New NICE guidelines For Insulin pumps (U.K.)

[SueM]

Well it would be except the link wont work

[xMenace]

Hard copy or a link?

[SueM]

Diabetes - insulin pump therapy: (Final appraisal determination) (http://www.nice.org.uk/guidance/index.jsp?action=folder&o=39807)

Fingers crossed this will work.

[Funnygrl]

What have they changed? The recommendations seem similar, except maybe that it's easier to get a child on a pump.

[JediSurfer]

I would love to try one of these pumps. But the thought of a cannula being constantly attached make me feel unwell.:(

[Funnygrl]

I would love to try one of these pumps. But the thought of a cannula being constantly attached make me feel unwell.:(
Good grief, have you ever even seen one? It's not like you feel it there. I usually forget where it is and find myself feeling myself up trying to find it to disconnect if I need to.

[Gary_W]

Funnygrl - The most important thing that has changed IMO is the definition of 'what is disabling hypoglycemia'.

Previously, this was defined as frequent upredictable episodes that required the assistance of another person i.e. you couldn't self treat. Instant get out of jail free for the NHS, as (even if you do suffer from those), you're not going to admit it to anyone as that would instantly be your driving licence gone.

Now, it is more of a lifestyle thing and no longer mentions the assistance of another. I personally believe that if you can make a case that hypos have a detrimental effect on your life then you've got a good case. Unless I'm reading it wrong anyway!

As an example... My work requires me to drive long distances and be at varying appointments at exact times. The DVLA requires me to not drive for 45 minutes after I have succesfully treated a hypo. If I have an accident in that timescale on the road and they interegate my meter, I may end up in jail / lose my licence. For this reason I obey the DVLA rules; hypos severely delay me when they occur and badly affect my work. There is no hiding place in sales, and if my bottom line doesn't look good then it affects my standard of living (I work on commision) and if it affects me badly I have the potential of losing my job. Hypos during work hours therefore cause me an awful lot of stress as if they cause me to miss an appointment I lose money and sometimes a lot of money. Hypos on my own time are inconvenient (unless I've got to go pick our daugther up in the car in which case they are also life-spoiling and stressful). For this reason, hypos badly affect my quality of life. And that is before we've even got to the night hypos that Lantus now gives me unless I eat 30g of carbs before bed. Which puts on weight which also causes me stress as I put weight on very easily indeed.

As I understand it, these are draught proposals that will come into effect in May providing no-one has appealed against the changes. The timescale for the appeals process closed at 5pm UK time today (5 1/2 hours ago) so if no-one's put in an appeal then they should go through as they stand. If they do, I think it may just have become easier for us Brits to get hold of a pump. Thanks for posting the link, Sue. I was going to do so myself tonight but you beat me to it :D

Rich - I feel slightly 'icky' about the idea of being plumbed into something 24/7 as well. However, diabetes is often about choosing between the lesser of two evils e.g. do we stab ourselves 4-8 times each day (not including blood tests) or do we accept the inflexible lifestyle that 2 a day means for most people (not meaning you, Sue :) )? I wasn't convinced I wanted a pump last year as everything was going well for me on MDI. Then my body decided to change and I've gone through a period of feeling pretty rough again requiring constant effort and fiddling with Lantus, basal tests etc. It's all too much like hard work for little reward when it does this, and I know full well that when I crack it, it will behave itself for a couple of months and then do it again.

I wondered why I would choose feeling rough over a fear that I might not like being hooked up to a canula before I'd ever tried it. I went to a 'pump session' at my local clinic 3 weeks back and met a few local pumpers. All of them went through similar feelings; being connected to a medical device almost makes you seem 'sicker'. But all were agreed that it had profoundly changed their lives for the better, and none would ever give the pump back.

It confirmed that I want to try it, and how I've generally been feeling physically and mentaly since that day have only reinforced my determination to give it a go. Whilst it may not suit, I'm not willing to exclude a treatment that clearly helps lots of people due to my fear of an unknown. Especially as the 'known' of everyday life isn't much fun at the moment as far as diabetes goes. If I can only get in front of the consultant then I hope I can persuade him to let me try one of their loan pumps and see if it can improve my quality of life.

Gary

[SueM]

As I understand it, these are draught proposals that will come into effect in May providing no-one has appealed against the changes. The timescale for the appeals process closed at 5pm UK time today (5 1/2 hours ago) so if no-one's put in an appeal then they should go through as they stand. If they do, I think it may just have become easier for us Brits to get hold of a pump. Thanks for posting the link, Sue. I was going to do so myself tonight but you beat me to it :D




Gary

You will be pleased to know no one appealed the new guidelines came into force this evening :) John Davis from INPUT told me today.

[Gary_W]

You will be pleased to know no one appealed the new guidelines came into force this evening :) John Davis from INPUT told me today.

Thank you very much indeed for letting everyone know; from my perspective, I like the look of these new guidelines a whole lot more than the old and it's really good to know that no-one has put a spanner in the works.

Gary

[BlueSky]

The document didn't make a lot of sense to me. According to the guidelines, the use of a pump is only appropriate if baseline HBA1c is 8.5%+. Only then does it become cost effective, in terms of the economic model they used. But people with much better control are getting pumps ... :confused: .

More importantly, the entire analysis is fundamentally flawed, IMO. The comparison was made between "analog based MDI" and CSII, presumably because data was only available on this basis. The fact that MDI can be enhanced substantially at zero cost by using a third insulin in conjunction with Lantus/Levemir was not considered. Conspicuous by its absence was a description of how this could be done and the benefits that can be achieved. The NICE guidelines are intended to ensure the optimisation of health resources, but it fails to consider a zero cost option :eek: . The mind boggles! It makes a nonsense of the evaluation, and it is not helpful for medical professionals and patients alike.

I have had great success with using Actrapid in conjunction with Lantus to satisfy my basal requirements, and I can't understand why this approach has not become a mainstream option. My HBA1c is about 6% and I have virtually eliminated hypoglycemic episodes, so I have achieved perhaps 80% of the benefit that getting a pump provides. My endo helped me figure out how to close those basal insulin requirement/action gaps, first using NPH and then Regular, together with Lantus. But the diabetes nurses are very suspicious of it. They seem to think that using a third insulin introduces complexity that lesser mortals, like us, can't handle. :mad:

Anyway Gary, my suggestion is to get hold of a loan pump and use it to figure out what your basal insulin requirement profile is. You will then be in a better position to identify options and decide on the best one for you.;)

[Lloyd]

No provable advantage for a T2 to have a pump?

My fasting glucose is now 100 to 140 points less on a pump than it was on injections, the pump treats Dawn Phenomenon, which many T2's like me have.

My A1c has dropped from 6.9 to 4.9

I have not been below 63 (3.5) or above 140 (7.8) in 3 months.

This was simply not the case with injections.

[REDLAN]

They seem to think that using a third insulin introduces complexity that lesser mortals, like us, can't handle.

I think unfortunately that many people find concepts such as carb counting, carb:insulin ratios difficult to understand - if the people on my DAFNE course were anything to go by.

it's one of the motivators for many people with diabetes to avoid eating certain foods, and eating almost the same thing each and every day - makes adjusting insulin much much easier.

I think the people that come on this forum are NOT representative of the average patient with diabetes. And this is who the NICE guidelines are for - the average patient, which is why ability to use a pump is specifically mentioned as a criteria.

the point is there is only so much money in the NHS - and the way it gets round this is by targeting it's resources at the most in need. So giving a pump to someone with an HBA1C with 8.5%+ so enabling them to get their HBA1C into the 7's will result in a better overall health outcome than giving a pump to someone with an HBA1C of 7.5% and enabling them to get into the 6's

For the average person with type 2 (and I don't think Lloyd that you're the average person with type 2 by any means :cool:) it's actually quite difficult to get the AVERAGE patient to make the recommended lifestyle changes. And the evidence is fairly clear - for the average patient with type 2, testing does no better than diet and lifestyle advice - the only apparent advantage is that patients who test more frequently are more likely to comply with the diet and lifestyle advice.

I think there is an issue, that doctors are no longer able to make a clinical judgment about the treatment that a particular patient requires. If you don't fit the boxes, then you don't get the treatment, which seems unfair under NICE.

The good thing is that treatment is now based on available evidence - the treatment has to be proven to work - unfortunately this means that NICE works at the level of the group rather than the individual (which is the level at which WE experience the guidelines)

[Real4]

it's one of the motivators for many people with diabetes to avoid eating certain foods, and eating almost the same thing each and every day - makes adjusting insulin much much easier.

I think the people that come on this forum are NOT representative of the average patient with diabetes. And this is who the NICE guidelines are for - the average patient, which is why ability to use a pump is specifically mentioned as a criteria.


These a fallacy here I believe. One of the smartest ways of dealing with complexity is to reduce that complexity, where possible. If you like food A at restaurant B and you've got the count down pat for that, there's some sense in making that a standard. Of course, you can have a different food at the same or different restaurant, but if you strictly count carbs you odds of being right just aren't as high as when you're having a repeat. Do enjoy your food though!

[BlueSky]

... giving a pump to someone with an HBA1C with 8.5%+ so enabling them to get their HBA1C into the 7's will result in a better overall health outcome than giving a pump to someone with an HBA1C of 7.5% and enabling them to get into the 6's ...
That is quite true. But something is wrong with the logic. Having a high HBA1c is not a good enough reason to give someone a pump. It certainly doesn't make economic sense if one considers the alternatives. Someone with an HBA1c of 8.5% is obviously not using MDI properly. Either they are eating too much carbo, the insulin regimen is inappropriate, or both. It isn't necessary to spend any money to get that HBA1c into the sevens. MDI performance can be improved enormously simply by pushing the right buttons. It means that doctors need to do what their title implies - actually teach patients how to achieve optimum health. ...:o

Where I live, no funding is provided for pumps, under any circumstances. Service organisations like Roundtable and Lions sometimes raise funds to get pumps for deserving children. But the rest of the 500 odd pump users in NZ pay for them out of their pockets. Neither the public health system nor private medical insurance companies are prepared to pay for insulin pumps. I can see why, and I don't think it will change.

Assuming a 5 year life and including the cost of supplies, using a pump costs and additional about NZ4,000 a year. That is a lot of money. The feeling, quite rightly, is that it would be unfair on other policy holders to force medical insurance companies to pay up for this. This little country simply isn't rich enough for the public system to foot the bill. And I can think of much better ways to spend my own money ;) .

[Lloyd]

For the average person with type 2 (and I don't think Lloyd that you're the average person with type 2 by any means :cool:) it's actually quite difficult to get the AVERAGE patient to make the recommended lifestyle changes. And the evidence is fairly clear - for the average patient with type 2, testing does no better than diet and lifestyle advice - the only apparent advantage is that patients who test more frequently are more likely to comply with the diet and lifestyle advice.



True, but any insulin dependent T2 with Dawn Phenomenon can see great improvement in fasting readings if they go on a pump, no lifestyle changes needed for that. Fasting readings make up the largest component of A1c, until your A1c goes below 7.3.

Saying you can't afford it or that it is not cost effective is one thing, saying there is no evidence that a pump can help a T2 is something else again, IT IS JUST NOT TRUE. It is by far the best method to treat high glucose in the middle of the night.

[REDLAN]

Having a high HBA1c is not a good enough reason to give someone a pump. It certainly doesn't make economic sense if one considers the alternatives.

If you download the PDF for the NICE guidelines, then giving a pump to someone with a high HBA1C was the ONLY circumstance in which it made economic sense.

when it comes to actual evidence this is where it gets interesting...

from RCT (randomised Control trials - the gold standard) the evidence that pumps are better than MDI is actually quite weak. However the committee decided that the short duration and small sizes of the trials meant they may not be particularly representative.

they instead used evidence from observational trials - which automatically suffer from selection biases e.g. you compare those who get selected for pumps with those who don't. From these studies they concluded that pumps lowered HBA1C's and the the higher the initial baseline HBA1c then the greater the lowering. When they performed QALY analyses, then those with HBA1C's above 9.0% turned out to be the only cost effective group.

the recommendation about disabling hypoglycemia is based on less evidence than the 8.5% recommendation. The evidence that pumps decrease disabling hypoglycemia is fairly weak. They however took evidence from patient experts that pumps improved the ability of people with diabetes to cope better with episodes of hypoglycemia. Reduction in hypoglycemia was NOT considered a cost effective use of pump therapy.

Saying you can't afford it or that it is not cost effective is one thing, saying there is no evidence that a pump can help a T2 is something else again, IT IS JUST NOT TRUE.

Section 4.3.11 deals with type 2 specifically, and for this they state that there is no evidence that pumps improves outcomes for type 2. They don't make it clear in the report whether they mean there is simply a lack of evidence or whether the evidence they have shows that pumps do not improve outcomes. They do however concede that pumps MAY be effective for a small subset of people with type 2.

interestingly for type 2's on insulin therapy, there is no difference in level of control between those using the older NPH insulins and those using the newer analogue insulins.

[Gary_W]

That is quite true. But something is wrong with the logic. Having a high HBA1c is not a good enough reason to give someone a pump. It certainly doesn't make economic sense if one considers the alternatives. Someone with an HBA1c of 8.5% is obviously not using MDI properly. Either they are eating too much carbo, the insulin regimen is inappropriate, or both. It isn't necessary to spend any money to get that HBA1c into the sevens. MDI performance can be improved enormously simply by pushing the right buttons. It means that doctors need to do what their title implies - actually teach patients how to achieve optimum health. ...:o



Hi BlueSky,

The guidelines do actually make reference to education. I haven't read this new draught as carefully, but certainly in the original there is wording that says that 'if a patient cannot achieve the required HBA1c without disabling hypoglycemia having had adequate educational provision...'. I know they are strict on the education side locally, and will not give out a pump if they feel that a patients problems are due to lack of understanding. Education is tried first.

In general, I do have a huge beef with the education over here (or lack thereof in a lot of cases). Through my own ignorance, I've damaged my body. There is the DAFNE course over here but it doesn't even get mentioned to most people locally until they ask about pumping. If you don't do DAFNE, you are in the hands of the local clinic and they vary wildly up and down the UK in what they tell the patient about self management. We moved to this area nearly 11 years ago, and in those years I was never told about carb counting, basal testing, I:C ratios, how to correct hypos without rebounding etc etc. All essential skills to live with our condition and none of them is rocket science. It wasn't until I found this place that my control become worthy of the word. To date, I feel utterly let down by my local healthcare system and this is coming from someone who has worked on the sidelines of healthcare for 18 odd years...

I was assesed for the DAFNE course last year about 2 months after finding this place. It was decided at that meeting that my level of education on this subject exceeded that taught on the course and it would be wasting my time and their money for me to attend... It worries me that you get a choice locally between a 1 week course which must cost a fortune or absolutely nothing. If you took your average T1 with average intelligence, you can teach them the basics of carb counting and how to basal test inside an hour. That hour plus a book such as 'Using Insulin' will be all that is needed for a lot of people to have their lives transformed from a rollercoaster to a life you can actually live again. As ever, the NHS pitches for the lowest common denominator and thinks everyone is as thick as two short planks. For that reason, they don't believe they can teach these skills to a group in less than a week. Sad isn't it?

What is also sad is that DAFNE talks in terms of CHO's, so your ratio is either 1:5, 1:10 or 1:15. There is no in-between. And this is what some areas insist you go on before you get a pump with its tiny variants in I:C and basal rates. I would argue that the way DAFNE is taught is actually counter-productive to pumping. Please understand I have not attended this course, my knowledge of it comes from a lengthy discussion with the nurse at the clinic when she was assessing me for it. This is the way it's taught here, so if it differs elsewhere I appologise for tarnishing its name ;)

I agree that, with suitable education, a lot of people can get much better control. Indeed, my biggest beef with the original NICE guidelines overe here was that the only way you could get one (if the guidelines were stuck to completely which fortunately they are not always) was to have a really high HBA1c or hypos that needed the help of another. I would say that, if you know what you're doing, you'd be hard pushed to have an HBA1c over 8.5. Yes, I understand from my own changes of late that things can be extremely difficult but if you can comprehend what needs to be done and have the will power to do it then you can get below that number on MDI and then become excluded from pumping.... I am sure there are people over here who failed on MDI who will also fail on a pump due to lack of understanding or will power. Even when I was completely out of control due to my lack of understanding and going between 3 and 18 on most days, my HBA1c stayed in the low 8s and I still wouldn't have qualified...

That is why I believe these changes are right; it is now focusing a little more on the quality of life aspect and hopefully some people who do know how to 'do' diabetes but have other issues that are grey areas will be considered for pumping. Yes, it's expensive but I personally pay an awful lot of money in National Insurance and I know full well that if I paid the equivalent in the USA then I'd have had a pump in a heartbeat. I see far stranger things funded over here on the NHS :)

Another thing to look at is long term pumping costs vs reduction in other costs. It is generally agreed that your average pumper has better control than your average MDI'er. I know there are people in both camps who defy this, but as an average I believe this to be the case. Better control = less emergency admissions, less chance of complications (laser treatment, dialysis, ITU beds etc). I saw a poster in our clinic recently that claimed that 9% of the NHS resources were spent on diabetes; when you consider that around 3% of the population has the disease (lumping all types together here), this is huge. Only a small fraction of that is going to be paying for supplies; most will go on treating the unfortunate stuff that can happen and is indeed more likely to happen if we do not or cannot take care of ourselves. Unfortunately getting any healthcare system (and govt) to stump up money NOW (funding things like education or indeed pumps) to help avoid things that may happen in 20 years time when it's no longer their 'watch' is difficult.

Gary

[BlueSky]

.... giving a pump to someone with a high HBA1C was the ONLY circumstance in which it made economic sense. ....
The evaluation methodology was indeed questionable. I got the sense when reading the document that they had probably decided on what the recommendation would be before they went and found data that substantiated it. ;)

Deciding on how to get the best public health outcome from a limited budget must be really difficult. It would be nice if there was a simple and consistent ranking algorithm, but there is no such thing.

As far as diabetes is concerned, the fact that it is a self-managed chronic condition complicates the evaluation process enormously. You can take a horse to water, but you can't make it drink. A pump won't give an unmotivated user good control. And for the most part, motivated diabetics will achieve treatment goals using the tools that are available to them. Having a pump just makes it easier.

[Lloyd]

interestingly for type 2's on insulin therapy, there is no difference in level of control between those using the older NPH insulins and those using the newer analogue insulins.

I require 23% more novolog then I did apidra. I have never used NPH.

Even on day 1, I used 20% less insulin pumping than I did on injections. That is now down to 62% as much. Fast acting insulin is more efficient.

Weight loss can be very important to T2's, larger amounts of insulin make that much harder to do.

Pumps can vary the basal 24 hrs a day, to keep your glucose low while sleeping.

[Funnygrl]

No provable advantage for a T2 to have a pump?

My fasting glucose is now 100 to 140 points less on a pump than it was on injections, the pump treats Dawn Phenomenon, which many T2's like me have.

My A1c has dropped from 6.9 to 4.9

I have not been below 63 (3.5) or above 140 (7.8) in 3 months.

This was simply not the case with injections.
Based on NICE guidelines, you need to fail MDI as well. So you wouldn't have qualified until you tried, and failed MDI, even if they did allow type 2s pumps. And I tend to doubt based on their standards you would have "failed" MDI.

[Funnygrl]

I require 23% more novolog then I did apidra. I have never used NPH.

Even on day 1, I used 20% less insulin pumping than I did on injections. That is now down to 62% as much. Fast acting insulin is more efficient.

Yes, you have used NPH. It's on of the components of 70/30. You didn't use pure NPH, which sucks slightly less than 70/30 does.

Had you switched from Lantus/Apidra to a pump I doubt your insulin use would have dropped as dramatically.