? 

 

FDA is looking for comments about new draft glucose meter rules in two open dockets. Open dockets are a unique opportunity where the FDA is focused on listening to the public – we need them to hear us. 

The current rules for glucose meters are from 2003. It may be another decade before FDA asks for public comment on meter rules.
We have until April 7th.

 

DC is a town where the number of messages matters. Many comments, even if they are repetitive, will help the diabetes community be heard.

Other interests will lobby for their views. We must speak up for our views. Our health. Our lives. 

 

How can you help?
We’ve made it easy with sample comments, a step-by-step guide to commenting to a FDA docket, and additional guidance information. 

1. Review the sample comments here:http://www.stripsafely.com/sample-page/guidance/

2. Use the step-by-step guide to post comments to the dockets:http://www.stripsafely.com/sample-page/comment2fda/

3. Share this email with everyone you know.
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Now is the time for the community to speak up. The more comments left on the dockets, the more support we give the FDA to make the changes needed for accurate diabetes testing. 

These dockets are only open until April 7
Don’t let another decade go by with inaccurate diabetes testing. 

Thanks and StripSafely,
Bennet & Christel

 

P.S. Want to learn more about the guidance? Check this out: 

http://www.stripsafely.com/sample-page/guidance/about-guidance/

 

 

So, please. Do it. Do. It. DO IT!

And thank you.