Discussion in 'Parents of Children with Type 1' started by WhyMyBabyGirl, Jul 19, 2009.
I'm all for more accurate meters, but I think the article is overstating things just a bit...!
"Such a wide (20%) error rate can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma."
Is this for real?
When Yossi had hypo convulsions, our Endo told us it happens an average of once a year.
OMG i was never told that!
Out of the families I personally know with diabetes, no one has had a seizure due to diabetes. I know about 10 families for about 8 years.
It is possible, but I don't think it is common for someone to have a seizure once a year.
Wow, 19 years and I have never slipped in to unconsciousness, maybe being an adult the whole time is a factor.
I know that it was very hard for my cousin in the early 1970's no meters and such, she was in an out of the hospital all the time with DKA and stuff, from the time she was diagnosed at 4 to she died at 11. they could not get to the hospital in time to save her.
My son has had a number of seizures due to lows. He's been hypo unaware for a while now and when he has a lot of lows in a row he will have seizures. Since going on the Navigator though, he has not had any bad lows and therefor no seizures. Woo Hoo!
I would love more accurate meters. With the ability to better manage comes also the need to have better numbers to work from. :cwds:ali
How long has he been on the Navigator?
I need to convince my endo that the Navigator is "accurate"
We do not see anywhere near a 20% error with our Aviva, and it's why we use it instead of the One Touch "linked" meter. The margin of error for children is small, and in our little test sample of one (well, two, because I've tested myself a lot), the Aviva is very, very consistent. The One Touch - not so much. Accuracy is also really important for CGM use. I can't imagine using a meter that's consistantly 20% off to calibrate the CGM. It would virtually render it useless.
we are 3.5 years in to this and no seizures or even the need for glucagon.
FIL has had D for over 20 years now and only once needed glucagon and no seizures for him either.
Three and a half years here and no seizures or loss of consciousness. I'm not naive and know it totally can happen, but I don't think for *most* it's once a year.
That said our neighbor is in his 50's (I think, probably early-mid) and was diagnosed sometime in his 30's I believe. I'd say he definitely has at least one or or both of those happen at least once a year, maybe more. I know they called EMS twice in two days a few months ago.
As for the meter accuracy or lack thereof, is it true that the higher the number, the less accurate it is? I thought I remembered reading that once and it seems true in our case. Lia had some really high numbers the other night (somehow I read the carbs totally wrong on a new snack we bought-soynuts). The first number was 459, the second was 373. I wiped both fingers with a damp cloth before each check.
Anyone try to research which meter is the most accurate? Ever try to look up clinical test results comparing different meters? Go ahead and try and please post the results here. I have tried and come up mostly empty. I have found clinical results for a few meters on their company websites but not many. I used to be able to find the clinical results for the Aviva. Last I checked I couldn't find that anymore.
I think this is intentional. If this info was easily available, everyone would switch to the best meter and throw an unholy fit if their insurance company wouldn't cover it. The other meter companies would either improve or go out of business.
Honestly I don't care if there are mediocre meters as long as we have access to the best one and I think that's the Aviva. I think it would be great if the Aviva were even better though.
We had always used one touch meters until we started the Navigator cause our insurance would only pay for one touch strips.
I have been surprised at the differences between the freestyle and the one touch (often the one touch number agrees more with the Navigator). I don't know if the freestyle strips are less accurate or what. If I retest with both I'm more likely to get similar (agreeing) numbers with the One touch. The Freestyle strips can give a lot of variation - even in the lower ranges - definitely more than 20%
We test all of our meters with the readings from a blood draw before using them. The real scary thing is that about 25% of the meters we have tested actually fail..... and that is against a +/- 20% standard. I could not imagine how many we would junk with higher standards.
There are abstracts posted for this week's AACC meeting here: http://www.aacc.org/events/2009am/abstracts/pages/default.aspx
You'll find some for bg meters and ketone meters etc. Look by day or search.
Here's one abstract Performance and practicability of a new ambulatory blood glucose monitoring system (Accu-Chek Mobile) under everyday conditions in diabetic subjects Oasis, Online Abstract Submission and Invitation System - Program Planner
Performance and practicability of a new ambulatory blood glucose monitoring system (Accu-Chek Mobile) under everyday conditions in diabetic subjects[SIZE=-1]Topic: Point-of-Care Testing [/SIZE][SIZE=-1]B. M. Gambke1, M. Br?ndle2, N. Hermanns3, U. Keller4, B. Teupe5. 1Roche Diagnostics, Design Verification and Validation, Mannheim, Germany, 2Kantonsspital, St. Gallen, Switzerland, 3Forschungsinstitut der Diabetesklinik, Bad Mergentheim, Germany, 4Universit?tsspital, Basel, Switzerland, 5Diabetes-Dorf Althausen, Bad Mergentheim, Germany, [/SIZE][SIZE=-1]Presentation Number: B-139[/SIZE][SIZE=-1]Keyword: glucose monitoring, point of care testing, diabetes[/SIZE][SIZE=-1]Objective/Relevance: The Accu-Chek Mobile system uses a new concept providing the reagent on a tape in a cassette. Objectives of the study were an examination of the relative accuracy using capillary blood, reproducibility with control solutions, and an evaluation under everyday conditions.[/SIZE]
[SIZE=-1]Methodology: Intended users were asked to use the Accu-Chek Mobile system in parallel to their own system. They had a minimum of 20 days to complete daily controls and 50 glucose measurements from the same pricking using both systems. Experiences with Accu-Chek Mobile system were assessed by a questionnaire. People rated statements on a scale from 1 ?strongly agree? to 6 ?strongly disagree?. Data were recorded by the participants themselves.[/SIZE]
[SIZE=-1]Results: 46 subjects with diabetes type 1 or 2, 29 from Germany, 17 from Switzerland, age 19 to 71 years, with a broad range of experiences in the use of blood glucose self monitoring, agreed to test the Accu-Chek Mobile system. Pooled measurements with control solutions yielded a SD of 6 mg/dl for the low control and CVs of 7.5% and 6.0% for the high controls. The Accu-Chek Mobile system is calibrated to provide IFCC-plasma-like glucose values. Simultaneously measured blood glucose values (Accu-Chek Mobile and comparison system) were converted to plasma-like values if appropriate. Regression analysis for several systems can be found in the table below. Data from the questionnaire showed high acceptance with ratings between 1 and 3 in the range from 84.4% to 100%.[/SIZE]
[SIZE=-1]Data of the regression analysis according to Passing/Bablok for the comparison of the Accu-Chek Mobile system with Roche, Bayer, Lifescan, and Abbott systemsComparison systemsN[/SIZE]
[SIZE=-1]measurements[/SIZE][SIZE=-1]Plasma glucose range [mg/dL]Correlation coefficient [r]Median deviation[/SIZE]
[SIZE=-1](Y-X)/X [%][/SIZE][SIZE=-1]Roche (1)97833 - 4860.9490.377Bayer (2)58547 - 3430.9255.298Lifescan (3)53834 - 4660.9695.958Abbott (4)61634 - 3840.9224.293(1): Accu-Chek Aviva, Accu-Chek Compact Plus, Accu-Chek Sensor(2): Ascensia Contour, Ascensia Contour Link, Ascensia Dex 2(3): One Touch Ultra, One Touch Ultra 2, One Touch Ultra Smart, One Touch Ultra Easy, Euroflash(4): FreeStyle, FreeStyle Mini, FreeStyle Lite, FreeStyle Freedom, Precision Xceed[/SIZE]
[SIZE=-1]Conclusion: The new blood glucose monitoring system (Accu-Chek Mobile) tested in ambulatory diabetic subjects demonstrated excellent agreement to other systems on the market. Handling caused no problems and the ease of use was highly appreciated. The new Accu-Chek Mobile system thus shows very good performance and practicability in the hand of the intended users.[/SIZE]
[SIZE=-1]Accu-Chek and Accu-Chek Mobile are trademarks of Roche.[/SIZE][SIZE=-1]Commercial Relationship:[/SIZE]
I don't know if any of these articles help you:
Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems - Draft Guidance - Not for Implementation
This guidance document is being distributed for comment purposes only.
Document issued on: October 24, 2006
FYI: Diabetes Technology & Therapeutics
Assessing Glucose Monitor Performance?A Standardized Approach
To cite this article:
John J. Mahoney, John M. Ellison. Diabetes Technology & Therapeutics. December 2007, 9(6): 545-552. doi:10.1089/dia.2007.0245.
Published in Volume: 9 Issue 6: November 22, 2007
FDA?s proposed CLIA waiver application guideline
Evaluation of Point-of-Care Glucose Testing Accuracy Using Locally-Smoothed Median Absolute Difference Curves
WASHINGTON, July 19 (UPI) -- An endocrinologist group has asked the U.S. Food and Drug Administration to increase standards for home glucose monitors, an FDA doctor said.
"We think this technology is not up to par for some of the protocols we see out there" like hospital treatment of critically ill patients, said Dr. Alberto Gutierrez, deputy director of the agency's in vitro diagnostics office.
The American Association of Clinical Endocrinologists wrote the FDA in May asking that the standards be tightened.
"Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened," the doctors' letter said.
One concern is hospitals have begun using home meters that are not as accurate as sophisticated meters that cost much more.
The FDA follows international standards for meters that allow the blood sugar reading to be off by as much as 20 percent. The FDA pressured the international standards agency to lessen the amount of deviation allowed in the meter.
The U.S. agency may set its own standards if the international group does not, the report said.
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