No.

Just back from my annual pump clinic. If anyone from my clinic reads this, I'm very sorry. I know I was awful. I had been building up to this for days. Weeks possibly. I already pretty much knew where it was inevitably going to go. I was ready to feel angry and disappointed before we started. You didn't deserve that.

It didn't help that we started with the 'Statins' conversation I've been expecting for several years but have, so far, been spared. It seems I've tipped over the edge of the 'how old' question even for your fairly relaxed attitude. I'm sorry that I find the whole statins/cholesterol thing such a tangled mess of claim and counter claim. I'm sorry that the research into their effectiveness (or otherwise) generally - and also in relation to type 1 is so clouded, murky and beshadowed by claims of vested interest and bias. I'm sorry that I ever read any of that stuff and couldn't just say, "Yes OK". To be honest I'm still not sure that the whole lipid/heart hypothesis isn't fundementally wrong anyway and that I have begun to suspect that the relative benefits shown in Statin studies over all those years may simply be "accurate measures for the prevailing bias". I'm sorry there is no way to accurately work out whether they would be worthwhile for me as an individual. I'm sorry I didn't, couldn't just take your word for it.

Thank you for agreeing to differ with me. And YES. I genuinely did mean that I would continue to think about this as I grow older.

I'm sorry I don't know what you mean by 'a hypo'. What number or frame of reference you wanted me to use. I'm sorry that by now (while you were still impeccably professional and cheery) you were probably wishing I would just shut up and go away.

I'm glad that you were pleased with the reductions I had seen in hypoglycaemia, particularly overnight with the combination of MM640G and CGM.

I'm sorry that it's not an option that is available to me.

I'm sorry that the CCG has approved no CGM applications on compassionate grounds in the last 2 years.

I feel sure that you would like to help more people with technology like this. I'm sorry that you are not able to.

Next year I will try to just come in, fill in my boxes on the forms, answer your questions, and then go away again.

64 Days with the Medtronic 640G: Ep 9 Review - the best and worst of the MM640G

Well, this is it. The last of my posts covering my time with the Medtronic MiniMed 640G. Thank you so much for bearing with me over the last few months. Normal wittering will be resumed shortly. However, as seems to be the way of things with blockbuster franchises (HA!) I have split this last episode into two parts. Part (i) covers all the little niggles and irritations I had while using the MM640G, while part (ii) looks at the things I loved, and reviews my results including reductions (if any) in hypoglycaemia and an HbA1c I had done at the end of my time using the pump. HbA1c is the test which measures how much of the glucose in your blood stream has stuck to red blood cells. It is often used as a measure of your likelihood of developing the long term complications of diabetes.

For those who really can't bear wading through all those minutes of video I will summarise the results below. The video gives a lot more detail though, and features a fluffy bunny. What's not to like?!

When it comes to the things I really liked/disliked about the MM640G you will need to bear in mind that I am comparing to a MiniMed Veo. All of the really good stuff about pumps generally - precise basal patterns, advanced dual and square wave bolus options for tricky meals, ease of use, bolus calculator, temporary basal rates, precision of doses and correction factors, blah, blah, blah... are already assumed to be present and correct. Some of the things I loved about the MM640G are precisely because they fixed annoyances I found with the Veo. But more on that later. First:

The worst of the Medtronic MiniMed 640G

Those who have read any of my reviews before will know that I can get unreasonably irritated by the slightest things. It will come as no surprise then, that while I generally loved the MM640G both with and without sensors, there were a few things about it that drove me nuts.

1. Pump lock
   After a few minutes the pump automatically locks and most interactions require you to play an annoying 'press the right button' game. This is no good if you are in a hurry, and is not an option that can be turned off.
   
2. Change of orientation
   It's now 'portrait' not 'landscape'. As someone who wears an insulin pump on my belt this is a bit awkward.
   
3. Belt clip
   As I mentioned in the first of these videos, the new belt clip is hopelessly flippy-floppy and needs a much firmer spring. The inbuilt tool for opening battery cap is cool though.
   
4. No small versions
   Medtronic have now abandoned plans to produce a smaller version of the pump. All MM640Gs will now have the little sticky-up bit to accept the larger reservoirs. The smaller reservoirs can still be used, but at present, with approximately 35u/day usage, the 'how full is my reservoir' icon on my status bar is pretty much permanently red.
   
5. Sensor overtape irritation
   The glue used on the sensor overtapes (and also the little patch that holds the sensor down initially) caused a red rash to appear after a couple of days of wear. Initially it was only toward the end of a sensor but in the end it began pretty much at day 2. I used an alternative dressing, but even that was pretty itchy. Weird - because I don't usually react to adhesives at all.
   
6. Sensor swap delays
   From start to finish swapping a sensor takes around 3 hours to begin providing new continuous data. That's a looooooong time!
   
7. Occasional sensor lag
   Mostly I found the sensor accuracy was brilliant. But sometimes, particularly if I treated a low to try to fix a below target BG reading, the sensor was a little slow in responding (perhaps 30 minutes behind reality). Additionally calibrations by BG meter do not necessarily reach up to match sensor glucose and BG fingerstick value, but often end up with some odd half-way house. If the sensor glucose value had drifted a little there were even occasions where calibration triggered an 'alert before high' which was doubly annoying.
   
8. Sensor Glucose Review
   The one-day graphs which allow you to flick back through previous days' results show no indication of SmartGuard interactions or insulin doses. Makes them about 10% as useful as they could have been.
   
9. Home screen without sensors
   For no apparent reason, the icons in the status bar do not align neatly when using the MM640G without sensors. There's a gap where one of the sensor icons(!) would go, which makes it look untidy and poorly considered. The enormous dotted line 'we have no BG information to show you' panel where recent meter BG readings go (when not using sensors) also irritated me more than strictly necessary. Just doesn't feel like the visual look of the home screen for most UK users, who will be using the MM640G without sensors, was given enough finesse.
   

Watch the video

The grumbles, gripes, and irritations - everyone will have their own, I'm sure.

The best of the Medtronic MiniMed 640G

Whether you use the MM640G with sensors or not there is a LOT to like about it. There are all sorts of little, pleasing improvements in the interface and options that make a massive difference. Add the wizardry of SmartGuard into the mix and things are taken to another level - but even without there are lots of tasty treats for non-sensor users.

1. Setting basals and temp basals
   There are now up to five basal patterns on the MM640G, and brilliantly you can copy entire patterns from one 'slot' to another to experiment with and then switch back if you need to later. The patterns also come with helpful names to keep track of which are which: Work Day, Day Off, Sick Day, Pattern 1, Pattern 2. Which pattern is set is not marked on the home screen, but thankfully setting any of them does not cause the 'alert circle' to appear like it did on the Veo.
   
   Temp basals can now be set in 15 minute increments for more precision and alter up and down by 5% at a time making them much quicker and less fiddly to set.
   
2. No TBR 'chime'
   Setting a Temporary Basal Rate no longer causes the pump to issue a useless wittery alert tone every hour, which means you can ACTUALLY USE THEM OVERNIGHT! In even better news - the end of a TBR is now indicated by a single beep. Brilliant!
   
3. Different Alert Tones
   There are now a series of different alert tones to indicate different things. There were a few on the Veo, but so many overlapped with either 'pip-pip-pip' or 'naah-naah-naah' that I find it much easier to work out what is going on on the MM640G without having to check the pump for 'information' alerts and being alerted (ha!) to things that actually require action. The ability to increase volume has also significantly improved.
   
4. No lockout during bolus delivery
   It is possible on the MM640G to do rather more things during the time while a reasonable sized bolus is being delivered - for example you can set a TBR. The Veo made you wait until the bolus had finished before allowing you to do anything (other than stop the bolus!). This meant I could group my pump interactions together and then get on with life, rather than having to wait around tutting.
   
5. Screen visibility in sunlight
   Really, really good - especially compared to some other colour-screen diabetes gadgetry I have tried. Not perfect from every angle, but really easy to turn a little and see very clearly even in direct sunlight.
   
6. Remote boluses from BG meter
   Not a full remote control with bolus wizard, but a really useful standby when digging your pump out from within clothing is impractical or inconvenient.
   
7. Waterproof
   Now rated as IPX8 - up to 12 feet of water for up to 24 hours.
   
8. SmartGuard - overnight hypoglycaemia
   Unsurprising if you have watched my Overnight Hypoglycaemia post, but SmartGuard overnight for me was a real stand-out winner. No readings at all for 9 weeks below 3.5mmol/L overnight, and hardly any below 4.0mmol/L. Some nights almost no basal insulin required, and others requiring my more 'usual' 6-7 units at night. Looking at the results it's hardly surprising I had so many problems and so much Severe Hypoglycaemia during my years on Lantus!
   
9. SmartGuard - results overall
   When compared to averaged results from 10 weeks of Libre sensors (the only other 24 hour data I have) time in hypoglycaemia fell by 90% during my 9 weeks with the MiniMed 640G. At the same time my overall levels, as measured by HbA1c fell by 0.3%. And all this with less effort and very little 'alarm fatigue'.
   

Watch the video

Improvements to the pump (with and without sensors) and the all important results.

Conclusion

It has been a great privilege to experience the MM640G system, and for me the results were spectacularly good. The comparison with Libre data is an interesting one, particularly where hypoglycaemia is concerned. Times wearing a Libre sensor were previously my 'best ever' results-wise. The ability to spot hypos coming during the day and try to head them off (I generally scan a Libre sensor something like 30-40 times a day), plus the ability to spot low levels overnight and make hurried basal rate changes meant that I generally had fewer hypos on a Libre than I would normally. And yet when compared to these data, the MM640G system reduced my time spent in hypoglycaemia by 90%. To be clear, that means that for every 10 minutes I spent below 4.0mmol/L trying my very hardest with a Libre sensor, I would spend only one minute when using SmartGuard. That and my HbA1c dropped over the same period from 6.3% to 6.0%. 0.3% - it's not a huge margin, but those fractions are pretty tricky to shave off once you get down below 7.0 in my experience.

My only hint of melancholy about the whole experience is, of course, the eye-watering cost of full-time sensor coverage (approx £3,500 per year inc transmitter). It's not something we as a family can afford, and full time CGM on the NHS is reserved for those who really need it most - and rightly so.

It feels a little like being given a chance to live in a multi-million pound mansion and drive an Aston Martin for a few weeks to see how I like it. I may think it's brilliant - but the reality is that it's not really an option that is really open to me long-term.

I have a pump clinic coming up in a week or two and will see what they say about the results - particularly my unpredictable and occasionally lengthy periods spent below 4.0 overnight. These do nothing to help my efforts to keep my Imparired Awareness of Hypoglycaemia under control. I may ask about the possibility of part-time sensor coverage. Even a few months in a year would make a massive difference (as long as the transmitter continued to function, of course).

My Veo is nearing the end of its warranty period, so I am looking to the future. I have some thinking and some sums to do after this experience - depending on what my clinic say.

Final verdict (with sensors and SmartGuard): 5/5
Final verdict (without sensors): 4/5
Final verdict (considering self-funding sensors): 4/5*

* because of Dexcom's more 'stretchable' reputation when it comes to sensor life

Disclaimer: I was offered a trial of the Medtronic MiniMed 640G system for 64 Days with full sensor coverage so that I could share my opinion and experience good or bad. I was not paid to write this post, and if I had thought the pump was terrible I would have written that. I was encouraged (not required) to post video blogs about my experience, but Medtronic did not have any control over what I posted.

64 Days with the Medtronic 640G: Ep 8 Fine-Tuning SmartGuard

For all the times when SmartGuard has worked brilliantly for me (and there are - too many to count), there have also been a number of situations in which it seemed to make a bit of a mess of things. Overshooting and leaving my higher than I'd like... kicking in when a hefty carb load was just about to arrive and stopping basal for that 30 minute minimum (during which time I would be having a high glucose alert)... or cancelling various parts of dual and square wave boluses which I then may not spot until slightly too late.

I'm sure each user would have their own list - but these are my own #SmartGuardFails and some of the techniques I have tried to fine-tune the alerts and levels to work around them. It's interesting how irritating these odd occasions can be, and I suspect it is only because, well for me anyway, SmartGuard has worked so *brilliantly* for so much of the time that they really stand out.

If you have any MM640G SmartGuard tips and tricks of your own (or any other comments or questions), please leave a comment below.

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.

64 Days with the Medtronic 640G: Ep 7 Overnight Hypoglycaemia

Those of you who can remember way back when this blog started (if you even exist, you have my undying affection for your extraordinary stickability) may recall that we were prompted to start writing a blog about my diabetes as a family after a particularly nasty overnight hypo. It was the beginning of me realising that I was *nothing* like as good at the whole 'pretending to be my own pancreas' lark as I had managed to convince myself that I was. I began to realise how much I didn't know, and that one event led me to connect with literally thousands of others wrestling their own diabetes into submission every day. My life, and particularly my diabetes management are very much the better for it.

Overnight hypos have been a bit of a recurring theme throughout my 25 years of living with type 1 diabetes. I am lucky in that I have never needed paramedic callouts, but there were many times along the way when Jane had to step in at breakfast time to 'bring me round' in the years before we started writing this blog. I look back at those early posts and am bewildered and ashamed that it took me quite so long to realise how much effect this was having on everybody else in the family. How unfair it was on them. At the time though, I guess I had convinced myself that my management was 'as good as could be expected'. I knew I was having 'A few too many highs... a few too many lows'. But doesn't everyone?

If you are the sort of person who approaches anywhere near 8 hours a night when you live with type 1 diabetes, you are spending fully a third of every day in the land of nod. That is an awful lot of time for things to go wrong - especially if your basal insulin dose is not adjusted correctly* or your requirements have moved since you last checked. You may be lucky enough to get clanging warning signs when you dip below 4.0mmol/L - enough to wake you up and sort yourself out. But you can't rely on them. And the more and longer the periods you spend below 4 during the night, the more of a hammering your hypo awareness will take and the less you will feel them. A classic vicious circle.

I am coming toward the end of my 64 days with the MiniMed 640G now (Medtronic have kindly allowed me to keep hold of their toy for a little while longer as there are a couple more posts I'd like to put together). Today seemed like a good opportunity to gather some of the snippets of video that I've been filming since the beginning and edit them into a 'SmartGuard vs Overnight Hypoglycaemia' post. Has Smartguard made any difference? Has my overnight hypoglycaemia reduced at all?

Watch the video below to find out what has been happening over the last 9 weeks. As always, I'd love to hear your comments or any questions, please leave them below or post on my Youtube channel.



*During the video, I mention how important I have found the concept of basal testing over the last few years, both on MDI (multiple daily injections) and also on a pump. Systematically testing and adjusting my basal insulin on an ongoing basis helps me to keep my meal doses and corrections working more or less as I expect them to (ha!). It was one of the most significant 'new concepts' I discovered when I first started comparing notes with other people with type 1 diabetes online. If you'd like to know more read this post by Gary Scheiner (Think Like a Pancreas) which explains the principle. It is written for pump users, but would be easy to adapt for once- or twice-daily basal insulin injection on MDI.