Freestyle Libre 3

[PaulAshby]

I don't have any insight into the internal decisions made by the NHS, but one possibility may simply be, that this is temporary and is related to bureaucracy and tenders and contracts. For example a search for NHS Glucose Monitoring tenders thows up this link which talks about CGMs. Now the Libre2 is not normally consider a CGM and hence may not covered by that tender.

So it also possible that the NHS have a tender to cover insulin pumps and related accessories which is separate from the tender that covers flash monitoring devices (I am thinking that CGM's may, in general, be more expensive than Flash monitoring, hence it makes sense to separate them).

So, they must have an existing contract with Abbott to supply sensors and that contract may actually specify that the sensors should be Libre 2s and hence it can not be changed to Libre 3s until the contract has expired and the tender renewed. (The contract in the link is for two years, so it is possible they Libre2 contract is also for two years, which means there is probably another year to go)

Of course, all this is total speculation on my part.

Sounds about right to me

 

[DavidDK]

I see there is some patent litigation going on between Dexcom and Abbott over the technology used in their products. I suspect this may have had a bearing on the launch of the Libre 3 in the UK.

 

[becca59]

Just worn 2 Libre 3s for 14 days as part of a trial. I am not party to any of the information they are producing. However, just wanted you to know the wearing of them is amazing. So discreet and less likely to be knocked off. Didn’t know they were there. So much less packaging too.
They are not hooked up with Apple yet only Android. So until that’s fixed I doubt they will be available generally.

 

[Andrew2018]

Thanks Kevin Bell.

I understand the differences between Type 1 and Type 2, but I have never understood the attitude of successive governments concerning why Type 1s are more deserving if getting technology to manage their diabetes and Type 2s are somehow less deserving, because if a delusional perception Type 2s have brought diabetes on themselves.

HM government's main aim

I'd have thought it simple, a type two has a degree of leeway, a type on lives or dies by the information they have on BG levels.

 

[Andrew2018]

Thanks sgm14 and counsellorneil.

I believe a statement should be issued imminently by the NHS about eligibility because I think access to the Libre 3 is supposed to start from 1 April 2022.

From the information leaked on the internet so far, yes it seems that the NHS want to integrate use of the Libre 3 with use of pumps.

And that is absolutely fine, provided patients want that.

I'm not ready yet to have to have to wear a pump. I just want what our brother and sister diabetics in Germany have had for the last year: access to a continuous glucose monitor proper with a sensor that is significantly smaller than the current Libre 1 and Libre 2 sensors, with a significantly better failure rate than the Libre 2 and significantly more accurate than the Libre 2 (being able to self-calibrate would be nice!), which provides readings directly to a smartphone or smartwatch every minute, allowing me to make treatment decisions.

My understanding (which may be incorrect) when the Libre 3 was put out into the world as a concept was that it would be "future proofed" to some extent. So going forward users would be able to access new functions, such as being able to connect the Libre 3 to a pump so insulin can be delivered; or being able to get readings sent directly to a smartwatch (which interests me); or the Libre 3 having the ability to communicate with smart insulin pens to keep a record of how much insulin a user has taken, how much insulin a user currently has left "on board" and perhaps dosing suggestions.

However, because the Freestyle Libre is a "closed system," unlocking such features (assuming they exist at all) is dependent entirely on the manufacturer (working with other commercial partners as necessary).

If access (via the NHS) to a Libre 3 is going to be conditional on wearing an insulin pump that would be overly restrictive in my opinion.

I'm hoping access won't be that restrictive.

Given the issues that seem to arise with the Libre system, if I used a pump, I'd be very worried !. Just had a sensor failure on Libre 2 where it went way off telling me I was hypo when I was'nt anywhere near, not to mention all the reading errors it gave today. It reminds me of the Libre trials, and I do wonder if the system is anywhere near reliable enough if you have to use a meter as a fall back.

 

[DavidDK]

Given the issues that seem to arise with the Libre system, if I used a pump, I'd be very worried !. Just had a sensor failure on Libre 2 where it went way off telling me I was hypo when I was'nt anywhere near, not to mention all the reading errors it gave today. It reminds me of the Libre trials, and I do wonder if the system is anywhere near reliable enough if you have to use a meter as a fall back.

You don't appear to be a fan of the Libre.

I like it because it gives me lots of data about trends; how my body reacts when I eat certain foods; and how exercise affects my glucose levels. And to react accordingly.

Most importantly, my body chemistry tolerates the sensor well and allows it to give me the data I need to make timely, rational treatment decisions most of the time.

But everyone's body chemistry is different.

There is a really interesting video on YouTube from 3 months ago by someone who goes by the YouTube handle Nerdabetic. In it he says all three iterations of the Libre system share the same underlying sensor chemistry (and lets face it for any glucose monitoring sensor to work within tolerable limits it is all about chemistry: both the sensor's chemistry and the user's body chemistry).

In his YouTube video Nerdabetic also says there is a known issue that may affect the accuracy of the Libre system if the user consumes in excess of 500 mg of vitamin C daily. Abbott do point this out in the smallprint of the literature they provide with their product and on their website.

Nerdabetic goes on to say that because of this known issue, apparently the US Food & Drug Administration ("FDA") who regulate and licence medical devices in the USA did not grant the Libre 2 permission to be used as part of a closed loop system and that the FDA is similarly unlikely to grant permission for the Libre 3 to be so used if the underlying sensor chemistry of the Linre 2 and Libre 3 are the same and the underlying issue is not fixed.

I have no idea what the situation is with the UK's medical devices regulator, the MHRA and unfortunately Nerdabetic's video doesn't go into what the position is in the UK.

Nerdabetic goes on to say that Abbott are supposed to be trying to fix this known issue with their sensors and how vitamin C affects accuracy.

Nerdabetic says other manufacturers' sensors have had known issues in the past. For example, a user taking too much paracetamol could be prone to affect the accuracy of sensor data (although Nerdabetic says that issue was addressed subsequently by those manufacturers).

 

[becca59]

Just to point out the FDA has now given clearance for Libre 3.

 

[DavidDK]

Just to point out the FDA has now given clearance for Libre 3.

Thanks Becca59

Just to clarify, I believe the US Food and Drug Administration has licensed the Libre 3 for use as a "standalone" continuous glucose monitor in the USA.

The Libre 3 is not yet licensed in the US for use as a component part of an automated, or closed loop, insulin delivery system using a pump.

I understand to get permission from the FDA for the Libre 3 sensor to be used as part of an automated, or closed loop, insulin delivery system requires an additional licence or authorisation from the FDA.

Again, I have no idea what the licence arrangement is in the UK granted by the MHRA, nor that granted in the EU by the European Medicines Agency, to the Libre 3.

 

[DavidDK]

I also see in the smallprint on Abbott's website that taking salicylic acid (found in analgesics such as aspirin) may also affect accuracy of sensor readings.

The smallprint on Abbott's website doesn’t mention what concentration of salicylic acid in the body is sufficient to affect readings.

I assume the same warning is replicated in the patient information leaflets that must be included with the product in the UK and EU.