Monday, 15 September 2014

New Kit! - Freestyle Libre Review: Part 1

Don’t you love the confidence I’ve used for the title? Part 2 will/should follow in a couple of weeks after I’ve got a decent length of usage. However I’ve had the Freestyle Libre for a few days and it’s getting heavily promo’d at the moment so time for a few quick thoughts and information.

First up I need to make clear the contributions made towards this piece. You may notice my blog has no advertising and I’ve never accepted payment for any pieces written – I can guess you’re not too surprised by this as any payment would not have been good value for money. This piece is slightly different though as Abbott Diabetes invited me down to a members club in central London last Friday and paid for my train (Standard Class – prefer First Class next time please;) ) and also provided coffee, fizzy water and a rather tasty fruit danish that I later discovered I’d under-bolussed for. At the meeting with some other bloggers I was given a Freestyle Libre handheld device and two sensors.  The only agreement that I was happy to sign was that they requested I write a couple of blog pieces and withhold them until today. Apart from that I’m free to say what I like and no promises were made by me and the grilling I gave the very nice Matt, Ollie and Fiona showed I wasn’t easily bought.

Anyway time to get going (I've got quite a lot of photos so to make it easy I've put them all at the bottom)….

As I tweeted last week the hype for the newest entrant to the CGM market, the Freestyle Libre was reaching silly proportions and as it coincided with the latest iPhone release the excitement was comparable. It did get to the point where I forgot which came with a new camera and which could measure my blood glucose – Apple; combining both would be nice by the way.

For those who have missed it Abbott Diabetes have launched a product called Freestyle Libre that they say is not a Continuous Glucose Monitor (CGM) but a Flash Glucose Monitor (FGM). A little more on this later but it shares many features that other CGMs do have. The launch came after European safety clearance in early September

The nice people sat us down and began the session blasting us with wondrous facts. All very ‘marketing’ and I’ll summarise the bits I managed to jot down in case it interests you. If like me, you really just wanted to skip on to the fitting part feel free to do that….
5 years in development
2 years of clinical trials
It seems to be officially pronounced Lee-bray. Although as it’s missing an accent on the e and I’m from the uncultured northern end of the country so for me it’s Libre to rhyme with n.
Abbott Worked with a high number of Diabetes Specialist Nurses and consultants before launch and provided plenty of samples around the country for them to look at.
Each sensor lasts 14 days before timing out.
The sensor takes a reading every minute it’s on the body and stores this data for eight hours only. The reader downloads the full eight hours of data every time it is connected by swiping. Upon swiping the last reading is shown along with a trend arrow showing which way the glucose reading is going.
The sensor goes on the arm. Only registered for use there and I sense this may partly account for the promised accuracy levels.
Each sensor costs £48.29 ($78)(all prices are excluding VAT as dedicated medical kit is VAT exempt for people with diabetes). 
Reader cost £48.29 ($78)
Reader works between 10 and 45 degrees Celsius – 50 to 113 Fahrenheit
Starter pack containing two sensors and the reader costs £133 ($216). 
Despite the hard sell to Diabetes Specialist Nurses this is not available on the NHS and knowing how NICE funding works I wouldn’t expect this to arrive quickly; even if it is desired by Abbott. Whether this turns the promoted-to DSNs into unofficial and unpaid reps for Abbott is a debate for another day.
The Libre is licenced for over 18s only. They are “committed to actively pursuing a paediatric licence too” but no promises were made about when.
The sensor is waterproof to 1m for up to 30 minutes. IPX7 standard.

If you’ve been here before you’ll know I also occasionally run an Enlite CGM sensor from Medtronic. I pay in full for this and as a comparison they cost £55 ($89) per sensor and last 6 days (officially). The bluetooth transmitter costs £490 ($794) and that lasts anything between 12 and 18 months. I also know there’s a big fan base for the Dexcom G4 but as I’ve not used it I can’t and won’t compare. I'm sure Grumpy Pumper will though.

Upon opening the box of the Libre sensor and inserter I was struck by the amount of plastic needed for such a small piece of kit. Apparently all needed to maintain the factory calibration, anything less can lead to poorer results. It still seemed a little wasteful though; we throw far too much packaging away managing diabetes! To place the sensor in the inserter is an easy process of lining up two lines. The next step was unsettlingly easy. The inserter was pushed against the skin and despite no noticeable sound or feeling, on removal a £2 coin (1 Euro) sized white sensor was left behind. I’ll pause here because that was pretty big for me. The Enlite can be a little painful going on; similar to an uncomfortable set-change for those that use an insulin pump. The lack of feeling is a huge progression so well done Abbott with that. A lesson learnt for me was that I should have placed it slightly higher up my arm. As it is it's just below my t-shirt sleeve position so next time I'd go higher to hide it completely.

We then got our hands on the reader. About the size of a small phone it comes with one button on the front lower-right, a touch screen and a slot at the bottom for the Freestyle Optium blood and ketones test strips. Nothing on the back apart from a QR code (that I'm struggling to scan), a serial number and a few other symbols including the all important CE mark. On the side is the charging socket which is the same connection as Blackberry and Nexus chargers. The re-charging means the unit is warrantied for 2 years and I shouldn’t expect this will be a problem. The menus on the touchscreen are relatively simple and easy to operate. You can see past readings, a graph of day long periods and other charts and reports. There’s also a teasing ‘Professional Options’ selection that needs a passcode. A check of the solid instruction book showed this is for a bolus calculator so just like the Accu-Chek Expert I can understand reluctantly, the regulatory need for a HCP’s input here. For me I wouldn’t use it but I can imagine multiple daily injecting users would be as excited by this feature as I was with the Expert. However, the world being what it is I wonder how long it will take others to spread the code? I’ve a feeling that before I publish this it will already be out there!

Then came the painful wait for an hour while the sensor warmed up. The time came with a teasing clock that counted down the minutes until it was ready. During this time Matt talked us through the reports available when you connect the reader to a PC or Mac that will be available after go-live. All are PDFs and the reader can store up to 90 days worth of data. It was explained that all reports had been developed after talking with the healthcare people about what they like to see when meeting a patient. This was where my ears pricked up again and I got a little annoyed. 

Apparently only 5% of patient users would desire the need for access to the raw data to analyse it themselves. In our group of five bloggers, three of us immediately said we expected it, not just desired; expected! So I’m hoping this will be taken back to enable a simple csv export to be made available. For me it comes back to it being my glucose reading and therefore telling me I can’t fiddle around with the numbers is retreating back to a world where the HCPs own my diabetes. They don’t; I do. And if I’m paying for my data to be collected I expect to be able to analyse it in a way that is useful to me. I wait with anticipation for developments here.

There were many claims of market leading accuracy and for those who are into the technical stuff they claim a MARD of 11.4%, with a slightly worse value of 15% on day one. However, they are confident the accuracy is maintained for the full 14 days. See part 2 for how this does.

So after an hour the reader beeped and I scanned my arm for the first time. To do this you wave the reader close to the sensor and it reads it. This can be done through thick clothing and I can confirm it works through a combined shirt, jumper and jacket with no issues. It’s certainly a strange sensation and one that still doesn’t feel natural three days on. When you scan the handset either beeps, vibrates or both and immediately shows a reading of your glucose. As the sensor is reading your interstitial fluid it will have a delay over the a finger prick test but in my tests so far I find this is between 6 and 8 minutes compared to 10 to 15 I experience with the Enlite. Why and how I have no idea but in my real world tests it does appear to be both accurate and fast. Fast enough to base a bolus on? I’m still not 100% confident but certainly more so that with the Enlite - in initial tests. 

So why have they named it FGM and not CGM? I’m not sure why as it does read continually, just that the results are only available when you flash, only stored for 8 hours and you can’t tie a specific time to a glucose reading if you haven’t flashed - a-ah, you saved every one of us! So in reality it behaves more like a blood glucose meter taking multiple readings when requested and separately creating a background graph that can’t be drilled into. 

The biggest feature of the kit is the ease and speed of use. It works, simply and easily. Big advantages in set-up costs compared to other systems but at this point I need to step out of the bubble and point out the blooming obvious. Close to £50 ($80) every other week is not a cheap option. Yes, it’s cheaper than the Medtronic system but that doesn’t mean it’s cheap. To enable full time usage will cost £1250 ($2025) per year. That’s the price of a small car! 

This is where cost becomes a deciding factor in whether you can justify it either full or part-time. Me? I’m not sure. It’s certainly more affordable but there are negatives that go hand in hand with the positives. I will explore these further in my next piece when I plan to run the Enlite and the Libre side by side to compare both items with accuracy, ease of use and further practicality.

Thanks for reading and please check out Sue at Desang, Mike at Every Day Ups and Downs, Grumpy at Grumpy Pumper, Laura at Ninjabetic and Jen at MissJenGrieves for their feelings of the day and Libre so far. On a personal note it was great to meet so many people who I’ve chatted to online frequently but never actually met in real life! Hopefully we can do it again soon and involve even more.

Thank you to the Abbott team for the invite and I appreciate the time your team took to talk to us and answer our probing questions. 

I really feel I’ve only touched the surface and looking at the other blogs I appear to be missing style or structure but I went for a brain dump of the biggest order and this is what you've got :) If you’ve got any questions at all please don’t hesitate to ask.

More info also available here: https://www.freestylelibre.co.uk/

Don't forget to check out the photographs below.

Dave