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Subject:
From:
Kemp Randolph <[log in to unmask]>
Date:
Tue, 9 Jun 1998 09:49:59 -0400
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<<Disclaimer: Verify this information before applying it to your situation.>>

In <[log in to unmask]>, on 06/08/98
   at 08:29 PM, Fran  Gillespie <[log in to unmask]> said:

>>Are you sure you don't have a prototype with the Complete? Look  in the
>>package inserts for the %CV for whole blood for the Complete.

>>>>Not sure what you mean here?

Two separate questions. The second  to make sure both meters are about the
same in measuring quality should have been two questions. Measurement is a
statistical process and is assessed by comparing the average of repeated
measurements to some agreed standard and measuring the reproducibility by
the spread of repeated measurements around that mean. The former called
"accuracy", the latter "precision". Think of some bell shaped curve for
the latter.

Accuracy comparison the more relevant here: does the Complete measure
whole blood glucose, as do all the other BM meters? The Elite, latest
strips for the Medisense, and SureStep are unfortunately calibrated to
plasma venous blood, an extract from whole blood samples. Latter about 12
% higher and in my opinion, as a Type 1, more dangerous for
self-monitoring,when it comes to hypoglycemia. Finger tip blood glucose
always drops faster as the body protects the brain so it gives you an
earlier warning. Whole blood calibration favors  that  bias. Since you put
(capillary) whole blood on the strip, the calibration of the "venous"
meter/strips is crazy, anyway -- if you put venous blood on them I suspect
they'll read venous high by 12% also.

So a word of warning in switching meter/strips. Be sure you know whether
the (accuracy) calibration standard is changing or not. If it is, shift
your expectations of dangerous, good, bad etc.

>>>>Actually I don't have duplicate code chips for both to be able to use
>>>>the same strips from the same vial..... but I opened new bottles up of
>>>>each at the same time.

That's the source of the problem. Calibration does differ from vial to
vial unless they have the same calibration code. Unfortunately the meter
manufacturers really put one over on the FDA: they are forced to print the
mean and range at 2 or 3 values of blood glucose on the vial but the
calibration chips apparently don't fully correct for this. They then have
the nerve to tell you not to use these numbers!  See how the corresponding
means on the two vials compare.(The vial range on the BM strips covers 99%
of the readings and is useless compared to the precision numbers on the
package insert.)

                                        Kemp Randolph
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Kemp Randolph <[log in to unmask]>
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