New NICE Guidelines for Type 1 Diabetes Published (at last!)

As some of you may know, over the last three years (THREE YEARS??!?) I have been working with a wonderful group of fiercely clever and passionate people as one of two 'patient representatives' on the NICE 'Guideline Development Group' which was revising and updating the NICE Guidelines for type 1 diabetes in adults. Expert consultants, eminent physicians, nurses, pharmacists, GPs, educators, editors, along with a host of other specialists including researchers and health economists who gathered and organised an almost unimaginable quantity of research data for the group to filter through and consider.

It has been a huge privilege to work with them all, not least Professor Amiel, the chair of the group, who is a complete inspiration and quite the nicest person you could meet. We have not been permitted to mention anything much connected with the discussions until publication, but at last, today, the guideline launches here: ‘Type 1 diabetes in adults: diagnosis and management'.

Hooray!

If you have been living in a cave for the last 16 years and have never heard of the National Institute for Health and Care Excellence (NICE), they are an independent body working as part of the Department of Health who publish guidance on all manner of healthcare topics which aims to set the 'gold standard' of evidence-based care, balancing clinical outcomes, patient preference and quality of life against the cold hard reality of NHS budgets (ie Yes! You can have something expensive... but only if published research shows it's reeeeeally good for most people).

As a patient, I *love* the fact that I can have a weighty, official, authoritative document that describes what has been shown to be the very best in diabetes care. It gives me something to consult to measure my own experience in clinic, and the right kind of pointy questions to ask if I think I should be getting something that isn't being offered. Plus if I think something should be available that isn't, the documentation is so comprehensive that (if I wanted to) I can dig down into the 'linking evidence to recommendations' section to unpick the reseach and discussions that underpinned the recommendations.

NICE seems to get a hard time in the press off and on (either for denying treatment, or for recommending it) and is frequently accused of bias or an almost corrupt collusion with the pharmaceutical industry. I have to say this could not be further from my experience of the guideline development process. Each meeting included a new declaration of 'conflict of interest' and anyone with a conflict, financial or otherwise, however minor, was not permitted to contribute to the discussion or was asked to leave the meeting entirely.

I am very proud to have been part of the process, and believe that this updated guideline, if fully implemented has has enormous potential to improve the lives of adults living with type 1 diabetes in the UK.

Here are a few things I'm really pleased made it into the final version:

Structured education

Offer all adults with type 1 diabetes a structured education programme of proven benefit, for example the DAFNE (dose-adjustment for normal eating) programme. Offer this programme 6–12 months after diagnosis.

If a structured education programme has not been undertaken by an adult with type 1 diabetes by 12 months after diagnosis, offer it at any time that is clinically appropriate and suitable for the person, regardless of duration of type 1 diabetes.

My feelings about the lack of structured education formed no small part of my journey toward joining this NICE committee. Carb counting, dose adjustment, correction factors, basal testing, guidance about exercise, alcohol and sick day rules. How can people be expected to make a decent go at managing their type 1 diabetes without these skills? And yet the number of people who have ever attended such a course is pitifully small. Unless I'm mis-remembering it's something like 6.5%. Let's hope that during the life of this guideline that changes significantly.

Access to test strips

Support adults with type 1 diabetes to test at least 4 times a day, and up to 10 times a day if any of the following apply:

• the desired target for blood glucose control, measured by HbA1c level (see recommendation 1.6.6), is not achieved
• the frequency of hypoglycaemic episodes increases
• there is a legal requirement to do so (such as before driving, in line with the Driver and Vehicle Licensing Agency [DVLA] At a glance guide to the current medical standards of fitness to drive)
• during periods of illness
• before, during and after sport
• when planning pregnancy, during pregnancy and while breastfeeding (see the NICE guideline on diabetes in pregnancy)
• if there is a need to know blood glucose levels more than 4 times a day for other reasons (for example, impaired awareness of hypoglycaemia, high-risk activities).

'Proper' testing frequencies of up to 10x a day (and making use of the results) shown to be more effective AND cost-effective. No more shocked looks permitted from non-specialist Drs or nurses suggesting a couple of times a week should be fine.

HbA1c Target

Support adults with type 1 diabetes to aim for a target HbA1c level of 48 mmol/mol (6.5%) or lower, to minimise the risk of long-term vascular complications.

Agree an individualised HbA1c target with each adult with type 1 diabetes, taking into account factors such as the person’s daily activities, aspirations, likelihood of complications, comorbidities, occupation and history of hypoglycaemia.

I've written about this before. Personally, as a patient, I am really pleased with the balance between these recommendations. Don't tell me to be happy with an A1c approaching 8% if there is real evidence that lower is better to guard against long-term complications. Don't tell people who have no problematic hypoglycaemia that their A1c is 'too low' because it's in the 6s (can't get used to the new numbers yet, sorry!). On the flip side, treat me as an individual, don't label me as a failure because you have a magic number in your head that I am working toward, but I'm not there yet.

Not exactly 'CGM for all', but...

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 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.
• Hyperglycaemia (HbA1c level of 75 mmol/litre [9%] or higher) that persists despite testing at least 10 times a day (see recommendations 1.6.11 and 1.6.12). Continue real-time continuous glucose monitoring only if HbA1c can be sustained at or below 53 mmol/mol (7%) and/or there has been a fall in HbA1c of 27 mmol/mol (2.5%) or more.

'Consider' is NICEspeak for a much weaker recommendation. It should be on the table, but it's not for everyone. The evidence for effectiveness of CGM was just not compelling enough to do anything else at it's current eye-watering pricetag. To be honest I was shocked at how weak it was, given the experience of people I know who self-fund CGM. Continuous Glucose Monitoring it seems just doesn't do well enough in Randomised Controlled Trials. But at least, here, it *might* be available on the NHS to the people who really need it.

And finally
It was great to see bi-modal (mixed) insulins being given the heave-ho, unless people really wanted to use them. From now on people should be able to start off on a proper flexible MDI regimen from the outset, along with some good education and support.

It was also really heartening to see how NICE reacted to the subject of language. The editors were updating the old recommendations for clarity and new styling (for example 'adult with type 1 diabetes' rather than 'diabetic' or 'patient'). I raised the question of the word control which is a difficult term for some people. Personally I cannot 'control' my diabetes - I do not have the ability to affect all the variables. At best I can limit some, and try to react to, or work around the others. I don't control my diabetes, I manage it. Because of the timing of the discussion, it was not possible given the time-restrictions to change the terminology used in the full guideline (though discussions will be had within NICE for future versions). I was very pleased though that for the 'Information for the Public' version, the phrase 'diabetes control' has been replaced.

What do you think? Will the new NICE guideline make any difference to you? Were you even aware that there was one to cover type 1 diabetes? Let me know in the comments below.

6.5% A1c target - A reply to a comment that got out of hand

I've had a couple of comments on my post about the proposed new HbA1c to aim for in the draft NICE guideline that is currently out for consultation. I was rattling in a 'quick' reply, when I thought - this is *ridiculous*. I can't even see this any more in this tiny box - so I've decided to post it here instead :)

Here are the comments:

Tamer Hassan said...
how do you achieve these numbers?

thanks

Tim said...
These numbers are impossible to reach...
Or at least give me some suggestions on how to reach these levels. Thanks.
Tim

'How to reach these numbers' is a question for your healthcare provider really. Don't just ask some random nutter on the Internet! However (and desperately trying to avoid sounding like Mr Smug of No 22 Smug Gardens, Bigheadshire) I have had a sub 6.5% HbA1c for over 3 years now, so I know that it *is* possible if only perhaps for the lucky few. Plus I've never had fewer hypos in my life with diabetes either - so it's not that I am 'paying' for A1c improvements with the hefty cost of Severe Hypoglycaemia.

I cannot really tell why some people seem to put in so much effort and get such scant rewards, and that is why I think individualised targets are SO important.

But it does seem pretty clear to me that the closer you can get to those standard-issue BG targets (5-7mmol/L waking, 4-7mmol/L pre meals and <9mmol/L by 2 hours after meals) for as many days in the week as you can manage, the closer you will get to these kind of tough, aspirational, borderline non-diabetic A1c targets. My own HbA1c has fallen by around 1.5% in recent years, and I think only around 0.5% of that is attributable to the pump - though Artoo has gone a LONG way to reduce my number of irritating low-level hypoglycaemia dips. When I look back over the changes that I have made in recent years I can see a few things that I think were important. I don't offer these as any kind of guide or advice - it's just what I did.

1. Education. Get access to proper structured education regarding diabetes management. In the UK we have DAFNE which is highly thought of, but other options are available. Things that should be included (in my opinion) are:
   
   1. carbohydrate counting, working out how to check and change insulin:carb ratios for different times of the day
   2. SMBG technique - when to test and what to do with the results *including* basal testing to PROPERLY adjust basal on an ongoing basis
   3. correction factors - when and how to correct (with insulin or fast-acting carbs) to aim bring you back into range without jumping aboard the gluco-coaster
   4. exercise and alcohol
   5. dealing with illness
   If structured education courses are not available in your country/area you can do a lot worse than buying 'Think like a pancreas' (Scheiner), 'Type 1 Diabetes' (Hanas) or 'Pumping Insulin' (Walsh/Roberts) which cover much the same ground. Though the benefit of peer support in group sessions should not be underestimated. Alternatively look at the free BERTIE online course.




2. Test more often AND RECORD THE RESULTS. Find some way of keeping notes daily as you go along. What you are eating, units and timing of doses (how long before... split doses...), exercise, mood, everything! Without a fairly detailed set of records I find it impossible to see what is going on. Personally I still love mySugr for this.




3. Gadgets - seek out new tech that can help you manage your diabetes more easily. It might be a 0.5u pen; a smartphone tracking app, or copy of 'Carbs and Cals'; or it might be a BG meter with a bolus wizard so that you can have properly fine-tuned ratios without having to worry about keeping the maths easy. Additionally, ask your clinic about access to Insulin Pump therapy and CGM.




4. Seek peer support - join a forum or two, join Twitter, read some blogs (thanks!) or even *crazy!* join a local group and meet face to face. Living with diabetes is tough, but it's even harder if you are battling on your own. For everyone there's a little corner of the internet that can provide support, encouragement and shared experiences.

At the end of the day we each have to find our own balance between living a life and managing our diabetes. Somewhere in the middle you'll find your perfect A1c and it won't drain all the joy out of life to reach it.

Good luck :)

Diabetes Speed Dating Clinic Type Thing

Some months ago I found myself looking back over the past few years.

If you've read our blog before (congratulations on your uncommon stick-ability) you may remember that we began writing about my diabetes as a family as a result of an unusually nasty hypo. One which made me question whether I was quite as competent at managing my diabetes as I liked to think I was. Posts from others in the household have dwindled rather, and you've ended up stuck with me. Sorry about that. But I look back over the past few years and realise that I have been on a full-on misty-eyed X-Factor-Strictly-Voice-finallist 'journey'.

I was reminded about this yesterday while reading a blog post by The Grumpy Pumper about his own story of venturing into the Diabetes Online Community (DOC). I have had similar conversations with Dave (@SowerBee) previously too.

It seems to go something like this...

1. Get diagnosed
2. Learn to muddle along in your own way, with varying degrees of success
3. Never, or almost never, meet or speak to another actual real-life person with diabetes
4. Feel slightly isolated and faintly dissatisfied with how you are doing but don't know what to do about it
5. Lose a bit of faith in suggestions made by various healthcare professionals/clinics/consultants/registrars/DSNs (what do *they* know - they don't live with this day-to-day, harrumph etc)
6. Carry on for 5/10/15/20 years
7. *Something* happens
8. Look for support online and/or meet other PWD face-to-face (eg on DAFNE)
9. Lightbulb moments ensue
10. Engage, share, try new strategies, feel empowered
11. Understanding and management of condition is transformed

Now here's the thing.

This is a pattern I see repeating, time and time again in the experiences of others just as it did with me.

But there are still so many people at point 5 or 6. People for whom the standard structure of clinic appointments just isn't quite working, but who either don't realise that 'peer support' like the DOC exists, or who would run a mile from the very idea of it, believing that it is 'not for them'. I know the second group well. I was a fully paid-up member for all the years that deep-down in my heart I knew I was struggling a little, but made myself believe that 'this was as good as could be expected' and 'nothing works'. Of the 300,000 people living with Type 1 in the UK how many are connected with others? 3,000? 10,000? That still leaves the vast majority 'soldiering on' on their own with only an Annual Review for company.

So what can we do for them?

Don't get me wrong. I'm not saying that peer support could fully replace 'proper' consultations with qualified and well-trained healthcare professionals. I am aware that dark, weird and scary corners of the internet exist, where all sorts of odd ideas are bandied about as fact (though these are hard to maintain in well-populated, mixed groups and in my experience the DOC doesn't stand for nonsense). But I'm also aware that there is nothing quite like hearing experiences of someone in your position, who does live with the same condition as you every day. Who faces the same struggles and has tried strategies that you might consider.

I've also spotted another phenomenon. If you attend a 'meet up' of forum posters, bloggers, tweeters or others who live with diabetes you will not be able to get them to shut up. In fact, you will struggle to get a word in edgeways. Questions will be asked, approaches and strategies compared, support offered, understanding and empathy for the sheer relentlessness of it all given freely.

I'm also aware that every day, up and down the land, dozens of people sit side-by-side with other people with diabetes in stony silence.

And this strikes me as odd. Or at the very least a massive missed opportunity.

I've been meaning to write this post for months, but kept putting it off because I could never quite get my head around the details. To be honest I couldn't even work out a proper title for the post (this you will have noticed). But the time has come to just 'put it out there' to see if some brave Consultant or Clinical Lead can do something with it. Someone like Partha perhaps?

Here it is: Wouldn't it be great if there was a way to harness all those wasted minutes in the waiting rooms at diabetes clinics. If there was some way of facilitating peer discussion and support while we are all sat there waiting for our number to come up. At the very least it might prompt some actual questions to ask in the appointment itself, rather than everyone just sullenly descending into smile-grunt-nod territory.

Something a bit like speed-dating. Sit opposite a person or two for 5 minutes, ask them how they are getting on. How long they have had diabetes. Is there anything they particularly struggle with. Do they have the same problem I do with this or that? What do they do about it? Ring a bell, everyone moves around... 'You'll never guess what that last bloke said...' 'Really? Oh I get that too...'

Of course there would have to be some sort of 'opt out' for people who simply can't face the idea. But I'd love it if we could break the unwritten rule in diabetes clinic waiting rooms that 'thou shalt not say anything to anyone'. For people to be actively encouraged to compare experiences and support each other. So that each clinic appointment would combine the very best of both D-meetups and HCP input.

If that was on offer - would you join in?

DIY DAFNE

I was reading up a little about dafne (Dose Adjustment for Normal Eating) yesterday, including an account of one person's experience of the introductory course which gave a pretty good overview of the approach. It surprised me in two ways. Firstly it made me feel pretty fortunate to have had the care teams I did when I was first diagnosed and in the early years. It was more than 20 years ago and at that time 'exchanges' were the thing (an exchange was a unit of 10g of carbohydrate - if you've come across dafne this will already be sounding pretty familiar). To keep things relatively simple to start with, the advice was to keep a standard set of doses each day, keep your mealtimes regular and of a measured amount of carbs. I never got on very well with premixed insulin as the requirement to have meals and snacks at precisely predetermined times each single day does not fit with any kind of life I know.

When I moved back to Bristol they quickly suggested I went on to basal-bolus 4 injection a day pen system. Much more flexible, they said. You could eat at different times if you needed to, or even miss a meal entirely in exceptional circumstances - suddenly getting caught in a motorway traffic jam was not a life or death crisis. If you wanted to eat slightly more, or less carbohydrate at a meal you could adjust the short-acting insulin dose accordingly. You were being your own pancreas. I suddenly felt much more in control of diabetes. At this stage the team were also telling me that people didn't really 'do' exchanges any more. People weren't being taught to be able to guess how many grams of carbohydrate are in that jacket spud. That some vague sense of relative proportions of food groups on the plate were the New Way. I remember thinking at the time that this made no sense at all. How hugely varied two rougly equal looking plates can be. How glad I was that I had been taught how to guestimate carbs from the beginning.

And that's the thing I think that really surprised me yesterday. Reading the account of the introductory course made me realise that I've been doing a sort of 'diy dafne' for years, long before it was developed as a course and hailed as the Next Big Thing. It appears, however, this is not a universal experience. The whole concept of basal-bolus was introduced to me in a dafne-type way. Why wouldn't it be? How else does it make any sense? I'd be interested to hear if anyone has been put on a basal-bolus system and not had that kind of introduction - matching the amount of carbohydrate you eat with your short-acting insulin doses, keeping a close eye on your blood glucose results, correction doses when you underestimate; something sugary when you overdo it. And if not... then just how they were advised to make it work.

Some units are more equal than others

All units of insulin are equal, you would think. But it seems some are more equal than others.

A week or so ago I had a very odd hypo. In fact it was that experience and some of the conversations we had about it afterwards that were the catalyst for us as a family to begin this blog. A place where we could write about our own experience of living with diabetes. Look at it from different angles, poke it with a stick, turn it over and over. The very act of writing these things down means you have to think about them quite carefully. To consider how you feel. To wonder what they mean. This in itself probably makes the writing worthwhile. Not in some maudlin, self-pitying, navel gazing way, but because when you've lived with a condition for a decade or two there is a tendency to begin to ignore it. To stop really thinking about it in any front-of-mind way. It's just there, the elephant in the room, squashing furniture, generally making a mess and getting in the way but largely ignored.

So even if you weren't reading this, it would still have been worth my writing it. Well not this bit actually, this is just the preamble. But the next bit definitely. In fact probably best if you just skip forward to the next paragraph and save us both some time. Here is an amazing thought though. A week or so ago I had an odd experience with a condition that I've been living with for about 20 years. And now, just a few days later you can read about that even if you live on the other side of the world. And if you have shared an experience that you read here, you can make a comment and you and I will know that someone else has been there. That it's not just us.

When the dust had settled on the hypo of the weekend before last we wondered why some of the symptoms of low blood sugar had extended for hours after normal and even quite high blood sugars had been restored. Why it had taken almost until the evening for me to fully 'get my words back'. It didn't help that when asked whether he thought this might ever happen again the doctor gave a pretty unequivocal, "Yes". It seems possible (though we are only guessing really) that a slight miscalculation of the size of jacket potato the night before might have led to a quite extended period of hypoglycaemia overnight. I woke with a start from a dream at one point which might have been my body trying to kick me back into consciousness to get something sugary, though my hypo-addled brain made up a convincing story about Derren Brown, subliminal mind control, advertising, Apple products and Twitter(!) and I just turned over. Maybe the length of period I spent with low blood sugars meant that part of my brain got stuck in hypo mode?

Overnight hypos are never a good thing. I'm lucky in that they are a far rarer thing for me now than they have been in the past, and they were never more than a few times a year even then. Nevertheless we have been left with a desire to try to tighten control again. If I am honest my focus has always been on keeping my sugar levels down rather than avoiding an occasional low blood sugar. Avoiding long-term complications and accepting hypos as a price to be paid for aiming at the tiny target range. Now I felt like I was being pulled in the opposite direction. Wanting to avoid having a hypo like that ever again.

I've been on Lantus glargine, a peakless basal insulin for a few years now. Peakless has always made a lot of sense to me in the context of a basal-bolus system and I certainly believe that it has helped cut out some night time hypos associated with a long-acting insulin which has a peak of activity. Of course peakless doesn't really mean peakless, it's just that the peak of activity for glargines is much less marked and the activity profile is far more level than other long-acting insulins. The shift to glargine involved the inevitable period of experimentation in terms of getting the new levels right. After the switch I found I was usually high first thing in the morning. I increased my night time dose from 10 units in increments of two in an attempt to get things back in line again. Initially I settled on 16 units, but all that extra insulin sloshing around made hypos during the day more common and after some more weeks (and quite a bit of chocolate) I settled on 14 units of glargine. Any diabetics reading will not be surprised to know that it wasn't quite as simple as that though... in that classic altering-your-doses-Kerplunk way, there was another unexpected consequence. Since beginning on a basal-bolus pen-injection system I had always taken my short acting injections before eating. Since I began using NovoRapid this has been immediately as I started eating. Now I was finding that if I injected before eating (especially if my levels were in the 4-6 target range) I would end up going low just after the end of the meal. It was almost as if the short-acting insulin, on top of the glargine was pushing sugars out of my bloodstream so rapidly that my digestive system couldn't keep up. The obvious answer was to give my digestive sytem a bit of a head start and wait till after the meal to inject. Obvious, yes; but after fifteen years of injecting before a meal I can't tell you how hard it was to try to remember the injection once it was all over and time for the washing up. I forgot to inject ridiculouosly often. Several times I even double-dosed forgetting that I had remembered. Not good.

After perhaps a year I spoke to my doctor about the difficulty and wondered whether there might be a different, slightly less aggressive short acting insulin I could switch to. Her advice was that it was more likely to be the higher level of background insulin and that I would be better reducing my night-time dose of Lantus. I tried it for a day or so, but immediately my morning sugar levels rose up and I went back to 14 units. Better the devil I knew.

So here I was again looking at my doses and thinking, maybe the 14 units of glargine was the reason for the hypo from hell. Maybe I did need to reduce that dose after all. It was time to give it a bit more of a thorough test. I tried it all last week. It was very interesting, and really quite confusing.

Two units of Lantus glargine make an impossibly big difference.

Over the last year or two it has not been uncommon for me to wake up with slightly low blood sugar. Something in the 3.5-3.9 range. Once or twice a week sometimes. A little fun-size bar with my morning coffee and I'm quickly back to normal. A few times a year I've woken up a little lower still and my brain function has started to fall to pieces. Repetitive action, confusion, talking nonsense and general family hilarity all round. So from that, I reduce my glargine night-time dose by 2 units and wake every morning with sugar levels pushing into the teens.

But it didn't end there.

Of all my meals, breakfast must be my most consistent in terms of matching units of short-acting insulin with carbohydrate. More often than not it's a bowl of high fibre cereal weighed on a set of scales, with skimmed milk and low fat natural yoghurt. Dietetically I'm on my best behaviour. But suddenly the usual rules did not apply. I would over-jab and under-eat and two hours later rather than finding my earlier high sugar levels corrected things would be just as bad or even slightly worse. I would find myself adding an extra four units of NovoRapid to bring my sugar levels down in between breakfast and lunch. Four units. Four.

Again after lunch some perfectly guessable bread/sandwich/piece of fruit carbs when matched with their usual dose of NovoRapid would result in significantly higher blood sugars than I would expect. Another four extra units of NovoRapid to try to keep things under control.

Well at least you managed to stave off the hypos though you say. Nope. Not a bit of it. Possibly partly because I was struggling to stem the ever-rising tide of blood sugars with usual meal/dose calculations no longer seeming to apply. Extra correction doses seemed to work OK as long as I was sat at my desk, but any kind of physical activity - even just a short walk to get some milk - was enough to drop me into needing something sugary. Thank goodness I didn't go to the gym that week.

I don't know whether this extremely fine balance between short and long-acting doses is familiar to anyone else but I find it very odd indeed. I can't explain how the reduction of just two units on one type of insulin can have such a huge effect on requirements for other dose-and-meal combinations, adding in an extra 8-12 units over the course of a day. Previously I had only experimented it for a day or so before reverting to what I knew, but to see the same things happening over the course of a whole week convinced me that it was not just a matter of miscalculation or bad guesswork. The whole balance of how many units to how much carbohydrate with how much activity had completely shifted. I may have had a few fewer hypos, but my overall control was so much worse that I felt I couldn't continue.

So for now I'm back to square one. The usual rules are applying again, and I'm just testing a whole lot more often. I might go back to having supper again. A piece of fruit just before bed that used to stave off the overnight peak activity of Insulatard in the years before the switch to glargine and the whole what-to-do-about-waking-up-high conundrum.

Your guess is very nearly as good as mine.

Update: Curiouser and curiouser...