C8 Medisensors Gains CE Mark Approval for The C8 Medisensors
11/07/2012 7:48 a.m.
C8 Medisensors Gains CE Mark Approval for The
C8 Medisensors Optical Glucose Monitor ™ System
For People with Diabetes
A New Non-Invasive Continuous Glycose Monitor is approved for marketing in Europe
Dear,
We are pleased to contact you with ur latest news: c8 medisensors, inc. have reirized
CE Mark Approval for ITS Optical Glucose Monitor System.Our New Non-Invasive Continuous Glucose Monitor (NCGM), Will Be Marketed in Europe.
The Comprehensive, 10-YEAR DIABETES CONTROL AND COMPLICATIONS Trial (DCCT) Clearly Demonstated that individuals with type 1 diabetes Who Kept Blood Glucose Levels As Close To Normal As Possible For As Possible Had Less Chance of Developing Disease-Relate Complications.The DCCT Found That the Risk of Eye Disease was reduced by 76%, Kidney Disease by 50%and Nerve Disease by 60%. [1]Since that time, other studies have confirmed the importance of tight glycamic control with minimal glucose excursions in reducing desaase-related complications not only in type 1 diabetes, but also in Type 2. [2-6]
In Addition, A Large Number of Studies have shown that continuous Glucose monitor (CGM) Can Improve Glycamic Control With Reded Risk of Hypoglycaiamia. [7-19] CGMS Are Adjunct Devices That Are intended to complement Finger Sick Blood Blood Glucose Tests.Traditional CGMS RELY ON A NEEDLE SENSOR INSERTED Under The Skin, which can cause pain or discomfort, and possesses Risk of infection. [20]In contrast, The C8 Medisensors Optical Glucose Monitor System Harnesses The Power of Light to Measure Glucose Levels.Using Raman Spectroscopy, Beam of Light Is Shone into the Skin and the Result Vibrates of Glucose Molecules are Measured to Give A Glucose Reading;End Achieved via Small, Pain-Free Portable Monitor, Discreetly Worn Under Clothes Against The Skin.
For Added Convenience tohe Readings Are Stored and Sent Wirelessly to the User’s Smartphone for Glucose Readings at A Glance, providing the Wearer with a Continuous Picture of Glucose Dynamics Thour The Day.A Good Underestanding of Glucose Levels is invaluable in managing diabetes and improving patient outcomes. [1]In Clinical Studies, The C8 Medisensors Monitor was Found to have comparable to Earlier Versions of Invasive Cgms When Those Systems were First Introduced, But with Less Pain and Less Risk of Infection.
“C8 Medisensors was co-footed by a Father Trying to Help His are Living With Diabetes, and As A Company, We Remain Dedicated To Helping Thue With The Disease,” Said Paul Zygielbaum, CEO of C8 Medisensors.“CE Mark Approval is a Landmark Step for This Unique Technology.OUR TEAM IS HUGHELY EXCITED TO BE WORKING TO MAKE NCGM AND THE OPTICAL GLUCOSE MONITOR SYSTEM AVAILABLE THRUOUT Europe. ”
The C8 Medisensors Optical Glucose Monitor System is not yet Shipping But Will Soon Be Available For Purchase Online Via The C8 Medisensors Website, www.c8medisensors.com .
The C8 Medisensors Optical Glucose Monitor System Is An Adjunct Device.It is contraindicated in pregnancy and forys under 18 Years of Age, as well as in individuals with very light or see Dark Skin Tones, Peripheral Vascular Disease Or Individuals Who Smoke.
11/07/2012 7:48 a.m.
What do you mean that precision is comparable to that of the first versions of continuous meters?
Was that precision good or bad?
Anyway, as my son is 12 years old, 6 are 6 to check their benefits.
Of course, if it works, it seems to me the best invention for the control of diabetes, ahead of the pumps.
11/08/2012 4:44 a.m.
Padre de Andrés, 17 años. Debut: septiembre de 2011.
Levemir (30ud. mañana y 24ud. noche) y Novorapid (en desayuno, comida, merienda y cena 40ud aprox - 24HC/día).
Medidor continuo DEXCOM G4 desde julio 2014
Hemo: 6.2 (Sept. 2013), 7.0 (Dic. 2013), 6.9 (Marzo 2014), 6,6 (Junio 2014), 6,7 (Sept. 2014), 7,0 (Dic. 2014), 7,7 (Mar 2015), 6,9 (Jul. 2015), 7,0 (Sept 2015), 7,4 (Dic 2015), 6,8 (Mar 2016), 6,6 (Julio 2016), 6,8 (Octubre2016)... 7,0 (Mar 2018)
Yesterday I was talking to the Commercial (911 14 73 98) and told me that they had already received European certification and that they wanted to market the device in all European countries before the year 2012 was completed. Its price is $ 4000,That, today they become 3136 euros.It does not need consumables, although an optical gel and adhesive patches that cost about 100 euros a year.Not being invasive, the authorization of the endocrine is not needed to acquire it, although obviously it is always better to comment on these things to the specialist.It lasts four years and you just have to calibrate it if you take it off: as it is not amphibious, if you are going to take you, you take it off and then when putting it, you calibrate it.It is necessary to have a smartphone to use it.It works with a Bluetooth alarm that warns of hypos and hyper and shows a graph of the evolution of blood glucose.
11/08/2012 6:19 a.m.
What is the useful life of gossip?If the conversion costs 4000 dollars (at best) it will be 4000 euros, you will see ... I think it's a lot of money, to see how the first opinions are ... Anyway, it is very good news thatMeters from different brands are coming out to see if the laboratories take a little prices.
Aandres if it serves you, the Dexcom is not recommended for children or pregnant either.I have been from the first day that I knew I was pregnant with the dexcom on (and the endocrine told me that if I could pay me, that now it will not take it away, normally rest a couple of week between sensor and sensor).And the other day I was with a father who has two children, the two with diabetes and the two carry Dexcom, and none approaches at age 18 ....
11/08/2012 6:54 a.m.
Miembro del equipo de moderación del foro
DM1 desde 1988
Mamá de 2 niños y a la espera del tercero
Bomba + Dexcom
Hello
Have you found some reliability study like those for Dexcom?
thank you.
Not advising children. I thinkIn reliability
11/08/2012 8:05 a.m.
The device lasts about four years.To me the fact that you do not have to pay consumables seems wonderful to me, I do not know how you will see it ...
The commercial told me that the C8 was not yet to be sold for children because even more rigorous tests had to be done (as with any medicine or device), but that everything would arrive.
11/08/2012 10:02 a.m.
and give you guarantee for those four years ???Even so, the joke comes to 1000 euros a year ... I trust very little of the non -invasive systems, to see if studies come out or if they try it in hospitals and we can tell us something our endocrine ...
11/08/2012 10:53 a.m.
Miembro del equipo de moderación del foro
DM1 desde 1988
Mamá de 2 niños y a la espera del tercero
Bomba + Dexcom
I already put this link in the other post on the C8: Link .../#More-959 >
Very large pot (it is a fairly wide belt), doubts about reliability in humidity conditions and is about to see the accuracy of their measurements with respect to other meters.
Even with everything, it is a joy that is available shortly.
11/08/2012 11:15 a.m.
Good, the device if they do everything they say would be C ... but I see some inconveniences: if I have not understood badThe pump catheter?.It is not submersible, we are going that the moisture, the water does not do well, and the sweat? ... With the price they have they could have already taken it with a screen or something and not that it has to be linked to a phone, that my6021 has Bluetooth but not Android and if I use Bluetooth for the meter, you could connect the phone to the hands free of the car.
And what happens to the 4 years that stops working, or that self -destructs.
Well, as we are unemployed, I will have to wait to buy the apparatus and change my mobile unless I touch the lottery: D: D (we will continue waiting :)) :)))
11/08/2012 2:31 p.m.
DM1 desde el 81 antes de naranjito.
Con bomba desde 2012
Minimed Veo parading
Minimed 640g desde 06/2015
Minimed 640g desde 19/03/2016 la 2a
Minimed 780g desde el 23/03/2021
Hemoglobina 12/01/2021->6.1
28/07/2021-> 6.4
The first to buy it that tells us his experience, so he gets us out of doubt ...
11/09/2012 5:29 a.m.
Basically, I see that it does not work for sport, which is one of the situations that would interest me.As you are not subject to anything, when moving a little, I understand that the sensor will move continuously in your day to day.I speak from ignorance, but I imagine that I would have to be reluctant in the gut constantly because it moves from its site all the time.I don't know.It does not convince me.Not to mention the huge girdle to be carried to hold there.
I also believe that they will make the conversion 1 dollar = 1 euro, something so unfortunate and shameful that they do more than one company when they bring their products to Europe.But still, $ 4000 would be $ 1000/year, which is still much cheaper than Dexcom and Guardian.
11/19/2012 3 a.m.
ISCI / debut: 1986 / HbA1c: 5,5%
Basically, I see that it does not work for sport, which is one of the situations that would interest me.As you are not subject to anything, when moving a little, I understand that the sensor will move continuously in your day to day.I speak from ignorance, but I imagine that I would have to be reluctant in the gut constantly because it moves from its site all the time.I don't know.It does not convince me.Not to mention the huge girdle to be carried to be held there.
Well, also speaking from ignorance, I don't see why not.
If in the day to day it moves continuously as you say and works, I do not see the reason for it to work worse when you do sports because it moves more.After all, instead clicking with a needle, what "click" is a beam of light.And I say that it will give the same as you click a little higher than a little below.The speed of response and analysis of a beam of light can already imagine that it is quite instantaneous.I believe that the inconveniences will not go there, if any.I think it will be more a reading and/or condition precision issue to the area for having a laser crossing your skin continuously.What I put in the initial note that the precision is that of the first continuous meters to me.
Let's see when the first comments arrive, whether from here or other countries.
11/19/2012 1:23 p.m.
Padre de Andrés, 17 años. Debut: septiembre de 2011.
Levemir (30ud. mañana y 24ud. noche) y Novorapid (en desayuno, comida, merienda y cena 40ud aprox - 24HC/día).
Medidor continuo DEXCOM G4 desde julio 2014
Hemo: 6.2 (Sept. 2013), 7.0 (Dic. 2013), 6.9 (Marzo 2014), 6,6 (Junio 2014), 6,7 (Sept. 2014), 7,0 (Dic. 2014), 7,7 (Mar 2015), 6,9 (Jul. 2015), 7,0 (Sept 2015), 7,4 (Dic 2015), 6,8 (Mar 2016), 6,6 (Julio 2016), 6,8 (Octubre2016)... 7,0 (Mar 2018)
Aaandres, obviously, does not work because in sport you move infinitely more and more violently than during normal day to day.How will it measure me while I do abdominals?or while I make a bank press?Or running, that your abdomen moves?Or worse, when I play paddle or tennis, or do you even tell you the golf, with the runners it causes?
The system has the great comfort and attractiveness of non -invasiveness, and that there is no cost of consumables.That is your advantage over competition.But in return, it measures worse in many more situations, its life is shorter (it has an expiration date the device) ...
11/23/2012 6:22 a.m.
ISCI / debut: 1986 / HbA1c: 5,5%
Surely you have more information than me.
I don't see it so obvious.
11/23/2012 7:43 a.m.
Padre de Andrés, 17 años. Debut: septiembre de 2011.
Levemir (30ud. mañana y 24ud. noche) y Novorapid (en desayuno, comida, merienda y cena 40ud aprox - 24HC/día).
Medidor continuo DEXCOM G4 desde julio 2014
Hemo: 6.2 (Sept. 2013), 7.0 (Dic. 2013), 6.9 (Marzo 2014), 6,6 (Junio 2014), 6,7 (Sept. 2014), 7,0 (Dic. 2014), 7,7 (Mar 2015), 6,9 (Jul. 2015), 7,0 (Sept 2015), 7,4 (Dic 2015), 6,8 (Mar 2016), 6,6 (Julio 2016), 6,8 (Octubre2016)... 7,0 (Mar 2018)
Carrying the Dexcom and with the usual ones that we are to the punctures for me that is not invasive is no advantage if that is why it has worse precision.The advantage is that you do not need consumables ....
I hope that one day the prices are low
11/23/2012 11:52 a.m.
Miembro del equipo de moderación del foro
DM1 desde 1988
Mamá de 2 niños y a la espera del tercero
Bomba + Dexcom
I am with ethics, the first is precision ... but that is related to the different situations.
The C8 is huge, nothing disguised, so practicing sports with him seems unlikely to me.
On the other hand, my greatest doubt is the issue of sweat, it does not interfere with the results? ... In addition, that if it is a belt, where do you put on the pump?
11/23/2012 12:23 p.m.
carrying the dexcom and with the usual ones that we are in the punctures for me that is not invasive is no advantage if that is why it is worse precision.The advantage is that you do not need consumables ....
I hope that one day the prices go down or at least approach those of the US, but, after pregnancy I will have to stop using the gossip, and it is a shame because for me it is health, but forever I can not afford it
Indeed, if we talk about worse precision, the advantage is zero.It would be sad (for them and for diabetics) 10 years of research to reach a product that offers less than what already exists.Hopefully it is not so.
If the precision was comparable (which is what they say on the web, but not in the initial article that has copied bar ), then the advantages are greater:
- You need less calibration than the current ones (based on fingerprints).In fact, if you take it off to shower and put it again, start automatically when it has heated, without the need to calibrate again.
- The readings go in your own mobile, as well as alarms.One less device (we all carry mobile) and you can also put the desired tone and alarm volume (I have read that the alarms of the current ones are not very powerful).
- Bluetooth technology: greater signal scope than the current ones (a priori).As for playing sports, sweat ... all the doubts that arise, it will be seen.But a beam of light is a beam of light.He shoots and penetrates the skin.The Raman effect is based on the determined vibration of each type of molecule.The glucose molecule vibrates in a certain way to a beam of light generating a color spectrum, other than all others.The varatejo in question receives that information and calculates how much glucose there are.As?No idea.But I don't see the sweat or movement could pertubate that.The molecules are there or are not, and at a certain level of concentration.
That arrives soon and we will leave doubts.
11/23/2012 1:13 p.m.
Padre de Andrés, 17 años. Debut: septiembre de 2011.
Levemir (30ud. mañana y 24ud. noche) y Novorapid (en desayuno, comida, merienda y cena 40ud aprox - 24HC/día).
Medidor continuo DEXCOM G4 desde julio 2014
Hemo: 6.2 (Sept. 2013), 7.0 (Dic. 2013), 6.9 (Marzo 2014), 6,6 (Junio 2014), 6,7 (Sept. 2014), 7,0 (Dic. 2014), 7,7 (Mar 2015), 6,9 (Jul. 2015), 7,0 (Sept 2015), 7,4 (Dic 2015), 6,8 (Mar 2016), 6,6 (Julio 2016), 6,8 (Octubre2016)... 7,0 (Mar 2018)
I still look like a huge dead, between the device and the girdle to wear it.Conspicing but not being able.And I like that I get bad ...
11/26/2012 3:34 a.m.
ISCI / debut: 1986 / HbA1c: 5,5%
Hi Gondrullo.
They just responded to Medisensors and you are right.It does not serve to do sports.
I attach the answer to the 3 questions I asked them (date of sale, use in children and utility to do sports):
"In relation to the issues that raise us, I try to answer them:
1) We are pleased to inform you that we have obtained very recently the CE brand, which constitutes the regulatory approval necessary to market the product in the European Union.Our intention is to launch the product to the European market before the end of 2012, starting with the United Kingdom (please take that date as a forecast, not as a commitment).We will update our website in relation to the novelties related to the product launch calendar in each country.
2) C8 Medisensors, together with health suppliers and regulatory agencies, is aware that the child population represents a particularly vulnerable group.However, for the moment, C8 Medisensors has chosen not to seek a pediatric indication for our non -invasive glucose monitor.
The regulatory requirements to obtain pediatric approval are complex and specific as regards this demographic group, therefore, specific measures being necessary to protect the safety of minors participating in the corresponding studies.
Adult devices can be inappropriate for use in minor people for multiple reasons, or may require design and/or labeling changes to adapt their use in child population.Health device manufacturers must take into consideration both an exhaustive risk management and the requirements derived from clinical studies, to certify the safety and effectiveness of said devices in children.The child population experiences large and rapid changes in a period of a few years, such as height, weight, growth and development, diseases or dysfunctions, hormonal changes, anatomical and psychological differences with respect to the adult population, level of activity and maturity, statusImmune, ... each and every one of which can have an impact on the safety and effectiveness of a device when it is used by patients below 18 years of age.
We certainly understand the challenge facing people in charge of minors with diabetes and, that is why C8 Medisensors does not rule out in the future to undertake the obtaining of a pediatric indication for our non -invasive glucose monitor.
3) The monitor should not be used during intense exercises.Since our monitor is of optical technology, with movement, intense exercise or sweating, the monitor can lose contact with the skin giving rise to readings temporarily failed or wrong. "
11/26/2012 4:09 a.m.
Padre de Andrés, 17 años. Debut: septiembre de 2011.
Levemir (30ud. mañana y 24ud. noche) y Novorapid (en desayuno, comida, merienda y cena 40ud aprox - 24HC/día).
Medidor continuo DEXCOM G4 desde julio 2014
Hemo: 6.2 (Sept. 2013), 7.0 (Dic. 2013), 6.9 (Marzo 2014), 6,6 (Junio 2014), 6,7 (Sept. 2014), 7,0 (Dic. 2014), 7,7 (Mar 2015), 6,9 (Jul. 2015), 7,0 (Sept 2015), 7,4 (Dic 2015), 6,8 (Mar 2016), 6,6 (Julio 2016), 6,8 (Octubre2016)... 7,0 (Mar 2018)
The company has Twitter in Spanish, in case you want to follow or ask something: @c8m_es
11/26/2012 11:49 a.m.