New update to NICE Guideline for T1 Adults

[everydayupsanddowns]

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

 

[Annette]

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!

 

[DeusXM]

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
the time and to calibrate it as needed, and who have any of the
following that persist despite optimised use of insulin therapy and
conventional blood glucose monitoring:
*more than 1 episode a year of severe hypoglycaemia with no
obviously preventable precipitating cause
*complete loss of awareness of hypoglycaemia
*frequent (more than 2 episodes a week) asymptomatic
*hypoglycaemia that is causing problems with daily activities
*extreme fear of hypoglycaemia. [new 2015]

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

 

[Pumper_Sue]

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:



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

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

 

[everydayupsanddowns]

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.

 

[everydayupsanddowns]

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.

 

[HOBIE]

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

 

[trophywench]

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

 

[Redkite]

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

 

[everydayupsanddowns]

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?

 

[Redkite]

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!

 

[trophywench]

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?

 

[Redkite]

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?

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!

 

[Pumper_Sue]

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?

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.

 

[Redkite]

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!

 

[DeusXM]

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.

 

[Redkite]

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.

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

 

[everydayupsanddowns]

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.

 

[Northerner]

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! 🙄

 

[Redkite]

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.