# Getting very angry with Abbott over Libre 2.



## Pattidevans (Dec 8, 2022)

I got very angry yesterday after installing the latest software release from Abbott for the Libre 2 which is supposed to correct the problems caused by the previous update.  Now I am not only getting the slooooow reporting of the actual number after a scan (up to 4 minutes) that I had before, I am also getting the "scan failure, try again in 10 minutes" notice frequently.  So I rang them.  I obediently re-booted my phone after clearing the cache as instructed.  This made no difference at all.  So then the conversation went on with me telling the agent that my phone worked perfectly before the update at the end of November  prior to the latest one, which was supposed to cure the problems caused.  I asked if there was any way I could revert to the original software version and was told NO.  So after me telling him I am using a Moto G6  Play phone using Android 9 he tells me it's not one of the compatible phones.  He was nice enough and obviously sticking to his script.  I then said, "so is it your recommendation that I buy a new phone?"  Apparently not... it is his recommendation that I use the reader.  I tell him that means carrying reader, phone and PDM at all times, when I can hardly carry a small handbag due to a  wedge fracture of my vertibra which causes pain.  He then says yes, that's what you'll have to do.  In conclusion he says "so can I report that you are complaining because your phone does not work with the sensor".  I said "NO you can't"   You can report that my phone which previously worked perfectly with the Libre 2 now doesn't work due to Abbot's so called 'upgrade' which was forced upon your users without notice or choice.  The problem lays with your software which is unfit for purpose"

FWIW this is what their website says on compatible phones:



> FreeStyle LibreLink will only work with phones that meet the following minimum requirements:
> 
> • Android Operating System 5.0 and higher, Near Field Communication (NFC) capability.



So my phone meets their recommendation.  I'd like to take this further... any ideas on how this can be done?


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## grovesy (Dec 8, 2022)

Sorry to hear this I can't answer your question. Though I had an experience with a caller handler earlier in the week, that made me think they are not as customer centered as they used to be.


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## rebrascora (Dec 8, 2022)

I can totally understand your frustration Patti and I am sure this situation was reported by someone else on one of the other Libre problem threads. Will see if I can find it as maybe you can club together to wage quite justifiable war on Abbott over this. 

Personally I love using the reader and will continue to do that when I get upgraded to Libre 2 particularly as I read so many reports of the phone app causing problems after updates, but then I often see my phone as a nuisance and intrusion and head out without it, but my reader as an essential and since it is so much smaller than my phone and scans so easily and reliably, it gets preference over my phone for pocket space along with JBs of course, especially since the strap on my little rucksack handbag broke and I haven't managed to fix it yet.


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## rebrascora (Dec 8, 2022)

Here we go.... post #41 on this thread...


			https://forum.diabetes.org.uk/boards/threads/librelink-with-ios-16.102176/page-3#post-1220535


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## Bloden (Dec 8, 2022)

I went thru exactly the same thing @Pattidevans. My phone WAS compatible but suddenly WASN’T after their upgrade (and it should be compatible, according to the website criteria). I insisted they send me a Libre 2 reader in the end, because it was the only way to solve the problem. I did all my complaining, etc via email because I knew talking to someone would just wind me up. IMHO Abbott have made a right pig’s ear of things. I can’t keep “upgrading” my phone cos their app is rubbish!


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## BadaBing (Dec 8, 2022)

Pattidevans said:


> I got very angry yesterday after installing the latest software release from Abbott for the Libre 2 which is supposed to correct the problems caused by the previous update.  Now I am not only getting the slooooow reporting of the actual number after a scan (up to 4 minutes) that I had before, I am also getting the "scan failure, try again in 10 minutes" notice frequently.  So I rang them.  I obediently re-booted my phone after clearing the cache as instructed.  This made no difference at all.  So then the conversation went on with me telling the agent that my phone worked perfectly before the update at the end of November  prior to the latest one, which was supposed to cure the problems caused.  I asked if there was any way I could revert to the original software version and was told NO.  So after me telling him I am using a Moto G6  Play phone using Android 9 he tells me it's not one of the compatible phones.  He was nice enough and obviously sticking to his script.  I then said, "so is it your recommendation that I buy a new phone?"  Apparently not... it is his recommendation that I use the reader.  I tell him that means carrying reader, phone and PDM at all times, when I can hardly carry a small handbag due to a  wedge fracture of my vertibra which causes pain.  He then says yes, that's what you'll have to do.  In conclusion he says "so can I report that you are complaining because your phone does not work with the sensor".  I said "NO you can't"   You can report that my phone which previously worked perfectly with the Libre 2 now doesn't work due to Abbot's so called 'upgrade' which was forced upon your users without notice or choice.  The problem lays with your software which is unfit for purpose"
> 
> FWIW this is what their website says on compatible phones:
> 
> ...


I really do sympathise with what you say. If it is any consolation (and I know it probably isn't) there are many people who are also experiencing identical problems on both Android phones and iPhones, if other forums are anything to go by.

My phone isn't on the list of "official" smartphones listed as compatible with Libre 2 and Librelink. However, if you go into the Freestyle Librelink app on Google Play store, there is a section that tells you whether the Librelink app is compatible with your mobile. It says mine is.

I've checked my phone using the diagnostic tools provided by my mobile manufacturer. According to those diagnostic tools there is nothing wrong with my phone and particularly its near field communication and low energy bluetooth, both of which are working "normally."

My Android phone's operating system upgraded itself from 12 to 13 in the last 5 weeks. I don't have a problem with that. When you buy a new mobile you pay for operating system updates and security patches for a period of time which are supposed to make your mobile more "stable," more secure and less prone to being hacked. Google and mobile phone manufacturers are entitled to update their mobile operating systems and phones.

Around 15 November 2022 Abbott put in Google Play store its first update to Freestyle Librelink. The primary purpose of the update was to allow the smart insulin pens Novopen 6 and Novopen Echo Plus to communicate with Librelink, but also to fix some bugs in Librelink.

My phone downloaded and installed that update. Since then the high and low glucose alarms don't work on my phone. Neither does the signal loss alarm. And my phone now registers constant false "scan errors."

Thankfully I am not hypo unaware. But what are you supposed to do if you are hypo unaware, you've gone to sleep and you are relying on Freestyle Libre 2 sensors and the Librelink app to issue an alarm to wake you (or a partner/friend/carer) up so you are alerted to your sugars potentially going low, so you can double check and have a fighting chance to do something about it?

I've contacted Abbott Customer Services on many occasions and gone through their checklist of things to try (all permissions allowed; turn all alarms off and on again; delete cache; restart phone; uninstall and reinstall Librelink; Abbott sending out replacement sensors on the basis that the sensor you're wearing is faulty). None of these "solutions" has solved the problem permanently.

Abbott put out a further update around 1 December 2022 which was supposed to fix the issues caused by the first update. But the second update still hasn't fixed the problem on my phone permanently.

There's a limit to the number of times I'm prepared to turn my mobile phone on and off again each day to make Librelink work properly.

I don't want to carry around a separate reader in order to get alarms. I remember when Abbott first began promoting the Libre 2 in the UK. At that time they were proactively encouraging users that everything could be done on one's smartphone using their Librelink app.

This issue has been going on for the best part of 6 weeks now and Abbott don't appear to be any closer to sorting the problems with Librelink out permanently for a number of users.

For me Libre 2 is unfit for purpose at present. 

And I agree, it is monumentally stupid that there isn't a simple process where you can simply remove the updates so that Librelink is put back to the state it was in before the original upgrade issued in mid November 2022.

It also extraordinarily disappointing no one in the NHS appears to be liaising with Abbott to encourage them to sort this problem out asap. Being able to get replacement Libre 2 sensors isn't enough.

I feel sorry for the customer service staff at Abbott. They will have been given a script and are forced to stick to it.

The Dexcom people must be rubbing their hands with glee though (notwithstanding that apparently the number of prescriptions for non-Abbott glucose monitors in England is reported to be comparatively very small since NICE updated its glucose monitor eligibility guidance in April 2022 and there was some "umbrella" guidance/edict issued by NHS England in August 2022 allowing a wider number of flash and/or continuous glucose monitors to be prescribed - which most integrated care boards/integrated care systems have either ignored or been tortoise-like in implementing). 

It will be interesting  to see how long it takes Abbott to fix this mess and how many customers they will lose in the meantime.


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## barrym (Dec 8, 2022)

I don’t want to minimise your problem, but just to put the other side, I have run LibreLink on Nexus 4, Wileyfox Swift, Pixel 3a, and currently Pixel 6a. Now I’m not suggesting for one moment that it’s been all problem free, but hardware compatibility has never been a problem.

As a test I would suggest trying Juggluco (also on Play Store), it does real time (?) CGM by hijacking the alarm signals, and allows a NFC scan to mimic the LL one. It will run alongside LL happily, and will hopefully confirm something.

Good luck!


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## Pattidevans (Dec 8, 2022)

barrym said:


> As a test I would suggest trying Juggluco (also on Play Store), it does real time (?) CGM by hijacking the alarm signals, and allows a NFC scan to mimic the LL



Thanks for the suggestio.  Does Juggluco upload to the LibreLink app online?  My Librelink is linked to my diabetic team.

All the same I think Abbott should be held responsible.


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## BadaBing (Dec 8, 2022)

Pattidevans said:


> Thanks for the suggestio.  Does Juggluco upload to the LibreLink app online?  My Librelink is linked to my diabetic team.
> 
> All the same I think Abbott should be held responsible.


@Pattidevans Abbott *must *be held responsible for the current issues. It is Abbott who has convinced the UK Healthcare and Medical Products Regulatory Agency, which regulates medical devices in the UK, to grant Abbott a licence to make available to UK patients their Libre 2 sensors and Librelink software on the basis that, in normal use, a Libre 2 sensor and Librelink app will provide high and low glucose alarms. 

I've just seen on another forum a user explain that they are very hypo unaware and rely on the Libre 2/Librelink to do what it is supposed to, who now cannot receive alarms following updates on their phone.

Again I ask: why is the NHS not taking any proactive steps to liaise with Abbott to resolve this matter for patients?


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## grovesy (Dec 8, 2022)

I wonder if people in NHS are aware of the problems people are having.


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## Bruce Stephens (Dec 8, 2022)

Pattidevans said:


> Does Juggluco upload to the LibreLink app online?


It can send to xDrip or Libreview (perhaps both for all I know). http://jkaltes.byethost16.com/Juggluco/mgdL/index.html


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## BadaBing (Dec 8, 2022)

barrym said:


> I don’t want to minimise your problem, but just to put the other side, I have run LibreLink on Nexus 4, Wileyfox Swift, Pixel 3a, and currently Pixel 6a. Now I’m not suggesting for one moment that it’s been all problem free, but hardware compatibility has never been a problem.
> 
> As a test I would suggest trying Juggluco (also on Play Store), it does real time (?) CGM by hijacking the alarm signals, and allows a NFC scan to mimic the LL one. It will run alongside LL happily, and will hopefully confirm something.
> 
> Good luck!


Hello @barrym. I hope all is well with you.

Prior to my Android phone downloading and installing Abbott's mid November 2022 update (and the Android OS update from 12 to 13) my phone worked perfectly with Libre 2 sensors and Librelink. Never had a problem with Libre alarms.

Post the updates/OS update, the Librelink alarms don't work.


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## BadaBing (Dec 8, 2022)

grovesy said:


> I wonder if people in NHS are aware of the problems people are having.


Perhaps not. I know I've spent all my time contacting Abbott Customer Services and my mobile phone manufacturer.

But I'm sure some of the disgruntled users must have contacted their diabetes clinicians over the last six weeks.


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## Bloden (Dec 8, 2022)

grovesy said:


> I wonder if people in NHS are aware of the problems people are having.


My DSN and consultant are aware because we chatted about the problem. My DSN sighed and said “I should ring them again “ but she’s incredibly busy.


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## Pattidevans (Dec 8, 2022)

I think I need to get onto my pump nurse to ascertain whether they're aware of the issue or not.

However I do think Abbott should be made accountable for this complete lash up and be held to account.  It is not good enough to blame people's phones, especially when their phones meet their published guidelines.  At first I  was inclined to bear with them as they said they were working on the software to correct their mistake, but I cannot swallow their shrugging off the problem and trying to make it the user's fault.  Especially after releasing yet another "fix" that simply makes things worse.

So I am going to put together an email to send to them.  I will pass it by you all before I send it, but I think it would be a good idea to encourage as many people as possible to send the same or similar email making the strength of feeling from the Diabetic world felt.

I belong  to a FB group and on other forum, so I will publish in those places.  It would be good if everyone could pass it on to other online groups.


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## everydayupsanddowns (Dec 8, 2022)

How frustrating for you @Pattidevans

No wonder you were cross - especially since your phone meets the published criteria


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## Benny G (Dec 8, 2022)

@Pattidevans, you can uninstall the app from your phone and then install and use one of the previous versions.

2.8.2 was the November update

2.8.1 was the October update

2.5.3 was the March update

Use the one that last worked properly for you.

https://www.apkmonk.com/app/com.freestylelibre.app.gb/


The apps are at the bottom of the page


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## barrym (Dec 9, 2022)

Pattidevans said:


> Thanks for the suggestio.  Does Juggluco upload to the LibreLink app online?  My Librelink is linked to my diabetic team.
> 
> All the same I think Abbott should be held responsible.


Yes it does, although I’ve never switched that on (as I use both apps) so don’t know how well. What is there to lose?


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## BadaBing (Dec 9, 2022)

Benny G said:


> @Pattidevans, you can uninstall the app from your phone and then install and use one of the previous versions.
> 
> 2.8.2 was the November update
> 
> ...


Thanks @BennyG it is very helpful to know about this archive of previous versions of Librelink. 

Presumably Abbott are completely unaware that this archive of their Librelink software from a third party source exists. None of their customer services staff have mentioned it when I've asked for technical support.

Also, presumably if someone does "roll back" the current version of Librelink to a version "before the Abbott uodates" they will lose the ability of their Novopen 6 and Novopen Echo Plus smart insulin pens to communicate with Librelink.


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## Pattidevans (Dec 9, 2022)

Benny G said:


> @Pattidevans, you can uninstall the app from your phone and then install and use one of the previous versions.
> 
> 2.8.2 was the November update
> 
> ...


Thank you for that BennyG, I will do that!  It would be useful if Abbott customer services would give out this info, but they probably won't.   The worry is, of course, that they will foist another faulty "upgrade" on us without our knowledge, but at least we can book mark that page just in case.


BadaBing said:


> Also, presumably if someone does "roll back" the current version of Librelink to a version "before the Abbott uodates" they will lose the ability of their Novopen 6 and Novopen Echo Plus smart insulin pens to communicate with Librelink.


Yes, if that's what you are using, but many of us aren't using those pens.  I am on a pump as are many other people, so do not need that ability.  How do we know those using those pens are able to use the update either since their phones might not be up to it?  Useless having the facility if the hardware that worked previously no longer does.

Notwithstanding I still do not think Abbott is being the least bit responsible in this issue.  If anyone wanted to write to the CEO it is Neil Harris at Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE


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## Docb (Dec 9, 2022)

I have been following this thread with interest and feel I must put in a word for the defence.

When I started with technology (i.e. computers and stuff) backwards compatibility was a big thing.  Whenever an operating system was updated it was confidently expected that software written for older versions would still function as intended. Over the years that philosophy has slowly but surely eroded to the point it is to all intents and purposes disappeared. More operating systems are now commonplace, all have more features and are continually being updated. Wireless interconnectivity is now universal with each system having its own protocols and these are continually being updated. On top of it there are more devices trying to interact with it all, each with their own peculiarities.  When you throw in the commercial side, where all the players are trying to protect their own position it can all get out of hand especially when the consumer wants it all for free.  

The whole thing is unbelievably complicated and expecting everything to work every time in the real world is an expectation too far.  

As I say, thats the other side of the story.  It is something I appreciate, and it goes a long way to explaining why I keep my Mont Blanc fountain pen, notebook and basic spreadsheet to hand.


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## Eternal422 (Dec 9, 2022)

I too have been following this thread and have sympathies on both sides, a Libre 2 user and also working in IT.  @Pattidevans, I definitely feel your anger and annoyance about the situation, it is not good customer service and more importantly as a medical device that we rely on so much it is not only frustrating but worrying as well.  I know there are alternatives and you can always use a BG meter, but that is rather beside the point of having the Libre and the freedom and extra information it gives you.

As @Docb says, we are in a world with a myriad of different devices, operating systems and other apps which makes testing a bit of a nightmare.  It was hard enough to test a program running on one version of an operating system on one bit of hardware and to get 100% reliability.  In this world it is impossible.  However, the speed of fixes being released from Abbott does seem rather slow and I would have hoped that they would have been more responsive even having to wait for approval from Apple (not sure of the Android process).  

I have been lucky up to now and not had any issues with scanning and am using the latest Apple version of Librelink (2.8.1) on my iPhone XS Max under iOS 16.1.1 with a pending update to 16.1.2.  I do now almost dread updates in case they cause the Librelink app to malfunction but I don’t want to sacrifice other fixes and security patches so will have to keep biting the bullet and doing the upgrades.  In the future if I do get any problems I would be tempted to try something like the Shuggah app to see if that can read the sensor Bluetooth outputs and get a reading.

Sad that on top of an already complicated life with diabetes we now have a layer of technology that adds complexity rather than making life easier which is the promise of these advances.

I hope you get some luck with either using a previous Android version or Abbott get a fix out that genuinely fixes the issues with the current version of the app.


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## Benny G (Dec 9, 2022)

@Pattidevans, the Moto G6 Play stopped getting OS upgrades and support in 2020, so my advice is to use the older app which you know works with your phone.

I get annoyed with technology, the android 13 update on my tablet is fine for my in-ear buds but makes my favourite 8 year old bluetooth headphones go out of sync. I have to go into the hidden settings in 'Developer Options' to change bluetooth settings, then the audio sync issue is gone. Android 13 has changed something in its bluetooth settings, @BadaBing I think this might be where your alarms have gone.


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## HelenC (Dec 9, 2022)

Pattidevans said:


> I got very angry yesterday after installing the latest software release from Abbott for the Libre 2 which is supposed to correct the problems caused by the previous update. Now I am not only getting the slooooow reporting of the actual number after a scan (up to 4 minutes) that I had before, I am also getting the "scan failure, try again in 10 minutes" notice frequently. So I rang them. I obediently re-booted my phone after clearing the cache as instructed. This made no difference at all. So then the conversation went on with me telling the agent that my phone worked perfectly before the update at the end of November prior to the latest one, which was supposed to cure the problems caused. I asked if there was any way I could revert to the original software version and was told NO. So after me telling him I am using a Moto G6 Play phone using Android 9 he tells me it's not one of the compatible phones. He was nice enough and obviously sticking to his script. I then said, "so is it your recommendation that I buy a new phone?" Apparently not... it is his recommendation that I use the reader. I tell him that means carrying reader, phone and PDM at all times, when I can hardly carry a small handbag due to a wedge fracture of my vertibra which causes pain. He then says yes, that's what you'll have to do. In conclusion he says "so can I report that you are complaining because your phone does not work with the sensor". I said "NO you can't" You can report that my phone which previously worked perfectly with the Libre 2 now doesn't work due to Abbot's so called 'upgrade' which was forced upon your users without notice or choice. The problem lays with your software which is unfit for purpose"
> 
> 
> 
> ...


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## BadaBing (Dec 9, 2022)

Docb said:


> I have been following this thread with interest and feel I must put in a word for the defence.
> 
> When I started with technology (i.e. computers and stuff) backwards compatibility was a big thing.  Whenever an operating system was updated it was confidently expected that software written for older versions would still function as intended. Over the years that philosophy has slowly but surely eroded to the point it is to all intents and purposes disappeared. More operating systems are now commonplace, all have more features and are continually being updated. Wireless interconnectivity is now universal with each system having its own protocols and these are continually being updated. On top of it there are more devices trying to interact with it all, each with their own peculiarities.  When you throw in the commercial side, where all the players are trying to protect their own position it can all get out of hand especially when the consumer wants it all for free.
> 
> ...


Thanks @Docb

I have some sympathy with your spirited defence. Up to a point.

I've lost count of the number of times Microsoft have updated their ubiquitous operating system, or issued security updates, only to occasionally cause havoc with third party peripherals that need to work seamlessly with Windows. But at least Microsoft has always been (reasonably) diligent in putting things right.

And Microsoft always communicates and works with manufacturers of third party peripherals so that any downtime caused by OS upgrades or security patches are resolved relatively quickly and permanently.

Microsoft doesn't usually have end customers having to endlessly fiddle with their PC settings to try and make bits of software work on their computers!

Abbott, Google, Apple and the phone manufacturers don't appear to be communicating and cooperating with each other. They really ought to when medical device software is being put on the Google Play and Apple stores that real live patients use and rely on every day.


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## BadaBing (Dec 9, 2022)

Benny G said:


> @Pattidevans, the Moto G6 Play stopped getting OS upgrades and support in 2020, so my advice is to use the older app which you know works with your phone.
> 
> I get annoyed with technology, the android 13 update on my tablet is fine for my in-ear buds but makes my favourite 8 year old bluetooth headphones go out of sync. I have to go into the hidden settings in 'Developer Options' to change bluetooth settings, then the audio sync issue is gone. Android 13 has changed something in its bluetooth settings, @BadaBing I think this might be where your alarms have gone.


Thanks @Benny G, I might try to help Abbott out and fiddle with the developer options on my phone and see if I can fix things.

Following one Abbott Customer Service session I already had to unpair my airbuds from my phone because Abbott thought they might be conflicting with the bluetooth signal between the Libre 2 sensor and Librelink. That appears to have been wrong.


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## Pattidevans (Dec 12, 2022)

Hi all
Sorry, been major busy with Christmas stuff and not had a minute to respond (why is it always wives who are responsible for gift buying, wrapping, cads etc?

First of all many thanks for the suggestions  of alternate software and most of all the roll back of Librelink which I shall be doing when this sensor finishes.   

I just wanted to say that it’s not so much the software and it not working that is making me angry - anyone can make a mistake - rather it is Abbott’s arrogant attitude towards it’s users and by extension the NHS who are spending millions with them which makes me angry.


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## BadaBing (Dec 12, 2022)

Pattidevans said:


> Hi all
> 
> I just wanted to say that it’s not so much the software and it not working that is making me angry - anyone can make a mistake - rather it is Abbott’s arrogant attitude towards it’s users and by extension the NHS who are spending millions with them which makes me angry.


Good morning @Pattidevans 

I'm not sure the NHS are aware properly about precisely what has happened with the Freestyle Libre 2 and Librelink in the last 5/6 weeks and just how many people it is affecting

Many people have been gamely contacting Abbott customer services and trusting that Abbott's IT people will resolve the problems with alarms and scanning using Librelink. That's what I've done up until now.

I've only this morning spoken to my diabetes clinicians to tell them that I pretty much can't rely on the Librelink alarms to go off on my mobile phone unless I constantly switch my bluetooth on and off, or constantly restart my phone or clear caches or uninstall and reinstall Librelink.

I asked my clinicians if they might ask whomever is responsible centrally in NHS England for liaising with the diabetes tech companies to contact  Abbott and, as Abbott's largest UK customer, "encourage" Abbott to sort the issues out quickly and permanently. 

Will my clinicians contact NHS England? I have no idea.

I read on another forum about some parents who rely on the Libre 2 to keep an eye on when their diabetic child, with little or no hypo awareness, is going hypoglycemic. 

They recounted an instance when the child's sugars were in the high 2's/low 3's and the Libre 2 alarms did *not* go off. Now of course, it is possible that the Libre 2 sensor might have been faulty in that instance, But the parents mentioned they'd noticed the Libre 2 system is functioning differently since the update.

Thankfully, the parents said their child is recovering from that episode of hypoglycemia that wasn't warned by an alarm going off.

Hopefully those parents will have the good sense to report this to the child's diabetes team so appropriate follow up action can be taken by the NHS.

One of the weaknesses of the NHS warning systems it seems to me is that the NHS doesn't get involved early enough - until something catastrophic or near catastrophic (and preventable) happens.


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## Pattidevans (Dec 12, 2022)

Yes, must find time to email my DSN today.  I've found that the best way to get her attention.


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## trophywench (Dec 13, 2022)

Er - would it be a good idea for DUK themselves to contact Partha Kar for him to have a go at Abbot?


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## BadaBing (Dec 13, 2022)

trophywench said:


> Er - would it be a good idea for DUK themselves to contact Partha Kar for him to have a go at Abbot?


If DUK and Professor Kar are prepared to do so, then yes please!

The situation is sufficiently concerning now. A number of those who are hypo unaware - including children - who (or whose partners, carers or parents) rely on the Libre 2 alarms are potentially being put at risk, particularly when sleeping.

Not everyone has access to a Libre 2 reader (when the Libre 2 was launched users were encouraged to use the Librelink app with a compatible mobile phone).


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## Eternal422 (Dec 13, 2022)

I wonder if folks who are experiencing problems with the Librelink app (seems to be the Android version from what I am reading) should report issues via the Yellow Card system (https://yellowcard.mhra.gov.uk/)?  It does say it is used for “medical device incidents” as well as reporting adverse reactions to drugs.  Maybe that would help make this more public and get a better response from Abbott?


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## BadaBing (Dec 13, 2022)

Eternal422 said:


> I wonder if folks who are experiencing problems with the Librelink app (seems to be the Android version from what I am reading) should report issues via the Yellow Card system (https://yellowcard.mhra.gov.uk/)?  It does say it is used for “medical device incidents” as well as reporting adverse reactions to drugs.  Maybe that would help make this more public and get a better response from Abbott?


@Eternal422, the short answer to your question is: yes, of course they should.

My understanding of the yellow card scheme is that for both drugs and medical devices, the Medicines and Healthcare Products Regulatory Agency is only interested in being notified about "adverse" effects of using a drug or medical device. So essentially: did the product make you, or contribute to you being, ill, and in what way?

Anyone who has suffered an incident of hypoglycaemia because they rely on the Libre 2 alarms but did not receive an alarm following the Librelink update should report that using the yellow card scheme.

There are many people - like me - who have been inconvenienced by the Librelink updates but who thankfully haven't suffered an "adverse" event so far, like a hypo, or who have been "hyper" for sustained periods because the Libre 2 alarms don't go off on one's mobile phone following the update. Presumably the MHRA won't be  interested in such incidents.

If my understanding of the yellow card scheme is right, it is a fundamental weakness with the scheme in relation to medical devices because it doesn't allow patients to notify the MHRA early enough about "clear and present" imminent "adverse events."

If the Libre 2 alarms (a critical feature for those who are hypo unaware or who are susceptible to hyperglycemia) won't work "normally" on a mobile phone following an update, then surely Librelink is no longer fit for purpose?

One shouldn't have to wait for a serious, catastrophic, or near catastrophic (but preventable) event to happen with a medical device.

In any event, everyone who believes their Librelink isn't working normally following the updates should be informing their diabetes clinicians. The NHS is Abbott's largest UK customer. They can encourage "Abbott to sort the issues out quickly and permanently.

At the moment the NHS don't appear to be doing anything. At all.


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## Pattidevans (Dec 13, 2022)

trophywench said:


> Er - would it be a good idea for DUK themselves to contact Partha Kar for him to have a go at Abbot?


Good thinking Sedge, been out all day but will ring DUK in the morning.


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## Bruce Stephens (Dec 18, 2022)

barrym said:


> As a test I would suggest trying Juggluco (also on Play Store), it does real time (?) CGM by hijacking the alarm signals, and allows a NFC scan to mimic the LL one. It will run alongside LL happily, and will hopefully confirm something


I've just started using it and I second the recommendation. I don't like the interface that much but it works fine alongside LibreLink (just turn off the alarms in LibreLink), and there's something rather nice in seeing the basic BG and arrow on the lock screen without needing to scan. (I just need to remember to scan with LL often enough so it can keep its statistics. Juggluco can also show TIR things but the display just isn't as nice as LL's.)


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## barrym (Dec 19, 2022)

Bruce Stephens said:


> I've just started using it and I second the recommendation. I don't like the interface that much but it works fine alongside LibreLink (just turn off the alarms in LibreLink), and there's something rather nice in seeing the basic BG and arrow on the lock screen without needing to scan. (I just need to remember to scan with LL often enough so it can keep its statistics. Juggluco can also show TIR things but the display just isn't as nice as LL's.)


I agree with your observations totally. My next step may well be a watch….. But is that really necessary? But Father Christmas may just think it is.


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## Bruce Stephens (Dec 19, 2022)

barrym said:


> I agree with your observations totally. My next step may well be a watch….. But is that really necessary? But Father Christmas may just think it is.


I'm slightly ahead of you. I had an older android watch (an LG Watch Urbane). After fiddling with the instructions (for xDrip+) I decided it was just too old.

So I bought a Pixel Watch. (Alternatives included Samsung Galaxy Watch 4 or 5, but I don't have a Samsung phone so that reduces their utility a bit. But they are a little cheaper than the Pixel Watch.)

And it works very well: Juggluco feeds xDrip+ (both on the phone), and xDrip+ is also installed on the watch. It provides a few watch faces and I think the one I'm using is the default which shows the date and time as well as the current BG and arrow and a graph.

So on my phone's notification line I have BG readings from Juggluco and xDrip+ (as well as the empty LibreLink notification).

There's a complication (a small bit of information that can be embedded in other watch faces) but it seems not so useful: it has two lines, the top line gives the rate of change of BG and the lower one shows BG and an arrow. But the second line is so tiny I can't read it most of the time. So either I'm doing something wrong (maybe there's a configuration somewhere) or it's just not usable. (Maybe it's usable on a bigger watch: the Pixel Watch does have quite a small screen, relatively.)


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## Bruce Stephens (Dec 19, 2022)

I note that there's an experimental Juggluco app for Wear OS, so it looks like it would be possible to read from the sensor directly from a watch. (I doubt I'd want to do that: one reason for using my phone over the reader is for the big display.)


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## Benny G (Dec 19, 2022)

I am still using a watch older than the LG Urbane, my Sony smartwatch has served me well. The watch is so old that I had to sideload Google services to allow xdrip+ to work properly. Used with Libre 1 and a blucon the warch can be used without a phone. (I only have 3 Libre 1 sensors left before I make the switch to Libre 2.)
I use the smartwatch for xdrip+ and as a stepcounter (which works as an activity tracker inside xdrip+) The watch also tells the time.

If you guys discover how to put Libre 2 direct to a smartwatch, without a phone, don't be shy: share.


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## Bruce Stephens (Dec 19, 2022)

Benny G said:


> If you guys discover how to put Libre 2 direct to a smartwatch, without a phone, don't be shy: share.


Looks like it works sometimes: http://jkaltes.byethost16.com/JugglucoWearOS/mmol.html

Overall it doesn't sound like an attractive option (to use Juggluco on the watch in either mode).


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## barrym (Dec 19, 2022)

Thanks for the watch info both. Will have to take a closer look.


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## Benny G (Dec 19, 2022)

Bruce Stephens said:


> Looks like it works sometimes: http://jkaltes.byethost16.com/JugglucoWearOS/mmol.html
> 
> Overall it doesn't sound like an attractive option (to use Juggluco on the watch in either mode).


Reading through the juggluco information, it looks interesting and very much a work in progress. I think when I switch to Libre 2 I will add Oop2 and stay with xdrip+ using the phone as collector and my old Sony smartwatch as repeat. 
The juggluco thing does look interesting thou


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## BadaBing (Dec 21, 2022)

Have just had my 4th Libre 2 sensor fail to provide high/low glucose alarms since I started using (96 hours ago) the new Freestyle Libre 2 Reader Abbott sent me last week.


According to Abbott Customer Services there is still no scheduled date for when they will issue an update which will fix (hopefully) the issues to alarms and scanning on some Android and iPhones following updates to Freestyle Librelink app and Android and iPhone operating systems in the last six weeks.


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## rebrascora (Dec 21, 2022)

BadaBing said:


> Have just had my 4th Libre 2 sensor fail to provide high/low glucose alarms since I started using (96 hours ago) the new Freestyle Libre 2 Reader Abbott sent me last week.
> 
> 
> According to Abbott Customer Services there is still no scheduled date for when they will issue an update which will fix (hopefully) the issues to alarms and scanning on some Android and iPhones following updates to Freestyle Librelink app and Android and iPhone operating systems in the last six weeks.


Really odd that the Libre 2 reader is not getting the alarms. I don't think I have seen anyone else post about that problem before. The Libre reader has always seemed to be the reliable fall back option for people. I wonder if the Blue tooth receiver is damaged. 
I am due to get my first Libre 2 sensors this week and will be starting the first one on Sunday, so will be quite interested to see if I have any problems.


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## BadaBing (Dec 21, 2022)

rebrascora said:


> Really odd that the Libre 2 reader is not getting the alarms. I don't think I have seen anyone else post about that problem before. The Libre reader has always seemed to be the reliable fall back option for people. I wonder if the Blue tooth receiver is damaged.
> I am due to get my first Libre 2 sensors this week and will be starting the first one on Sunday, so will be quite interested to see if I have any problems.


Yes, I've never read about anyone having problems with alarms using the Libre 2 Reader either.

Nor have I had that many Libre 2 sensors not do what they are supposed to do in one go before.

Impossible for me to tell if the Libre 2 sensors have come from a poorly manufactured batch. At least two of the four sensors were replacements that Abbott sent me in substitution for Libre 2 sensors that didn't last the full 14 days.

If only Abbott had Jay Blades and the BBC Repair Shop team; they'd sort this catastrophe out!

Am going to have to fingerprick test until I receive replacements from Abbott.

Anyway, I hope your transition to the Freestyle Libre 2 is uneventful and problem-free.


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## Benny G (Dec 21, 2022)

rebrascora said:


> Really odd that the Libre 2 reader is not getting the alarms. I don't think I have seen anyone else post about that problem before. The Libre reader has always seemed to be the reliable fall back option for people. I wonder if the Blue tooth receiver is damaged.
> I am due to get my first Libre 2 sensors this week and will be starting the first one on Sunday, so will be quite interested to see if I have any problems.


Counting down the last days of Libre 1.

@rebrascora Have you asked for one of Abbott's readers to take advantage of the alarms? Having access to both the new and old reader would give you options.


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## rayray119 (Dec 21, 2022)

grovesy said:


> I wonder if people in NHS are aware of the problems people are having.


Don't think my area is they would more inclined to give people something else.


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## freesia (Dec 21, 2022)

I've just been reading this thread and now realise why my alarms have stopped working. Luckily i've not had any issues as i scan often (apart from an overnight/early morning hypo the other day for which no alarm went off). 

My sensor is due to be changed tomorrow night so am i right in thinking the alarms won't be available if i start it up with the phone? I do have a reader but its the convenience of the app that i like. I'm extremely not technical so reading all of the other things i could do makes me feel a bit panicky.


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## Bruce Stephens (Dec 21, 2022)

freesia said:


> My sensor is due to be changed tomorrow night so am i right in thinking the alarms won't be available if i start it up with the phone?


The alarms are only available on the device which started the sensor. So if you started with the phone then the reader's not going to produce alarms (or read the sensor at all).

(If I understand correctly if you start the sensor with the reader and then use Juggluco on your phone, Juggluco can steal the Bluetooth (and so the alarms). I haven't tried that (and now I don't have a reader I won't).)


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## freesia (Dec 21, 2022)

Bruce Stephens said:


> The alarms are only available on the device which started the sensor. So if you started with the phone then the reader's not going to produce alarms (or read the sensor at all


If the sensor is started with the reader should the alarms work on that? I assume its the app itself thats not producing the alarms?


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## Bruce Stephens (Dec 21, 2022)

freesia said:


> If the sensor is started with the reader should the alarms work on that?


Yes.


freesia said:


> I assume its the app itself thats not producing the alarms?


That's my understanding, yes. The sensors are sending out the glucose reading once a minute, and it's whatever receives them that produces the alarms (when configured).


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## rebrascora (Dec 22, 2022)

Benny G said:


> Counting down the last days of Libre 1.
> 
> @rebrascora Have you asked for one of Abbott's readers to take advantage of the alarms? Having access to both the new and old reader would give you options.


Hi, yes, I have obtained a Libre 2 reader thanks and looking forward to trying out the alarms.


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## Benny G (Dec 22, 2022)

@rebrascora Good, all set for the big day.


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## Benny G (Dec 22, 2022)

Reading on the xdrip forum I can see that Juggluco is making good progress towards taming Libre 3 (for use with xdrip on phone and watch). I will definitely give Juggluco some special attention in the near future.


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## rayray119 (Dec 22, 2022)

8.7 today


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## Pattidevans (Dec 23, 2022)

It was time for a new sensor yesterday, so I uninstalled Librelink from my phone and installed version 2.5.3 which worked perfectly for me previously.  I then started the sensor with my phone.  I had thought I could also use the reader to read the phone if I did it right away, though I did not expect alarms on it, however, it's just telling me that I can't use the reader with the sensor as it has been started with anothr device.  Although my phone is reading the sensor properly again I'm not now getting alarms.  I thought it was just some setting, but I have carefully gone through all the settings on Librelink and cannot see anything wrong there.

Anybody got any idea what phone settings I may need to tweak?


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## BadaBing (Dec 23, 2022)

Just to let everyone know, I received a couple of Libre 2 sensors from Abbott late yesterday.

I put one of them on. And my Libre 2 Reader gave me a couple of high glucose alarms. Hoorah!

So the Libre 2 Reader is working fine. I was just unlucky with four successive Libre 2 sensors.

Merry Christmas and a prosperous 2023!


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## freesia (Dec 23, 2022)

Pattidevans said:


> Although my phone is reading the sensor properly again I'm not now getting alarms. I thought it was just some setting, but I have carefully gone through all the settings on Librelink and cannot see anything wrong there.
> 
> Anybody got any idea what phone settings I may need to tweak?


I think its still a problem with the app not giving alarms. My phone has always worked ok with the app for scanning but since the updates the alarms just won't work. I've turned the phone off, cleared cache, turned alarms off then back on, nothing makes them work. I hope they get it sorted soon.


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## Pattidevans (Dec 23, 2022)

freesia said:


> I think its still a problem with the app not giving alarms. My phone has always worked ok with the app for scanning but since the updates the alarms just won't work. I've turned the phone off, cleared cache, turned alarms off then back on, nothing makes them work. I hope they get it sorted soon.


I'm not sure they are even trying Freesia.


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## freesia (Dec 23, 2022)

Surely they would have to as they're marketing it as having alarms. If someone hasn't got a libre reader and has no hypo awareness, it could be fatal. Are DUK onto them do we know?


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## christine.h (Dec 23, 2022)

Pattidevans said:


> It was time for a new sensor yesterday, so I uninstalled Librelink from my phone and installed version 2.5.3 which worked perfectly for me previously.  I then started the sensor with my phone.  I had thought I could also use the reader to read the phone if I did it right away, though I did not expect alarms on it, however, it's just telling me that I can't use the reader with the sensor as it has been started with anothr device.  Although my phone is reading the sensor properly again I'm not now getting alarms.  I thought it was just some setting, but I have carefully gone through all the settings on Librelink and cannot see anything wrong there.
> 
> Anybody got any idea what phone settings I may need to tweak?


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## christine.h (Dec 23, 2022)

How did you get the 2.5.3.version please 
I informed my nurse and I an getting the Libra 3 ASAP alas I saw the email after she left for the Christmas period I have Hypo unawareness I have found rhe reader so will use that but it means changing the new sensor oh what fun it is to have tech and be diabetic lol I adore the DASH better than the Medtrum Nano


freesia said:


> Surely they would have to as they're marketing it as having alarms. If someone hasn't got a libre reader and has no hypo awareness, it could be fatal. Are DUK onto them do we know?


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## christine.h (Dec 23, 2022)

I also filled in the yellow card on line


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## Pattidevans (Dec 23, 2022)

The 2.5.3 version link is here on the first page of this thread.  https://www.apkmonk.com/app/com.freestylelibre.app.gb/


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## everydayupsanddowns (Dec 23, 2022)

Pattidevans said:


> Anybody got any idea what phone settings I may need to tweak?



Not on Android (assuming notifications etc are enabled, including ‘time sensitive’ if that’s a thing on Robot?).

However, one possible glitch-solver is always to fully power the handset down and restart it.

Surprising how many times that half-joke of turn it off, turn it in again works!

Sorry you are still having such a runaround with this


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## freesia (Dec 23, 2022)

everydayupsanddowns said:


> However, one possible glitch-solver is always to fully power the handset down and restart it.


I've tried this twice, the alarms still don't work when using the app


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## everydayupsanddowns (Dec 23, 2022)

freesia said:


> I've tried this twice, the alarms still don't work when using the app


Ah shame


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## trophywench (Dec 23, 2022)

I thought L2 was the same as L1, in that if you start it with the Reader, you can then also use your phone but that the alarms will only sound on the Reader and not on your phone.  If you start it with phone, the Reader doesn't work at all.


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## Benny G (Dec 23, 2022)

Pattidevans said:


> It was time for a new sensor yesterday, so I uninstalled Librelink from my phone and installed version 2.5.3 which worked perfectly for me previously.  I then started the sensor with my phone.  I had thought I could also use the reader to read the phone if I did it right away, though I did not expect alarms on it, however, it's just telling me that I can't use the reader with the sensor as it has been started with anothr device.  Although my phone is reading the sensor properly again I'm not now getting alarms.  I thought it was just some setting, but I have carefully gone through all the settings on Librelink and cannot see anything wrong there.
> 
> Anybody got any idea what phone settings I may need to tweak?


Hi @Pattidevans, the app you rolled back to 2.5.3 was released back in April 2021, at that time if you wanted to use a phone and a reader together you had to start the sensor with the reader, then set the phone as the second device (with alarms only available on the first device - the reader)

Here is a thread from April 2021 discussing this very issue:


			https://forum.diabetes.org.uk/boards/threads/libre-2-multiple-phones.92892/
		


For you @Pattidevans, your phone seems to be scanning your sensor via NFC correctly, but with no alarms, more like a Libre 1 sensor.
The alarms rely on your Bluetooth connection, and are a secondary feature. I don't use the Bluetooth alarms of Libre link, (I use xdrip+ with Libre 1 sensors) so I will have to pass that issue to the wider group.


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## Pattidevans (Dec 24, 2022)

It's all academic now because my phone decided all on it's own to update the app to the latest one (2.8.2) during the night.  Alarms not working and sensor taking up to 4 minutes to show results of a scan.  Phoned Abbott again as really this sensor is now useless.  They are replacing it.... but only after I jumped through hoops with phone and LibreLink settings again.  In the end the very pleasant customer services lady admitted that they know they have made a mess of the software, rather than blaming my phone, and she did reassure me that they are still working on an up date which they hope to release soon.

I said to her that the update was meant for people who use Novorapid pens and pointed out that they were actually a minority of T1s as many people use pumps and even those on injections do not all use those pens or NovoNordisk insulin.  So whereas they may benefit, or not... the majority of us have been disadvantaged and that the internet is completely full of complaints (running to hundreds) about this last update.  She asked if she could report my comments back.  I said certainly.  

I am somewhat mollified by her attitude.


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## Benny G (Dec 24, 2022)

Sorry about that @Pattidevans, there is a box to tick to turn off app updates on an app by app basis. In Google play go to your Librelink app and tap the 3 dots in the top right corner and remove the tick for auto updates.



You should be able to uninstall the updated app and reinstall the older app, then turn off auto updates as shown above. As you are already using a new sensor the data in your Librelink app will start fresh, but will be available in Libreview on your PC.


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## BadaBing (Dec 24, 2022)

Pattidevans said:


> It's all academic now because my phone decided all on it's own to update the app to the latest one (2.8.2) during the night.  Alarms not working and sensor taking up to 4 minutes to show results of a scan.  Phoned Abbott again as really this sensor is now useless.  They are replacing it.... but only after I jumped through hoops with phone and LibreLink settings again.  In the end the very pleasant customer services lady admitted that they know they have made a mess of the software, rather than blaming my phone, and she did reassure me that they are still working on an up date which they hope to release soon.
> 
> I said to her that the update was meant for people who use Novorapid pens and pointed out that they were actually a minority of T1s as many people use pumps and even those on injections do not all use those pens or NovoNordisk insulin.  So whereas they may benefit, or not... the majority of us have been disadvantaged and that the internet is completely full of complaints (running to hundreds) about this last update.  She asked if she could report my comments back.  I said certainly.
> 
> I am somewhat mollified by her attitude.


@Pattidevans, when I spoke to one of various Abbott Customer Service people over the last couple of months, I was told a slightly different story about the Librelink updates.

Abbott have issued two updates. I was told the first update (which downloaded on my mobile mid November 2022) was supposed to "fix" some issues with alarms. I did query this with the person I spoke to at the time because I remember checking the Google Play store and it definately said the update was to allow users of these new smart insulin pens to communicate with and download insulin doses to Librelink.

The person I spoke to then said the second update (which my phone received on 1 December 2022) was supposed to allow these new Novo smartpens to communicate with Librelink..

I got new Novopen smart insulin pens recently (I had been using the same insulin pens that I got when I was first diagnosed decades ago and several good people on this forum suggested I really ought to get new pens). Anyone who uses Novo Nordisk insulin and needs a new durable insulin pen will now be prescribed a Novopen smartpen.

They are very useful. I pride myself on having an excellent memory, but sometimes even I forget when I last injected and the number of units.

But I really, really, really, need the Librelink alarms on my mobile to work again properly. Soon!

I've also put on and had to take off four Libre 2 sensors in a row over 96 hours because I couldn't get high and low glucose alarms on my brand new Libre 2 Reader. All four Libre 2 sensors were faulty. 

I'm just very thankful I'm hypo aware. Have read at least two accounts elsewhere - one of which involved a child - where Librelink alarms didn't go off, the users went into severe hypoglycaemia and in one case the user woke up to paramedics treating them (with all the potential implications that has if one drives and one wants to keep one's driver's licence).

I read in an earlier post that you were thinking of contacting DUK to see if they might contact NHS England to encourage Abbott to sort the problems out. I was wondering if you spoke to anyone at DUK.

I am now thinking seriously about reporting the problems I've had to the MHRA as a Yellow Card incident. The MHRA really will make Abbott sort this mess out pronto.


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## Proud to be erratic (Dec 25, 2022)

BadaBing said:


> I am now thinking seriously about reporting the problems I've had to the MHRA as a Yellow Card incident.


I personally think you should report your problems as a yellow card incident and believe others should also do this.


BadaBing said:


> The MHRA really will make Abbott sort this mess out pronto.


I'm far from confident that the MHRA will sort this out pronto, particularly if your report is an isolated incident. Whereas I strongly suspect the MHRA will need a modest barrage of complaints, before they sit up and pay attention.

The harsh reality is that there is no evidence that the NHS manager for this highish value contract is in any way informed about the myriad of defective Libre sensors - not least because that contract manager is not in the information loop for defect reporting and Google searches have not revealed to me who, by job title if not personal name, that contract manager is or where based.

I have said before, the change in legislation in respect of the Sale of Goods Act moved the responsibility for faulty goods from the manufacturing source or wholesale supplier to the seller. At very first glance that seemed contradictory (why burden retailers with problems from manufacturers?) but after a moment's thought it made great sense. If a retailer has lots of complaints about the goods they are selling they will stop retailing these and that makes it far more evident to manufacturers about the business they are losing: they then either improve (and have to convince their lapsed retailer that they have improved, or that product sinks (perhaps with the manufacturer). This is market forces at their best.

Other Gov't or public interest contracts are normally subject to Treasury rules, which includes a clear audit trail that the Contract Manager is closely monitoring the performance of their Contract, with regular reviews and close scrutiny of supply or service delivery to the end-users. There is no evidence this is occurring with Abbott and the Freestyle Libre sensors. 

Pertinent questions to anyone's MP might attract attention - such as : Given there is some evidence of consistent failures and problems with software from Libre 2, does the Public Accounts Committe know about these? Is scrutiny of NHS higher value contracts in the purview of the PCA? Is the Secretary of State for Health aware that there are underlying problems? Are NICE aware of these problems? Could the MP provide an email address for the Contract Manager for these sensors, so that they can at least be informed of this serious medical issue? Such questions could be presented individually to the relevant responsible person - but I suspect more headway would be gained from an MP taking the initiative; it might take a little longer to get the scrutiny started, but would allow an MP to bask in their initiative to get this resolved and would suit most MP's egos!


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## BadaBing (Dec 25, 2022)

Proud to be erratic said:


> I personally think you should report your problems as a yellow card incident and believe others should also do this.
> 
> I'm far from confident that the MHRA will sort this out pronto, particularly if your report is an isolated incident. Whereas I strongly suspect the MHRA will need a modest barrage of complaints, before they sit up and pay attention.
> 
> ...


Merry Christmas @Proud to be erratic. I hope you are enjoying the festive season.

Had to break off to respond to your post.

Because of my job, I know a little bit more than the average UK consumer about how medicines and medical devices obtain approval to be supplied to the public in this (and other) countries.

Pharmaceutical products and medical devices are regulated in the United Kingdom, as they are in the European Union (by the European Medicines Agency), the USA (by the US Food and Drug Administration) and every other mature democracy. 

Because drugs and medical devices are regulated, they are a special category of goods.  The regulatory regime is there to add an extra umbrella of protection for the public at large beyond that given by usual consumer protection legislation. It allows the regulators to order products are taken off the market, if necessary with immediate effect, and for products to be recalled, if those products are found no longer to be work or be safe.

It is the responsibility of medical regulators in each country to approve and licence the use of drugs and medical devices to patients.

The Medicines and Healthcare Products Regulatory Agency ("MHRA") is an agency of the Department of Health and Social Care. It was set up by the Blair government in 2003. It replaced the old medicines controls agency and the medical devices agency. 

The MHRA authorises and licences drugs and medical devices for sale and prescription and use by the public in the United Kingdom. 

In the United Kingdom it is the exclusive remit of the MHRA to certify that every drug and medical device sold over the counter (or online) or provided on via prescription in the UK (a) works and (b) is safe. The MHRA has the power to revoke any licence for any drug or medical device if that drug or medical device ceases to work or be safe.

All mature democracies with a medical regulator have a process in place to allow healthcare professionals, or individuals who use drugs or medical devices, to report adverse events that are believed to be caused by the use of any drug or medical device. In the UK that process is the Yellow Card System.

Of course it is trite to say a single yellow card report sent into the MRHA is unlikely to result in the MHRA taking action. Which is why other people need to report issues too if they believe the current issues with the Librelink app or faulty sensors have "_caused, or almost caused, an injury to a patient or other person, or a wrong *or delayed diagnosis and treatment* of a patient_" [from the MHRA's own website].

I am a fan of getting one's member of Parliament involved in issues IF I think it is appropriate and proportional to do so and IF it is likely to have the desired effect. 

However, there are laws, rules, regulations which the MHRA *must *follow and their decision-making process must always be based on evidence and never on any one UK member of parliament "getting involved." If the MHRA were to fail to follow the laws, rules and regulations that govern what they do, and the evidence, then any decision the MHRA make to revoke a licence or withdraw products would almost certainly be subject to successful challenge through the courts by judicial review.

That's how the process works in the UK. And rightly so.

As I have said in other posts, I suspect very few people have raised yellow card events with the MHRA so far. They haven't done so because - just as I have - they have trusted Abbott to fix the problems quickly or send out replacement sensors.

I say again, I have read accounts on other forums of individuals who say they have suffered severe hypoglycaemia because they were relying on receiving an alarm from Librelink on their mobile phones before their sugars went too low. Alarms which never happened since the Librelink app was updated 6/7 weeks ago. And at least one of the individuals whose accounts I read say they had to be treated by paramedics as a result. 

I don't intend to contact my MP about the issues I've had. I know my MP sufficiently well to know that they simply won't be interested *unless* I had gone into a diabetic coma (which thankfully I haven't thus far), and therefore it would be a complete waste of my and their time. 

I would rather send a yellow card report into the MHRA and trust that others will do so too.

As for whomever "the NHS manager is who is responsibile for the high value contract with Abbott," that is wholly irrelevant to the MHRA's role and responsibility in law for ensuring drugs and medical devices work and are safe. 

The fact that the relevant NHS manager responsible for the high value contract is not aware of what is going on (I know I - and others - have reported our experiences to our diabetes clinicians - if those clinicians have failed to pass that information onto anyone higher up the NHS "foodchain," then there is something very wrong within the NHS's reporting systems that *must *be fixed) should not stop anyone reporting a Yellow Card event if they think it is appropriate to do so.

Happy New Year!


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## Benny G (Dec 25, 2022)

Chatgpt:

Here is a summary of the regulatory process for drugs and medical devices in the UK:


The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for approving and licensing the use of drugs and medical devices in the UK.
The MHRA has the power to revoke any license for a drug or medical device if it is found to be unsafe or ineffective.
The Yellow Card System allows individuals to report adverse events that they believe may be related to the use of a drug or medical device.
If a problem with a drug or medical device is reported, the MHRA may take action, such as revoking a license or ordering a recall, based on the evidence and following the laws, rules, and regulations that govern its actions


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## Proud to be erratic (Dec 26, 2022)

BadaBing said:


> Merry Christmas @Proud to be erratic. I hope you are enjoying the festive season.
> 
> Had to break off to respond to your post.


Hello @BadaBing, I certainly am enjoying the festivities; just wish I could keep my BG down - it is determined to bounce me back into the mid teens by the end of each 4 hr correction period. Even a particularly aggressive correction yesterday, followed by an enjoyable walk with my grandson and which got me into the 4's, was back in the teens 4 hrs later. Changed my insulin batch, raised my basal, running out of ideas. But that's for another day. I'm awake early now, to take another correction.


BadaBing said:


> Because of my job, I know a little bit more than the average UK consumer about how medicines and medical devices obtain approval to be supplied to the public in this (and other) countries.


I'm happy to bow to your much deeper knowledge about the process below.


BadaBing said:


> Pharmaceutical products and medical devices are regulated in the United Kingdom, as they are in the European Union (by the European Medicines Agency), the USA (by the US Food and Drug Administration) and every other mature democracy.
> 
> Because drugs and medical devices are regulated, they are a special category of goods.  The regulatory regime is there to add an extra umbrella of protection for the public at large beyond that given by usual consumer protection legislation. It allows the regulators to order products are taken off the market, if necessary with immediate effect, and for products to be recalled, if those products are found no longer to be work or be safe.
> 
> ...


I presume you meant likely rather than unlikely.


BadaBing said:


> Which is why other people need to report issues too if they believe the current issues with the Librelink app or faulty sensors have "_caused, or almost caused, an injury to a patient or other person, or a wrong *or delayed diagnosis and treatment* of a patient_" [from the MHRA's own website].


And I agreed with this in my earlier posting. Although I have a  unsatisfactory relationship with Libre 2, I feel almost certainly "it is me" and my body doesn't like Libre 2 so I don't think I can justify a yellow card report. The only leverage I mightbhave is that my Consultant has asked my GP to write a script for Dexcom One and my GP has written to me saying they cannot write that script, since the BOB ICS has not yet approved Dexcom One. So I could reason that I am getting a wrong treatment from Libre 2, with my fully documented history of 50% failures and neglect by my ICS in not recognising that a low/no cost option is available from the NHS Formulary - solely because my ICS is being tardy in implementing the simple enough update to NICE Guidance Note NG19.
I just think this is stretching reasonability; Abbott  have replaced all defective sensors; I have specifically agreed with each replacement request that I was not put at medical risk and did not need extra medical attention. I've just been inconvenienced.
So I guess I need to try a different path to the Yellow brick road ....


BadaBing said:


> I am a fan of getting one's member of Parliament involved in issues IF I think it is appropriate and proportional to do so and IF it is likely to have the desired effect.


I recognise the 2 IFs. 
My MP is a Lib Dem who gained an otherwise seemingly safe Conservative seat after a by-election and benefitted from a knee-jerk response to Boris's misbehaviour during Covid. If the letter box drops are indicative of my MP's determination to improve UK Politics, then the right letter to her might trigger some action. But I also recognise the reality that it might not catch her attention.
I'm still mulling over my options and at risk of confusing myself, never mind my MP. I guess my real problem is that our regional ICS is just invisible; it was quoted by my GP in her written response to me telling me she can't write the script for Dexcom One. But no-one (not my GP, nor the PALs for the ICS, nor the S Bucks Hospice that has been kindly monitoring and helping me post Chemo) can provide a specific structure for the BOB ICS, or a contact phone no or email address within the ICS. Everyone says the ICS hasn't yet approved Dexcom One, no-one can be specific about who or what is in the ICS. It makes George Orwell's vision of the future so true; or the Yes Minister TV series has become alarmungly phrophetic. Probably hundreds of people working in the name of an ICS that has a title, but no substance.


BadaBing said:


> However, there are laws, rules, regulations which the MHRA *must *follow and their decision-making process must always be based on evidence and never on any one UK member of parliament "getting involved." If the MHRA were to fail to follow the laws, rules and regulations that govern what they do, and the evidence, then any decision the MHRA make to revoke a licence or withdraw products would almost certainly be subject to successful challenge through the courts by judicial review.
> 
> That's how the process works in the UK. And rightly so.
> 
> ...


I do wonder about whether it is irrelevant to the MHRA  role and responsibility. How, exactly, does the MHRA raise a concern to a Supplier of a possible dangerous medication? Surely, apart from approaching Abbott with their evidence, they must involve or inform the NHS or the Dep't of Health that they are investigating something. Is there a Protocol that the MHRA must, or should, follow and is that protocol in the public domain? If the MHRA were formerly ISO 9000 accredited, they would have been obliged to tell the originator of the Yellow Card something about  their response (although the cynic in me thinks that feedback would be vague and obscure - the public doesn't really need to know how the MHRA conducts its business, in case the public takes too much interest!)


BadaBing said:


> The fact that the relevant NHS manager responsible for the high value contract is not aware of what is going on (I know I - and others - have reported our experiences to our diabetes clinicians - if those clinicians have failed to pass that information onto anyone higher up the NHS "foodchain," then there is something very wrong within the NHS's reporting systems that *must *be fixed)


Agreed: from talking with a DSN on my recent DAFNE course I couldn't help feeling there is a lot wrong with the reporting chain, partly because staff feel overloaded and burdened with immediate patient issues in front of them; and partly because there is not that instinctive sense 'if you see something that is wrong and you walk on by, you condone that wrong and thus approve that wrong'. But I also know that is the easy bit - the difficult bit is how to correct that wrong in a timely, sensible  and appropriate way.


BadaBing said:


> should not stop anyone reporting a Yellow Card event if they think it is appropriate to do so.


Agreed.


BadaBing said:


> Happy New Year!


And a Happy New Year to yourself.


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## BadaBing (Dec 26, 2022)

Proud to be erratic said:


> I presume you meant likely rather than unlikely.


No, I meant what I said. If only one person reports an MHRA Yellow Card incident, the MHRA *is* unlikely to do anything. But if many people do, I would expect the MHRA at the very least to engage with Abbott to make them resolve the issues many people have complained about.

The Libre 2 has been licensed by the MHRA to provide low and high glucose alarms via the Librelink app on a compatible mobile phone. At the moment Librelink is failing to do so on many people's compatible phones. Some people rely on those alarms. I know I do to treat hyperglycaemia in a timely way to minimise diabetes complications happening in the medium and longer term


Proud to be erratic said:


> And I agreed with this in my earlier posting. Although I have a  unsatisfactory relationship with Libre 2, I feel almost certainly "it is me" and my body doesn't like Libre 2 so I don't think I can justify a yellow card report. The only leverage I mightbhave is that my Consultant has asked my GP to write a script for Dexcom One and my GP has written to me saying they cannot write that script, since the BOB ICS has not yet approved Dexcom One. So I could reason that I am getting a wrong treatment from Libre 2, with my fully documented history of 50% failures and neglect by my ICS in not recognising that a low/no cost option is available from the NHS Formulary - solely because my ICS is being tardy in implementing the simple enough update to NICE Guidance Note NG19.
> I just think this is stretching reasonability; Abbott  have replaced all defective sensors; I have specifically agreed with each replacement request that I was not put at medical risk and did not need extra medical attention. I've just been inconvenienced.
> So I guess I need to try a different path to the Yellow brick road ....


Whether a particular flash glucose monitor or continuous glucose monitor performs reasonably well for any given individual depends on a number of factors, including whether that particular medical device works well with the individual's own body chemistry.

I'm very lucky in that the Freestyle Libre system sensors (when it works) works extremely well with my own body chemistry and give readings which are within the working parameters of the Libre system when compared to a blood fingerstick test. It is one of the reasons why despite the frustrations of the last few weeks, I prefer to continue using the Freestyle Libre system.

But Abbott need to fix the issues of Librelink alarms failing to go off on mobile phones, and too high a failure rate of Libre 2 sensors, because I believe those problems have delayed me diagnosing and treating hypoglycaemia and hyperglycaemia in a timely way.

The issue you mention with the various integrated care systems/integrated care boards (the former clinical commissioning groups) *not *making other manufacturers' flash and continuous glucose monitoring products available in the health regions the ICS/ICB (former CCGs) are responsible for, despite the change to NICE guidance in April 2022 - and the edict that was issued by NHS England in August 2022 to make other third party flash and continuous glucose products available - is an entirely separate issue.

It has more to do with (a) ICSs/ICBs claiming they don't have the time and resources to train staff to educate diabetic patients to use the new third party flash glucose monitors and continuous glucose monitors that are available, and (b) an unwillingness - however wrongheaded and pennywise-but-pound-foolish - by ICSs/ICBs to spend money on the new third party flash glucose monitors and continuous glucose monitors for fear that doing so will eat up a disproportionate amount of their budgets (which budgets they are required by law to balance every year, just as local councils have to balance their budgets annually).


Proud to be erratic said:


> I recognise the 2 IFs.
> My MP is a Lib Dem who gained an otherwise seemingly safe Conservative seat after a by-election and benefitted from a knee-jerk response to Boris's misbehaviour during Covid. If the letter box drops are indicative of my MP's determination to improve UK Politics, then the right letter to her might trigger some action. But I also recognise the reality that it might not catch her attention.
> I'm still mulling over my options and at risk of confusing myself, never mind my MP. I guess my real problem is that our regional ICS is just invisible; it was quoted by my GP in her written response to me telling me she can't write the script for Dexcom One. But no-one (not my GP, nor the PALs for the ICS, nor the S Bucks Hospice that has been kindly monitoring and helping me post Chemo) can provide a specific structure for the BOB ICS, or a contact phone no or email address within the ICS. Everyone says the ICS hasn't yet approved Dexcom One, no-one can be specific about who or what is in the ICS. It makes George Orwell's vision of the future so true; or the Yes Minister TV series has become alarmungly phrophetic. Probably hundreds of people working in the name of an ICS that has a title, but no substance.


If you live in a constituency with an MP who is empathetic and prepared to engage with you, I truly envy you. Unfortunately I don't! And I am *not *prepared to risk diabetic coma (with all the attendant medical risks of possible brain and other organ damage) to get my MP's attention.


Proud to be erratic said:


> I do wonder about whether it is irrelevant to the MHRA  role and responsibility. How, exactly, does the MHRA raise a concern to a Supplier of a possible dangerous medication? Surely, apart from approaching Abbott with their evidence, they must involve or inform the NHS or the Dep't of Health that they are investigating something. Is there a Protocol that the MHRA must, or should, follow and is that protocol in the public domain? If the MHRA were formerly ISO 9000 accredited, they would have been obliged to tell the originator of the Yellow Card something about  their response (although the cynic in me thinks that feedback would be vague and obscure - the public doesn't really need to know how the MHRA conducts its business, in case the public takes too much interest!)


Because the laws of this country, the laws made by UK Parliament, give the MHRA the legal powers to revoke a licence for the sale to the public of *any *drug or medical device made available to the public, and to mandate that a particular drug or medical device is no longer sold and taken immediately off shelf and/or recalled.

There are significant penalties for any pharmaceutical company, medical device manufacturer and retailers who fail to comply IF the MHRA decides to revoke a licence and mandates product be removed.

That's why.

The only other institution in the UK that  has that sort of power is one of His Majesty's judges following legal action.

I say once again the MHRA is an executive agency of the Department of Health and Social Care. It's part of the NHS.


Proud to be erratic said:


> Agreed: from talking with a DSN on my recent DAFNE course I couldn't help feeling there is a lot wrong with the reporting chain, partly because staff feel overloaded and burdened with immediate patient issues in front of them; and partly because there is not that instinctive sense 'if you see something that is wrong and you walk on by, you condone that wrong and thus approve that wrong'. But I also know that is the easy bit - the difficult bit is how to correct that wrong in a timely, sensible  and appropriate way.


All any of us can do is trust that our clinicians will do the right thing, not dismiss concerns we report to them as trivial, and inform the right people up the chain of command about our concerns.

However, each of us as patients has the power and agency - through the MHRA's Yellow Card Scheme - to do our bit (our moral/public/community duty?) and report to the MHRA concerns to try to ensure all medicines and medical devices on the market in the UK (a) work and (b) are and remain safe.


Proud to be erratic said:


> And a Happy New Year to yourself.



And to you!


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## 42istheanswer (Dec 26, 2022)

Proud to be erratic said:


> Hello @BadaBing, I certainly am enjoying the festivities; just wish I could keep my BG down - it is determined to bounce me back into the mid teens by the end of each 4 hr correction period. Even a particularly aggressive correction yesterday, followed by an enjoyable walk with my grandson and which got me into the 4's, was back in the teens 4 hrs later. Changed my insulin batch, raised my basal, running out of ideas. But that's for another day. I'm awake early now, to take another correction.
> 
> I'm happy to bow to your much deeper knowledge about the process below.
> 
> ...



I think in your case, where it is a different issue of your GP is unable to prescribe a medically recommended "treatment" due to delays by the ICS/ICB it is entirely appropriate to write to your MP - as a "local issue" pressure from your MP may well have the desired outcome!


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## mark king (Dec 26, 2022)

This is a big read of which I've only done a fast read.  This is my set up.
I'm using L2 but use Libreview to read L2 back and glooko for my Omni pump back to my Diabetic nurse.
I start my L2 sensor with its PDM first followed by my phone. The alarms ONLY sound on the pdm.  I have noticed that I get more "try again in 10 mins" errors of late but in general both systems work well.

That said in January coming I am due to change over to Dexcom G7, after in house training, by recommendation of my diabetic nurse.  They are expecting to do this for many if not all present L2 users.   I'm in Wyre Forest Geo area. 
I've had a quick look-see and the Dexcom has a much better looking customer support interface, but then I've not yet spoke with them on any problems so time will tell.

Best


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## Proud to be erratic (Dec 26, 2022)

mark king said:


> This is a big read of which I've only done a fast read.  This is my set up.
> I'm using L2 but use Libreview to read L2 back and glooko for my Omni pump back to my Diabetic nurse.
> I start my L2 sensor with its PDM first followed by my phone. The alarms ONLY sound on the pdm.  I have noticed that I get more "try again in 10 mins" errors of late but in general both systems work well.
> 
> ...


Thanks @mark king. As far as I can tell, Dexcom One is a fairly different 'beast' to G7 and that is reflected in the greater unit price of G7; arguably more akin to comparing apples and oranges (both edible fruits, yet pretty different).  Over this seasonal break I'm going to do more research, hunt down you tube videos to fill in the gaps that the Dexcom site doesn't seem to provide.

I like having alarms on my L2 reader and for quick Libre scans; with my android phone for recording data such as insulin and carbs. I understand the Dexcom One Reader is very basic; but I admit I've not fully researched that - and I understand I'm likely to need a specific app for recording data, which can be visible to a 3rd party, such as the DSN team. I'm not clear if the Dexcom app Clarity will do that. So lots of holes in my knowledge at present. 

Meanwhile I've opened up various 'rabbit holes' and need to pause and decide which way to turn, ie where to put my maximum effort in deciding how to proceed. I'm slightly confusing myself with too many possible options, none of which at the moment seem ideal for my making real progress. However, all of this is going further away from the original topic of "Abbott and unsatisfactory Libre 2" and apologies for adding to the digression.


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## Bruce Stephens (Dec 31, 2022)

Bruce Stephens said:


> Looks like it works sometimes: http://jkaltes.byethost16.com/JugglucoWearOS/mmol.html
> 
> Overall it doesn't sound like an attractive option (to use Juggluco on the watch in either mode).


I note the latest update for Juggluco says it can use Bluetooth between the phone and the watch (for when you're using Juggluco on the phone to read the sensor). (Previously it had to use wifi, which only works when you're in some place where both the phone and watch can connect to the wifi.)


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