Monday, 15 September 2014

FreeStyle Libre - Flash Glucose Technology








FreeStyle Libre… The new diabetes product that has been the talk of the town, or certainly the Diabetes Online Community (DOC), for the past few weeks.

The technology itself is called flash glucose. It isn’t marketed as a CGM (Continuous Glucose Monitor) or a blood glucose machine, it’s something different… something completely new (and very interesting) to the diabetes market. The way that the Libre works is by reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. The sensor itself (approximately the size of a two Euro coin) measures glucose every minute in interstitial fluid through a small (5.0mm x 0.4mm) filament that is inserted just under the skin of the arm. A touch screen reader is then used to scan (flash) over the sensor (it can scan through 4cm of clothing) which then gives the user their blood glucose result in a pain free, discreet and convenient way, as many times as you like - No finger stick calibration is needed. A historical trace is then formed over time and the also reader shows the user which direction their blood glucose is heading in – Steady, slowly going down, rapidly going down, slowly going up or rapidly going up.

The Freestyle Libre has been marketed as;


A revolutionary new glucose sensing technology for people with diabetes”

“A significantly advance the field of glucose monitoring”

“Offering a convenient and painless way to get more frequent glucose readings, which should help to improve diabetes management




But we all know that marketing means nothing to a consumer these days if it’s not backed up with genuine user reviews and opinions, especially when it comes to a medical device that we, people who have diabetes and don’t just talk about it, need to use on a daily basis… need to trust every second that we are using it… So that’s why Abbott (the pharmaceutical company behind the FreeStyle Libre) invited me and a group of other people with Type 1 diabetes to London last week, to be amongst the first in the world to be able to try the Libre before it hit the shelves! 


What does the Libre look like?

Ok, so I was given a starter kit to take home with me – 2 sensors and a reader. The shiny yellow packaging with an orange butterfly is familiar to me and told me that it was an Abbott product (I have a few Abbot products at home), but packaging is just a barrier to me getting to what I want and really doesn’t mean much to me at all. After ripping my way through that barrier, I found inside the sensor box the sensor itself (in sterile packaging), an inserter (also in sterile packaging) and an instruction manual. Inside the reader box is the reader, a battery charger and USB cable, along with user guides, starter manuals etc.




The sensor itself, when on my arm is about the size of a £2 coin and about the thickness of 2x £2 coins. It has a super sticky adhesive to make sure it doesn’t ping off and that’s all you can see. The needle comes straight out with the inserter and gets throw in the sharps bin (if you geta Libre you will need one of those MASSIVE sharps bins).




The reader is relatively small (see pic below), easy to hold or pop in a pocket or handbag and is very lightweight. It feels like it would bounce if it hit the floor (this is something I won’t be testing out!), the screen, if you push gently on it, is quite flexible and doesn’t seem like it would break if you accidently left it in your back pocket and sat on it. Saying that though, it does feel a bit… cheap. Though at the price it rocks in at I wouldn’t expect to be holding something that would give the iphone 6 a run for its money!

The reader only has 1 button, it has a large colour screen that’s also touch screen, a decent sized text for those who, like me, refuse to wear their glasses, and it well lit (more about the reader later). A nice surprise that I wasn’t expecting when I opened it is that it can also test blood glucose in the way that most of us are used to, with a finger prick, and is also a blood ketone meter!

The Libre doesn’t come with a case or any accessories to ‘funk’ it up but from what I’ve seen, people in the DOC are pretty good at doing that themselves and I’m sure it won’t be long before some of the more creative people have pimped their Libre's.





Is it comfortable? Does it have to be worn on the skin?

It’s very comfortable! I can’t feel a thing when I’m wearing it, sleeping on the side that it’s on or when I’m moving my arm (not that I madly flap my arms around anyway!) The only time I’ve felt it is when I pulled my handbag strap up my arm and caught it but that didn’t hurt, I was just aware that I did it.

When I asked the Abbott staff if it could be worn elsewhere I was told no, only on the back of the arm for now. This has been the 1st time for me that I’ve had anything on my arm (I've never injected there or inserted a pump cannula) so I wasn’t overjoyed at the thought but as I said, I can’t feel it and often forget it’s there.




How much does it cost?

The starter kit containing 2 sensors (lasting 14 days each) and a reader costs £133.29 +VAT

The reader on its own costs £48.29 (with a 2 year warranty) +VAT

A sensor on its own costs £48.29 +VAT

Note – People with diabetes don’t pay the VAT on medical products. Please get in touch with Abbott for more info about this.


Did it hurt putting the sensor on?

Not at all! I didn’t feel a thing and I was really surprised by this! I’m used to feeling a pinch and a slight sting when I insert my insulin pump cannula but the Libre was pain free – everyone else who tried one that day said exactly the same. One of the staff from Abbott who was there on the day watched me as I inserted the sensor and said that I scrunched my face up just before putting it on. I must have been anticipating a sharp scratch, but I was very pleasantly surprised.


When can I get one?

We were told that the Libre will be available to buy online from the end of September/early October. You might want to contact Abbott yourselves nearer the time to see if they have a specific launch date.


What does the reader do?

As I said before, the reader is used to manually scan over the user’s sensor in order to see an instant blood glucose reading - all information is stored for 90 days. The reader also has many options to view the data depending on what you want to know.

The main screen, after scanning, shows the time, battery left, amount of time before the sensor ends, the glucose reading, the trace history on a graph and an arrow to show which direction your blood glucose is heading. Other options include; a logbook, daily graph (with options to look back over other days), average glucose in 4 time blocks (going back 7, 14, 30 and 90 days), daily patterns, time in target (also above and below target) and your personal target range, low glucose events (anything below 3.9mmol/l) and sensor usage showing the amount of times you have scanned.

All of this information can then be downloaded to your computer via a USB which is included. I’m yet to download but I’ll blog about it when I do.







How easy is it to set up?

It was really easy! I’m not one to read instructions but for this I wanted to make sure that I didn’t cock it up so I did have a look at the enclosed manual. Step by step the process of inserting the sensor is explained with text and pictures – If I can do it, anyone can!! When it came to setting up the reader you just need to follow the instructions on the screen – date, time, target blood glucose etc. and you’re all set! The reader takes 60 minutes before you can scan for the first time (and I imagine this is the same when starting with a new sensor) but has a lovely countdown clock letting you know when it will be ready for use. As far as makig changes goes I’ve been able to re-set the time on my reader and adjust my glucose target with no problems. There is only 1 button on the reader, which makes navigation through the menu’s quick and easy, the rest is done via the touch screen.


Who can use it?

The Libre will be available to people in the UK, France, Germany, Italy, Netherlands, Sweden and Spain. Currently Abbott are only able to sell the Libre to people over the age of 18, though they did stress that they are committed to actively pursuing its use in patients under 18. Watch this space!!


Will I still need to prick my fingers?

Personally I have been using my old blood glucose meter but not as often as I was. For me, I need to use my old blood glucose meter to calculate my insulin:carb doses and correction doses, my meter also bluetooths that information to my insulin pump, therefore eliminating the need to go rummaging around in my bra to press buttons on my pump when I’ve stashed it in there.

Abbott did stress that if someone is making decisions about taking insulin based on a reading from the libre they should check their blood sugars on a separate meter as there is a 5 minute time delay from the number you see on the screen to what your glucose level is. There is an option for Health Care Professionals to work with patients who use the Libre which will allow them to set the Libre up to give insulin suggestions, however I haven’t been able to try this feature yet as I’m not working with my HCP with my use of the Libre. Abbott did say that they are trying to reach as many HCPs with the Libre as possible so they can help patients if they have any questions or want to discuss their diabetes management alongside using the Libre.

Something I’ve also been doing when using the Libre and testing my glucose on my meter is comparing the results to see what difference there is in the given readings. So far I haven’t noticed differences that are jumping out at me and suggesting that the Libre is way out when it comes to accurately measuring my blood glucose. As I mentioned earlier, we need to be able to trust technology, which is why I’m comparing it to other meter readings on occasion.


How accurate is it?

This is a tricky one... Upon meeting with Abbott we were told that they were very confident that the Libre was more accurate than the current technology out there, The first day went very well and after making comparisons with my trusted accuchek blood glucose meter I was impressed at how close the readings were - only 0.2mmol/l out at the most!

As the days went by this gap slowly widened and I did begin to question the accuracy (taking into account the 5 minute time delay) and if I would base any insulin calculations on the information given by the Libre.

About 30 minutes ago though I flashed and had a reading of 3.7mmol/l (hypo). I didn't feel low so I checked on my meter as Abbott had recommended we do to make sure we weren't
making decisions solely based on one reading and saw that my meter read at 4.0mmol/l. Which was correct?? I grabbed a third meter which showed 4.5mmol/l! I flashed 20 minutes later and the Libre says my glucose is 3.3mmol/l... I don't feel hypo at all and 2 meters say I'm not, but do I risk not treating in case the Libre is correct? What if I wanted to get into my car? Do I now need to wait 40 minutes based on the Libre but not the machine that I have used and trusted every day for the last year?

I think you would need to make up your own minds on this one... 





What if a sensor doesn’t work?

We were told that if any problems occur with sensors or readers then to get in touch with Abbott who will replace or refund. The staff that I spoke with said that they are confident that the readings won’t ‘drift’ over the 14 days but if someone does find a problem then to contact their customer service team.

My Pros and cons:

Pros: 

  • Convenience - It's so quick and easy to pull the reader out of my pocket or bag, flash it over my arm and look at the reading that shows I just 1 secon
  • It's a pain free way to check blood glucose
  • It has boosted my confidence - I feel much more able to get on with my day knowing that I can easily check my glucose as and when suits me
  • I can 'flash' as many times as I like
  • I can see how certain foods affect my blood glucose
  • I can see which direction my glucose is heading in which enables me to act accordingly
  • I can see trends that I've never seen before - in the last few days I've seen that my overnight glucose is between 9-15
  • It's comfortable to wear and insert
  • It enables me to download 90 days worth of data which I can analyse myself and send to my diabetes team if necessary
  • It's incredibly cheap in comparison to some technology (some readers cost hundreds!)
  • It's easy to set up - I often worry about this as I'd hate to make a mistake and not be able to use it
  • It's aesthetically pleasing - colour screen, charts, large text etc.
  • It's not bulky - one of my worries about having something 'stuck' on me is that it will be obvious through clothes. My pump is easily stored in my bra and I'm pleased that the Libre sensor is discreet enough to cover with clothes if I wanted to
  • The battery life seems to be good, though this will depend on how many times you 'flash'
  • It doesn't need a finger prick calibration
  • It is enabling me to self-manage better and is making me feel much more involved in my diabetes care now that I am more aware of what my blood glucose is doing - It's strange how 'in the dark' I felt when restricted to finger pricking a certain amount of times a day

Cons:

  • If you don’t scan for more than 8 hours you can’t see a trace history – on the rare occasion I do sleep for more than 8 hours
  • Low glucose events – recorded when bg gets to 3.9mmol/l or below but I often feel hypo when my glucose goes below 4.5 – this eliminates some of the personal element
  • I could become reliant on the technology
  • It could cause me to become obsessive about testing my glucose levels
  • It doesn’t completely eliminate the need for finger prick testing
  • It offers the option to test blood glucose and blood ketones but doesn’t include a lancet, test strips or ketone strips
  • If my HCPs didn’t want to help me with the Libre/didn’t buy into the idea then I couldn’t use all of the options available to calculate insulin doses (to allow access the insulin calculator need HCP access code)
  • When making notes I can only put rapid acting insulin in whole numbers – Not accurate for pump users as we can use 0.1 units etc. on pump and some insulin pen users can use 0.5 units
  • Not as many options for looking at trends as my current meter - accuchek combo which offers daily, weekly, charts, scatter graphs, pie charts, standard deviation etc.
  • Can only put on back of arm – I much prefer using my stomach
  • And the biggie... I can’t afford it. Yes it’s an amazing price compared to current diabetes technology that can be self-funded but as a student who isn’t able to work full time, I can’t spare £96 a month.


So... would I buy this product (if I wasn't a poor student?) At this point in time, the jury's out on that. This is only my 3rd day of using the sensor and apart from the mixed messages with my hypo(?) I have been very impressed. I plan to make a few video blogs throughout the next few weeks so please keep an eye out for more updates. I hope this blog has been helpful for you! If you can afford it then perhaps it might be worth trying it out for yourself as the initial start-up cost is much lower than CGM technology... everyone is different and this may be the product you've been looking for!


Feel free to ask me questions on twitter - @ninjabetic1 or on facebook - ninjabetics and I will do my best to answer them all.



Ninjabetic x 







For more details about Abbott's FreeStyle Libre please visit their website at https://www.freestylelibre.co.uk/
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