FREESTYLE LIBRE ON SALE!!!!

[Andy_P]

Just spotted your post. I have just had a similar issue with my 5th sensor. I have had them all on my left arm. I could feel an itching sensation after the first week on the 5th sensor but kept it on for the full 14 days. When I removed it it was very red and itchy (see attached image) I will be contacting customer support in the morning! Needless to say sensor no. 6 is on the other arm.

 

[tim2000s]

Hmmm. Is it possible that the issue is reusing the same arm and not giving it a time to breathe and recover?

 

[Andy_P]

I should also add I have been using Opsite to cover the sensors but this has not given any irritation it seems to be the circle underneath the sensor that has been irritated. I am also on scanner number 2 as the first one had problems with the blue button being responsive. It also stopped recognising a blood glucose strip. The scanner and sensor were replaced by Abbott.

 

[Emmotha]

I wonder it wearing the patches without a break causes some kind of autoimmune response to something in the glue? I wonder if their testers ever wore it longer than 1 patch?

 

[Hill28]

This Emma.

Darren and Andy, could you post the sensor serialnumber, just in case it's not the auto-immune response..?

 

[Andy_P]

Hi mine was 0M00000M33R.

 

[logindetails]

From the pics (esp Darren's & Andy's) it looks like irritant (ICD) or allergic (ACD) contact dermatitis.

If it's ICD you may or may not (hopefully) get a similar reaction from another sensor.

ACD would be more serious as being allergic to the adhesive backing would mean that you should not use the sensors at all.

Try a patch test before using another sensor:
Remove the adhesive backing from the old sensor, cut off a small piece and tape it to the inside of your forearm.
If a rash appears there in the next 72 hours you are likely allergic to some component in the sensors' adhesive backing.
Repeat the test with help from your GP to be sure.

 

[darrenh04]

Hi Andy. Just like mine. Glad to hear some one else has had this after a few been ok. Not in a bad way, but feels less like it is just me. Please do report it. Have you reacted to the next one?
Just going away for xmas so will post SN of two sensors when back in a few days. I have been changing arms with each sensor.
I was wondering, as Emma mentioned, could you build up a response to the adhesive over time. Would interesting to know how many the testers used and also are Abbott testing different adhesives for stickiness etc.
Good idea about the patch test. I was thinking I could cut a bit off an old one I didn't react to and see what happened now as this would show if it has built up over time, but had sharps collection just over a week ago so they have gone. :-(

 

[Hooked]

Just spotted your post. I have just had a similar issue with my 5th sensor. I have had them all on my left arm. I could feel an itching sensation after the first week on the 5th sensor but kept it on for the full 14 days. When I removed it it was very red and itchy (see attached image) I will be contacting customer support in the morning! Needless to say sensor no. 6 is on the other arm.View attachment 9986

That looks so sore!
I'm pleased to hear people are reporting issues like these to Abbott; it makes them aware so they can improve their product.

 

[smidge]

That's all interesting. My skin irritation with the last one was very mild compared to that - but still itchy and red. I think mine might have been caused by the sensor lifting slightly and contaminants getting under the lifted edge - which I then trapped next to my skin with optitape for another 5 or 6 days. When I took the sensor off, there was a lot of grime (yeuck!) under the edge of the sensor where my skin reaction was. If it happens again, I'll do as logindetails suggests.

Like Emmotha, I was also wondering whether we are now truly the guinea pigs of continuous use of Libre. I only ever saw reports from people who had used two of them prior to release. Looking at how small my arms are, and the damage the needle does on entry, I was actually wondering where I could place the next couple to avoid the already damaged sites. I can still feel a slight sorenesss from the site of two sensors ago - not as in skin irritation, but as in where the needle went in. I also think that I get higher BGs for a day or two after inserting a new sensor - like when I have the flu jab - I'm keeping a record and will report back on that after the next couple - but I'm wondering if my BG reacts very badly to the damage that big needle causes. I do hope Abbotts did proper trials of long-term use of these - at least a year. They would have to wouldn't they?

Smidge

 

[tim2000s]

HI Smidge, I'm not sure they would have to do a long term trial of at least a year, indeed, I'm not sure they would have been able to.

I'd be surprised if they were using a new adhesive though. We all know that there exist already sets and CGM sensors which use tried and tested adhesive. I would have approached the manufacturers of these and either used what they have or asked them to develop me something that would last the requisite 14 days using known safe compounds.

That doesn't mean that there have been extensive tests of the adhesive, and if we go back to the data released by Abbot, 1 out of 30 testers stopped using the system due to skin irritation. If you extend that to (let's guess) 50,000 of us in Europe who have bought in, then it is still more than 1,600 people that could expect to experience skin irritation.

My experience in wearing something like kinesio tape for a long period of time is that your skin does have a reaction to it, simply because it doesn't like having the glue on there, even if there is nothing that shows up at first.

I'd almost certainly class us as the User Test phase of this product release. There is no way that the small sample that they used in the "trials" would have been able to uncover all the potential user issues. I think this is backed up by the level of response that is being received in terms of replacements/exchanges/etc. If you pay a high price, you need to offer this on something so new. I'd hazard a guess that as they iron out the issues, the price will drop and the replacement process will tail off. Think of this as extended R&D if you like!

 

[smidge]

I suspect Tim is right - there is no way they'd have developed a new adhesive - why would they when there are already ones in use for similar purposes.

Interestingly, when I removed the hospital's CGM the other week, there was a very slight skin irritation at that site too - that was on my abdomen - it wasn't red or sore, just a small patch of flaking skin. I only wore that for 7 days, so I expect if I'd worn it a further 7 the irritation would have been worse. Abbotts are very clear that the Libre sensor must only be worn for two weeks. Maybe reducing the likelihood of skin irritation is partly the reason for that. Many of us have started to wear them an extra day or two to let them acclimatise. Maybe that's not helping. My last one - the only one that reacted - was on for nearly two days longer than the others - a day early to acclimatise and nearly a day late being removed because I had to get home from work before removing it.

Smidge

 

[Hooked]

Over on facebook some people are mentioning skin irritation as well.
https://www.facebook.com/photo.php?fbid=10152416799351152&set=gm.801009946632470&type=1&theater

 

[logindetails]

I'm pleased to hear people are reporting issues like these to Abbott; it makes them aware so they can improve their product.

The quote below is from a 2008 study into -

Allergic Contact Dermatitis from Medical Adhesive Bandages in Patients Who Report Having a Reaction to Medical Bandages

Quote:
We were particularly disappointed in the lack of cooperation from the adhesive bandage manufacturers. We were never provided with adhesive samples or even a complete list of the ingredients of any of the bandages or tapes that we used in this study, despite numerous phone calls, E-mail correspondence, and in-person meetings with company representatives. The Material Safety Data Sheets obtained for the products that we used in the study were also of very limited benefit owing to their profound lack of detail. For example, the entire ingredient list for 3M Nexcare Active Strips (Nexcare Active Strips, 3M, St. Paul, MN) read, "Foam strip with adhesive and absorbent pad."

Unless Abbott manufacture the sensors' adhesive backing it's unlikely they will be able to improve the product by tweeking the chemical make-up of the backing as they do not know what chemical(s) cause the adverse reaction.

 

[Andy_P]

The quote below is from a 2008 study into -

Allergic Contact Dermatitis from Medical Adhesive Bandages in Patients Who Report Having a Reaction to Medical Bandages

Quote:
We were particularly disappointed in the lack of cooperation from the adhesive bandage manufacturers. We were never provided with adhesive samples or even a complete list of the ingredients of any of the bandages or tapes that we used in this study, despite numerous phone calls, E-mail correspondence, and in-person meetings with company representatives. The Material Safety Data Sheets obtained for the products that we used in the study were also of very limited benefit owing to their profound lack of detail. For example, the entire ingredient list for 3M Nexcare Active Strips (Nexcare Active Strips, 3M, St. Paul, MN) read, "Foam strip with adhesive and absorbent pad."

Unless Abbott manufacture the sensors' adhesive backing it's unlikely they will be able to improve the product by tweeking the chemical make-up of the backing as they do not know what chemical(s) cause the adverse reaction.

I have just got back from a visit to the GP and was given a Steroid cream to treat the irritation 'Mometasone Furoate'. She described the rash as Contact Dematitus'

I am now experiencing itching under Sensor no.6 on the opposite arm and the GP suspects this will look the same when removed. She did say that other than the itching it was not doing any harm.

I have reported all of this to Abbott including pictures and they (like Darren's post) asked me lots of questions and are sending me packaging to return Sensor no.5 which luckily I still have. They are also keen to receive further feedback on any further irritation.

If anyone else is experiencing issues, please log it with them on 0500 467 466

Andy

 

[logindetails]

..... I do hope Abbotts did proper trials of long-term use of these - at least a year. They would have to wouldn't they?

To evaluate the accuracy of the sensor Abbott used 75 subjects wearing 2 sensors each over a period of 14 days.

- @ 12:50

I think we are their major test bed.
I also think that the the reason that it is now not possible to become a new user of the Libre system is not because of lack of sensors but that Abbott now have a user base that they consider large enough to provide data they can use to tweek whatever needs tweeking to improve the accuracy/reliability of the sensor.
When Abbott open up sales again in 2015 I'll bet that they will be supplying an improved sensor but I doubt they will advertise the fact that the original users were the guinea pigs which enabled them to make the improvements.

 

[tim2000s]

When I made the not unreasonable request to find out how the Libre had been tested and what the make up of the test population looked like (i.e. T1 and T2 diabetics), I was given very short shrift. They wanted to tell me nada.

 

[rubold]

A bit rich to be using customers as test pigs. I know of at least one other monitoring device being tested where the subjects are paid a large sum per day. The only condition being they need to be able to achieve at least one hypo episode during the 24 hours. This is all being done in a clinical environment. I can't say anything else at present, as it is commercial in confidence.

 

[Hill28]

I work in an EU institution and have followed the Committee for public health for some years. The only thing Abbot has to do for authorization is to get CE certification. Deskresearch is sufficient to get it, EU rules are unfotunately not too tight on medical devices...that explains the totally marginal testing abbot did.

So please be all very careful if you get unexpected side-effects since you're not 'covered' by any back up tests.

 

[Emmotha]

Is this why it's not released in the US?