Our Blog / the diabetes online community on accuracy

Good friends of StripSafely,  Amy Tenderich and Catherine Price have outstanding posts on FDA’s new glucose meter draft guidance.

In a comment at Diabetes Mine I played along with with Amy saying:

Thanks Amy

Can I play with your chord / music metaphor?

In all fairness I think FDA has been trying to sing the song of better standards for quite some time, clearly since 2010. Maybe better put that they have been crafting a symphony and StripSafely is a Punk Rock tune.

Regulations is a long slow symphony. If anything is striking a chord it is that the all the community will be more successful by singing out of the same hymnal and in harmony. That means all the community PWDs, FDA, Industry, payers and CMS.

Speaking of harmony. Catherine, at ASweetLife, has a nice piece that
is a melodious companion to your piece here: http://asweetlife.org/feature/fdas-new-guidance-on-blood-glucose-test-strips/

There are some real strengths in FDA proposals we can sing along with. Lets be sure to sing out loud an clear that insulin is a very dangerous drug and to quote Catherine’s piece, “inaccurate meters cannot be used directly for making therapy adjustments.”

Thanks Amy for this great piece and thanks for the sing along metaphor.

(also you never want to hear me try to sing) LOL

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4 Comments

  1. I”m not sure that a symphony would be the best, most effective metaphor — unless, perhaps, it is from the school of Charles Ives, who was supposedly inspired by two bands playing two different pieces at the same time.

    There are certain things for which the diabetes community sings mostly in unison — more accurate devices, better insurance coverage for and availability of devices, supplies, and medications, better access to care, education, and appropriate food choices.

    But there are places where we don’t even sing in harmony, and Wagner (or even Webern) would be hard-pressed to call it counterpoint. The search for {a|the} cure is but one of them. Do we want drugs to come to market more quickly (avoiding some short-term deaths by their delay) or more safely (trading off those short-term deaths for fewer long-term deaths from their side-effects)? Do we want more people screened and diagnosed early, or do we want those who have been diagnosed taken better care of? Do we want monies allocated to where the bulk of the diabetes population lies (type 2, lower-income, overweight, etc.) or do we “let type 2 manage itself” while we look more aggressively at type 1?

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  2. Lovely. Great points and staying in the silly metaphor.

    A cure will be glorious. In the mean time better is still better. So if those are Charles Ives two tunes there is no reason they can’t harmonize. Many T2D medications play an equally melodious tune for quality of life in T1D.

    All people trying to stay in range and avoid hypos need accurate testing to stay in tune.

    LOL

    Thanks for joining the choir.

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  3. Thanks for the shout-out, Bennet! I was about to email you the press release about the (terrifying) AADE studies, but I see that you are on top of that already. :)

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  4. From my perspective, I do think that the FDA dedicated an entire meeting to this issue in which hospitals and the like dominated the conversations when they were, in fact, using meters and test strips for a purpose that the FDA had never cleared them for (using SMBG supplies at point of care). The FDA realized that was a problem when I called attention to that fact, but they tried to split the difference with separate guidance documents for OTC and Point of Care which I don’t think is practical in any way, shape or form. Its a bit like throwing the baby out with the bathwater to use another metaphor. I’m trying to write my comments in a cohesive fashion. Wish me luck with that!! However, we don’t need to say the same things, we as a community need to demonstrate to FDA that the issue is important and our comments will do that, regardless of whether we say the same thing or not.

    Reply

So, what do you think ?