25 not out - stick THAT up your nose diabetes!

At some point during the last week (I'm not entirely sure which day) I made my quarter century of living, more or less successfully, with type 1 diabetes. Twenty five years later and I've still got both feet, my eyes are pretty much unscathed and my kidneys still seem able to cope with clearing up after all the stuff I throw at them. Not a bad effort.

Also this week, I stumbled across two interlinked snippets of information that interested me:

We're dooooooooomed!

The first came via a retweet from Dr Pratik Choudary about some research from the T1D Exchange that suggests that the longer you have lived with type 1 diabetes, the more likely you are to experience severe hypoglycaemia (needing assistance of a third party, family member, friend or paramedic to recover). I've come across Pratik's work during my sifting of research for the NICE Guidelines update, and he seems to have his finger on the pulse, so was intrigued - interesting people sharing interesting stuff...

I confess I was slightly surprised at the findings. I suppose in a sense there is a certain logic to them, older people will have any residual 'helping hand' action from their own pancreas long gone, and more opportunity to have succumbed to a degree of hypoglycaemia unawareness. Still a bit odd that incidence of severe hypoglycaemia looks to increase year on year though - I would have expected a good deal of difficulty in managing BG in early childhood (tiny doses... erratic hormones... growth spurts... irregular physical activity) and certainly during teenage years (rebellion... wanting to fit in... more growth spurts and raging hormones). Even during young adulthood and middle years there's a degree of chaos going on with life in general. Particularly if people become parents themselves - when focussing entirely on yourself tends to slip into the background, replaced with sleep deprivation and general exhaustion. By contrast my own life seems to have become slightly more settled post-40. Much more time to sort out my own stuff.

When we began writing our blog it was not at all uncommon for Jane to have to help me out early in the morning from a nasty low (thanks Lantus!). When I look back, I am ashamed that I put everyone through this for so many years and did not sort it out earlier. But thanks to the support, wit and wisdom of the DOC, over the last few years I have gone a long way to reduce my hypoglycaemia in general and severe hypoglycaemia in particular. I can't remember the least time I got so low that someone in the family had to lend me a hand - but it was probably three or four years ago.

I for one have exactly the opposite experience of the T1D Exchange findings. What about you? If you are living with type 1, are you seeing more or less severe hypoglycaemia than before? Should we accept an increase in severe hypoglycaemia as inevitable*?

* The answer, of course, is NO!

Nasal Glucagon

Photo: Mike Hoskins

The second thing that caught my eye came as an email, following a presentation at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Paris last week, concerning a novel new glucagon treatment that is in development. Glucagon is used as an emergency treatment for severe hypoglycaemia. Currently it involves injecting sterile water into a vial of powder, mixing into solution and injecting into a person who has become so hypoglycaemic that they are either unconscious or otherwise unable to consume any high glucose treatment. Glucagon is a great treatment, but the current delivery method is pretty complex. I first came across the 'nasal puff' concept via Mike Hoskins in the US, who posted on Diabetes Mine following involvement in a trial of the device. It's ingenious! Developed by a tiny private company with parents of T1D children at the helm, it seems driven by passion and practicality.

I know that when I have tried to mention Glucagon kits to anyone among my family and friends they immediately take on a distinctly 'rabbit in the headlights' expression and start mumbling about "erm... yes... or I'd call an ambulance". The idea that at a time of extreme stress, possibly in the middle of the night, someone entirely untrained in giving injections would be able to calmly proceed through a multi-step process of mixing, drawing up, selecting injection site and administering (especially if I were thrashing about) seems crazy.

This new treatment involves simply 'puffing' dry powder up the nose. It doesn't need to be inhaled (designed for people who may be unconscious), simply pushing the base of the container ejects a cloud of dry glucagon into the nasal passages where it is absorbed directly. No needles, no mixing, no faffing about in the dark.

The device is not currently available, but phase 3 clinical trials are currently underway and I will watch the story with interest.

Disclosure: I was not paid to mention Locemia's nasal glucagon device (ha! chance would be a fine thing!). It just sounds like a great idea.

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?

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



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 :)

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

SmartGuard
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.

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

Abbott Freestyle Libre results vs BG meter - Review part 2

Last day of 2nd sensor. Complete with crazy-flat overnight graph.

In this update to my initial review of the Abbott Freestyle Libre I wanted to share my experience of what it was like to use and also to provide the promised comparison with results from my regular fingerstick meter (the Contour Next Link USB). If you have been living in a cave and have no idea what I'm on about you can get an introduction to the Libre here.

It is probably worth pointing out at the outset that the Libre WILL NOT give you identical readings to your BG meter all the time. It just won't. They are not even measuring the same things. If that's what you want the Libre to do, you can pretty much stop looking, because it's not going to happen - not with the Libre and not with *any* technology that measures glucose in interstitial fluid and then converts that into an estimate of plasma glucose values (so all current CGM options). More on that later. But first - what is the Abbott Freestyle Libre like to use?

Do the sensors come unstuck?
I found the Libre to be extremely comfortable and unobtrusive to wear and both sensors stayed firmly stuck for the full 14 days. I was almost never aware of the sensor being there, with the exception of one or two times when I leant on it or absent mindedly scratched near it (having forgotten it was there). I did deliberately try to remember it when towelling off after showering to make sure I didn't accidentally dislodge it, but apart from that I barely gave it a second thought. There was very little in the way of itchiness for me and at the end of 14 days the sensor removed to reveal, well... nothing very much. Insertion of the second sensor was as painless as the first. I have seen some comment online where people have found that sensors came loose after just a few days, but that certainly didn't happen to me. With infusion sets I have found that the adhesive seems to need 12-24 hours to get up to full strength. I suspect it is the same for the Libre sensors. If it gets loosened early on you may need to over-tape it with Opsite Flexifix, Tegaderm or something similar. There's not a lot of 'edge' on the sensors and I can see the possibility of the sensor getting 'levered off' if knocked in just slightly the wrong direction.

I wonder what my levels are now?
I think this picture sums up my experience of living with the Libre for 28 days. Since I started attempting to *actively* manage my blood glucose levels four or five years ago I spend quite a lot of time wondering what is going on between my BG checks. I have never really known how often this happened until now - but the Libre released me from any monitoring constraints. So there you go. An average (average!) of 31 checks a day. Something like once every 30 minutes during waking hours. I had expected that my frequency would drop off after the initial excitement, but I remained fairly consistent through the full life of the sensors - checking more frequently when levels were changing more rapidly and leaving hours between checks at times in the day where things are generally more stable. The inconvenience and discomfort of 'traditional' punctured-finger-and-strip-fiddling monitoring means I would never check this often via a BG meter, but for 28 days whenever I wondered what my levels were, I found out. It is easy to underestimate how much of a transformation this is. Any time. Every time. All the time. I could know what my levels were *and* what they had been over the last 8 hours. There was no longer any reason not to look. No 'avoiding' the numbers (whatever they might be!) in between my 'normal' testing routine. Rather than feeling swamped and judged by data I felt completely liberated.

Basal test every day
In my previous post I mentioned how amazing it was to suddenly be able to see what had happened overnight every morning. Overnight basal tests are - as everyone who has undertaken them will know - a real chore. Waking every couple of hours to check blood glucose via fingerstick is a very effective management technique - but it's no fun. But look at what happened when I had 28 consecutive basal tests - the result is at the very top of this post. I couldn't help but tinker with my overnight basal profile gradually moving it from a bit wobbly, to ridiculously level (at least for a short while!). Seeing the patterns every day meant it was easy to spot the general trends and ignore the one-offs. And I made alterations to the 'shape' of my overnight pattern that I would *not* have made without those data.

New technique
After I had been living with the Libre for around 7 days I noticed that I had added a whole new technique to my management armoury. The preventative TBR (temporary basal rate). I've regularly used them since I started with Artoo to cover activity and other things, but this was slightly different. Because of the constant availability of data and the trend arrow that accompanies each check, I found myself setting short sharp TBRs - perhaps 50% for 30 minutes or an hour - to head off an impending dip in glucose levels. I was slightly surprised to realise that the 'level' trend arrow on the Libre doesn't actually mean level as such. It just means not rising/falling fast or very fast. In the first week on sensors I ignored a lowish level because of the 'flat' arrow only to dip below 4.0mmol/L an hour or so later. By using preventative TBRs for flat or more accurately reading-flat-but-slightly-falling readings that were just 'a bit near the edge' I managed to avoid several low level hypos and without bouncing up into double figures. Similarly, micro-boluses of small fractions of units when levels were high-ish (but not yet out of range) allowed me to be bolder in preventing BG drift. WIN!

Data analysis
I really like the simple, clear overview screens on the Libre. They might be a bit simplistic for some, but by dividing the day into four chunks and averaging 7, 14, 30 and 90 days of results in those sections I found it very easy to spot patterns and filter out the ebb and flow of 'diabetes randomness'. I particularly liked the 'Daily Patterns' graph which only appears after 5 days of results are stored and offers an average of daily results along with a 90th and 10th centile shaded area (it's a simplified version of the Ambulatory Glucose Profile graph - see image). It becomes very easy to see which periods in the day are providing the most challenges. You get a similar view (but with many more options, and helpful traffic lights) when you connect the Libre to your PC (or Mac - hooorah!). The Libre software niftily allows you to create smart PDF reports recording all sorts of averages, graphs, low glucose events and mealtime patterns which can really help to understand what has been going on. Additionally any mealtime notes and/or carbs and other details that you may have chosen to record on the libre are transferred for review too. If you have a particular penchant for number crunching you can also download up to 90 days results and details as a 'tab separated' txt file ideal for import into your spreadsheet package of choice. Look for the 'File' menu at the top of the screen, and choose 'Export Data'.

The end result of my 28 days? I had some of my BEST results all year. Lower post-meal spikes, fewer lows, fewer highs. Not bad Abbott! Thank you very much Freestyle Libre.

Ready to insert second Libre sensor

Libre results vs BG meter
Well... this is all very well you say. But if the results the Libre is providing are complete garbage, then it doesn't matter a hoot how nifty the downloaded PDF reports might be.

So how reliable were the results?

It's a good question. And not necessarily an easy one.

As I suggested earlier the Libre is reading glucose levels in interstitial fluid (via factory calibrated sensors) and then interpreting those through an algorithm to present values intended to reflect plasma glucose levels. That's a whole lot of steps in between what the Libre reads and the results you receive. And much as I realise a lot of work will have gone into ensuring that those results will be mostly OK for most people most of the time - clearly it is likely or at least possible that some variation will occur. Not least because the glucose values in interstitial fluid will 'lag' behind blood glucose values (typically 10-15 minutes, though the Libre aims for 5). Things are complicated further by the +/-20% variability which is allowed between BG fingerstick strips (though again these days meters tend to perform more like +/-5% or 10% most of the time).

What matters more to me is not whether results are identical all the time - it is more whether the results I get are useful. Whether any variation is modest enough that the readings, trends and analysis help me manage my diabetes better.

In order to understand what I was getting from the Libre I tested both sensors against my standard BG fingerstick testing routine. This is usually between 6 and 10 fingerstick tests a day, including premeal and post-meal tests as well as those around driving, exercise and activity. Whenever I took a BG fingerstick test on my 'normal' meter (the Contour Next Link USB that works with my pump) I cross-checked with the Libre. At the end of each sensor I then downloaded all the data and compared it on a spreadsheet to see what (if any) differences there had been. I do not for a minute pretend that this is a scrupulously scientific test - or that the results here might apply to anyone else. I took these comparisons purely for my own interest, and share them here in case others find them useful.

Here's a summary table from the first sensor - there were 94 pairs of results (BG meter vs Libre) over the 14 days:

Sensor 1

	BG meter	Libre	Avg +/- % (against BG meter reading)	Avg +/- mmol/L (against BG meter reading)
Average	7.8mmol/L	7.4mmol/L	10.1%	0.7
SD	2.8	3.0	8.9%	0.6
Distribution of readings
Number of readings where Libre higher			18	19%
Number of readings where Libre lower			70	75%
Number of readings equal			6	6%
Number of readings within 0.5mmol/L			43	46%

I don't know about you - but that looks pretty darned good to me. Yes, in amongst that there were some readings which were substantially different. A handful of times around 40% different from the BG meter - to put that into context one was a 4.4mmol/L that read as a 6.1mmol/L - one needs watching the other doesn't. There were also results where the Libre read hypo, but my BG meter confirmed I was in the 5's.

But the vast majority of the data feed is well within usable limits for me. The SD line gives a useful estimate of the range of most of the results. So from an average of 0.7mmol/L difference the most of the results were somewhere between 0.1 and 1.3mmol/L out.

You will notice that in most cases (but not always) the Libre was reading lower than my BG meter - with the result that overall the average of all results for the Libre comes out at 0.4mmol/L lower than my Contour Next Link, but with a slightly wider range (SD of 3.0 vs 2.8). Amazingly though, almost half the time the Libre was reading within 0.5mmol/L of my BG meter - and don't forget that at least some of the differences in readings could be down to the 5-10 minute 'lag' between BGs and interstitial glucose - especially if BGs were moving fairly rapidly at the time.

What I think this means for me in practical terms is that if I was running off results from the Libre more or less full time, with only a few cross-checked results where BG was moving rapidly or if things 'didn't feel right' I would most likely run a little higher most of the time. This would probably do wonders for my avoidance of hypos, but I suppose it may also have a small knock-on effect on my HbA1c.

But.

Isn't there always a 'but'?!

Things get a little more interesting when I switched to Sensor 2. As soon as that sensor started reading the graph 'jumped' down the screen. If the first sensor had tended to read a little lower, this sensor was taking that to new levels. Now Abbott do suggest that the Libre sensors may not read quite so accurately on day 1, but that days 2-14 should be relatively steady. Even on the second day though readings on the Libre were consistently 2mmol/L or more lower. And since there is no calibration option there was absolutely nothing I could do about it.

Here are the results for the first 5 days of that sensor:

Sensor 2 - days 1-5

	BG meter	Libre	Avg +/- % (against BG meter reading)	Avg +/- mmol/L (against BG meter reading)
Average	7.1mmol/L	5.4mmol/L	26.2%	1.7
SD	2.3	2.3	13.7%	0.8
Distribution of readings
Number of readings where Libre higher			1	2%
Number of readings where Libre lower			43	98%
Number of readings equal			0	0%
Number of readings 1.5mmol/L or more out			26	59%

You can see the difference in performance for yourself - over twice as far out. Suddenly almost 60% of the time the readings were 1.5mmol/l or more different and almost always lower. I had a few overnight traces that looked as it I'd been on the verge of a hypoglycaemic coma all night - when in reality I'd just been bobbling along in the low 5's (I know because I panicked and checked). On several occasions the Libre just reported 'LO' - with (allegedly) a level too low for it to record.

After several days of 'waiting to see' I contacted the lovely folks at the Abbott helpline who ran through a few checks to make sure I had the sensor in the right place and generally could tell my Libre from my elbow. I had been given a handful of Freestyle Optium Neo strips with my pack of goodies and the helpline person suggested I tried cross-checking against the Libre's inbuilt BG meter rather than some other technology (interestingly these strips also read a smidge lower than my ususal meter). As it turns out the reading on that occasion was pretty close (typical!) so I left it at that and wished I'd called them earlier.

The plot thickens
A couple of days later I had a call from Fiona who I'd met at the Libre pre-launch meeting called to say that a software glitch had been discovered (and fixed) in some of the very early sensors which was causing some interruptions in data and other concerns. I related the issues I'd been having with the second sensor and while they didn't seem to exactly fit with the software glitch described, Fiona offered to replace the second sensor.

In the meantime, and certainly into the second week, the second sensor seemed to be settling down considerably and behaving much more like the first. Here are the results averaged from days 6 to 14:

Sensor 2 - days 6 to 14

	BG meter	Libre	Avg +/- % (against BG meter reading)	Avg +/- mmol/L (against BG meter reading)
Average	6.9mmol/L	6.5mmol/L	11.7%	0.8
SD	2.2	2.1	10.2%	0.6
Distribution of readings
Number of readings where Libre higher			15	27%
Number of readings where Libre lower			38	69%
Number of readings equal			2	4%
Number of readings within 0.5mmol/L			21	38%

Not exactly back to the performance of the first sensor, but pretty darned close. Of course it did take those 5 days to settle. And if I'd been stumping up hard-earned cash for that sensor I suspect I might have been quite miffed that data from 36% of the life of the sensor was fairly useless to me.

I would have expected that a relatively consistent error would have still yielded useful 'trend' data - but in reality I found it very difficult to detach myself from the uneasy feeling that 'red' (hypo) results gave. However much I knew, or suspected, that my *actual* BG level was 1.5-2.5 points higher it was impossible for me to use the information in the same way when the margin of error was that great.

So in the end I am left with one spare sensor yet to use (which I plan to put into action around Christmas time) and just a very slight sense of unease as to what future sensor(s) might bring. When it worked at the 10% MARD that Abbott promise in the marketing literature I found it an incredibly powerful tool. If it were available on prescription and performed consistently like that I would be banging the table and asking to swap my (fairly generous) fingerstick allowance for Libre sensors - topping up with as many strips as I needed on top of that out of my own pocket.

But.

If other sensors only perform to the accuracy of the first 5 days of Sensor 2 then it's a whole different ball game. I wonder if Abbott may come to regret their decision to go for factory calibration. From a user's perspective I have already seen several posts from people who would find it very useful to have a 'manual override' setting where you could offset Libre readings which are consistently out to bring them more in line with our own fingersticks.

All in all I love the Libre and I am really hoping that future sensors live up to overall positive experience I have had so far.

Now that the online shop has opened I'd be interested to hear your experiences if you have used the Libre yourself.

Final verdict: 4/5.

Update: Freestyle Libre now licensed for use in under-18s

15 Checks, Diabetes Audits and Prawns

Last week saw the publication of the National Diabetes Audit (NDA) for 2012-2013. It's a bit like Ofsted for diabetes clinics and includes results for just over 70% of the places providing care for people with Type 1 and Type 2 diabetes in England and Wales. If you want to dig into the vast and weighty documents yourself, they are published online here: www.hscic.gov.uk/nda.

I got as far as skimming Report 1 'Care Processes and Treatment Targets' (check out that horrendous BG testing technique on the cover folks... right into the nerve-ending-packed softness of the fingertip! Use the sides people use the sides) before one of the stats just jumped out and hit me between the eyes.

Way less than half of all Type 1s are getting the routine healthcare checks they should.

40%. Forty. Percent.

My daughter reliably informs me that in GCSE terms that comes out as an 'E'.

The actual figure is quoted as 41.3% and it has been falling since 2010. That's almost a quarter of a million people living with type 1 diabetes who are missing even the most basic annual checks to help them keep on track.

When it comes to actively supporting people to manage their condition effectively by offering them some sort of structured education course the stats are even more eyewatering. Less that 4% of people being offered a place on a course. A measly 1% actually make it onto the courses. There's a lengthy rant right there... but that will have to wait for another day.

Diabetes UK lists 15 healthcare essentials that people with diabetes should get each year:

1. Get your HbA1c measured at least once a year
2. Have your blood pressure measured and recorded at least once a year
3. Have your blood fats (such as cholesterol) measured every year
4. Have your eyes screened for signs of retinopathy every year*
5. Have your feet checked
6. Have your kidney function monitored annually
7. Have your urine tested for protein each year
8. Have your weight checked
9. Get support if you are a smoker
10. Receive care planning to meet your individual needs
11. Attend an education course to help you understand and manage your diabetes
12. Receive care from a specialist paediatric team if you are a child or young person
13. Receive high quality care if admitted to hospital
14. Get information and specialist care if you are planning to have a baby
15. See specialist diabetes healthcare professionals to help you manage your diabetes
16. Get emotional and psychological support

* eye screening is now handled separately and bizarrely is no longer included in the NDA

The ones in bold are the checks that are covered by the NDA. Eight or nine routine measures to check that nothing nasty is lurking, and to be able to do something about it if things are going awry. These checks are not about passing or failing - they are about protecting us.

So what is going on?
Is it just people not showing up?
Is it that the appointments are not available at convenient times?
Is it that people simply do not *know* that these simple routine checks are so very important?
Is it a lack of resources?
Overstretched NHS?
Un-engaged individuals?
Are clinics not helping patients?
Or are patients not helping themselves?

My guess is that it is *all* of those things.

I wrote once before about the exponential rise in the number of appointments that were involved in my 'annual review' and the situation is much the same. Decentralised care may work well as a buzz word, but patients have ended up with 4 or 5 appointments instead of 1, which makes the whole process much more of a faff.

But here's the harsh truth.

Faff or not - if you are living with type 1 diabetes you need to do whatever you can to make sure that you get those checks.

They are not for the benefit of the doctors. They are not for the purposes of making someone's spreadsheet look snazzier. They are for YOU. We live in a world where people struggle to get access to any insulin at all - let alone the particular type and/or colour of pen that they prefer. The very least we can do is turn up for (free!) appointments designed to help us to make it through life with our feet on and our eyes working.

It absolutely appalls me that the figures are what they are. And the people most likely to suffer as a result are not the clinics or doctors, but the very people who are not getting checked.

Yes I'm sure some clinics could help with more flexible appointment times. Some employers might need to be reminded that under the DDA (or whatever it is called this week) they need to make 'reasonable adjustments' to support employees with diabetes in keeping these kind of routine healthcare appointments.

But at the end of the day we have to find ways of attending.

Prawns
Perhaps it would be easier if diabetes was a bit more like prawns.

After 25-odd years I am very glad that diabetes is often a relatively slow-moving adversary. But perhaps part of the problem with all those thousands of appointments from the patient perspective is that diabetes is not enough like prawns.

Perhaps it's not prawns for you. Maybe it's peanuts. Or yoghurt. Or fresh ravioli with ricotta.

When I was in my teens I had an absolutely delicious pub meal out while on holiday. I chose a local speciality of prawns in their shells. They were fabulous. On the way home in the car I began to feel a little uneasy. I used to suffer a little with motion-sickness so put it down to that. I still felt a bit odd and over-full at bedtime. But then... we had eaten rather a lot. I woke with a start in the early hours and knew instantly that things were not right. Not right at all. Somehow I managed to stumble, in the dark, with excruciating urgency to the tiny the bathroom where I remained until the following morning in a wretched, heaving heap.

I still struggle to look at a prawn.

The trouble is there is no such immediate come-back for a missed appointment here or there. Eating a big ole serving of 'not enough time at the moment' prawns in 'missed appointment' sauce doesn't bring me out in a sweat just thinking about it. But the results of missing those checks are potentially even more catastrophic.

80% of the NHS budget that is spent on diabetes goes on treating complications. We owe it to ourselves to do what we can to change that statistic. To beat diabetes one day at a time. To keep ourselves well.

Making sure we get all our routine healthcare checks is a tiny step in the right direction.

The Diabetic Ice Cream Social 2014

The Diabetic Ice Cream Social has been my baby for a few years now. It’s really been everyone’s baby. It’s been a special thing for me to fight misconceptions, and to spread a little bit of change in everyone’s mindsets as to what a person with diabetes can and cannot eat – as well as what moderation looks like. The idea that a person with diabetes gave themselves a disease is repulsive to me, as well as the idea that foods are ‘bad’ or ‘off limits.’ As a person with an eating disorder, as well as diabetes, I feel that moderation (and not deprivation) are key to managing our daily lives with a modicum of enjoyment and success.

So, in 2011, when a local Indiana chef wrote a poorly educated column on type 2 diabetes, he stopped my world. In his misguided crusade against people with type 2 diabetes, he sought to attack the local Diabetes Youth Foundation of Indiana for holding an ice cream fund raiser in order to help children with type 1 diabetes go to diabetes camp.  There isn’t just something wrong with attacking children with type 1 diabetes trying to enjoy life as any other child – there is also something wrong with someone who tries to shame our food choices, and create food militancy. Food militancy is something we don’t need in our body image obsessed society. Food militancy is one of the triggers for disordered eating, and many of the common eating disorders affecting our current society – including diabulimia.

Food militancy is also creating a lot of shaming of people with type 2 diabetes and this has got to stop. NO ONE gave themselves diabetes – not a type 1 and not a type 2. People with diabetes are people who were predisposed to developing the disease, for one reason or another. No one knows what triggers type 1, and though obesity may trigger type 2, the fact is that millions of obese people will never develop type 2 diabetes. We all struggle making the healthiest choices for ourselves, and we all need to learn moderation… and we all suffer from bad luck. Life just happens. The #1 risk factor for developing illness is living. Being alive. But one thing is for sure: none of us need deprivation and shaming.

This is what we seek to spread with the Diabetic Ice Cream Social. We seek to spread a renewed view of the person with diabetes; a renewed perspective, as well as a healthier attitude toward food. I have had some pushback from a few folks with different perspectives – and that’s fine. I respect their life path for managing their conditions. But at the same time, I have had thousands of partners in this crusade – the crusade for freedom to make the best choices we know we can make in order to manage diabetes, without fear or shame from others.

The Diabetic Ice Cream Social is a celebration of life – and you may choose to celebrate it any way you want. You can have an ice cream scoop in any way you please: make it lactose free, fat free, sugar free, make it sorbet, make it wine. Make it whatever you prefer – but make it a statement that says you love life, and you appreciate living it, even with diabetes. Make it with family, with friends… or toast the full moon. Make it your own.

This year, 2014, I am very busy with many life challenges and responsibilities – so I won’t be able to lead the crusade as I always do. I won’t be too far from the fray, though. I will be right here, having my scoop, and cheering it on. My friends at The Blue Heel Society have agreed to take on the Social for me… perhaps for a year or so, we’ll see. But they are just as gung-ho about diabetes awareness as I am, so please know this event will keep going. Give them your full support, as I know I will.

This year, while you have your favorite treat… have it will wearing your favorite pair of blues: blue shoes, that is.