# New update to NICE Guideline for T1 Adults



## everydayupsanddowns (Dec 15, 2014)

A some of you may know I've been on the Guideline Development Group for this over the last few years as a 'Patient Representative'. Members are sworn to secrecy about all discussions that take place around the table, so I've not really been able to say anything about it.

But...

We are now in the phase in the process where the Guideline is out for consultation with stakeholders.

If you are interested, you can read the 'in development' Guideline here: http://www.nice.org.uk/guidance/indevelopment/gid-cgwaver122/consultation

Interesting stuff in there about general target A1c's, recommendations for personalised targets, level of testing which has been shown to be effective (and cost effective!), basal insulins, hypo-awareness and lots more besides!

It is due to be published later in 2015


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## Annette (Dec 15, 2014)

Interesting stuff (ok, I didn't read all 650 pages of it, I'm a skilled skim reader  ) - and I learnt a few things I didn't know as well!


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## DeusXM (Dec 15, 2014)

Scanning through now but looks GOOD! 

A1C target of 6.5% or lower? Testing 10x a day is ideal if you're not at that A1C? About time! Not so sure about the warning against low GI diets though. Pre- and post-prandial targets look nicely tighter too. Also looks like they're pulling away from Lantus if they're recommending detemir over glargine.

There is a bit of a kicker in here though:



> Do not offer real-time continuous glucose monitoring routinely to
> adults with type 1 diabetes. [new 2015]
> Consider real-time continuous glucose monitoring for adults with
> type 1 diabetes who are willing to commit to using it at least 70% of
> ...



If you're not passing out from hypos, say goodbye to getting a Libre on the NHS, folks....


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## Pumper_Sue (Dec 15, 2014)

DeusXM said:


> Scanning through now but looks GOOD!
> 
> A1C target of 6.5% or lower? Testing 10x a day is ideal if you're not at that A1C? About time! Not so sure about the warning against low GI diets though. Pre- and post-prandial targets look nicely tighter too. Also looks like they're pulling away from Lantus if they're recommending detemir over glargine.
> 
> ...



Basically it hits the people who want to keep good control and rewards those who haven't. Stable door and horse springs to mind.


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## everydayupsanddowns (Dec 15, 2014)

Well, I think the problem with CGM (and has been for a long time) is that it is ferociously expensive and lots of the clinical trial data just are not that impressive. If you gave everyone a CGM you'd spend millions and actually not get that much back it seems. It might be like those folks who get CGM funded by insurance in the US and it just stays in the drawer because they don't like it/find it too intrusive/whatever. 

The Libre was not out when this was written, of course - nor was any of its data published/examined (since strictly speaking it is not CGM). 

There is another group looking at CGM integrated with pumps at the moment as part of a diagnostic advisory committee - so that will be interesting. 

The data/studies are getting better so hopefully things will move in the right direction.

Good to know that the door is left open though for specific cases with people who DO have a problem that CGM can help.


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## everydayupsanddowns (Dec 15, 2014)

Interestingly, regarding Lantus - it was very much the new kid on the block for the last guideline in 2004. Levemir was not even out yet. 

If you are interested in any of the number crunching and discussion that went into any of the recommendations you can read through the 'evidence to recommendation' sections in the full guideline.


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## HOBIE (Dec 15, 2014)

Well DONE MIKE " for representing us lot ! I take it was lots of meetings etc


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## trophywench (Dec 15, 2014)

Well of course anyway - even if the NICE Guidelines say something's brilliant and SHOULD be done - doesn't mean it will be!


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## Redkite (Dec 15, 2014)

Yes, it looks good - someone posted extracts on some of the Facebook forums - but I'm not happy with the CGM guidelines....if you manage to get CGM you'd have to kiss goodbye to your driving licence


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## everydayupsanddowns (Dec 15, 2014)

Redkite said:


> Yes, it looks good - someone posted extracts on some of the Facebook forums - but I'm not happy with the CGM guidelines....if you manage to get CGM you'd have to kiss goodbye to your driving licence



How so Redkite?


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## Redkite (Dec 15, 2014)

Because to qualify for CGM you have to have suffered severe hypoglycaemia and/or hypo unawareness and/or frequent hypos with no warning signs....all of which if declared to the DVLA will result in no licence!


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## trophywench (Dec 15, 2014)

Yes Redkite that's correct.

So what's wrong with that?

That people should have to display a definite NEED for such expensive equipment is absolutely fair enough in my book.

What other NEEDs are there for one?


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## Redkite (Dec 15, 2014)

trophywench said:


> Yes Redkite that's correct.
> 
> So what's wrong with that?
> 
> ...



I think having type 1 is need enough!  Having used CGM for my son (whenever I can afford to), it makes a tremendous difference to his control.  The cost/benefit analysis should focus on avoidance of even more expensive complications of diabetes imo!


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## Pumper_Sue (Dec 16, 2014)

trophywench said:


> Yes Redkite that's correct.
> 
> So what's wrong with that?
> 
> ...



I used to think exactly the same until I tried a CGM, All I can say is wow what a difference it makes using one.


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## Redkite (Dec 16, 2014)

Pumper_Sue said:


> I used to think exactly the same until I tried a CGM, All I can say is wow what a difference it makes using one.



Well said Sue!


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## DeusXM (Dec 16, 2014)

> That people should have to display a definite NEED for such expensive equipment is absolutely fair enough in my book.
> 
> What other NEEDs are there for one?



Because it's not just those whose diabetes is out of control who benefit from more monitoring. Keeping your diabetes in check requires constant monitoring - there isn't some magic point where you get your A1C under 6.5% and then don't need as much information. Getting and maintaining control require the exact same methods - you collate as much data as possible, and amend your treatment as required.

Therefore both those who are in control, and those who aren't, need access to exactly the same tools. 

Otherwise, all that's going to happen is doctors are going to start beating up patients who can't get A1Cs under 6.5 but also aren't having tonnes of hypos, and then those people aren't going to get the tools to support them getting a healthier A1C. Those people are then going to be at risk of complications, which are expensive to treat.

I take on board though Mike's point that these were drawn up before the Libre was under consideration. I just hope that NICE looks on it as a blood sugar monitor, rather than a fully fledged CGMS/alarm system.


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## Redkite (Dec 16, 2014)

DeusXM said:


> Because it's not just those whose diabetes is out of control who benefit from more monitoring. Keeping your diabetes in check requires constant monitoring - there isn't some magic point where you get your A1C under 6.5% and then don't need as much information. Getting and maintaining control require the exact same methods - you collate as much data as possible, and amend your treatment as required.
> 
> Therefore both those who are in control, and those who aren't, need access to exactly the same tools.
> 
> ...



That's the point I was trying to make - you've put it much better than I did!  People with diabetes shouldn't just be sent away with targets, they need the tools to meet those targets.  And the costs upfront will result in savings later on when these same people have avoided expensive complications and are still in the workforce contributing taxes.  But no government wants to look further into the future than the next election


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## everydayupsanddowns (Dec 16, 2014)

I can only give my personal view on this. When I was accepted as a patient rep on the Guideline Development Group one of my biggest hopes was that there would be a weight of evidence that showed how effective CGM was and that the guideline would widen the take-up of CGM for all the reasons you are all stating.

I had never had experience of any kind of continuous data at the time but on forums and blogs I saw time and time again how much difference it seemed to make to individuals.

Unfortunately the reviewed evidence just did not back that up.

The thing is that CGM is SO expensive that you actually have to have pretty hefty effect sizes and you have to see these pretty much all the time for the cost of the treatment to balance the long term risk of complications. Sadly the reviewed evidence (and I absolutely trust that the brilliant technical team searched for and found everything that could be included) showed a significantly mixed bag - with no real explanation. In HbA1c terms sometimes it dropped a smidge (.3% on average), sometimes it was not affected at all. Generally people felt better with CGM and on balance there were significant (though again not universal) improvements in hypoglycaemia and severe hypoglycaemia - but really nothing much to cling on to for HbA1c. 

Now my guess would be that most of these studies are funded by the machine manufacturers - so presumably they show the devices in the best light they can - and even so they weren't able to show really big numbers consistently.

It's like it works brilliantly for some people, and not at all for others - and actually not very well in trial populations (which is weird because often these are just the motivated types you'd expect it to work for).

Undeterred the GDG commissioned an entirely new economic model (section 8.2.5) which ran through a large computer-generated population designed to reflect the average T1 in the UK and with the average incidence of complications at their averaged HbA1c. Then they ran 'lifetime' CGM cost from average age against average benefits (including A1c and 'quality of life' measures) to see whether the numbers stacked up. 

They didn't.

So they added best improvements and most intensive BG strip usage into the mix so that effectively everything was weighted toward CGM winning. And it still would not measure up.

10x a day = £1000/year
CGM = £3,500/year

But you just don't seem to get £2,500's worth of benefit each year in NHS terms - unless you are actually struggling.

With the (pre Libre) evidence that was considered - it seems that on average CGM is just too expensive and not effective enough for 'general release'. I'm gutted about it, but I have to concede the cold hard economics of it. 

Yes it might get a motivated patient from 7.0% to 6.5% or 6.0%, but the 'curve of complications' is really starting to bottom out down there and the incidence of complications is lower... so fewer savings to be made... Unless of course you are in and out of A&E with severe hypos multiple times a year. etc etc.

I am not sure whether the Group will revisit CGM in the light of Libre (does seem likely) but I will have to opt out of any further discussions on CGM because I accepted a free trial of the Libre and so, in NICE terms, I have a conflict of interest.

In terms of the guidance and driving - I think it's important to recognise that CGM and DVLA rules are not mutually exclusive in that carefully written recommendation. If you are having lots of severe hypos then clearly the DVLA are going to be a bit twitchy (and rightly so) but this is an 'any' list not an 'all' list. The last two bullet points



> *frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities
> *extreme fear of hypoglycaemia.



Could apply to many T1s who would benefit from CGM and are not necessarily be banned from driving. It's down to the clinic/consultant to make a clinical judgement. Heck depending on whether whoever it is thinks 3.9 counts as hypo I certainly qualify under the first one if I argued strongly that the fear of those levels without warning signs *every time* was ruining my quality of life and causing me problems.


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## Northerner (Dec 16, 2014)

I think there would certainly be an argument for limited-time use of CGMS (or more probably, Libre) for recently-diagnosed T1s so that they have the best possible opportunity to understand their diabetes and how they respond to their daily activities and preferred diet. I'm pretty sure I would have avoided quite a few hairy moments in the first couple of years and would know more going forward (hate that phrase, but appropriate!) about certain things that I'm still largely in the dark about. 

It's a bit like pumps, really. My consultant once told me that I ought to be the kind of person to qualify for a pump because I have shown consistently that I am prepared to put in the work, and have the understanding, to achieve excellent results. I don't want one, but there are certainly areas of my life that would be much improved by the flexibility provided by one - such things, however, would show no improvement at all in my HbA1c.

I am very fortunate in many respects, but that doesn't mean that I don't work hard, and I have noticed a cycle over the years of working hard, then burnout and lapses, then gearing myself up to working hard again. Diabetes is hard to live with, and I know the effect of that can be hard to measure, but ought to be a consideration on an individual basis if the person would clearly benefit from CGMS albeit on a limited, not lifetime, basis. I've probably strayed from the point of the thread quite a bit!


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## Redkite (Dec 16, 2014)

Thanks for explaining the process Mike; at least they went into the cost/benefits in detail.  I'm surprised at the findings though, it seems so much at odds with our own experience!  I hope when the closed loop devices begin to reach the market, that they won't also be unavailable due to cost.


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## Pumper_Sue (Dec 16, 2014)

My maths work out at £345/ year for a transmitter Plus £46/ month for a sensor, equals £897 per year. That's obviously using a pump with a receiver already integrated.


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## Redkite (Dec 16, 2014)

Pumper_Sue said:


> My maths work out at £345/ year for a transmitter Plus £46/ month for a sensor, equals £897 per year. That's obviously using a pump with a receiver already integrated.



Well that's true as well, that people do get longer use out of each sensor - however NICE have to cost them on the licensed usage (e.g 6 days for Medtronic enlites).  Although if their use became more routine and widespread, perhaps the unit cost would fall?  Government health providers and the big medical insurance companies surely have a lot of bargaining power when it comes to negotiating prices - and Medtronic etc. would make bigger profits selling more sensors at a reduced price than a marginal quantity at a high price.

Maybe the benefits cannot yet be clearly demonstrated because there aren't enough "ordinary" type 1's routinely using sensors, and therefore the statistics are skewed towards the "difficult cases"!!!!


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## Flower (Dec 16, 2014)

Thanks for this information Mike, it's really interesting.

I'm glad to see guidelines for the use of CGM, previously there weren't any specific guidelines. They do cover the issues that my consultant explained to me a few years ago when we applied for funding.

As a life saving piece of technology it's worked for me as I haven't gone unconscious for the past 3 years since using it and as a plus my HbA1c has fallen to 6.2%- but its first and main aim was for my complete lack of hypo awareness. It was weighed up against the cost of a pancreas transplant which was the route I had started to go down and not just on the costs of additional test strips and admittance to hospital.

It will be very interesting to see how and where the Libre fits in to funding considerations.


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## Phil65 (Dec 16, 2014)

Thanks for the read Mike, although I now have RSI in my scroll finger! 
A couple of stand-outs for me are:

A1C target of 6.5 = unhappiness from my D team! (I fully understand the benefits of tight control but correct me if I am wrong ....is there a NICE guideline on the SD?)
Good that they recommend testing 4-10 times a day but many GPs will be aghast at this and the cost implication in prescription strips.
Excellent ref the need for Carb Counting courses and the importance of them.
HbA1C testing every 3-6 months....also good.

I am sceptical about the effectiveness of NICE, for instance my consultant 4 years ago said that I didn't meet the NICE guidelines for a pump as my control was very good. I pushed hard and asked whether I should let my control slip to meet the criteria! .....I got a pump! I wonder how many will get CGM this way?


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## everydayupsanddowns (Dec 16, 2014)

Phil65 said:


> A1C target of 6.5 = unhappiness from my D team! (I fully understand the benefits of tight control but correct me if I am wrong ....is there a NICE guideline on the SD?)



Well not as such... but the BG targets were reviewed and updated too. And if (by some miracle) we were all able to hit those targets - which have evidence to say they are the right ones to go for - guess what? I reckon we'd have an A1c of sub 6.5.

The 6.5% was recognised to be quite a *big thing*, but the evidence was pretty clear. The benefit increases way down past 7.5 and if a person *can* get there while at the same time keeping a lid on hypoglycaemia, then good for them. Clearly it's an aspirational target and it's important to recognise that individualised targets are stressed as vital.

Let's hope it stops people being told off for having an A1c that's 'too low'


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## pippaandben (Dec 17, 2014)

I am type 2 - possibly 1.5- and on MDI of insulin. Took 18 months to reach this point and have now been on insulin for 18months. I am now beginning to have to up both basal and carb ratios slighty as I presume my resistance is increasing. Is any of this covered in the new guidekines for type 1s  - or would that be a totally separate guideline issue?p refuses to test to see what camp I fall in on the basis that treatment is the same!!!


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## heasandford (Dec 17, 2014)

Excellent thread - although I haven't had time to read the actual report yet! Great comments from everyone.

I have to say, the Libre has showed up how little I appear to be able to do to alter my results, I did expect it to be transforming and I would always be in target! Well, not exactly, but I think many of the tips I've picked up here, and being constantly 'on the case' have had a better effect on my HbA1c,(49-56 year before pump, 48-53 this year, 48 this week) and I don't see any improvement in the future due to Libre, judging by the results. Likewise the SD which is my constant downfall. However I really, really love the Libre and maybe that has a longterm effect on my mental health and burnout?


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## everydayupsanddowns (Dec 17, 2014)

pippaandben said:


> I am type 2 - possibly 1.5- and on MDI of insulin. Took 18 months to reach this point and have now been on insulin for 18months. I am now beginning to have to up both basal and carb ratios slighty as I presume my resistance is increasing. Is any of this covered in the new guidekines for type 1s  - or would that be a totally separate guideline issue?p refuses to test to see what camp I fall in on the basis that treatment is the same!!!



Not really pippaandben - the guideline isn't a textbook in that way. It's more of a review of clinical evidence and best practice. eg What options are available for rapid insulins, and which work best for most people?

In your shoes I'd probably be looking for something a bit more 'hands-on' and practical. Something like 'Using Insulin' by John Walsh/Ruth Roberts or 'Think Like a Pancreas' by Gary Scheiner. Those are both brilliant, practical books that can help you understand basal-bolus better and fine ture your approaches.


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## heasandford (Mar 18, 2015)

Is there any update since the consultation finished?


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## everydayupsanddowns (Mar 18, 2015)

The consultation comments (received from stakeholders like INPUT, professional bodies and pharma) now need to be reviewed by the Guideline Development Group before the final guideline is published - due end of the Summer/early Autumn I think.


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## heasandford (Mar 18, 2015)

Thanks - I have to admit I missed the deadline, but recognise what I would have said would have made no difference in light of your (very straightforward) comments. I am just interested if they are going to make any changes and of course what that might mean for the future.


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