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Re: [IP] Accuracy of DEX

email @ redacted wrote:

> I had had a terrible problem with the accuracy of the Glucometer DEX, and the 
use of disks. I had many results that were different fron doctors report.I 
finally switched to Glucometer Elite XL and have not had a problem. Have any 
of you had similiar problem./    

<< Professional mode = ON >>

All home glucose meters fall into the regulatory category of waived laboratory tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA88).  In order for a test procedure to qualify for this category, it must meet certain minimum criteria.  First, the instructions for use of the device must be understood and followed unassisted by someone with a seventh grade education; and second, the device must be return results within five percent (5%) of a standard value (i.e. a comperable non-waived laboratory test) half of the time.  Unofficially, the required accuracy is considered to be overall within 20% of that standard.  Of course, the appropriate conversion must be applied for comparing meters that return a blood glucose measurement against the serum glucose measured by non-waived laboratory tests.

All, repeat all, meters must meet these requirements.  If a meter is not advertized at being more accurate than other meters (there is one -- the Precision claims accuracy within 3% instead of 5%), then you can reasonably expect to have this accuracy with your meter.  

<< Professional mode = OFF >>

Manufacturers are very careful that there be no body of evidence built that their meter does not meet the above criteria.  If that could be demonstrated, then the FDA would pull their approval for marketing as a waived laboratory test under CLIA88.  As a result, they generally have *very* liberal replacement policies.  If you suspect your meter is not as accurate as the above criteria require, a telephone call (with *some* evidence, of course) will, more often than not, get you a replacement meter.

Also, the choice of meters generally can be made based on matters other than accuracy and precision.  If you like the features of one, or the ease of use of another, or (as in my case) your insurance will support only one meter, then that is the basis you should use for your decision.  

While it is possible that an occasional meter may give problematic readings, it is also highly probable that varied readings are be an accurate reflection of your blood glucose.  I encourage you not to discount widely swinging readings as just a problem with your meter.

Jim Handsfield
Division of Laboratory Systems, Public Health Practice Program Office
Centers for Disease Control and Prevention

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The opinions expressed are mine and do not necessarily reflect those of the Centers for Disease Control and Prevention, the U. S. Public Health Service, or any other agency of the United States Government.
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