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.

 

 

22 comments

  1. Claire

    You have overcome my hesitant nature and my reluctance to post a comment because I don’t know for sure what to say. Moo.

  2. Shannon

    Your Receipt
    3 Your Receipt
    2 Your Preview
    1 Your Information
    Your Comment Tracking Number: 1jy-8ayq-ynrz
    and
    Your Receipt
    3 Your Receipt
    2 Your Preview
    1 Your Information
    Your Comment Tracking Number: 1jy-8ayq-joxs

  3. Sarah

    I mooed all over that stuff! Thanks for making it super easy for anyone (even a super lazy teenager) to make a comment on those articles.

  4. Pingback: FDA Wants YOUR Opinion on Glucose Meter & Test Strip Accuracy : DiabetesMine: the all things diabetes blog
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  6. KEA

    I was able to copy & paste to the first link, I hope I am still on time!

    I read here n there the deadline was extended to May 7th, 2014…Moo! If you catch this and there’s still time! MOO! (we hope!)

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