I'll throw a complication into this...
The glucometers we all use in the field are the same used by patients for daily testing. FDA standards haven't changed for these units since the mid-1980s, where they were only required to have a sensitivity or accuracy range of +/- 20%. Yes, I said that right- glucometers in the US have a margin of error of +/- 20%.
Some links that discuss and provide research/evidence:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm
http://www.scribd.com/doc/28534516/FDA-ISO-Standards-for-BG-Meters-06-24-2009
http://www.nytimes.com/2009/07/19/h...l=1&adxnnlx=1298124021-fEgRNPsG/iimfRts+yVQSg
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=26309
http://www.ncbi.nlm.nih.gov/pubmed/16143321
So, thoughts? Knowing that this tool may potentially be inaccurate, how does it play into your clinical assessment?
The glucometers we all use in the field are the same used by patients for daily testing. FDA standards haven't changed for these units since the mid-1980s, where they were only required to have a sensitivity or accuracy range of +/- 20%. Yes, I said that right- glucometers in the US have a margin of error of +/- 20%.
Some links that discuss and provide research/evidence:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm
http://www.scribd.com/doc/28534516/FDA-ISO-Standards-for-BG-Meters-06-24-2009
http://www.nytimes.com/2009/07/19/h...l=1&adxnnlx=1298124021-fEgRNPsG/iimfRts+yVQSg
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=26309
http://www.ncbi.nlm.nih.gov/pubmed/16143321
So, thoughts? Knowing that this tool may potentially be inaccurate, how does it play into your clinical assessment?