One itme I had with one touch for me was extremely sensitiive to water/hydration on my body causing false positive highs. Drink a glass of water and readings back in line.
The FDA's March 16-17, 2010 Gaitherburg, MD meeting were painfully clear.
Our meters are NOT accurate!!!
Here are the links for transcripts of those meetings:
March 16, 2010
http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM208598.pdf
March 17, 2010
http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM208601.pdf
As a T1D I feel that the current accuracy standards of blood glucose meters are woefully inadequate. We use the readings from these meters to calibrate the dose of insulin, a medication with the capacity to kill us.
I found the following from an FDA report back on Novemebr 2005 and yanked a small but instructive comment about non glucose specific and glucose specific testing technology:
"In a patient who was receiving this maltose containing intravenous immune globulin product, when the blood glucose level was measured using a glucose non-specific methodology, the result was reported as 231 milligrams per deciliter. This represented a falsely increased value, due to the presence of maltose.
When the patient's blood glucose level was measured using a methodology that was specific for glucose, the result reported was 84 milligrams per deciliter, and this value represented the patient's actual blood glucose.
So, had a treatment decision been made on the basis of the first glucose result, the 231 milligrams per deciliter, insulin might have been indicated.
However, based on the glucose result obtained using a glucose specific methodology, which gave the patient's actual glucose level, insulin would not have been indicated."
The FDA has always assumed that these riots are caused by intravenous actions
and that the stomach/intestine/liver act as fire wall to prevent these sugars from getting into the blood system where metering is going on at fingertips.
For me they are wrong and dangerous. Every time I eat a substance with malto dextrose, galactose, zylotrol et all I routinely see the non specific glucose caveman meter fingerprick technology jump 40 to 100 points off reliably.
The only way to combat this is to use glucose specific technology in my case.
No real studies have been done to identify the leak rate on human bodies/livers to these man made sugars to balance of blood system and I object strenuously about the lack of science.
So far the assumption is that this is only an intravenus situation, and like frozen foam destroying refactory bricks on a space shuttle dooming its crew and destruction of the plane ; I say au contraire.
2023-FOODANDDRUGADMINISTRATION_glucoseerrors.doc (279 KB)I have to laugh to keep from crying. For a control loop of any process, be it blood glucose control or temperature control of one’s home, the feedback element must be reliably accurate. The FDA and the medical technology industry have decided that we don’t need good accuracy. Their decision places much more value on ease of use, speed, size of meters, and cheap strips. I wonder how many of these decision makers must use insulin to stay alive.
I'll agree with all of that except the part about "cheap strips." Mine sure aren't! LOL
Fair point. When I said “cheap,” I was thinking in comparison with $2-3 per strip. I think that the brand name strips we use are too expensive and I suspect that the profit margin is too high. It appears that the market is starting to exert its influence with the emergence of generic strips from Wal-Mart and others.
I would be willing to pay a reasonable amount more for strips that reliably measured actual BG +/- 5%.
There is absolutely no need for cheap strips ( read cost effective) to be inadequate or inaccurate.
Electronics industry and PC industry have repeadtedly demonstrated the ability to field volume products and high quality and cost effectiveness. Witness the $100 vcr's and digital cameras from Japan when we in America were selling 10 studio VCR units a year at a $100K plus.
I am tired of hearing the boneheaded arguments, sophistry justifying all us of being ripped off on over-regulated, low volume products. As one cannot dose with a cgms, all the delays, prescriptions and regulation on a monitoring product seem absolutely absurd.
Properly done we should all be able to all have low cost CGMS if it would help us.
So Sam and Guitarnut:
Did I answer your questions????
And here with the other shoe drpped is two reports right off FDA web site documenting two glucose meter strip technology their capability:
I wonder where all the clucking chickens went?
2021-K0926021freestyle_lite_strips.pdf (147 KB) 2022-K0606201_aviva_test_strips.pdf (90.7 KB)