[Acb-diabetics] Insulin Loading Devices
Patricia LaFrance-Wolf
plawolf at earthlink.net
Thu Oct 22 01:14:55 GMT 2009
I'm glad to hear aboou the count-a-dose. I found it very accurate in the
several years I used it before getting a ppump.
-----Original Message-----
From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Mike Freeman
Sent: Wednesday, October 21, 2009 5:34 PM
To: acb-diabetics at acb.org
Subject: Re: [Acb-diabetics] Insulin Loading Devices
Chris, Veronica and Pat:
In fact, the FDA essentially did just that although for what seemed by its
lights good and sufficient reasons. There are various "classes" of medical
devices, each of which has a certain specified testing regimen in order to
be approved for marketing by FDA. Originally, the Count-a-dose was not
classified as a precision medical device and was therefore subject to less
rigorous testing than were insulin syringes and pens. Last year or the year
before, FDA reclassified the Count-a-dose in such a way that it required
more extensive testing to continue to be marketed. On its face, this would
seem a good thing in that all of us would wish that our insulin-measuring
devices be as accurate as possible. However, MediCool, the company making
the Count-a-dose, said it couldn't afford the additional testing so decided
to no longer make the Count-a-dose.
The news is not all grim, however. DDI, maker of the Prodigy Voice Talking
Blood Glucose Meter, has bought the Count-a-dose molds from MediCool and
will produce the Count-a-dose which, of course, will be known as the
"Prodigy Count-a-dose". The DDI version is in FDA testing and approval
proceedings as I write this. So while we all know that FDA proceeds with all
deliberate speed (with the accent on the "deliberate"), DDI anticipates
again producing the Count-a-dose late this year or some time early next
year.
I own two Count-a-doses though I don't remember where I stored them
(undoubtedly in a safe place); I bought them in case I ever had to use
syringes. I use and prefer insulin pens. But Veronica's and Pat's reasoning
for wanting a syringe-based device is sound though, truthfuly, I suspect
unused pen cartridges have the same refrigerated life as do bottles. But
there's another reason why some want to use syringes: they're cheaper so
those without health insurance find them more affordable. But for this, I
see no reasons not to use pens: they're so convenient!
Mike Freeman
----- Original Message -----
From: Christopher Gray <chris at bayareadigital.us>
To: "Discussion list for diabetics and/or ACB issues."
<acb-diabetics at acb.org>
Date: Wednesday, Oct 21, 2009 16:27:49
Subject: Re: [Acb-diabetics] Insulin Loading Devices
>
>
> It's hard to believe that the FDA would force the discontinuance of any of
> these devices. Let's hope somebody can clarify this a bit.
>
> Chris
>
> On Wed, 21 Oct 2009,
> Veronica Elsea wrote:
>
> > Actually, I'm glad you brought this up, Chris. I can't for the life of
me
> > understand why the count-a-dose went away. As someone who uses an
insulin
> > pump, it really would be a good idea to have a back-up insulin delivery
> > system. The insulin pen is really impractical because it would get used
so
> > infrequently that when I did need it, the cartridges would most likely
be
> > expired. I use the same insulin vials when I'm filling my pump
cartridge, so
> > as a back-up, something that would just allow me to use a syringe with
the
> > insulin vial I already have would sure be nice.
> > So if someone can answer this question for you, it would help me as
well.
> > Thanks.
> > Veronica
> > Check out my new CD, "We Woof You A Merry Christmas," at
> > http://www.laurelcreekmusic.com
> > Veronica Elsea, Owner
> > Laurel Creek Music Designs
> > Santa Cruz, California
> > 877-607-6407
> >
> > _______________________________________________
> > acb-diabetics mailing list
> > acb-diabetics at acb.org
> > http://www.acb.org/mailman/listinfo/acb-diabetics
> >
>
> ----------------------------------------
> Christopher Gray, President
> Bay Area Digital
>
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>
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