bloodless BG diabetic research

[sicko666]

Two pieces of info i thought might be of interest to people about bloodless glucose monitors, i have contacted both companies and gotten responces that sound encouraging ,heres there info.

The first one sounds like it might actually really arrive this year!!!! BUT as i dont have, or ever likely to have the money they want for it perhaps someone who does might be able to investigate further ( dam i wish i had the money but unless i rob a bank! )...
Its expected to be available here in the UK in "the fall" this year ( i know its a miracle, variable here in the UK surly not? ), only problem is they said it probably will cost me $4,000 which means i would never be able to get one, but heres the link to their website for you rich people to investigate further:

http://www.c8medisensors.com/

I really,really wish i had the money!!!!!!
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Heres the second device thats under development in the USA, i contacted them and their reply is below. Its another IR needle free blood glucose machine but this one sounds like the type that would replace the current BG machine testers, as yet it seems to be only in its early stages unfortunately but i though if enough people here in the UK contact them maybe, just maybe they will not forget about us when it is finally released...

Good Afternoon,

Thank you for your interest in Grove Instruments. At the present time we run our clinical studies out of Worcester, MA. Our device measures blood glucose noninvasively via the use of the Optical Bridge (http://groveinstruments.com/about.html). There are no needles involved with our device. We are currently in the development stages, so I cannot provide you with any cost information as of yet. If you have any more questions please feel free to pose them through email to [email protected].

Thank you,

Briana Rawson
Grove Instruments

A long suffering needle phobic, ian.

 

[KateF]

C8medisensors looks really promising, although their press release on their EU filing for CE marking went in more than 90 days ago which suggests, to me, that they may be answering questions so it is hard to say when they will get their approval - hence their statement they expect to do their EU launch, post approval, some time in the second half of 2012.

Got our fingers crossed the tech works and although it is a lot of money I think it is worth it for the improved control so I'm hoping we are lucky enough to get the opportunity to purchase one. I don't expect to see NHS funding for them anytime soon as I understand the NHS doesn't fund CGM?

 

[sicko666]

I agree, lol as at the moment i have NO blood testing because of my needle phobia so this device or ANY other bloodless devices would give me better control than the non existent control i have now lol!!! Though the cost is what is the killer, believe me if i had the money i would get one when their released, they did say in a previous email to me that because there was no actual blood letting involved they didnt expect it to take to long to get approved ( heres hoping! ), even if i cant afford to get one the fact one might be around might make the "big" companies pull there fingers out sooner to make one i might be able to afford....

As for the NHS not funding CGM i am not sure, because of my own situation i have been told i am going to receive a letter from my own long term care team about getting a pump with built in CGM, lol, of course i will only believe it when it actually happens, but maybe, just maybe.....

Ps the reason i mentioned the second one was because its not a CGM but a device that looks like one of those temperature testing devices, it apparently only takes 20 seconds to test with but no blood letting it used at all. This i thought might be a future direct replacement device for BGM devices that are used now by the majority of diabetics. So the numbers being used would be larger than CGM and consequently costs would be less because of the numbers involved, lol, wishful thinking again i know, but if people dont actually know about them how can they pester their care teams about getting one, and hopefully that might make N.I.C.E. act faster than the snails pace they do now lol....

Lol..... 35years+ type 1, still waiting for something other than harpoons daily to keep me alive lol, it is 2012, not 1612 right? :lol:

 

[KateF]

Sicko, Very sorry that your needle phobia has stayed with you all this time. My oh was lucky to eventually see a good psychologist who got him to manage insulin injections and prick testing. Blood tests still are currently very difficult, but compared to where we were it is a miracle. His consultant would not prescribe the injector and pushed for a good psychologist.

I can appreciate that your situation is sufficiently different to ours that you deserve NHS funding for the C8medisensors product and hope you get it. I've been saving for some time as I thought we may need to fund some treatment so we are lucky enough to be able to go for it.

I imagine they have a good chance of receiving CE marking. They are using an older technology, albeit one other people seem to have been unable to perfect, so there should hopefully be data to support their safety argument. I can't find any efficacy (I.e. how well it works) data on either their website or google. I am hopeful that they had some data which they revealed to the investment community to gain the funding for their IPO or the recent $19m they raised

Going for EU approval before FDA approval in the US also make sense as EU approval is faster. That does mean we have a good chance of early access to this or other tech, in the future. C8 are also doing a us trial so I imagine they must be fairly confident of EU approval/product quality in order to spend the big sums the trial will cost.

There is no register of applications for CE marking so we will have to watch for their next press release and pray that EU diabetics get some great tech for Christmas!

 

[Anonymous]

I would imagine that, with enough clinical data and evaluation of risks, that this gaget should receive CE marking by the end of the year. This is because Notified Bodies (such as BSI) evaluate the data and the design dossiers for the device, turning round applications quite quickly. As for the FDA route, well, that could take up to two years! So in that respect, we will be fairly lucky but not for much longer. The Medical Devices Directive is under review and it is likely that Notified Bodies will be under the cosh a bit more!

 

[sicko666]

Sicko, Very sorry that your needle phobia has stayed with you all this time. My oh was lucky to eventually see a good psychologist who got him to manage insulin injections and prick testing. Blood tests still are currently very difficult, but compared to where we were it is a miracle. His consultant would not prescribe the injector and pushed for a good psychologist.

I can appreciate that your situation is sufficiently different to ours that you deserve NHS funding for the C8medisensors product and hope you get it. I've been saving for some time as I thought we may need to fund some treatment so we are lucky enough to be able to go for it.

I imagine they have a good chance of receiving CE marking. They are using an older technology, albeit one other people seem to have been unable to perfect, so there should hopefully be data to support their safety argument. I can't find any efficacy (I.e. how well it works) data on either their website or google. I am hopeful that they had some data which they revealed to the investment community to gain the funding for their IPO or the recent $19m they raised

Going for EU approval before FDA approval in the US also make sense as EU approval is faster. That does mean we have a good chance of early access to this or other tech, in the future. C8 are also doing a us trial so I imagine they must be fairly confident of EU approval/product quality in order to spend the big sums the trial will cost.

There is no register of applications for CE marking so we will have to watch for their next press release and pray that EU diabetics get some great tech for Christmas!

Thank you both for all the extra info, theres a lot there i had no clue about and i bet a lot of other diabetics did not know either, its like all the information is hidden away and inaccessible to the general public when it comes to any medical devices, well not unless you know what it is your looking for or have higher access given because your a medical professional anyway, lol i dont know what they think i would do with the information except respect their honesty and openess! Thank you for all the extra information.....Lol, i did even volunteer to be the only uk tester for both the devices if they wanted me to be one ( even saying i would not tell anyone, or tell everyone if thats what they wanted! ) so i know the second of the two devices is only having "in house" internal trials in the US at the moment ( dam shame, lol but you have to ask these companies just in case lol! ).

Sorry for the confusion i produced above KateF , i will not be getting the C8 device myself but a standard insulin pump with a CGM built in, maybe, i do not know who makes it or weither or not i will actually end up getting one or not, lol, theres just the tiniest, weiniest, glimmer of a possibility lol, but i have had a few of those in the past too that ended up resulting in nothing, but maybe,just maybe this time........lol :wink:
As for seeing phyciatrists i know they can work for the majority of people to overcome there fears, but i have been seeing them since childhood and they just cant seem to help me ( though if anyone is reading this and does have needle phobia too, do seek help as i have met many people who this method has helped, i just happen to be one of those lucky few it dosent lol lucky me! ).

Lol if anyone does manage to get one of these ( lol it will not be me, it costs just under what my total yearly income is from the social! ) please do let us know ( lol i might go rob a bank if it is actually any good lol! ).... :lol: :wink: :thumbup: :wave: