# CGM Self-fund



## bigpurpleduck

Hi all,

Firstly, sorry for not participating in other threads recently. I've had a horrible week with the D and am beyond exhausted. Been up every 1-2 hours every night since Tuesday, and have had either several hypos or several highs every day. I feel awful.

Anyway - my question is, does anyone know how much a CGM costs to self-fund? I know my PCT will fund one for a few days, but I really don't see the point in this as my insulin needs change with the direction of the wind. I'm specifically wondering about the Medtronic CGM which bluetooths BG to the Veo. I had a look at their site, but it just said to contact customer services for prices and right now I just don't have the motivation to do so.

Many thanks


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## Freddie99

In a word, the answer is alot. Firstly you have to pay for the transmitter that sends the data from the actual sensor to yout pump. Even when I could have got it at a discounted price when I started pumping it was beyond my means. After that you have the cost of sensors which is quite something also. 
Perhaps for further information give Medtronic a call?

Tom


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## Liz!

Each sensor costs about ?37. They have just been licensed to be left in for 6 days.


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## shiv

Yep, the transmitter is in the hundreds of ?, and the sensors are about ?30 each. 

Could you borrow the transmitter for a month and just pay for the sensors? Not exactly what you want, but might be some sort of compromise?


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## Pumper_Sue

If you are considering self funding for the Continuous Glucose Monitoring aspect of the Paradigm? 
VeoT System, the price of the Continuous Glucose Monitoring Starter Kit including the MiniLink, 
download software, CareLink USB Adaptor and a box of 4 glucose sensors is ?250 when purchased 
at the time of the pump (or ?535 if purchased at a later date).  When used with the Paradigm? VeoT 
System, sensors need to be changed every 6 days and the cost will depend on whether you wanted 
to use these occasionally in order to immediately adjust insulin therapy when sick, exercising etc or 
whether you wanted to aim to use sensors all of the time. A box of 10 sensors ?375.00 or a box of 4 
sensors is ?160.00.  Glucose sensors have a life of 6 months from point of manufacture so the 4 
box should be considered if you are only anticipating occasional sensor use. Continuous use of the 
sensors could cost as little as ?6.25 per day.  The cost of the Paradigm? VeoT Insulin Pump is 
?2,850.00
This info is from medtronic as I emailed them a couple of weeks ago.

The Dexcom 7 is renowned for being more reliable with better cgm results.
http://www.advancedtherapeuticsuk.com/home 
Some people have made their sensors last a month 
http://www.input.me.uk/continous-glucose-monitoring/ the navigator is here as well.


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## shiv

Pumper_Sue said:


> Some people have made their sensors last a month



Can I just ask where you've heard that? I'm pretty interested in the Dexcom but know the sensors cost ?60 each, obv making it more expensive than the Medtronic sensors, but if they last a month then obv they are wayyyy cheaper in practice.


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## Pumper_Sue

shiv said:


> Can I just ask where you've heard that? I'm pretty interested in the Dexcom but know the sensors cost ?60 each, obv making it more expensive than the Medtronic sensors, but if they last a month then obv they are wayyyy cheaper in practice.



Hi shiv,
People on other message boards are saying this  So it's the users not anyone with a financial interest.


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## shiv

Oh yes I thought you meant people using them, I think officially they are okay-d for 7 days at the moment. It does make them more appealing hearing people have made them last so long. 

Basically I have a tiny bit of inheritance left and I've always promised myself I'll save it to go travelling at some point, but now I'm leaning towards putting it towards a CGM and occasionally self funding one...and obv would want to get the max amount of time out of each sensor. So yes. Something to think about.


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## Pumper_Sue

Hopefully Shiv, CGM will be available on the NHS in the near future. 
I am working on a case for having CGMS from my PCT now. But suspect pigs might fly before it's forthcoming


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## shiv

I suppose. I might win the lottery in the mean time though  Sorry, I didn't mean to take this off topic.

Emma, any more thoughts?


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## Donna

I bought a Dexcom last year.  It cost ?875 or ?975 I think for the transmitter and receiver and ?240 for 4 sensors.  I am no longer using it though.  I tried everything to get the sensors to stick to me for more than a few days.  As soon as they started to come off the results would be inconsistent or completely wrong and most of the time didn't register at all. I rarely got one to last 7 days even. It was a very expensive outlay and I am very disappointed.


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## Pumper_Sue

Donna said:


> I bought a Dexcom last year.  It cost ?875 or ?975 I think for the transmitter and receiver and ?240 for 4 sensors.  I am no longer using it though.  I tried everything to get the sensors to stick to me for more than a few days.  As soon as they started to come off the results would be inconsistent or completely wrong and most of the time didn't register at all. I rarely got one to last 7 days even. It was a very expensive outlay and I am very disappointed.



Hi Donna, have you tried sticking tape on top of the sensor or using skin tac to stick it down?


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## Sugarbum

Im glad Ive read this- seems Ive done exactly the same research!

last week I phoned Medtronic to ask about self-funding the CGM and nearly fell of the chair, I knew it was expensive but this was quite a shocker. Especially as you have to pay out so much for the starter kits.

I also enquired about the Dexcom. They didnt call me back! Shame. I met someone with one last week (a silver durfer with a zimmer! she was great!) who rated the dexcom. She had bought it from America online. My only disapointment on viewing the Dexcom was the size.

Shiv- et al- if you can view one before you decide to make the purchase, defo worth it. My silver-surfer had it in a spi-belt, but I personally need to think more about whether carrying one more device attached to me is carry one more too many.......if you get what I mean.

Shame we cant sort out a dexcome time share


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## bev

Donna said:


> I bought a Dexcom last year.  It cost ?875 or ?975 I think for the transmitter and receiver and ?240 for 4 sensors.  I am no longer using it though.  I tried everything to get the sensors to stick to me for more than a few days.  As soon as they started to come off the results would be inconsistent or completely wrong and most of the time didn't register at all. I rarely got one to last 7 days even. It was a very expensive outlay and I am very disappointed.



Hi Donna,
Were you covering the sensors with a tape or tegarderm - it is unusual to have them come off. We self-fund sensors and the transmitter is around 450 and the sensors are 35 per week - but we dont use them every week as Alex doesnt really like them - so try to use every other week. I have heard that some sensors can stay in for longer than the 6 days - but the trouble is that they then cause infections and send levels high - we cant do more than 5 or 6 days on a Medtronic CGM as Alex gets infections and it irritates his skin. I have to say though, that using sensors is brilliant and it gives you an insight into what is happening when you are not testing and it helps to build up a pattern to enable you to make a change. I have heard that the dexcom is the most accurate and also that there are new Medtronic ones coming out in March or April that will be easier to insert - more like a mio.Bev


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## Donna

I tried everything to make them stick, Tegaderm patches, flexifix, skin tac.  It would work for a while and keep the edges stuck but once the sticky stuff on the pad started to give up around the actual wire, the wire started to move about and it could get any results.  I would just keep getting ??? every time I moved.  Even getting up to make a cup of tea!!  Very frustrating, I just couldn't trust it to give me results when I wanted them.


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## bigpurpleduck

Pumper_Sue said:


> If you are considering self funding for the Continuous Glucose Monitoring aspect of the Paradigm?
> VeoT System, the price of the Continuous Glucose Monitoring Starter Kit including the MiniLink,
> download software, CareLink USB Adaptor and a box of 4 glucose sensors is ?250 when purchased
> at the time of the pump (or ?535 if purchased at a later date).  When used with the Paradigm? VeoT
> System, sensors need to be changed every 6 days and the cost will depend on whether you wanted
> to use these occasionally in order to immediately adjust insulin therapy when sick, exercising etc or
> whether you wanted to aim to use sensors all of the time. A box of 10 sensors ?375.00 or a box of 4
> sensors is ?160.00.  Glucose sensors have a life of 6 months from point of manufacture so the 4
> box should be considered if you are only anticipating occasional sensor use. Continuous use of the
> sensors could cost as little as ?6.25 per day.



Many thanks to all, especially Sue.

More thoughts? I want one. But it's insanely expensive, and we can't afford it right now.

Does anyone know if there are implications with the NHS funding my pump if I self-fund a CGM? Will my DSN & consultant still advise on on basals, etc?

Clearly need to start playing the lottery on a regular basis.


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## novorapidboi26

Does the accompanying pump respond to the data from the cgm, if not its not really a long term solution is it.....or is it...?


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## shiv

novorapidboi26 said:


> Does the accompanying pump respond to the data from the cgm, if not its not really a long term solution is it.....or is it...?



The Medtronic Veo, when used with a CGM, responds if BG levels fall below a certain level (determined by the user) - it cuts off insulin for 2 hours. Obviously, the insulin can be restarted at any point before the end of that 2 hours, it's designed to be a safety net for people who hypo during the night.

The artificial pancreas is the next step, in which the pump and CGM would 'talk' constantly and would use insulin and glucose to balance glucose levels.

CGM can be a very long term solution, particularly if you have say no hypo awareness - they can alert you to falling levels. What makes you think it isn't long term? I know I'd love one if I got the chance (I'd love a cure more, but I'll take what's available).

Emma - there's no reason why your consultant and DSN should stop advising you if you self fund CGM. There are some parents on the CWD who self fund CGM and they certainly still get all the advice they can get from their teams.


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## everydayupsanddowns

Hi Emma

You might want to PM the delurking Alison (of Shoot up or Put Up) who began posting here a few weeks back. Either that or just check out her blog which details how she managed to successfully secure funding for her Paradign pump/CGM combo.

I don't think it's easy by any stretch, and I have no idea whether being in Scotland would make it easier or even more impossible, but I'm edging around the whole pump/cgm question myself with my team at the moment (new consultant has taken over in the hospital and I'm yet to have met her to see what her views are on the subject).

Have you had the CGM for the week or whatever? If it were available to me I'd jump at that first so that a) I could see what it was like and b) I'd get some 24 hour results even if only for a few days.

Good luck with it.

M


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## novorapidboi26

i only ask as the cgm allegidly has a delay from the real blood sugar swimming about....so for avoiding hypos yeah......

but i suppose any delay be it constant or variable could be compensated for with the pump computer........


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## shiv

The current ones are on about a 15 min time lag. Thing is, a lot of people/parents don't use them to find out exact what their BG level is - they use it to spot trends and patterns in BGs, for alerts if they are dropping quickly, etc.

The new CGMs coming out this year (I hear) are apparently going to be much more accurate and up to speed.


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## bev

shiv said:


> The current ones are on about a 15 min time lag. Thing is, a lot of people/parents don't use them to find out exact what their BG level is - they use it to spot trends and patterns in BGs, for alerts if they are dropping quickly, etc.
> 
> The new CGMs coming out this year (I hear) are apparently going to be much more accurate and up to speed.



Hi Shiv,
Yes you are right - its more of a picture into what is going on behind the scenes. But you can also programme the pump to alert if you are dropping at a particular rate per minute so you can avoid a hypo or hyper situation.Bev


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## shiv

Hehe yes bev that's what I said - "for alerts if they are dropping quickly, etc" 

I'm all about playing the lottery in an attempt to make CGM a reality!


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## Liz!

I've hd CGM a few times and the lag is actually half an hour. I could realise I was hypo (even without warning signs, by finding I couldn't walk!!) and treat the hypo before it told me I was hypo - sometimes it didn't even tell me as I had treated it and was coming up again. But at night it was worth it. It is NOT fundable by the NHS. But your Consultant can apply for 'special case' fuding, but there has to be a real reason for it. 

I have been offered it, but I'm not keen as the sensors leave a bit of themselves inside you each time. This is a substance that your body cannot break down or excrete in any way as it has no way of doing so. Bio-accumalitive in other words - it'll stay in you till you die. They don't know if it will harm you or not. Not enough research, and not done over long enough time frame. I'm not happy with that, but if you are more likely to die of a hypo then it's worth it.


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## shiv

Liz, they can and are funded by the NHS. It's hard to get it, it's hard for children to get it let alone adults. But it can be done.


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## Pumper_Sue

Hi Liz, the lag depends on the sensor. I have been told it's 5 mins for the Dexcom 7. I will check this when I see the rep this afternoon.. Nice rep man is coming past the door so going to bring me a DanaR to see as well 
Medtronic is about 20 mins lag I think but not sure on this.

People have to remember that a sensor is a tool to be used so must be set up properly and the understanding of it's usage is paramount for getting the best use out of them.



> I'm not keen as the sensors leave a bit of themselves inside you each time. This is a substance that your body cannot break down or excrete in any way as it has no way of doing so. Bio-accumalitive in other words - it'll stay in you till you die. They don't know if it will harm you or not. Not enough research, and not done over long enough time frame.



Could you point me in the direction of this info please? I would love to read about it 

Shiv is right the sensors can be funded but very few have them on the NHS.
They are not NICE aproved yet, so the PCT does not have an obligation to fund.


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## bev

Liz! said:


> I've hd CGM a few times and the lag is actually half an hour. I could realise I was hypo (even without warning signs, by finding I couldn't walk!!) and treat the hypo before it told me I was hypo - sometimes it didn't even tell me as I had treated it and was coming up again. But at night it was worth it. It is NOT fundable by the NHS. But your Consultant can apply for 'special case' fuding, but there has to be a real reason for it.
> 
> I have been offered it, but I'm not keen as the sensors leave a bit of themselves inside you each time. This is a substance that your body cannot break down or excrete in any way as it has no way of doing so. Bio-accumalitive in other words - it'll stay in you till you die. They don't know if it will harm you or not. Not enough research, and not done over long enough time frame. I'm not happy with that, but if you are more likely to die of a hypo then it's worth it.



Hi Liz,

It sounds to me as if you didnt have your settings right on your pump. If your pump didnt alert you within half an hour of a hypo - then settings should have been changed. You can set the 'veo' to tell you at what rate you are dropping so if you see two arrows pointing either way then you know that you are either hypo or hyper. The way to use a sensor is to be pro-active - so looking at the screen on the pump should help you decide which way levels are going - before they get there if that makes sense. Did you have much training when using a sensor as you really need to be using them for a good few weeks/months before you can understand how they work. Using a couple of sensors doesnt give you the full picture.

I have never heard of sensors being dangerous. Can you explain what the substance is that is deposited in the body. As far as I know, the sensors dont deposit anything - it just takes interstential (sp?) fluid to read the level of glucose.

As far as funding is concerned, the NHS do fund sensors - at least for children anyway, if it is deemed necessary to long term care, and there is a noticable improvement on the HBA1C and quality of life.Bev


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## everydayupsanddowns

Dear Jim

Please can you fix it for me to get funding for a Dexcom for at least 75% of the year.

Thanks very much
Mike (aged 41 and three quarters)


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## Northerner

everydayupsanddowns said:


> Dear Jim
> 
> Please can you fix it for me to get funding for a Dexcom for at least 75% of the year.
> 
> Thanks very much
> Mike (aged 41 and three quarters)



The first line gave your age away!


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## Pumper_Sue

This is from INPUT.............


The PCT has no obligation to fund CGM as its not NICE appraised yet, so they are at liberty to say no, unfortunately.


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## shiv

INPUT etc are waiting for the CGM technology to improve before pushing it to be up for NICE appraisal. As I say, it CAN be funded but they are not obliged to which obviously means they deny most people funding.


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## Adrienne

Hi

We have used CGMS from Medtronic attached to the first sensor pump, the 522 for four years now.    They are absolutely fantastic.

They work differently for different people.   Lots find they do lag behind, it is generally supposed to be 15 minutes but again different for different people.  

Some people find they are actually ahead instead of behind so no hard and fast rules.

For us they can be either.  However we use them for trends.   We have had so much better control with the ability to see what is going on constantly and can make changes by tweaking according to the data we can see.   It is proven that you can get better results from using full time (not part time) sensors with all the alarms and alerts switched on.

Medtronic have a new sensor coming out end of March/beginning of April.  It has already been launched and it is becoming available from the DUK conference end of March/beginning of April, whenever the conference is.   They are more like the Mio's for insertion, I believe they have their own insertion device like the Mio and are at a 90 degree angle.   The needle cannot be seen and it is much shorter than now.  

However the best bit with these is that the whole of the bit inside you can take a reading making it so much more accurate.   At the moment it is just one end that takes the readings and if that is jolted then you get dodgy readings.

The Dexcom is much larger and much more popular in the USA.   We saw a lot of the USA cwd adults wearing them at the conference we attended.   It is a stand alone product at the moment (but definitely watch this space in the next couple of months and it won't be stand alone anymore) which means another gadget if you already use a pump.   It is more accurate, the sensor part is totally different and has a coating of some sort.   When you take paracetamol whilst using the Dexcom, it sends the readings into orbit so it is recommended you don't take paracetamol whilst using a Dexcom, it is to do with the coating, someone else may be able to describe this better.

As regards to what Liz has said I have my contacts in Medtronic and I am finding out from the horses mouth so to speak and will get back to you on that.

CGMS do feature in the NICE guidance but not well enough yet but INPUT will be on the case as Shiv has said.    In the NICE guidance it says everyone should be offered the use of a CGMS.

Re Self funding sensors -   don't do it if you think you have a case for funded.   If your PCT know you are self funding I can guarantee you, you will never get PCT funding for them after that.  This has been proved unfortunately a couple of times but families on the cwd email group who in desperation for sensors self funded and are now just stuck.   Not a great place to be.

Whilst there is no obligation to fund sensors there are ways that they can be asked for and the great hospitals in the UK do manage it, you just have to be in the right place at the right time.   People do get funded for sensors but it can be hard to get them.   Hopefully one day they will sit up and smell the roses as they really do help and will cut costs in the future.


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## Liz!

The information below is taken from the warnigs for the Freestyle Navigator sensors. But they all use polymers on the sensors.

Warnings/Precautions: Infection, inflammation, or bleeding at the glucose sensor insertion site are possible risks of inserting a sensor into your skin. If you believe your results are not reliable, or are inconsistent with how you feel, perform a blood glucose mode test to measure your glucose. If the problem continues, discard the old sensor and insert a new sensor. Performance of the system under conditions of fluctuating hydration levels such as during renal dialysis has not been evaluated. Unintended dislodging of the sensor due to excessive perspiration, exercise, or bumping, may cause unreliable or no results without warning. A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined. Performance of the FreeStyle Navigator? system has not been evaluated in pregnant women.

Personally I can see that use of a sensor over years, when it has left bits of polymer inside you, may make future sensor use inaccurate, or absorption of insulin erratic, so I'm waiting till I'm sure they have overcome this problem.


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## Adrienne

I forgot to mention that you get better results if you drink regularly.   You need to keep the sensor 'wet' and to do that you need to drink.   It does help, honestly


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## Liz!

Also just found information on the internet about a warning to Dexcom from the FDA for not giving patients information about the fact thet sensors can break inside the body and leave wires inside people:

Failure to submit MDR reports within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur as required by 21 CFR 803.50(a)(2).

Specifically, the firm (Dexcom) failed to submit MDR reports to the FDA for complaints involving sensor wire fractures underneath patient's skin as exampled by:

1. Customer Report: 09-5141, dated 7/11/2009 reported a sensor wire broke off in a three (3) year old and reported a piece of it was under her skin. The mother reported the child had surgery under general anesthesia to remove the broken wire underneath her skin.

2. Customer Report: 09-0274, dated 1/6/09 reported the sensor wire tip broke off in patient's body. The DexCom representative advised patient to not to pursue extraction. The report states "sensor break with fragment retained under the skin".

3. Customer Report: 09-3516, dated 5/07/09 the report states (that when) the nurse went to pull the old sensor off the sensor wire it was not there. The patient's nurse reported she could see it under the skin but she could not get hold of it with tweezers and then it disappeared. The nurse thinks "it came off and is still in his skin. "

4. Customer Report: 09-3641, dated 5/18/09. Patient reports 2 sensors have broken off under his skin. His most recent sensor looks broken upon removal today, and he can feel the wire under his skin. Site is red and he is going to prescribing physician.

5. Customer Report: 09-5555, dated 7/20/2009. Patient called (to) report a failed sensor and has irritated skin. Patient reported he thought the wire came out completely, but his doctor removed a "hair like structure" from under his skin.

6. Customer Report: 09-4237, dated 6/17/2009. Patient is a 30 month old child. Mother called to report sensor wire breakage under skin of child. Patient taken to the ER when an infection developed.

Presumably this info is now incorporated into their customer leaflet. But did anyone know this info, was it given as a warning as something that COULD happen? 

I don't trust new technology which is so invasive, you must have noticed! BUT I think if the sensor is just metal i might try the Dexcom over the Minimed one.


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## Adrienne

Hi Liz

If you notice all these problems are dated in 2009.   I would think with the fast advancement of technology that this would have been dealt with.  However without contacting Animas or those in the know I cannot say this for definite.

I have noticed that your posts are very doom and gloom about technology especially sensors which doesn't help others when they are asking questions.

Perhaps if you want to list all the negatives you could back it up with actual recent up to date data or evidence from the companies themselves, in this instance Animas re their Dexcom.  Considering they are worldwide, you have listed only 6 cases where something has gone wrong and as I say back in 2009.   A very small proportion in my view of the total number who use them in the USA and all over the world.

However I can confirm that I will be getting answers very shortly regarding Medtronic sensors re what you said :  

"....the sensors leave a bit of themselves inside you each time. This is a substance that your body cannot break down or excrete in any way as it has no way of doing so. Bio-accumalitive in other words - it'll stay in you till you die. They don't know if it will harm you or not. Not enough research, and not done over long enough time frame...."

This is disturbing and I need to hear it from the powers that be if that is the case regarding Medtronic only.   I cannot comment on Abbott sensors (Navigator) or Animas (Dexcom).   Those companies will have to be contacted if anyone wants to know.

I'll let you know what Medtronic say as soon as I hear.     

Please can I ask nicely that unless you have definite and up to date information, unlike the 2009 stuff, please don't post these really negative and sweeping statements, it doesn't help anyone.  Thanks.


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## Pumper_Sue

May I point out Advanced Therapeutics (UK) ltd are the distributers of the Dexcom not animas


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## bev

Adrienne said:


> Hi Liz
> 
> If you notice all these problems are dated in 2009.   I would think with the fast advancement of technology that this would have been dealt with.  However without contacting Animas or those in the know I cannot say this for definite.
> 
> I have noticed that your posts are very doom and gloom about technology especially sensors which doesn't help others when they are asking questions.
> 
> Perhaps if you want to list all the negatives you could back it up with actual recent up to date data or evidence from the companies themselves, in this instance Animas re their Dexcom.  Considering they are worldwide, you have listed only 6 cases where something has gone wrong and as I say back in 2009.   A very small proportion in my view of the total number who use them in the USA and all over the world.
> 
> However I can confirm that I will be getting answers very shortly regarding Medtronic sensors re what you said :
> 
> "....the sensors leave a bit of themselves inside you each time. This is a substance that your body cannot break down or excrete in any way as it has no way of doing so. Bio-accumalitive in other words - it'll stay in you till you die. They don't know if it will harm you or not. Not enough research, and not done over long enough time frame...."
> 
> This is disturbing and I need to hear it from the powers that be if that is the case regarding Medtronic only.   I cannot comment on Abbott sensors (Navigator) or Animas (Dexcom).   Those companies will have to be contacted if anyone wants to know.
> 
> I'll let you know what Medtronic say as soon as I hear.
> 
> Please can I ask nicely that unless you have definite and up to date information, unlike the 2009 stuff, please don't post these really negative and sweeping statements, it doesn't help anyone.  Thanks.




Hi Adrienne,

I have also contacted Medtronic as it is clearly a worry if you have a child using one of their sensors. They are making enquiries and will forward me the reply - so will let you know - unless of course you hear before I do.Clearly as our children use sensors this is a worry - but would rather hear it from 'the horses mouth' as you say.Bev


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## Adrienne

Pumper_Sue said:


> May I point out Advanced Therapeutics (UK) ltd are the distributers of the Dexcom not animas



Sorry Sue,  I have always just assumed that as they are merging the Animas pump with the Dexcom like the Medtronic sensor pump, that they were Animas.  Whoops


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## Ellie Jones

Sometimes in life, the horses mouth isn't the best source of information!

As the 'horse's mouth' has a vested interested not to inform....

In the case that Liz points out...

The FDA (Fedral Drugs Agency) is American and only deals with Drugs/medical Equipement that is licenced to be sold in the American market..  Each country around the world have their own Licencing Agencies/goverment departments that set out procedures, testing standard, reporting creteria etc...  In the UK we have the MHRA,  http://www.mhra.gov.uk and also to a certain extent governed by the European EMEA 

As it can be seen this is 6 cases where dexcom failed to follow it's licencing agreement with the FDA and notify them of equipemt failures...  The FDA arwareness of these cases is due to patient/HCP reports!

So big question, if they failed to aheard to the legal licencing obligations, are they going to tell Joe Public if they phoned them?  As yes dexcom do make American patients aware of the issue but only because they were forced to to provent their licence being withdrawn by the FDA!

I'm not looked into CGM's very much as I'm not in a position to self-fund nor in a position to seek a 'special case' funding..  I am not even sure that my clinic pocesses a loan CGM! (last I heard in 2008, they had one to evaluate with children, but it's where abouts were unknown, in a draw somewhere! but it was one of the old ones, that had to be downloaded to a computer to see the results)  But for me the real concerns is if and what long term damge could what ever it leaves behind cause?

As to lag times, they have improved over the years, but when you think about it when we take our BG from our fingers, it's has a lag time to it, hence the different reading you get with each stab of different fingers!


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## Liz!

The info is about Freestyle sensors which somewhere said are no longer being marketed due to 'problems'. Can't remember where I read that though. I don't know whether it is true of the Medtronic ones. Or the Dexcom. I think people should know the risks as well as the good stuff. The risks are NEVER mentioned. If it was my child anyway. I'd like to know the answers too.


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## Adrienne

Liz! said:


> The info is about Freestyle sensors which somewhere said are no longer being marketed due to 'problems'. Can't remember where I read that though. I don't know whether it is true of the Medtronic ones. Or the Dexcom. I think people should know the risks as well as the good stuff. The risks are NEVER mentioned. If it was my child anyway. I'd like to know the answers too.



Hopefully answers will be on its way.  Obviously I'm interested in the Medtronic ones but I have friends who use and friends who want the Dexcom but that would be up to them to find out.  I'll let everyone know once I know anything.

As to the 'horse's mouth'  I can assure you Ellie that I have two extremely good sources in Medtronic, better than good infact and we will get a correct reply, hence the reason I want it from the horse's mouth.


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## Liz!

Thanks Adrienne. 

I really am not gloomy about all technology... I was one of the first people ever to use a pump in the 1980s. But I was also one of the first to use 'human' insulin and it was not good for me. Analogue proved even worse, i only got better after going back to animal insulin, so... i am very, very careful about new stuff now, and question everything.


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## Adrienne

Liz! said:


> Thanks Adrienne.
> 
> I really am not gloomy about all technology... I was one of the first people ever to use a pump in the 1980s. But I was also one of the first to use 'human' insulin and it was not good for me. Analogue proved even worse, i only got better after going back to animal insulin, so... i am very, very careful about new stuff now, and question everything.



That's fair enough.   I would love to have seen those old pumps.   Gt Ormond Street wanted my daughter on a pump when she was 6 months old and we met the company and were up for it but back then we needed our local team to ok it, GOSH couldn't do that.   Unfortunately they wouldn't back us up so we had to fight and eventually when she was 6 we could use the patient choice and moved to a much better hospital and she got her pump.   It really is a postcode lottery out there as to whether you are at a good hospital or not.

Where I live now the local hospital (Tom's knows it well) have a great adult team who do pumps.   However their children's team is really frighteningly awful with the consultant telling 9 year olds she will cut their legs off it their levels are too high !!!!

I too question everything and everyone, you just came across as unhappy about it all and so I questioned that 

I'll let you know what Medtronic say.


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## CGM-Sweety

*using the freestyle navigator from abbott*

Hallo here some personal informations, maybe also interesting for some of you

I'm living in Germany and wear the freestyle navigator from abbott more than 1.5 years non-stop. The Sytem with transmitter costs 1500Euro and one sensor costs 65Euro. But I wear one sensor at an average more than 20 days (sometimes also 30 days) with absolut stable and accurate signals. That's a big abvantage of the system. (Licensed is the sensor only for 5 days!).
I also havo to pay out of pocket, so its an practicable solution for me.

kind regards from
CGM-Sweety


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## Adrienne

CGM-Sweety said:


> Hallo here some personal informations, maybe also interesting for some of you
> 
> I'm living in Germany and wear the freestyle navigator from abbott more than 1.5 years non-stop. The Sytem with transmitter costs 1500Euro and one sensor costs 65Euro. But I wear one sensor at an average more than 20 days (sometimes also 30 days) with absolut stable and accurate signals. That's a big abvantage of the system. (Licensed is the sensor only for 5 days!).
> I also havo to pay out of pocket, so its an practicable solution for me.
> 
> kind regards from
> CGM-Sweety



Wow 20 or 30 days, that is remarkable.   We did learn at the Friends for Life Children with Diabetes conference that sensors would be ok in the skin compared to canulas which do need to come out.   They told us that it is highly rare to get a site infection with the sensors.   I know a girl that wears the Medtronic sensor for about 9 days and she has got 12 days out of it.

I can't wait for the new Medtronic sensors, I think they will be amazing and so much more accurate than they are.

Thanks for you message


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## Adrienne

Hi

This is from Medtronic directly regarding the lag time of their sensors (not anyone else's just Medtronic)  :

"There is always a lag time of up to 20 mins between BG and SG (sensor glucose) and if a person is rising or falling rapidly it will take time to catch, this is why with the Veo we advocate the predictive alerts, these can be set to pick up any sudden changes in SG and predict when you will reach your present limits. The key is setting these up correctly and when first on a sensor these will need to be adjusted as you become more aware of your personal set of circumstances.  Correct calibration ensures the SG follow the BG correctly, I would guess from what you say that there may have been needed more education on the sensor using predictive alerts, accurate calibration.

*Predictive alerts*The Predictive alerts calculate when you may reach your Low or High Glucose Limits, then send you an alert before you reach those limits. A Predictive alert tells you that if your sensor glucose measurements keep falling or rising at the current rate, you may reach your Glucose Limit in the number of minutes you selected.  For a LOW PREDICTED alert, the pump plays three consecutive tones, in falling pitch, if an audible beep has been selected as the alert type. For a HIGH PREDICTED alert, the pump plays three consecutive tones, in rising pitch, if an audible beep has been selected as the alert type.

*Rate of Change alerts*
The Rate of Change alerts tell you when your sensor glucose (SG) changes at, or faster than, the per-minute rate pre-selected by you. There are two alerts:

? FALL RATE for SG decreases at or faster than your pre-selected rate. The pump plays two consecutive tones, in falling pitch, if an audible beep has been selected as the alert type.

? RISE RATE for SG increases at or faster than your pre-selected rate. The pump plays two consecutive tones, in rising pitch, if an audible beep has been selected as the alert type.

When these are used together even with a lag time excursions can be prevented."


So those with VEO's and sensors need to use those predictive alerts.   My daughter is being upgraded tomorrow to a VEO and we will be setting them.

Re the other stuff, that is a clinical issue and I will be getting an answer about that soon and will pass it on.


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## Adrienne

Hiya

Anyone remember this thread and I quote Liz here :  

A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined. 

This is the response from Medtronic when they answered :

Medtronic Diabetes has done rigorous testing of our sensor which included biocompatibility, irritation, and leaching. Medtronic Diabetes has never found any material left behind by one of our sensors in any of our testing. 

We are unable to provide specific testing information as it is considered proprietary.

Hope that helps


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## everydayupsanddowns

Thanks Adrienne.

Still no closer to getting a CGM, but these responses are helpful.

M


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## Liz!

That's good to hear Adrienne. I'm having a Medtronic 3 days CGM soon. Maybe longer. It's the freestyle one that leaves stuff behind. I've got someone enquiring about the Dexcom.

Why specific testing information proprietary though? Surely if you are going to use it you should be allowed to read any of the problems they have found. 

In fact all the research data conclusions SHOULD be available somewhere.

Interestingly on one of the FDA summaries of safety and effectiveness data of the Minimend CGM, it states that the sensors have been 'modified' and now no longer have the 'outer hydrophilic membrane'. I wonder if it is this outer membrane that comes off on the Freestyle?


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## Adrienne

Liz! said:


> That's good to hear Adrienne. I'm having a Medtronic 3 days CGM soon. Maybe longer. It's the freestyle one that leaves stuff behind. I've got someone enquiring about the Dexcom.
> 
> Why specific testing information proprietary though? Surely if you are going to use it you should be allowed to read any of the problems they have found.
> 
> In fact all the research data conclusions SHOULD be available somewhere.
> 
> Interestingly on one of the FDA summaries of safety and effectiveness data of the Minimend CGM, it states that the sensors have been 'modified' and now no longer have the 'outer hydrophilic membrane'. I wonder if it is this outer membrane that comes off on the Freestyle?



Maybe or maybe they found it worked better without it.    There are new medtronic sensor coming out beginning of April.  They have been launched but officially able to be used at the upcoming DUK conference in April.  They are very different and much more accurate so I understand and they need to be, to keep up with the Dexcom.

They will be inserted like the Mio's and will be shorted but it will be the whole of the bit inside that takes the readings rather than just the end, so much better.  I am keeping my fingers crossed.


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