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RE: [IP] Meter Question



According to Bruce Bode, MD and Paul Davidson, MD ("The Insulin Pump Therapy
Book, Insights From the Experts", p. 86), the results of blood glucose tests
conducted on whole blood are typically 15% lower than laboratory
measurements done on serum or plasma.  That is consistent with the results
I've obtained by taking my tests at the same time I'm having blood pulled
for bg., hba1c, etc.  My CDE also told me that home test accuracy is very
bad above 450 mg/dl.  It does not surprise me that your meter only read 350
when your actual bg was above 600 mg/dl.  A little disappointing perhaps...

Kelly

-----Original Message-----
From: James Handsfield [mailto:email @ redacted]
Sent: Monday, March 04, 2002 8:33 PM
To: email @ redacted
Subject: Re: [IP] Meter Question


Jennifer Harkleroad <email @ redacted> wrote:

> I beg to differ on the idea that all meters are precisely accurate.

I'll put on my professional hat for this one.

Federal regulations require all waived laboratory tests, which includes home
glucose test meters, to achieve certain standards before they may be
marketed.  There are two basic standards:  1) the device must be simple
enough so that the instructions may be read, understood, and followed
without assistance by someone with a seventh grade education; and 2) the
device must have results that are within 5% of a standard equivalent
laboratory test (moderate complexity) 50% of the time.  That precision level
is approximated as +/- 20% of the laboratory tests (not another meter).

If you compare meters against each other, the ranges of precision have to be
compounded (IOW, the precision ranges will be quite a bit greater than +/-
20%) to get the appropriate range because they are not independent events.
It is inappropriate for that reason to compare the results of home test
meters against each other.  The only reliable test is to do your own test at
the same time you are having blood drawn for a laboratory glucose test.

These standards were/are developed by the Standards Branch of the Division
of Laboratory Systems of CDC where I work.  I have provided statistical
support for this branch on several occasions.

If you believe your meter is not sufficiently accurate or precise, contact
the manufacturer.  They generally have very liberal replacement policies.
But giving comparisons against other meter results won't suffice.

Jim Handsfield
email @ redacted

The opinions expressed are mine and do not necessarily represent those of my
wife who runs our house and makes more important decisions than I do.
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