Libre available on NHS - big news and bigger caveats

Last night the rumour mill reached fever pitch as Non Disclosure Agreements were stretched to their very limits. And this morning the Twitterweb was a-buzz with the news that Abbott's Freestyle Libre flash glucose monitor is to become available on the NHS from 1st November*. JDRF issued this nifty press release and everyone's second-favourite cat-loving pyjama-wearing T1 ex-schoolteacher and all-round good egg, Adrian Long, was even glimpsed on Sky News in the early morning undertaking some top Libre punditry and sharing his love of 'Libs'.

* subject to local healthcare economic approval, CCG friendliness, moon in jupiter, blah blah blah.

Of course, no sooner had the long-awaited announcement been made than people began to get a bit sniffy about it, or unbelievably optimistic - depending on their frame of mind. Either Libres were about to be handed out to everyone immediately, whether they wanted them or not; or it was going to be a postcode lottery / the end of CGM funding / a complete disaster.

The official announcement from Abbott covers the whole of the UK, including Scotland, Wales and Northern Ireland. Freestyle Libre will be on the 'drug tariff'. Which means that it will be able to be prescribed, and reimbursed by the NHS.

BUT (and depending on your point of view this might be a small niggle, or a deal breaker), this is subject to local health economy approval.

It's an important step, but it might not be the end
I think I probably come down more on the side of 'wildly optimistic' about the announcement. But the 'local health economy' / local clinical commissioning group (CCG) approval thing is a bit of a worry. Even the JDRF announcement is rather cautious, stressing how important it is that the technology actually does end up reaching people. There may still be some work to do in your area to encourage the bean counters to play fair.

Balance of costs
The cost to the NHS of one Libre sensor is going to be £35. For people using intensive insulin therapy who might be using 8 or more finger stick test strips a day, the costs more or less balance out. Assuming an average-ish strip cost to the NHS of £14.50/pot it costs the NHS about £2.32 a day for 8 strips, versus £2.50/day for Libre sensors lasting 14 days where you can be checking 15, 20, 30 times a day or more. I am reminded of the real-world data that Abbott shared recently. In general, across all their users, the more people used Libre, the better their results. Fewer hypos, fewer highs, more time in range and a lower predicted HbA1c.

Even if you are not prepared to take on the heaving behemoth that is your local CCG and try to turn them around to the idea, I can certainly imagine myself having an interesting conversation with my GP (who, of course, runs their own business) about exchanging my strips for sensors for all the added benefits that gives me. It may be that as part of that negotiation I suggest paying for my own strips for DVLA and other occasional requirements. The cost analysis undertaken by NICE for T1 demonstrates that 8-10 strips a day can be cost effective (more BG information is associated with better BG outcomes and reduced complication risk). There may be niggling details and rules about 'local formulary', but it's certainly a conversation I'd be interested in having with my GP if the local CCG drag their heels (as they have been known to do in my area).

Getting your GP and/or hospital clinic on-side and banging the table for you is a good plan too. Speak to them and get them to apply pressure to the CCG to ensure readers and sensors are listed in the local formulary (which is located at Hogwarts just down the corridor from potions and defense against the dark arts).

But what about 'proper' CGM?
Some people have worried that all these funds getting diverted to Libre will spell the end of CGM funding. Personally I don't see that happening. CGM is currently only weakly recommended in national guidance for people who have significant problems with recurrent hypoglycaemia and have lost all or almost all of their hypo warning signs. The submissions to the NHS for approval were very clear that while Libre can really help some people reduce their exposure to hypoglycaemia with extra information, they are not a substitute for CGM alarms/sensor augmented pump for those with no awareness.

Diabetes UK have put together a position statement on Flash Glucose monitoring which I was pleased to be involved in, and which I think clarifies many of the issues about the Freestyle Libre. What it is good for and who can benefit from it. Thankfully it involves people with Type 1 and Type 2 diabetes - and actually I think should be applied to anyone with any of the many types of diabetes who are intensively using insulin. The recommendations on page 4 are very interesting.

Of course some people have been able to carefully negotiate the fiery hoops to secure full or partial NHS funding for CGM in their own particular case. I'm not sure I see the availability of Libre as affecting the clinical reasons which led to their funding being granted - unless they wanted to swap of course! Freestyle Libre is not a CGM, and does not issue alarms. If those alerts are important to you, then CGM is the better option. But for others the lack of 'alarm fatigue' is a positive benefit of Libre.

Onward and upward
I am really encouraged by this announcement. It's been a long time coming and a lot of work has been done behind the scenes to get to this point. Huge thanks to Lesley and Melissa at INPUT, the team at JDRF and Diabetes UK, and not forgetting Dr Partha Kar in getting us this far.

I am absolutely convinced that Freestyle Libre has a huge potential to help thousands of people who are quietly struggling with their diabetes management. Not in extreme enough need with frequent A&E visits to attract CGM funding, but just keeping going not knowing what they don't know about their BG fluctuations. I really hope the technology can be made available so that those quiet strugglers can go from doing OK to doing really well. Can reduce their long-term complication risk and improve their quality of life.

Another Non-invasive BG Meter?

Stumbled across this yesterday. I'd heard rumours of this new non-invasive BG monitor a while back, but it looks like they are gradually creeping towards a finished product.

It's not a continuous monitor (so can't offer trend arrows on the device or any kind of automatic alerts) but *is* measuring blood glucose values so, perhaps, might be sufficient for DVLA. Measurements look to take 10s and are made by passing radio waves through thin areas of skin such as your ear lobe, or more likely that stretchy bit between your thumb and fingers.

Results are displayed on the device and can be blue-toothily uploaded via a smartphone/tablet app to a cloud-based software platform. The app promises to use the uploaded data "to calculate and forecast immediate trends in your blood glucose levels, allowing you to adjust your food or medication intake according to your activities or how you are feeling". Sounds promising, but a bit wishy-washy and vague in terms of what that might actually *mean*.

The non-invasive nature means, of course, that you could monitor your BG many more times a day without burning through strips. Ideal when waiting for BGs to come up (or start dropping) and allowing some of those 'sugar surfing' techniques (is it just me whose toes curl every time I hear that phrase?). Also pretty handy for testing on-the-go in situations where fiddling with strips and lancets is impossible, much like Abbott's Libre.

Currently in clinical trials and the website suggests it may be available for pre-order (whatever timescale that means!) at some point in 2016

Another to go on my long list of possible 'ones to watch'.

More details at www.gluco-wise.com/

Disclaimer. I have no relationship with the manufacturers of this device and I've not been paid to write this post or publicise the product in any way.

Gimme 5 - a new hypo strategy

It is. Is it? Isn't it?

Here is a conversation I have had at pretty much every annual review I have ever had for my diabetes:

HCP: How many hypos are you having?
Me: Well... erm... that kinda depends on what you mean
HCP: What?
Me: On how you define 'hypo'. What you mean by it. What number or experience you use.
HCP: Erm... well... I... er...

You might think that it is a fairly simple question. Anything below 4.0mmol/L right? "Four is the floor" and all that.

Except that in the US it would be below 70mg/dl (3.9mmol/L) not below 72mg/dl (4.0mmol/L) - so suddenly there are a whole bunch of results that don't 'count' if you live over the pond just to make the US version a round number.

The matter is even more complicated by inherent meter inaccuracy. I have to say I trust my current Contour Next USB more than any other I have ever owned. Previously if I wasn't sure of a result I would immediately retest and could get a new result perhaps a mmol/L or two different in either direction. With my Contour Next USB, double checked results are more often than not *exactly* the same, or at most within a few decimal places. But this aside, ALL blood glucose meters are only legally required to work to within +/- 20% of a lab value. As I have pointed out before this can mean that your 4.0 (72) reads anywhere between 3.2 (58) and 4.8 (86). So which of those sub-4s would you count if some of them might be over 4 with a different strip or from a different finger? I can't spend my whole life (and all my test strips) triple-checking everything and taking the mean value...

But even if we set aside the imperfections in the data feed and assume that all the numbers are the actual numbers, it still isn't that simple. Particularly if, like me, you have ever experienced a degree of hypoglycaemia unawareness. Because you, dear non-diabetic reader, could be quite happily pottering along right now with a plamsa glucose concentration of 3.8mmol/L and no warning signs, and no one would care a hoot. For me and rest of the pancreatically-challenged horde though... things are different. If we don't get clanging warning signs at every 3.9 there is a breed of healthcare professional that will believe you are a danger to yourself, society at large and will be lucky to make it down the stairs without collapsing into a coma.

Don't get me wrong. I do not underestimate the severity of Impaired Awareness of Hypoglycaemia. Far from it. I have lived with it, and through it, and (particularly if associated with Severe Hypoglycaemia as it so often is) it is miserable for you, your family and everyone you are close to.

But if people without diabetes can be 3.8 and not hypo... then... well... er... Are we pancreas impersonators supposed to perform better than a fully-functioning non-D?!

Added to this - some guidance describes treating levels below 4.0mmol/L to avoid hypoglycaemia. From this standpoint 3.x-3.9mmol/L could be seen as offering a sort of 'buffer zone', a tiny whisker of breathing room before things might start getting messy. But 3.what?

This study suggests that most non-diabetic people will begin to experience some early warning signs in the region of 3.6-3.9mmol/L

While this study puts the level at which the brain begins to malfunction as 3.0mmol/L. And this, after all, is what we are actually trying to avoid at the end of the day.

But you don't have to have lived with diabetes for very long before you realise that the more 3.7's you have, the harder they are to spot. And the more likely you are to start getting 3.2s. And so on... and so on...


Plus ca change
And so it goes... I have some sub-4s, I try to have fewer. Some months it works. Other months it doesn't. Sometimes people are advised to 'run a bit higher' for a while (though there is little evidence that this relaxing of targets actually works to be honest). And I'm always caught by not really knowing how important a handful of readings between 3.5 and 4.0mmol/L are in the absence of Severe Hypoglycaemia and with relatively reliable warning signs that usually kick-in around 3.0-3.5mmol/L. And yet some clinic appointments make me feel like an abject failure for missing a 3.8 here or there. And the lower your HbA1c, the more twitchy your clinic tends to be about how many 'hypos' you are having - the very people who will be asked about your fitness to drive, for example. It's a quandary.


New strategy... Gimme 5
So as of this month, I have decided to try something new. I have been treating 5.0 as if it were 4.0. Any reading below 5.0 I have been treating as if hypo with fast-acting carbs (I have never been a follow-up carb person). And anything below 5.5 I have been treating more moderately with a smaller amount of fast carbs and/or a short sharp TBR - say 30-60 minutes dropped down to 10%.

Results so far are fairly encouraging. As an approach it certainly hasn't resulted in the general hike in BG averages that I have seen previously when trying to get rid of a few more of those pesky dips below 4. Hard to be sure and I'd have to run the system for a few more months but my best guess is that I might have lost perhaps 25-40% of sub-4 readings so far.

What do you think? Am I the only one who drives themselves nuts over this? How do you go about hypo-busting?

Abbott Freestyle Libre available to new customers again

There were excited murmerings on Facebook last week and on Friday I received a phone call that confirmed what many, many people have been waiting for over the last few months.

Abbott have begun to take on new customers for the Freestyle Libre again

Wooooo hoooooooo!!!

I think it is probably fair to say that Abbott were a little taken aback by the level of demand for their new toy immediately after launch (the Libre 'flash' glucose not-quite-CGM monitor). It wasn't long before they realised that consumer enthusiasm was going to outstrip their production capabilites and they took a tough decision to stop taking on new customers in order to protect supply to those who had signed up first. Probably the right thing to do, but pretty frustrating for many people - myself included, who hadn't quite got around to registering with their e-shop early on.

Some people have got quite cross about this, but I'm more inclined to give them the benefit of the doubt. This was a completely new piece of technology in a relatively small market place (certainly in the UK). They had to anticipate what sort of level of early take-up there might be, but it's not entirely surprising that they didn't get it spot-on. And deciding to limit supply so that fewer people got better service rather than many people getting rubbish service seems to have quite a consumer-focussed feel to it. They didn't just take everyone's money and not deliver, they concentrated on ensuring that those who signed up early could get full-time sensor coverage if they wanted it.

But for the rest of us, the weeks turned into months... and still we waited.

Until now.

As of last week they have begun to issue emails to people who signed up on the website. They are doing this on a 'first come first served' basis, so those who asked to be told when Libre was available to new customers in October/November 2014 will be hearing first.

Of course they will have to weed out a bunch of dead results from those expressions of interest. People who have changed their minds and so on - so if you recive an email you will need to act on it pretty promptly.

According to what I've been told by Abbott, it works like this:

• People will receive an email alert which (I think!) outlines the process
• People then recive a second email which gives them a relatively short window of opportunity to respond
• They then need to sign up as a new customer
• You also need to place an initial order to activate your account (minimum of one sensor approx £50)
• Thereafter a maximum of 2 sensors can be ordered every 14 days

Looking forward to receiving my email :)

Update: Hurrah! No more waiting list!

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

Abbott Freestyle Libre review - BG monitoring goes all flash

In recent weeks the mentions, rumours and tidbits about Abbott's shiny new gadget have been reaching fever pitch. If you are of a Twittery persuasion and follow more than about two UK-based-diabetes-type tweeters you cannot fail to have noticed this. Abbott's 'Freestyle Libre' has it's official European launch at EASD today (EASD is a massive professional conference for all things European and pancreas-challenged). I was thrilled to be invited to meet with some folks from Abbott on Friday last week along with a select group of bloggy and tweety types with borderline legendary status for a sneaky peek before the official launch. Quite how I managed to swing an invite remains something of a mystery. We gathered in an upper room in a trendy Soho establishment, were treated to a tasty breakfast and we were sworn to secrecy until 1pm today. Much to my surprise it transpired that we were not just going to be able to handle the technology on the day, but were actually going to be given a chance to experience the Libre ourselves for 28 days, being supplied with a reader and two sensors to take home. It was suggested that we might want to consider writing a post or perhaps tweeting a few characters about our experience, but this was by no means mandatory. Nor did we even have to try the Libre at all if we didn't fancy it.

What on earth are you on about?
In the unlikely event that you have never heard of the Libre, or Flash monitoring, here's a brief overview: It's not quite a CGM. It's not quite a Blood Glucose monitor.

Too brief? Oh, OK... here's a bit more detail: The Abbott Freestyle Libre is a new kind of blood glucose monitoring technology that sits somewhere between existing CGM options and traditional SMBG (fingerstick) monitors. It measures interstitial glucose levels using what Matt (Abbott's techical bod) described as 'wired enzyme technology' and Fiona (communications lead) referred to as 'special sauce'. If you've not looked into CGM before, interstitial glucose is not quite the same as blood glucose. It is measured in the fluid that surrounds the cells in tissue rather than from the blood itself. Typically these levels lag slightly behind BG by up to 10-15 minutes, but Abbott are using an algorithm to adjust readings which they claim reduces this lag to 5 minutes or less on the Libre. The measurement is performed with a tiny, flexible filament inserted under the skin and attached to a small, flat, circular sensor, roughly the size of a £2 coin. Abbott recommends that the sensor is worn on the back of the upper arm which seems to give optimum results and is less likely to be knocked off by doorframes. If you are writing a blog post, you will also notice that this location is virtually un-photographable one-handed - see below. The Libre's sensor measures glucose levels once every minute and stores 8 hour's worth of data. One of the main differences between the Libre and traditional CGM is that the data are not sent via transmitter/receiver continually. To access the information you simply wave the reader (or is it 'flash'? or perhaps 'swipe'?) over the sensor and you will be given a glucose concentration reading taken at that moment along with a graph of data from the previous 8 hours. Data points on the graph are created every 15 minutes averaged from the readings taken at 1 minute intervals. You also get the 'trend arrows' which will be familiar to CGM users and give an indication of which direction, and how fast glucose concentrations are changing. The near-field communication works anywhere between 1cm and 4cm and will happily ready through clothing, even as much as a skiing jacket they said. I've already smiled to myself as I walked down a street and checked my levels by swiping my reader over the arm over my coat.

Sensor shenanigans
I was hugely impressed with how easy it was to insert the sensor. It was also absolutely painless, significantly less 'stabby' than a set insertion for Artoo. Everyone around the table inserted their sensors at the same time, and noone seemed to feel a thing. The sensor came in two parts that needed to be pushed together which seemed to 'prime' the self-serter. Then you chose the back-of-arm location you fancied and applied gentle pressure to the composite gizmo which gave a reassuring click. Interestingly Abbott mentioned that an awful lot of care, attention and engineering boffinry had gone into the seemingly simple process. Including the 'click' which happens only as the inserting spring/needle withdraws. As a result you don't tense up on insertion, because by the time you hear the click - it's all over. Dave (@sowerbee) did ask whether much of the resulting plastic was recyclable, but it seems that almost none of it is - to keep the process as simple, reliable and precise as possible the idea of a reusable inserter seems to have been dropped quite early on. Long term Libre users will probably also need to get a bigger sharps bin - much like the self-serting Mio sets for the Veo, most of the plastic leftovers need to head for incineration. Once you have inserted the sensor the handset begins a 60 minute countdown before the first reading is available. The sensors are being described by Abbott as 'factory calibrated'. While traditional CGM sensors have required occasional BG/fingerstick calibration throughout their life, Libre sensors are manufactured in such a way that this is not necessary. I did ask what would happen if you had forked out your own hard-earned for a sensor only to find that it was stubbornly and continually miles out from your BG monitor and it was suggested that this would be a 'contact customer services' moment. I got the impression that if you could demonstrate that a sensor was massively misbehaving through no fault of your own they may well send a replacement.

Sensor life is 14 days.

From what I can tell there is no way to extend or restart sensors. Each is electronically paired to the handset and begins to count down 14 days from the initial 60 minute 'Start New Sensor' countdown. Smart cookie Chris (@grumpy_pumper) asked what might happen if your reader developed a fault at some inconvenient time - say 5.45pm on the Thursday before Easter. It would be days before a replacement receiver could be sent, so even if the new reader could be paired with the old sensor (and thinking about it now, I'm not even sure it could) several days of 'sensor life' would be lost. Without promising anything concrete, again Abbott seemed to suggest that they would try to behave fairly. Certainly in a market where they must anticipate a significant number of customers will be self-funding they are aware of the need to be seen to be fair if any problems occur. Abbott's research data suggest that sensor accuracy is likely to be slightly further out from BG meter readings during the first 24 hours after insertion, and then more accurate through days 2-14. Early days for me, but this certainly seems to have been my pattern with the first sensor. It is remaining very comfortable after the first few days. I'm currently on day 3 and on the whole I would not know it was there. If I had my insertion time again I might attempt to make sure it was just higher up my arm than my t-shirt sleeve line, but the sensor is very discreet and if anything just looks like a nicotine patch to everyone else so it's not particularly problematic if it is on show. It certainly doesn't scream 'medical device'.

The reader
The reader looks very like a normal BG monitor. It has a single button and then uses a decently responsive touch screen to navigate between various functions, displays and data handling options. Nice clear colour screen too. It was really easy and straightforward to set up and is very intuitive to use. No real need to go digging around in the handbook so far. The reader stores 90 days of data, and provided that you swipe your arm at least 3 times a day at the right moments you get a full 24 hour picture of changes in glucose levels. So far I have been swiping with such frantic, gleeful regularity that I can't actually tell you what happens to graphs where you've run over the 8 hour sensor storage limit, but I suspect you would just see a gap. Along with the 8-hour graph that you can see each time you swipe you can also dig back through a logbook of recent swipes, which you may have tagged with references to insulin, food, medication, exercise etc or view daily graphs 24-hours to a screen or check a variety of analytical screens.

The handset will also function as both a standard blood glucose monitor or blood ketone monitor (using the appropriate Freestyle Optium strips). Somewhat inevitably, the Abbott bumpf suggests that you check your BG level with a fingerstick meter if your levels are changing rapidly (where the potential difference due to lag between interstitial readings and blood glucose readings could be more marked) or if the result on the Libre doesn't match how you are feeling. It's nice to know then, that with a few strips and a fingerpricker in your pocket the Libre reader gives you access to fingerstick checks without the need to carry a whole extra bag of kit. On the whole though, the marketing claim is that you could use results from the Libre in place of almost all your normal fingerstick tests. I'm really interested to see whether I would have the confidence to do this so I'm currently testing at my usual SMBG schedule alongside Libre swipes to see what sort of differences I find. Those of us with more than a few years T1 mileage will already be aware that BG meters themselves are not exactly the most consistent performers, meter-to-meter or even strip-to-strip on the same meter.

The reader can also function as a bolus wizard in a similar way to the Insulinx or Accu-Chek Expert, though you need the support of a healthcare professional to get this set up and access this functionality. Like most meters the reader has an operating temperature range of 10-45C so while you can apparently scan through a ski jacket, you would probably need to keep the reader toasty in an inside pocket to avoid it grumbling about being a bit chilly. Battery-wise the sensors are unpowered and the reader is recharged via USB. A full charge is expected to last around 7 days of normal use.

Alarming
As has been mentioned, one of the main differences between the Freestyle Libre and conventional CGM is that the data is not pushed by transmitter to the receiver. This means that the Libre cannot alert you with beeping/buzzing noises if your levels are soaring or crashing. This may be a significant concern for some, particularly when it comes to night-time, but part of me is quite glad. I always had a sneaking concern over how I would respond to a CGM repeatedly wittering and warbling to remind me that I'd made an almighty hash of estimating yet another buffet meal and that my glucose levels were still stubbornly stuck in orbit. The fact that the checking on the Libre is always initiated by me and can occur as often as I want it to is, if anything, something of a relief.

Data crunching
The handset offers a number of nifty, inbuilt analytical functions which can really help you to get your head around this avalanche of new data. I think I'm going to leave a detailed description of these for a separate post as I suspect many of you are losing the will to live by now. Briefly though, you can view results for 7, 14 30 and 90 days for Average Glucose, Time in Target, number of Low Glucose Events (where levels have stayed below 3.9mmol/L for over 15 minutes) or view a Daily Patterns graph, provided you have more than 5 days of glucose data stored. You can also export data via USB cable to be compiled into PDF reports and which can use something intriguingly called AGP (ambulatory glucose profiling). More on that later when I've got more data stored, but it looks really interesting. Helpfully several of the views display results grouped/averaged by time period so, for example, you can easily spot which time of day I've been having most fun with in the past 3 days.

What does it cost?
Abbott are offering a Starter Pack for £133.29 which includes a reader and two sensors. Otherwise the reader (on its own) costs £48.29 and sensors £48.29 each. These prices are ex-VAT so people would need to fill in the paperwork to get their VAT exemption on medical grounds. At those prices a full year's sensor coverage runs to just over £1,250 which is certainly not cheap, but when comparing with existing CGM options it is probably worth bearing in mind the significantly greater cost of handsets/receivers and transmitters for those options. Especially where transmitters are only guaranteed to last 6 months.

Freestyle Libre sensors/receivers will be available to purchase from Abbott's online shop from the end of September/beginning of October 2014 and once you have a receiver you could choose to buy sensors to cover as much or as little of the year as your budget allowed.

What has it been like so far?
In a word, amazing.

I have never had access to any kind of continuous data before, so I guess it was always going to be an eye opener, but I have been really impressed with the similarity between my standard fingerstick readings and results on the Libre. In a follow-up post once this first sensor has run its course I intend to do a little compare-and-contrast number crunching of the results, but already I am wondering what it might be like to more or less 'fly solo' with the Libre for the second sensor and only cross-check with SMBG if things felt wrong.

For the first time ever I have a full picture of what has been going on overnight every single morning. And if I wake up blearily overnight I am FAR more likely to swipe the Libre for an instant check than I am to get up, go downstairs and test. Not only that... but swiping the Libre does not involve turning any lights on or faffuing about with strips and finger-squeezing so there is far less chance of disturbing Jane in the rare event that my BG meter happened to be upstairs. I've already caught one sneaky overnight low that I am 100% sure I would have simply ignored/not checked via SMBG. Much comment has been made about the Libre for under 18s. Currently it is only licensed/available for adults but it was made very clear on Friday that Abbott are leaping through the regulatory hoops for a paediatric license as fast as they can. The phrases used were 'actively pursuing' and 'great need'. Sadly Abbott cannot predict the timeline, but certainly gave the impression that this was something they are already working towards as a priority. I can imagine that swipe-the-lump-under-the-duvet monitoring would hugely appeal to parents of children with diabetes who choose to test during the nighttime.

One of the other things I have already noticed is that the Libre makes glucose monitoring so effortless that I am inclined to check more frequently rather than less. Certainly in these early 'novelty' days. Part of this, I know is my own foolishness. I have been carefully logging and recording my BG levels, food, exercise and all manner of other details for several years now. It was one of the changes that made a massive difference to my own management and understanding of how my diabetes behaves and really helps me spot patterns and fix things. I made an agreement with myself early on that I would stick to a regular testing schedule and add in extras if things needed checking, but (importantly) that I would log every BG check I made to ensure I wasn't kidding myself by only writing down the good ones. Perhaps it's just me, but as noble as that set-up is I still find that there are occasions where I suspect I might be a tiny bit higher or lower than I'd like but don't want to mess up a good week's worth of results with another red flag so I'm tempted to make a small correction on instinct and hope to solve an imagined problem by the time I next test. This can be particularly the case if I'm having a week where I've had frustrating red flags peppering my results because results are 0.1 mmol/L past the cut-off rather than being real, proper, decent mess-ups. Yes it is silly. I know it's silly. But I do it anyway. And sometimes I end up treating a hypo-that-never-was and sending myself sky high in the process. Jane says it's because I am too much of a perfectionist. Too competitive with myself. And she's right. Again.

But with the Libre I am released from this - at least in part. If I want to check how a correction is going I don't need to wait until I think I'll be out of red flag territory. The curve on the graph will be there whether I check or not, so I might as well actually know. This, for me I think is going to be something of a Big Thing. Less double guessing and more data-driven responses. I may never play Uncertainty Tennis again while I have a sensor in my arm.

I am very interested to see how things progress over the next few weeks and will transfer some results into Excel (manually unfortunately as there is no direct .csv export from the Libre software) to try to understand how close or otherwise the results have been between fingerstick SMBG and Freestyle Libre. Unsurprisingly though, the trend arrows and graphs are already winning me over.

Does it replace fingersticks? My first few days certainly look really promising. Abbott themselves concede that there will always be at least some continuing requirement for good old fashioned punctured fingers. I'll write an update in a few more days with some of my own n=1 observations about numbers.

Left-right: Me, Dave, Jen, Laura, Chris and Sue

Brucie bonus
Aside from meeting the fab folks from Abbott and PR gurus WeberShandwick who laid on a really interesting and engaging event, one of the very best parts of the morning for me was getting the chance to meet face to face with some amazing folks from the #DOC. Jen (@missjengrieves), Laura (@ninjabetic1), Sue (@desangsue), Dave (@sowerbee) and Chris (@grumpy_pumper) are every bit as lovely as you would imagine. I look forward to reading their thoughts on the Libre later on.

Try these other posts too:
Laura (@ninjabetic1): FreeStyle Libre - Flash Glucose Technology
Laura (@ninjabetic1): FreeStyle Libre downloaded data
Jen (@missjengrieves): Freestyle Libre Review – a gamechanger for diabetes management?
Dave (@sowerbee): New Kit! - Freestyle Libre Review: Part 1
Dave (@sowerbee): Libre FGM v Enlite
Sue (@desangsue): New Freestyle Libre Sensor System


UPDATE: Abbott Freestyle Libre vs BG meter

Disclaimer. Abbott kindly paid my train fare, treated me to breakfast and allowed me a trial 'starter pack' of the Freestyle Libre which I am allowed to keep. They encouraged me writing a blog post about my experience, but said they would have been quite happy if I hadn't bothered. They certainly didn't insist that I only said nice things - if at this point I'd thought the product was rubbish I would have said so. I've not been paid to write this post or publicise the product in any way.

C8 MediSensors - A bright future for CGMs?

Some months ago I was made aware of a new piece of diabetes techno-gubbins in the pipeline which sounded really interesting. Any poor souls who have read these ramblings before will probably already know my interest in continuous glucose monitors (CGMs). So I was delighted to be invited by the lovely Andrew to a little round-table chinwag with various other diabetes bloggers, campaigners, movers and shakers along with a couple of people from C8 MediSensors who have developed an entirely new approach to CGM which has the potential to be a complete game-changer. A non-invasive, optical CGM. It is currently classed as an 'investigational device', so it's available for use in clinical trials, but not yet available for sale anywhere in the world.

In proper 'disclosure' style I'll mention at this point that my train fare was covered, they laid on some tasty sandwiches and I was offered a modest amount to cover attending the day. I wasn't asked or paid to write anything about it, but I wasn't forbidden from doing so either and as I say - this is already a proposition that interests me (and I suspect, some of you) very much.

What C8 MediSensors hoped to gain, I think, was some end-user input for the potential UK market. The device is not yet available anywhere (they hope to have European CE mark approval by the end of the year and plan to launch in the UK and Europe first). This wasn't a marketing push, or a sales pitch, not yet anyway - this was much more of a two-way dialogue. Picking our collective brains about what we thought would be important to UK punters, how well understood we thought the concept of CGM was in the UK. What potential attributes of app and interface we felt would be welcome and/or irrelevant.

What on earth are you talking about?
The device being developed is one of those rare things. A real first. It's a non-invasive continuous glucose monitor (nCGM). It measures glucose concentration not with an inserted sensor beneath the skin, but with a small beam of light. Let me say that again. No sensors. No sensor stabbiness every 3-7 days. No sensor cost. No consumables at all of any note. As someone who has looked into the challenging financial implications of self-funding a CGM in the UK you can see why this would attract my attention.

Essentially the nCGM is the world's smallest Raman spectrometer. Apparently the initial 'proof of concept' device was about the size of a sideboard, but you'll be pleased to hear that they have managed some ingenious Wayne Szalinski style miniaturisation since then and the current device and rechargeable battery are each roughly matchbox-sized and together weigh a little more than an iPhone. Not exactly nano-technology, but certainly viable. If you are interested in a bit more nitty gritty on the device itself we were shown a short video which shows the CGM in use.

There are still some wrinkles to consider of course. The 'belt' that holds the device against you is not the most beautiful fashion accessory you could imagine. You can't immerse the device in water. You can't really use it while running, leaping and turning somersaults (the light sensor needs gentle but consistent contact with the skin to take its readings every 6 minutes and might complain if it gets jiggled about a lot). There are even 'light screen'/dark shirt precautions that might need to be made if travelling alternately from bright sunshine to deep shadow since light can 'leak' horizontally under the skin. Currently the device is intended/tested for over 18s only, though young people and other user groups are certainly being considered for the future when research data/regulatory approval permits. Data display is currently only available via an Android smartphone, though an iPhone version is on the cards.

Crucially, with this CGM you just put it on and it begins collecting data within minutes. If you want a break, even for just a few hours, you can just take the whole thing off for a short while. It's still a CGM of course, so it's more 'trend' information than definitive BG levels and occasional fingersticks will still be part of the picture, but if you've looked into CGM before you'll know that already. Interestingly, the plan is to launch with a 30-day money back scheme allowing users to try it for themselves before they commit to permanent ownership.

I came away from the meeting very excited. After 8 years of development, and many clinical trials they have data that shows the C8 MediSensors Monitor to give results comparable in accuracy to 'traditional' CGMs, but without the ongoing sensor cost. In fact the suggested price point of the device ($4,000 or roughly £2,500 at the time of writing) is somewhat cheaper than one year's worth of full-time sensors, theoretically putting it within reach of many more people than can currently self-fund. In a clinic environment I would imagine this is a device that makes perfect sense. How many CGMs stay on clinic shelves, I wonder, for want of sensors to offer patients?

Encouragingly C8 MediSensors also seemed keen to build a relationship with users, foster something of a user community. Founded by a parent of a T1 child and his two college room-mates, they seem to have something of a patient's eye-view mentality. Essentially wanting to engage not just with Healthcare Professionals, but with the Diabetes Online Community. With us as end-users.

It will be very interesting to see what happens next. Whether CE approval is forthcoming, and quite how the launched device performs in the wild.

Hold on to you hats. This could completely change the landscape.

EDIT: C8 Medisensors announced that they had received CE Mark approval on 25th October 2012. Things seem to be getting a little more interesting!

UPDATE: Has the light gone out on C8 Medisensors optical CGM?

Meter accuracy - the narrow window

I've been stewing over the question of meter (in)accuracy over the last few weeks after my experiences with the iBGStar. Possibly because throughout much of April my levels have been a bit wobbly which often puts me in a grumpy frame of mind as Stacey at www.portablepancreasgirl.com noticed. Not helped by the report today that suggest 80% of the massive NHS diabetes budget goes on treating (largely avoidable) complications.

In our fight to avoid complications our 'window on the world' of how our choices are affecting our bodies are blood glucose (BG) meters. BG meters currently have to meet accuracy criteria set by the International Standards Organisation in order to pass muster. This is a good thing.

But...

According to ISO15197 the required level of accuracy for BG meters is +/-20% against lab results 95% of the time. So the very best they need to aim for is that a lab reading of 7.0mmol/L (126) would show as somewhere between 5.6 (100) and 8.4 (151). And 5 times out of 100 it could be much worse. In other words testing at 5.6 and then 8.4 just 5 minutes apart using the same meter with the same pot of strips (or even seconds apart from the same drop of blood!) would pass the International Standards Organisation criteria for accuracy.

Similarly under the requirements 3.2 (58) and 4.8 (86) could be identical readings from a lab test of 4.0 (72). But 3.2 and 4.8 are not the same as far as anyone trying to manage their diabetes is concerned. One is 'reach for the jelly babies' time, the other is 'nothing to see here', while the actual result was 'better keep an eye on that'.

With modern diabetes management techniques we have the potential to manage our condition with a level of accuracy which should guard against complications. But the snazziest insulin pump and whooshiest rapid analogue insulins are being let down by a sloppy data feed.

To play it safe perhaps I should adjust my pre-meal targets to take account of potentially errant readings. So lets see... with a 20% buffer at either end that gives me a target 4.8 - 5.6 (86-100). Aim for that narrow a window? Hmmmm, perhaps not. Unless I want to drive myself mad.

Fortunately most meters far exceed the required level of accuracy most of the time. But as for the 'official' requirements... Good enough? No I don’t think so really.

iBGStar - Designed to read high?

After posting my little write-up about the iBGStar last week I was interested to receive some follow-up from the boffins at Sanofi over the weekend.

You may recall that when I sent some feedback from my sneak peek/trial of the iBGStar I was called by a lovely representative of Sanofi who asked me to send back the first meter which seemed to be giving peculiarly high readings so that they could take a look at it. Sadly the replacement meter that they sent gave very similar results.

Here are some extracts from the letter:

"The returned device and test strips were both tested and were found to meet all the required specifications and function normally. However the manufacturing site has advised us that due to the new technology used in the iBGStar monitor, there can be results variations if directly compared to a different type of monitor."

No surprise there, Sherlock.

"The iBGStar has been developed to give readings which are automatically corrected against Haematocrit* and plasma values. Both of these corrections can mean that your new iBGStar monitor may give readings higher than you are used to. If you have any concerns over what this change of readings may mean, we would advise you to consult your doctor or other healthcare practitioner for further training."

It would seem that whatever correction factor(s) Sanofi have used for the iBGStar it is likely to read higher than other monitor(s) you might be using at the moment. Which begs the question - why did they use those correction factors? Plus or minus 20% of a reading is a pretty flippy-floppy requirement, but I don't see any reason to make maximum use of this variability all the time, unless all the other meters are getting it wrong.

If you are considering switching to the iBGStar it would probably worth keeping back half a pot of strips from your old monitor and cross-checking between the two over a few days. That way you will have some sort of idea what differences in readings (if any) might be involved for you, and be able to adjust (or talk to your clinic about adjusting) your correction factors accordingly.

*Haematocrit refers to how densely packed the red blood cells are in a sample - blood samples usually consist of 40-45% red blood cells. This varies from person to person (or, for example, with dehydration) and can raise or lower the apparent BG reading.

iBGStar Review - blood glucose meter for iPhone / iPod Touch

I was delighted to be invited in January 2012 to be one of the first people in the UK to use and review the iBGStar - a blood glucose meter by Sanofi Aventis designed to work with an iPhone or iPod Touch. The agency that sent me the meter and asked me to provide feedback prior to the UK launch and swore me to secrecy until today, when it becomes available for purchase in Boots. I was provided with an iBGStar and a supply of strips free of charge, and I've not been paid to write this review or say anything, good, bad or otherwise - what follows is just my opinion after a few weeks' use. To save my fingers I'll lazily just be saying iPhone from now on. If you've got an iPod Touch you'll need to do a little mental inline editing.

I should start by saying that I reeeeeally wanted to like this meter right from the outset. The designer in me has long had a love for that fine fruit-based technology company. I've been logging all my BG results on Apple products for years and the idea of a meter which plugs straight into an iPhone or iPod Touch has immediate appeal.

First impressions
The first thing you notice is that it is absolutely tiny! There's also a pleasing 'Apple' influence to the general design. The shiny curved edges on the front, the smooth nicely shaped matt-finished reverse side and, perhaps nicest of all, the fact that the on-off 'button' is seamlessly built into the front fascia of the device. The designers have also bothered to build-in a nicer-than-expected screen on the front of the meter which displays results and a small animated prompt during BG tests which means that it is perfectly possible to carry out a test whether the meter is connected to your iPhone or not (handy if, for example your phone ran out of charge when you were out for the day). First impressions? Even before I'd got a strip out of the pot - this is going to be amazing.

How small is small?
By my reckoning it's about 55mm by 24mm (including the dock connector). Everything about this meter is smaller. The strips are smaller, the pot they come in is smaller. The supplied finger pricker (more about that later) is small too. The supplied black zip-up case is perhaps 50%-60% the size of a standard Roche Accu-Chek one and maybe 70% the size of the case for the Contour-Link meter that works with 'Artoo' my pump. If you took the strips, fingerpricker and iBGStar loose in a coat pocket they would take up very little room. The iBGStar aligns well with the width of my iPhone4 and is just slightly narrower than my 1st Gen iPod Touch. Of course you don't keep it connected to your mobile device the whole time, and with another nice touch they provide a small cap to cover the dock connector which doubles as a little clip to secure the meter and stop it getting lost in the bottom of a pocket or bag if you take it 'loose'. The advantage of this tininess, of course, is that it makes it much less hassle to take your meter with you. And you don't have to worry about all the careful logging etc when you are on the run, unless you want to. The iBGStar can be used perfectly well on its own and will remember and allow you to refer back through several readings on the device itself (it stores 300). When you have a bit more time you can sync with your iPhone and add any insulin doses/carbs/notes to keep your records up to date. If you were having a period of lazy no-logging the 'unplugged' iBGStar helpfully displays an average figure when first turned on allowing you to keep a general eye on things. To get the most of the meter though, you'd want to download and use the iBGStar App.

The iBGStar App
Downloadable free of charge from the App store, compatible with iPhone, iPod Touch and iPad. Requires iOS3 or later. I haven't tested any iCloud-based shenanigans for people with multiple devices, so I cannot confirm or deny whether the iBGStar App would allow you to use several devices concurrently. Having taken a while to find a logging app that suited me I was a little worried that the iBGStar app might be a bit clunky, but was pleasantly surprised. Data entry is slick and easy and individual records consist of tabbed 'cards' which can be flicked through on the home screen. Easy enough to add and edit things like insulin dose and carbs eaten, while a series of 'notes' can be added from a prepopulated menu of food/exercise/dose/meds/general. There are some pretty sensible entries already there 'ate fatty food', 'light exercise' and so on, but you can edit and amend any of the pre-defined choices to make the app work for you. You can also add any extra ones that you might find helpful. There are some other sweet personalisation touches too. For example you can choose the 'background theme' to the home screen from six choices (cityscape, beach, forest...) and as you flick through the result cards watch the sun rise, set and the stars come out depending on the time that the BG reading was taken. I liked the zoomable 'scatter graph' in the data analysis section too, which colour-codes readings above and below the target range you specify. You can also view averages, numbers of tests and even Standard Deviation (how raggedly spread out or tightly packed your results are) over 7, 14, 30, 90 days or a custom range. Critically it is also very easy to email-out the results data, including all notes, carbs and doses for printing and waving in front of your Doctor or DSN. The only tiny quibbles I had with the app were that it did not allow fully pump-friendly dose recording (Artoo does meal doses to two decimal places, the iBGStar App only allows one) and the 'logbook' view is a bit limited showing BG results only - with the 'expanded view' being particularly useless and simply showing the same BG data a bit more spaced out rather than revealing data for doses, carbs etc.

Taking a test
The supplied finger pricker is er... a bit flimsy. It's servicable enough and at least has a variable depth setting, but lacks the smooth solid action of my Accu-Chek MultiClix and has a slightly worrying, plasticky, 'cracker novelty' feel to it. It stayed in the box. The sample size is a modest 0.5 microlitres, strips don't need coding and results take around 6 seconds. One slightly surprising irritation was that the strips felt like they were the 'wrong way round' in the pot. Unlike any other meter I've had the 'sample' end of the strips for the iBGStar are not the end that you grab hold of, so each time you get a strip out you need to turn it around before pushing it into the meter. The strips themselves are also a fairly uniform black so it's not always immediately obvious which end is which. There is a tiny notch in the 'meter' end, but in low light and for overnight tests this was a full 'lights-on' meter. I also found it slightly tricky to apply the sample in that the finger-to-strip alignment seemed to need to be a bit more precise, and the strips themselves a little less 'slurpy' than other meters I've used. If you use the meter plugged into your iPhone and with the iBGStar app running you get a little swooshy animation on the phone screen after the 'apply sample' prompts. I preferred to use the meter separately and then plug it in to sync data and log meal and/or other details. The iBGStar has a rechargeable battery and is supplied with a mains charger or can be charged via computer USB port. I have a fairly intensive testing schedule but a full charge still lasted my me a good two or three weeks. Helpfully the iBGStar begins to show remaining charge as a percentage once you have dipped below 50%.

Accuracy
So far, so good. If I were finishing the review here it would be a straight 4.5 stars. Unfortunately though I have a nagging worry. Quite by chance, when I was asked to review the iBGStar I had recently switched from an Accu-Chek Expert to a ContourLink (the latter sends results to Artoo via bluetooth). When I switched between those two meters, out of interest I did a couple of tests between the two. Now I had three meters on the go, and strips for all of them, so I did a few random tests across them all. Now at this point I must absolutely stress that these tests are in no way 'properly' scientific. The sample size is one - me. I do not have access to any lab results for any of the blood samples so I can never know which of the meters, if any, was ever giving a truly accurate result. All meters are permitted to have a 20% variation from a lab result (there's a whole blog post right there) so any result could be a bit high on one, a bit low on another. All I can say is that I got a larger-than-average drop of blood, stuck a strip into all three meters, tested and compared the results. To begin with it was all hunky-dory. But then I noticed a test where the iBGStar read quite a bit higher than the Contour. A few more tests followed and by and large the Contour and Expert were closer together, the iBGStar almost always higher. And the higher the level, the more extreme the variation. As a pattern I actually liked that predictability. I know people who find their correction doses less and less effective as their BG rises. A meter that reads a little higher at higher levels could be ideal - set the correction factor appropriately and you would automatically get a more effective correction when you needed it. Sadly though I soon found the results that broke the pattern. Results with larger differences at lower levels, and results will almost no difference at higher levels. I mentioned this in my 'feedback' to the agency who had sent me the iBGStar and had fantastic customer service experience from Sanofi Aventis who sent me a new meter along with some control solution and asked for the old one back so that they could have a look at it. I've not heard whether they found anything, but the results with the new meter (which passed the control solution test) are very similar to the first.

Once I had the replacement I spent a couple of days cross-testing the three meters just to double check before I mentioned this experience here. There were 22 tests taken over a 2 day period including before and after meals, before and after exercise and overnight. For what little they are worth here's what I found when I looked at the results:

• In general terms the iBGStar read the highest averaging 8.9mmol/L (160mg/dl) and the Contour the lowest averaging 7.7mmol/L (139). The Expert averaged 8.0mmol/L (144).
• The average difference between the iBGStar and the Contour was +1.29mmol/L (+23mg/dl)
• The average difference between the Expert and the Contour was +0.35mmol/L (+6mg/dl)
• Notwithstanding the official 20% 'acceptable' variation, I consider +/-0.5mmol/L (9mg/dl) to be a better indication for my own purposes of whether or not readings are 'more or less the same'
• Only 18% of results between the IBGStar and Contour were within 0.5mmol/L
• Between the Contour and Expert a much more respectable 73% came within 0.5mmol/L (with more than a quarter of results coming within 0.2)
• As soon as differences between meters reach +/-1.5mmol/L (27mg/dl) it begins to make a difference of almost half a unit on an insulin dose or correction for me. An extra 0.5u when I don't need it could even risk dropping me into a low level hypo
• Over the 2 days 37% of readings on the iBGStar were 1.5mmol/L or more higher than the Contour
• There were no readings that showed that much variation between the Contour and Expert. None.
• The single worst difference was 10.5mmol/L (189) on the Contour vs 15.8mmol/L (284) on the iBGStar - a difference of 5.3mmol/L (95), that's more than 50% of the reading - the Expert read 11.2 (202).

Again I must stress that these are just my own not-very-scientific results. I have no idea which results, if any, were the 'real' ones, but the variation in the iBGStar and the lack of variation between Contour and Expert cast a shadow of doubt over the iBGStar for me. It may just be something to do with my blood chemistry and the iBGStar's strips - I have no idea. I may be the only person in the UK who would find this variation.

Conclusion
I really like this meter. It's small, nicely designed. The app is great, very easy to use and ticks almost all the boxes for me. I successfully used it on its own for a week and a half, even after I had noticed its tendency to read a little high. I simply reduced my 'usual' correction factor to take into account the possibility that the meter might think I'm higher than others I have used before. At the end of the day BG meters for use at home are only ever going to give you a general guide as to your levels. If you read the small print in the handbooks they never pretend to do anything else. Back in the real world though, I do need my meter to perform as consistently as possible. If it's going to have a quirk, that's fine - but it has to be a reliable quirk. My life 'playing at being a pancreas' is full of enough variables without adding another into the mix. I'm sure the iBGStar will work well for many people - unfortunately I'm not one of them.

Final score: 3/5

UPDATE: Sanofi checked the first meter and gave this response.

Guest post: BG monitors for blind/visually impaired people

A few days ago we had a comment on our D-Tracker review from someone called 'Faulty Headlights' who was wrestling not only with diabetes but also with blindness. I can't imagine how hard that would be. As the conversation continued I became increasingly interested in the challenges faced by blind and partially-sighted people, especially in relation to available blood glucose monitors and their usefulness (or otherwise). Julie (Faulty Headlights) kindly agreed to write a guest post sharing her experience of the currently available options. If you have any experiences to share please add a comment below.

Three Blind M.... Monitors???

Living with diabetes can be challenging enough for some people, dealing with injections, blood monitoring, carb counting and so on.

I've lived with diabetes for 21 years now but 5 years ago I lost my sight do to bad control. If I thought it was difficult controlling it then, I was pretty darned puzzled as how I was going to manage not being able to see. I know I have help if I need it but I have always tried to be as independent as possible and didn't want my independence taken away from me just because I had lost my sight.

So not long after I learnt to use a computer I started looking into accessible products for diabetics with visual impairments. Mainly blood meters.

The first monitor I came across was the SensoCard plus (now discontinued), I liked this machine very much. Nice large display with one large tactile button on front and two smaller buttons on side for navigating menus, also. Clear speaking voice for reading results, a slot for easily coding machine and USB port for connecting to PC. Why oh why did they discontinue this one!

I asked around about another and was pointed towards the RNIB who specialise in audio products for the blind and visually impaired. They told me about the Clever Chek machine and there not seeming to be any other option I went for it.

Big mistake! It was awful! I’m sure there are other people using this machine who like it ok but they're probably all over 60 and still using phones like bricks too. Oops sorry, did I just write that?

The Clever Chek machine is bulky and has five buttons on the front, it has a large display and volume control which I guess would be good for people with hearing problems as well as sight. It has many features the same as the SensoCard plus but much much more difficult to use and there is way too much spoken information on start up which just isn’t necessary .If put in a pocket or bag it switches itself on with a merry little tune and tells you and everyone else in the vacinity thank you for using this product followed by date and time. Who ever designed this machine did not have the blind in mind. The strips seem to need more blood and I’ve been given so so many false readings in the past. I’ve compared them against my dad and sisters machines and readings were well off, maybe this is just my machine? I might have got a faulty one but I'll not be asking for another. One good thing about this machine is that it is codeless and... and... um? Nope, I'm struggling to think of anything else!

I was pointed towards the RNIB yet again and now they have a new audible blood monitor. It's called the SuperCheck2. It looks a bit like an mp3 player and has only two buttons. GREAT! It too has volume control, USB port for connecting to PC where you can store results and print for your doctor, large display, memory for up to 500 results and gives you averages over a week month and so on. It has a nice clear voice which reads pretty much everything a sighted person can see on their machine and is also codeless. Brill! On each of the three machines there is a 'dipped' area so you can feel where to insert the strip. The strips have one rounded edge and one flat edge so it's easy to know what end is inserted into the the machine.

What I like about this machine is that you can set alarms to remind you when to test your blood sugar and it doesn't look like a brick.

Technology has come on so so much over the years and it is good to see companies thinking about accessibility. One company I am pleased with is Apple who have made many of their products accessible to blind and visually impaired people with their voiceover.

I was recently told of new blood monitors called the BGStar and the IBGStar which connects straight into an ipod where your results can be displayed and stored. I don’t have a lot of information on these yet but am excited to see how it works and if it will be made accessible with the voiceover on iPod touch and iPhone. Technology really has come a long way, can you remember the old machines from many moons ago? Again, BRICKS!

I have now downloaded and tested 4 different iPod apps designed for diabetics to store their blood readings, exercise plans and carbs and so on. I was disappointed to find out that none of them were completely screen reader or voiceover friendly. Some of the icons were read aloud but others like time and date were not. I think apps like these are a great idea for both sighted and visually impaired diabetics, I mean, how many times have you shown up to your diabetic clinic with out your record book? Many of these apps also allow you to sync it to your computer or to email your results straight to your doctor. Nice one!

Julie.

UPDATE: See also the Caresens 'Voice' Blood Glucose Monitor for Blind/Visually Impaired people that I saw at the INPUT event in Truro