I just got invited to the following, anyone been involved in one of these?
Talk with FDA expert Courtney Lias and Patient Advocate Bennet Dunlap about Glucose Monitors and Test Strips Monday, March 31, 1:30–2:30 pm (EDT)
Just how accurate or repeatable does a meter have to be? I would think the repeatability would be more important that the absolute accuracy.
Hi John, welcome to our wonderful site!
We hold live interviews on this site on a regular basis, every member gets invited to those events. The event will be held here at our site, on the home page, you can ask questions, listen to Emily and her interview partner(s) and learn a lot, here about test strip accuracy. you can find more live events here:
http://www.tudiabetes.org/events/event/listByType?type=live+interview
Hope i could help, feel free to ask if there are still questions.
SC
I'm curious about this. My meter correlates pretty closely to my A1C so I'm ok with it but any improvement would be useful. I sort of have "dullabetes" since I am very regular in my habits so I don't have as many surprises as I used to. At the same time, the +/- 20% standard is sort of ridiculous. Or is it? I'm not sure that they can make meters, particularly a meter that's schlepped around in your pocket, purse or backpack, more accurate. Maybe a meter in a lab is more accurate and all that but what about the fact that these devices are, at least in my experience, very reliable? I would prefer a meter as tough as the one I have to one that's a wee bit more accurate that is fragile and requires tender handling.
Unfortunately, I'll be on vacation on Monday and probably nowhere near a computer that will hook up for this. Still, I like the chat/ interview format pretty well and the ones I've been able to attend have always been an hour well spent. I'd like to see them do them more in primetime sometime, so those of us w/ jobs, etc. could attend...
I have worked in electronics for 40+ years. They can make things that are very precise.
However there are usually tradeoffs and things that contribute to have measurement systems that have some amount of error.
Is there a good place to go to that discusses the way that the meter actually measures the blood? I doubt the they are just measuring the resistivity of the blood. Or maybe that is what they are doing.
These folks are coming from the Strip Safely campaign, advocating that the FDA tighten standards for test strip and meter manufacturers to improve our ability to test with confidence. I think it's a pretty good idea and wonder how they arrived at +/- 20% as reasonable.
Well I went and read the ISO 15197 spec that was proposed last year. I agree that they should tighten up the standards, and impose some standards on what the meters should meet.
You really can't compare things if you do not have standards. Some will complain, I'm sure, that it will drive up the cost. Well so be it, at least we will be on the same plying field. Plus or Minus 15% seems like a large window. But again I have not found the information that shows where the variables are in the measuring system. I am ignoring us, the users, the meters have to meet a testing standard that is a lab standard. The variability that we introduce is over and above that.
John, this is going to be a little different than the live event/interviews that swisschocolate described. please click on this link and register
http://www.tudiabetes.org/events/patient-network-live-chat-diabetes-glucose-monitors-and-test-stri
it's going to be live from the FDA with Bennet and Ms. Lias. I believe there are a limited number of guaranteed places. It sounds like you could truly add to the conversation. I hope you can attend and perhaps report back.
Yes this is the one I am going attend. I have my password already.
I think that precision (test/retest) is very important these days, but if a meter is off consistently by 10-15 points, it isn't a big deal. The thing is that our other tools are highly dependent upon good readings from our BG meter. A CGM is going to put out some pretty crappy numbers if the inputs from our BGM are off by a lot, and now we are moving towards automated insulin pumps that use glucogon and insulin coupled with a CGM that (I believe) is dependent upon those blood glucose meter readings.
Then you have new tools like the very fast acting inhale-able insulin Afreeza that I think are more dependent upon fairly accurate readings. The occasional reading that is way off could result in a pretty nasty correction.
Very good points. When the human is reading the numbers we can put a judgement factor on them. Like you point out when we start interfacing with other systems that make judgements on the numbers we could get in serious trouble,
Sorry then, i got confused...