Posted by on Tuesday, 27 January 2015

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 target 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?

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

'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

  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 :)

Posted by on Saturday, 17 January 2015

Medtronic MiniMed 640G 'SmartGuard' Pump - Preview

The Medtronic 640G launches Feb 2015
I was absolutely made up to receive an email a few weeks back that invited me to go along to the Medtronic UK 'Bloggers and Patient Advocate' meeting in sunny Watford today. It seems that Medtronic are keen to connect a little more with the diabetes online community in the UK, share a little of what they are up to and generally get some grass roots feedback. The group is a mix of MDI and pump users (Medtronic, Animas and Roche, with and without various CGM alternatives all present). It includes both people with diabetes and parents of children or young people with diabetes. It was lovely to meet up with a glittering array of familiar and less familiar faces, Annie (@understudypanc), Lesley (@INPUTdiabetes), Laura (@ninjabetic1 and #ourD), Lindsay (@LwSweetpea88), Sue (@desangsue), Dave (@SowerBee), Chris (@grumpy_pumper), Paul (@TheTeamBG and #GBdoc), Gavin (@Diathlete), Kris (@diabeticbanana), Kyle (of @mysugr), plus @JDRFUK youth ambassador George (and his mum!). We were joined by 6 folks from Medtronic who were very excited by some of their new toys that are just about to launch. I believe that this group has met several times before with more of a 'brain-picking' workshop feel, but today was much more of a full-on sales pitch with a sneak peek of the new MiniMed 640G insulin pump which launches in the UK, Sweden, Denmark and Australia on the 1st 2nd of February (regrettably it looks like FDA approval for the US could take years). We were lucky enough to get a short amount of hands-on time to play with the 640G and I just wanted to share a little of what I saw today. I won't be able to go into too much detail for a full-on review here I'm afraid, because there was LOT of information shared and while I tried to take some notes, all too quickly we had to hand the devices back in. Plus since the official website doesn't launch for another couple of weeks I've nothing to check against. I will try to get someone from Medtronic to glance over the post and set me straight if any of this is complete nonsense. I'll post (and add think about ignore mark) corrections as necessary :)

Those familiar with Medtronic's Veo may have come across the term 'Low Glucose Suspend', the facility where overnight the Veo (when used with Enlite CGM sensors) can automatically stop basal insulin supply if the pump detects a predetermined low glucose threshold has been passed. This has been shown to significantly reduce the severity and duration of overnight hypoglycaemia in clinical trials and was welomed (particularly by parents of T1 children) as a major step forward towards developing the 'artificial pancreas'.

The MiniMed 640G takes this approach to a whole new level with 'SmartGuard', an algorithm that begins to take effect significantly before you have hit your 'low' level, attempting to dodge some of those pesky hypos altogether. The sensors are Enlites again, but with a new (and apparently much improved) 'Guardian Link' transmitter to boost performance.

More on that later, but first a quick overview:
  • Colour screen which apparently reads easily in sunlight
  • Waterproof (yay!) including swimming
  • Reservoirs available in either 180u and 300u
  • Up to 5 different basal patterns with up to 48 rates per 24 hours each.
  • Pairs with Contour Next Link USB (new 2.4 version)
  • Limited bolus options via meter, full bolus wizard on pump
  • Completely re-worked interface with many more 'user-friendly' options and updates
  • More customisable alarms (and at louder volumes)
  • Already licensed for use by children
  • Size-wise it's very similar to the Veo, just a few millimeters taller, wider and deeper

The thing Medtronic were clearly most excited about was obviously 'SmartGuard', so it's probably worth trying to note down what I can remember about how that works. SmartGuard builds significantly on the premise of Low Glucose Suspend by making the whole thing much more predictive. While Low Glucose Suspend only kicks in when you are already registering low, SmartGuard acts earlier trying to head off the low by temporarily stopping basal (in much the same way I started doing while wearing a Libre sensor - see 'new technique'). They had a snazzy graph in the presentation to explain how it works, which I've attempted to recreate here. On the pump you set a 'low' limit that you do not wish to fall below - anywhere between 2.8 and 5.0 in 0.2mmol/L increments. Above that the pump sets additional 1.1mmol/L and 3.9mmol/L guides. SmartGuard is triggered if sensor glucose values fall below that upper line (3.9 above your low limit) AND are falling sharply enough that you are predicted to fall below the 1.1 line within 30 minutes. All insulin is stopped for at least 30 minutes from that point (including basal and any partial dual or square waves still in progress). If your numbers stay down, the insulin stays off for a maximum of 2 hours. Basal delivery (only) automatically resumes once you have risen above the 1.1 line AND are predicted to remain there for the next 30 minutes. Users can, of course, cancel the SmartGuard intervention at any point (eg if they would prefer to treat the impending low with some tasty fast-acting carbs. Rather neatly you can also choose whether or not the 640G alarms or alerts at any of those points and even tailor what times of the day (or night) to switch SmartGuard on or off. Alternatively you can simply run the system as the current Low Glucose Suspend works.

It was claimed that in the 'Pilgrim' study, the same algorithm that powers SmartGuard was able to avoid 80% of potential hypoglycaemic events both day and night. If those results could be reproduced 'in the wild' it would be nothing short of groundbreaking. A handful of people have recently been able to use the 640G on a trial basis at Kings College Hospital and two of them (including @desangsue) shared their experiences. Responses from other hands-on users are also very encouraging and seem to suggest that many found SmartGuard alone was sufficient to cope with moderate exercise. After a short while to build trust, many were also happy to simply let SmartGuard do its thing silently and alarm-free, only realising when checking the pump later that they had been spared a low-level dip here or there by some automated basal jiggery-pokery. The only mandatory alarm that sounds would be if your sensor glucose fell below your 'low limit'. This is a good thing. But the customisability of those alarms, while preventative action is automatically taken without confirmation being required seems to go a long way to prevent CGM 'alarm fatigue'.

Fancy new meter
The 640G pairs with a Bayer meter that looks just like the existing Contour Next USB, but this souped-up '2.4' version has some extra cleverness under the hood. For starters you can use it to deliver a quick manual bolus of any number of units you choose without having to fish the 640G out of your pocket. You can also create up to 8 bolus presets (which can include predetermined square or dual-wave options and doses) on the 640G that can be fired from the meter. Frustratingly you cannot vary the doses of these presets from the meter itself at the point of delivery - which would make this much more useful for me - and neither can the meter act as a fully fledged bolus wizard as it does with Roche pumps. However *some* meter bolus options are certainly better than none, and I can see that these could be very useful for snacks and preset mini-corrections or standard preboluses. The new BG meter also acts as the USB conduit for uploading data to the Carelink software package which (mercifully) is also getting a complete overhaul very soon.

Sensors schmensors
That's all very well you may say, but I'm about as likely to get funding for full time sensors as I am to become the next Pope - is this all about SmartGuard, or is there anything here for non-CGMers?

It is true that Medtronic are putting a lot of emphasis on SmartGuard - they are keen to describe the 640G as a 'system' rather than just a pump. It seems they are trying to work with Healthcare Professionals and NICE, seeking to allow more people to access this sensor augmented, 'virtual pancreas' approach. Swift murmerings were made about price points and volume but no real detail given as to if (and how much) sensor cost may fall if there is a greater uptake.

However even without all that sci-fi automation there is much here to please regular pumpers.

A colour screen is pretty much a given these days, but the layout and icons here are well thought through and in themselves allow quick access to a detailed and drillable overview, similar to but richer than the 'back button' on old MiniMed pumps. Bolus and basal adjustments are available direct from the 'home' screen, and everything is navigated by the 4-way/OK controller plus two other buttons - one for 'menu', the other for 'back'. Pleasingly, pressing and holding the 'back' button takes you directly to the home screen however deeply you are embedded in within menu options, which is a nice touch.

A great deal of attention seems to have been paid to the available options to make the pump more customisable and personalisable for individual users. For many things (such as basal patterns) you can now choose named versions eg 'work day' or 'illness' that make them more self explanatory to use, alternatively you can still opt for the more usual numbered options. You also have the option of setting all sorts of presets, including temporary basal rates of predefined length/intensity (again with named alternatives). Whatever you choose to populate from the available options in setup screens get shown in the selection menus, but you don't have to wade through dozens of items that you never use if you don't want to set them up. So you might choose to set just two of eight available TBR presets one for 'moderate activity' and another for 'light activity', then when setting a TBR you can choose either of those or dial in a custom one. Overall it felt logical, intuitive and that several regular tasks would be faster to achieve. The added complexity might mean an additional button-press here or there for one or two things, but in the hour or so we had to play with the 640G most things I wanted to access within a few presses I could.

Battery life is anticipated to be around 2-4 weeks, depending on use. The 640G needs the slightly larger AA batteries (rather than the Veo's AAAs) to power the colour screen. In the top menu bar the battery (and other) icons re-colour to indicate their status. On the battery front, as well as the usual 'low battery' warnings at 25% and again (if I remember right) at 5% there is also an inbuilt 'get out of jail' rechargeable battery that will allow the pump to limp on for up to 8 hours if you find yourself stranded in a motorway traffic jam or somewhere with no shops over a Bank Holiday having paid no attention to the icons/alerts when you set off. I also unwittingly tested the "what happens if you need to change battery in the middle of things" situation and a trial TBR I had set running happily carried on after I took the battery out to have a look. Another neat trick is that the standard-issue belt clip can be swiftly detached and is moulded in such a way that it can be used instead of a coin to unscrew the battery cap. Just a nice bit of attention to detail which speaks highly of the amount of effort Medtronic have put into the design of things.

Infusion sets and reservoirs are exactly the same ones used in the Veo, but special mention must go to the 'Infusion set change' alarm which you can set as a reminder. This particularly caught the imagination of Paul B who said that as a feature, it was pretty much enough to win him over on its own.

My biggest disappointment on the day was to discover that those infernal (and entirely useless) TBR hourly chimes are still present on the MiniMed 640G and it doesn't look like you can turn them off either. After all the effort that has clearly gone into usability and user-experience... The mind boggles. [EDIT: This turns out not to be the case after all. See the end of my compare/contrast video blog for details.]

To be honest I'm going to have to stop there - it's suddenly got rather late and I had thought I was just jotting down some quick notes. It was a very interesting day and there were other snippets (such as the iPort) that will have to follow later.

In short, I will have had Artoo for 4 years in November this year, at which point the warranty runs out and my robot counterpart begins to live on borrowed time. While I'm not champing at the bit for a new pump, I had absently been wondering what I might look at next. I am still interested to find out more about Roche's Insight pump. Omnipods don't feel right for me, and until today I was fairly certain that the Animas Vibe was my front runner because of Dexcom integration (and longer sensor life if I ever take the plunge to self fund). I know that for many the lack of a fully functioning remote handset on the 640G will be a dealbreaker, but that really doesn't bother me much. Today has given me much to think about and Medtronic's new offering very clearly sets itself apart in the market by doing something that absolutely no other pump can do.

Video blogs now available

Update: I have been given the opportunity of trialling the MiniMed640G for 64 days and will be posting video diaries of my experiences. Watch the videos.

Disclosure. Medtronic generously paid my train fare and laid on a tasty lunch. I was not asked and have not been paid to write this post or publicise their products in any way, but thought you lot might be interested.

Posted by on Thursday, 15 January 2015

6.5% - Are they mad?

I haven't really got time to write this today, but I have waited too long with too many blog posts bouncing around in my head so I'm just going to rattle this one in quickly to clear some head space.

The situation has been exacerbated in recent years because of my position as one of the patient members of the NICE Guideline Development Group (GDG) for the update to the Type 1 Diabetes in Adults Guideline. It has been an enormous privilege to be part of creating the guideline. Filtering through all the research and discussions looking for definitive, evidence-based, best-practice approaches to treating and managing type 1 diabetes has been incredibly interesting (and quite hard work!). Part of the NICE process is that members of the GDG are sworn to secrecy until the guideline is published. This is partly to promote a healthy, open dialogue within the group and also because - research being what it is - new stuff emerges all the time and blabbing about what the group thinks about a topic early on, might cause upset, especially if it changes later as new results/research are found or economic models are run.

As a consequence there are all sorts of really interesting things I have come across, or thought, or wanted to comment upon over the last 2 years which I have not been able to. Around the middle of December though, the 'consultation' version of the Guideline was published - you can read it here. The consultation document is the first glimpse the world gets of what we have been working on and it allows stakeholders to comment on the recommendations before they are finally published. So at last it feels like I can pop my head over the parapet.

One of the aspects of the consultation document that immediately prompted some comment on diabetes forums and Twitter was the recommendation regarding aiming for an HbA1c of 48mmol/mol (6.5%).

On the face of it, this sounds like madness. In a world where so many people struggle to meet the existing target of 59mmol/mol (7.5%), which fewer than 30%* of people with type 1 can manage, why on earth would you set the bar at 48mmol/mol (6.5%). Currently (and rather appropriately) achieved by just 6.5% of people with Type 1*. Why on earth would you set a target that almost 95% of people cannot reach?

Why indeed.

The section starts on page 160 and the recommendations are made on page 194.

8.1.2 Review question: In adults with type 1 diabetes, what is the optimum target HbA1c level that should be achieved to reduce the risk of complications?
39. Support adults with type 1 diabetes to achieve and maintain a target HbA1c level of 48mmol/mol (6.5%) or lower, to minimise the risk of long - term vascular complications.[new 2015]

Surely the patient reps on the group were up in arms at such lunacy?

Well actually no. If anything I was pushing for that very recommendation. And the real reason is the question. Questions are important. And without them, answers rarely make any sense.

I wasn't interested in knowing whether research said achieving 6.5% was easy. I was more interested in whether it was worth it. And even more importantly - how much it was worth it.

From the papers reviewed there was that familiar 'curvy' shape when complications were plotted against HbA1c values. At higher levels the line is really steep - zooming upwards with frightening menace. As HbA1c values fall down toward 8.5% things are curving off, though it is clear that even small improvements could potentially make a big difference. The argument that I was always given for the target of 7.5% was that below that level the added difficulty outweighed the more modest improvements of the levelling curve. But actually the improvements below 7.5% are far from level and when it comes to all the nasty things diabetes can throw at you - worth having if you can do so safely and with a decent quality of life.

The next recommendation is critical too.

40. 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, co-morbidities, occupation and history of hypoglycaemia. [new 2015]

So far from being a 'failure stick' to beat us with - I hope that this new recommendation (if it makes it to the published version) - becomes a source of support for anyone who has the time, skill, good fortune and technology to aim for a sub-7 A1c. And that the next one promotes a tailored programme of support, strategies and treatment options for everyone to achieve their own perfect balance between diabetes management, results and still having a life.

Mostly I hope no one gets told off again for having an HbA1c that is 'too low' by a clinic that assumes you *must* be having severe hypos all the time.

What did you make of it? Do you think it will help or hinder your efforts?

Follow up: How do you achieve these numbers?

* National Diabetes Audit 2009 - 2012