CGM Self-fund

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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.
 
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.
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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
 
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!
 
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, 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 :D
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.
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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. :(
 
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.
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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
 
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)
 
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.
 
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.
 
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.

🙂
 
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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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 🙂
 
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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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. 🙂
 
May I point out Advanced Therapeutics (UK) ltd are the distributers of the Dexcom not animas 🙂
 
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. 🙂
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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
 
Pumper_Sue said:
May I point out Advanced Therapeutics (UK) ltd are the distributers of the Dexcom not animas 🙂
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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 😛
 
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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