GlukometersISO 15197

DiabetesForo's profile photo   04/12/2011 4:35 p.m.

Following the debate about the contour link that we have had in other threads, I have asked and read several things regarding the reliability and accuracy of the glucometers.

ISO 15197: 2003 regulates how glucometers should be exact.
And here the surprises begin:

- 95% of the results of a glucometer must coincide within a margin of more/less 15 mg/dl with respect to glucose concentrations for values ​​less than 75 mg/dl.

That is, if a glycometer marks 90 but in reality there are 75, it is perfectly legal ... and the opposite, if a glucometer marks 45 and we are actually in 60 is also legal.

- For glucose concentrations greater than 75 mg/dl, "error" margins of up to 20%are accepted .... 20%!!!: Shock:
That is, if we are at 120 you can mark from 96 to 144 ... if we are at 200 you can mark from 160 to 240 ...:-/

From what it seems, this iso is being reviewed at this time and the error margins may decrease to 5%.

In a study conducted by the University of Massachusets, J.P.Lock, compared 4 glucometers:
Freestyle Lite de Abbott, Ultra2 of Lifescan, Bayer and Aviva de Roche.
In this link you can read (the one who knows English: d): Link ... yrimas.pdf
Summarizing a lot:
When the glucometer error margin is established in 10%:
Abbott achieved 95%, Roche 92%, lifescan 80%and Bayer 59%.... The percentage is the number of measurements within the margin of error

When the margin of error strengthened, at 5%:
Abbott reached only 75%, Roche 60%, lifescan 49%and bayer 27%

That is, against more precise we want them to be the less reliability glucometers give ... although all glucometers comply with the legality of the norm.

Finally, clarify that the contour Link analyzes the total blood while the rest of the glucometers analyze plasma .... fact that can condition a lot when comparing results.

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DiabetesForo
04/12/2011 4:35 p.m.
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I am glad to confirm something that suspected you from a long time ago and that I have commented a lot in the consultations.I have sent an email to my hospital.Thank you!!!

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Velia
04/13/2011 5:57 a.m.

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That strong seems to me ... the truth that I look a lot at the results and that they can vary so much is worrying.
This reminds me of a glucometer that let me try Bayer (that I even made a consultation in this same forum of the concern I had) I never noticed and now it turns out that it is demonstrated that it is the least reliable ... I already said

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Quim
04/13/2011 10:19 a.m.
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Well, the truth is that I didn't know all that, but I am not surprised.Before some analytics I have looked at the levels and usually they never coincide, for example in the lastMarking more than I have and so it has ever happened to me that I notice hiccups when the glucometer marks 70 and should not, if nothing, I trust more than what the body tells me than of the apparatus.

By the way, I have a Menarini G-Meter (my first glucometer).

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Lew
04/13/2011 3:48 p.m.
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reflot the thread to link a news that has come out today: Link ... -Norma-iso
A study demonstrates that the results of blood glucose of Contour XT exceed the precision standards of the ISO Standard

Barcelona (12/15/2011) - Drafting
• The study was presented at the IDF World Congress of Diabetes that has been held in Dubai

• The results obtained by patients and health professionals were almost identical
A new study presented at the World Diabetes Congress (WDC) of the International Diabetes Federation, which has been held in Dubai, demonstrates that the results of the new system for blood glucose analysis of Bayer Contour XT and the glucose strips of glucoseIn Blood Contour Next exceed not only the precision standards of ISO 15197: 2003, but also the strictest criteria expected of the new standard for early 2012, since the results obtained by both patients and health professionals werealmost identical.The study demonstrates the excellent precision and accuracy of the system even when patients who have not received training are used.

The reactive glucose strips in Contour Next belong to a new generation of blood glucose reactive strips that use the GDH-Fad enzyme in combination with a bayer patented mediator to measure glucose in capillary blood.

The study presented at the WDC evaluated the accuracy of the Contour XT meter in the hands of its potential users: people with diabetes and health professionals.98.9 percent of the results of the capillary blood of people with diabetes were within the +/- 15 percent interval and 99.5 percent of the results of capillary blood glucose obtained by professionalsSanitary were in an interval of +/- 15 mg/dl.

Blood glucose analyzes were duplicated with the meter using a capillary sample of two punctures on the finger (superficial and deep), as well as a venous sample.All the results of the meter analysis were compared to the laboratory results with the YSI analyzer.

The precision was evaluated as the percentage of results that were within the criteria accepted by ISO 15197: 2003 and based on the most strict precision criteria expected of the new standard.

Exceeds the criteria of ISO 15917: 2003

According to ISO 15917: 2003, the criterion of compliance with this standard is that 95 percent of the results obtained with the glucose meter are in a range of +-15 mg/dl of difference with respect to the laboratory reference forglucose values ​​below 75 mg/dl, and within 20 percent for glucose values ​​equal to or greater than 75 mg/dl.

The study recruited 93 people with an average age of 33, of which 78 percent had type 1 diabetes, and 22 percent, type 2 diabetes. The results with the capillary samples of the deep puncture were similar to theOf superficial punctures, whether the Aceur XT analysis is made by people with diabetes or health professionals.

The results were calculated separately for glucose & lt values; 100 and ≥100 mg/dl, and similar results were observed when the calculations were done for glucose & lt values; 75 and ≥75 mg/d.The average hematocrit was 44 percent with values ​​between 32 and 52 percent.No serious non -anticipated side effects related to themeter.

New Generation Precision

To meet high precision standards and individual requirements of diabetes patients, Bayer has developed the glucose analysis of glucose blood count XT and reactive blood glucose strips in Contour Next blood.The new chemistry of the strip incorporates a mediator patented by Bayer that reduces background noise to identify blood glucose, especially at low levels, where it is more important.

The strips tolerate multitude of different storage situations maintaining precise results, and minimize signal interference from common substance substances (such as paracetamol and vitamin C) and hematocrit.The meter also has a patented algorithm that makes multiple pulse measurements, which provides specific information points for the meter to evaluate them, facilitating a unique calculation of compensated glucose concentration.

Bayer presented the meter in September at the Annual Meeting of the European Association for the Study of Diabetes, and is now available in Spain, Portugal and Italy;In the rest of the countries it will be launched soon.

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DiabetesForo
12/14/2011 3:11 p.m.
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Or I have read badly or say that the glycemia carried out by health professionals are slightly more accurate :)) :)) :))
The difference is minimal, but I find the subject horn

Normally the trust interval used in statistics is 5%, taking the highest.
Precision describing figures that can go up to 15% are still surprising ... that or they take us by idiots.

I do not know, but it smells that the comments we had been doing long ago were not very disabled ... but a laboratory does not pay this study, which, by the way, does not compare with other glucometers but with a venous sample: shock: shock: shock: shock: shock: shock: shock:

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DiabetesForo
12/14/2011 3:16 p.m.
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Good night,

I find the glucometers very interesting.I have already found another thread that talks about Bayer's contour link that seemed very interesting to me.

We have had a bad experience with Bayer's elite glucometer: in the medical center this glucometer, although we used another brand, the reactive strips are protected from one in one and it seemed very hygienic.But ... when measuring blood glucose if the drop was not fat, it gave us hipin the usual glucometer and then in the elite with a fat drop and was not in Hicm.

That is why when they gave us the contour link next to the bomb, I thought about it and continued with the old man, although from time to time I try the contour link.

We use: One Touch Ultraeasy of Lifescan, if anyone has references of this glucometer that tells us.

Ciao

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Martina
12/15/2011 5:05 p.m.
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Hello everyone

Let's see if I can clarify something, I am a nurse from a health center and you live with all glucometers, apart from I use them for being diabetic.

Piecemeal:

1st differences that are allowed today for values ​​greater than 75 mg/dl are +- 20% with laboratory.95 % of the results of a glucometer have to be at 20 percent difference.As Owash commented, that difference is very wide and there is an ISO regulations that are modifying it for this year, looking for more demand with precision.The study that Owash shows from the new contour meter XT, and the contour and a study strips is a study that has surprised me in a favorable way.This new strip reaches a precision for +-5 % of 90 % of the results, and if all the strips of all houses are put, and it is the most precise.That is important.In our health center we were presented with the meter and looks very good, a priori all patients who have elite are changed to the Contiour XT, we also give it to those who want to change as normal.Apparently the elite that had been almost 20 years and in principle has not given too many problems they change it for a strip that according to them is the most accurate today (new reagents in the strip, with new software in the glucometer),It looks good but we will see it.Regarding the comment that in the hands of professionals it gives a figure and in the hands of another patient, it refers to the fact that the professional does it with venous blood (extraction for analytics) and the patient with capillary blood, it is logical that there is some variation but notIt is remarkable.

I understand that we want everything super precise but it is impossible, not even among hospitals laboratories the figures coincide, which we have to look for what is most accurate today, without waiting for it to be super perfect.

Regarding the opinion of Ultra Easy Lifescan, good for tastes, I am in favor of looking for a simple and super precise meter.I think people should inform themselves first and not choose a glucometer for size, color, or because an MP3 looks like, but each one is free ...

I suppose there are too many glucometers in the market but with respect to commercial houses I did to those of a lifetime, Menarini and Bayer.I'm sorry for the rest but I've been seeing things and removed from strips for many years ...

Greetings, any questions tell me and if I can answer it I will be happy to send you an answer.

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DiabetesForo
01/15/2012 7:29 a.m.
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Within the health field Bayer is usually carried out all the professionals of professionals;Strips integrated into the glucometer and durability are its best qualities.
Regarding accuracy, I refer to the study that I have linked to the beginning of this post.At the moment, I have not read any more than the meters compare so in the meantime I am left with the most exact is that of Abbott.

All glucometers have had and have their problems: the absorption of the strips, the ergonomics, the reliability, the size, the puncture, the accuracy ... or even the interactions with the maltose.

The appearance of the glucometer seems important to me;The first thing is that of the correct values, obviously;But it is very important to be comfortable with an device that you use several times a day.We must bear in mind that one of the things we hate most is to perform a blood glucose ... If we also do not like the appearance of the glucometer, worse we will feel.
That is why laboratories take housings, stickers and all kinds of articles to tune the "glucos"

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DiabetesForo
01/15/2012 8:53 a.m.
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Good night,

Is it worth changing from One Touch Ultra Easy to Contour XT?In the medical center I have been efficient this last meter, but I'm afraid to change.

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Martina
03/02/2012 6:01 p.m.
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Hi Martina just tell you my opinion, if as you have down in the post your girl has 6.8 of glycosilada that is an excellent control, I would not do any change for my part.
Another thing would be that the glycosylated were high.

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juanqui2791
03/03/2012 8:15 a.m.
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Martina, you don't have to change glucometer but you want ...
If the ultraeasy is doing well, it gives you security and for you it is comfortable ... there are no reasons to change it.

Ultraeasy design often like crying ... It is easy to take it for them, it looks like MP3 and some somewhat more striking colors than the rest.

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DiabetesForo
03/04/2012 2:05 a.m.
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Every day I am more hallucinated ... These days Angela was Pachucha I did many controls, her trend inexplicably was down, but a nights of the glucometer marked 300 and 345 ... fortunately I made a couple more measurements,What my surprise that their figures were 200 and 196, in 2 consecutive measurements in the first case, and 210 and 197 in the 2nd ... Let's go, almost na ... the glucometer used is that of Menarini, and the strips are identicalto those of the contour link.

Martina, I loved the Onetouch ultra Easy, along with the most reliable optium I have had, apart from adjusting quite well to we have.The pity are the strips of the optium, a castañita the slowness of absorption.And the Onetouch stopped supplying strips in our community so to hunch.

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Velia
03/05/2012 4:27 a.m.

De los buenos tiempos, siempre quiero más...
Mamá de Ángela, ¡16 añitos, fiera!. Debut: octubre de 2003.
Bomba insulina Medtronic Paradigm Veo desde junio 2005
Última hemo 6.1

     

Thanks for answering me,

The truth is that my daughter's glycosylated hemoglobins have been great, until today, with the Ultra Easy, for this and thanks to your advice I will not change it.

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Martina
03/05/2012 1:43 p.m.
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Martina, the Counter XT is excellent, but does not justify the change, if you are comfortable with which you use (which is very good too).

Greetings

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Yanina.Perez
03/05/2012 10:08 p.m.
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Hello, I am new and it is my first intervention although I have appeared my name is Jesus and I greet you all.

Although I have been controls for 1 year a month ago that I have already put pasta treatment (diabetes 2).

A relative lent myself a glucometer and for a few weeks I have used that and logically I have been guiding my figures.

Yesterday I went to my usual pharmacy and offered the Bayer Contour XT and this morning I have already begun to use it, curiously or curiosity I
Corroia and this morning recently lifted I have taken the measure with both.
The borrowed (Arkray Glucocard G+) gave me a result of 125
The new Bayer Contour XT gave me a result of 150

Before taking the measure, I had made 30 minutes of bicycle (7 in the morning) ... I give the data in case they are appropriate.

Forgive myself but I am very fish in this and the pills have already produced me three times down of sugar.

Today I return the borrowed glucometer and logically I stay with mine and it is this that must accompany me throughout
The time that this disease will last and reading the post they supply doubts.

I would appreciate your comments.

Thanks and greetings.

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jvc
04/24/2012 8 a.m.
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The best thing you can do is trust a single glucometer.
The glucometers measure in a similar way, but not exactly the same ... In addition, as you have read there may be large differences between a blood glucose and another.

If you are happy with that device, trust the measurements that come out (unless it is something very rare).

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DiabetesForo
04/24/2012 1:19 p.m.
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: -L X (Well, after reading this I have had to count up to three, taking into account that my girl has an unstable type 1 diabetes, that the glucometer marks 060 or 040 is the difference between eating some cookies (in the first case)or engineer sugar as if there were no tomorrow (in the second case).

Now I understand those occasions when marking 060 and ingesting some sugar does not improve their symptoms, and other occasions when being "allegedly" in 040 with three cookie he bounces and is planted in 190. This also explains that with some declines aroundA 025 have milder symptoms than others from 045 ..

Does anyone know how I can get the contour XT in Andalusia?

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Con_Q_de_quimica
06/11/2015 1:02 a.m.
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I would try to call Bayer and ask for it.I have a contour Next, and I called Bayer last week requesting another spare in case I lost or robbed of mine having another, and they sent it totally free, shipping costs and everything.www.diabetes.bayer.es/products/contacto-servicio-tecnico/index.php

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Artorias
06/11/2015 2:03 a.m.
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Thank you very much for the info! I just sent you an email, to see what they tell me ...

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Con_Q_de_quimica
06/11/2015 12:11 p.m.
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