Posted by on Wednesday, 26 August 2015

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'.


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.


  1. You've highlighted some interesting stuff. I need to go through the NICE document carefully. Here's a few immediate comments. The access to CGM is interesting. I had one for a week (as part of a study) and found it useful. However, when I look at NICE's list of criteria (and indeed, their list of criteria for accessing more than 4 test strips a day) one thing came to mind: DVLA. Any query about your ability to recognise hypos, or any change in frequency of hypos (or, sometimes I think ANY hypos at all) will result in DVLA refusing a licence. Anecdotally from talking with other T1Ds (and I would like to see a study done), hypos are something that diabetics are careful about sharing with their doctors for fear of losing their licence. If I have a hypo after digging my veg patch for a couple of hours that is totally irrelevant to whether I should be allowed to drive, but DVLA don't take into account the reason for a hypo, or where or when you have them, only that you have had them. I would like to see NICE provide guidelines for DVLA too.

  2. Thanks Richard. The DVLA is mentioned as one of the reasons why you may need to test more frequently (both patient reps made sure of this!).

    It is important to look at DVLA guidance very carefully, not least because there have been some small changes to the wording on the new forms since it first came out. What the DVLA are critically interested in is hypoglycaemia where the person is unable to treat themselves and needs third-party intervention. Not just 'could you pop to the kitchen and fetch me...' but a hypo so low that you lose the ability to self-manage eg paramedics or glucagon injection.

    Apart from that the questions are do you get *any* hypoglycaemia and whether or not you still have decent warning signs. Unless things have changed, I believe the cut-offs are more than one episode of Severe Hypoglycaemia per year and/or a complete absence of warning signs however low things get (as opposed to occasionally missing a 3.8). To be honest, I think those are probably fair. I wouldn't want to be driving in those circumstances.

    Honesty with your Dr/clinic is crucial IMO. Otherwise, if you begin to develop any unawareness (as I have in the past) you will not get the treatment/support you need.

  3. Thank you so much Mike for all the work you have put into this NICE committee.

    These guidelines are very clear, logical and well written.

    It’s a shame that the evidence base isn't strong enough to recommend widespread use of the new generation of CGMs just yet. This is a rapidly changing field, especially with improved accuracy and sensor designs that don't require calibration. The ability to use smartphones as the receivers will help a great deal. It takes years to get a new study from the ethics committee stage, through to collecting several years’ data, and then on to publication. I'm convinced that CGM use will become much more commonplace in the near future though.

    The collaboration between Google Life Sciences and Dexcom looks particularly interesting. As do sensor augmented pumps such as the Medtronic one that you have just reviewed.

    The need for structured education in the management of Type 1 is vitally important. It really isn't possible to self-manage a basal / bolus regimen without this knowledge. From a personal view I would suggest offering a course perhaps sooner after diagnosis, say at 3-6 months. There's increasing evidence of the benefits of good early metabolic control in retaining beta cell mass in adult onset diabetes, with all the benefits that this confers.

    In my experience, a CGM really made this early period much more manageable in terms of optimising the basal bd levemir, learning about the effects of exercise and providing early warnings of potential hypos.

    At four years post diagnosis my HbA1c is 44, I’m on 0.2 units / Kg insulin daily - setting the low alarm limit on the CGM to 4.5.

    Thank you for including the paragraph on self-administration of insulin for in-patients in the guidelines - this is something I very much support on the committees I attend in our NHS trust.

    With best wishes,


  4. Thanks for your work (and that of the committee) on these guidelines. I think that too many people with diabetes don't know that guidelines exist, that they are created through a rigorous and unbiased process, and that they greatly influence the dissemination of best clinical practice, coverage for therapies, expenditures, health outcomes, and quality of life. For those who like to compare and contrast, here are two articles about how the American Diabetes Association guidelines are created: and the recent Type 1 Diabetes Through the Life Span position statement:

    1. Thanks for the links Kelly, will have to have a read :)