Freestyle Libre Update - July 2018

Sometimes my blogs are general and are timeless classics. (Yes I am lolling lots at that and my tongue is firmly in my cheek.) The point I'm making is that if you fired up the DeLorean and came from the future most of the post will still be correct. This one is slightly different as the information is pretty specific to July 2018.

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Each summer Abbott Diabetes Care invite bloggers from across Europe to their Diabetes Exchange Europe events. The purpose of the event is for Abbott to learn from the diabetes community and also for the bloggers to learn from Abbott about their products and how these are being developed. Here are my thoughts from last year. This year’s event was held in Dublin and saw 34 bloggers attend from right across Europe and also one from Canada and two from Brazil. Imagine the Eurovision Song Contest with slightly less singing or voting.

*Full disclosure is that those attending were not paid but received standard class travel, nice food, nice accommodation and a full programme of events. Not all attendees are Libre users and a signed agreement confirms that we are not obliged to report anything or only say good things about the company or its products. We were also asked to delay sharing the details below until today due to key financials being reported by the parent company. I am more than happy to discuss integrity and bias if you desire; but please don’t do it secretly; I prefer to know what people think.

I've got a few blogs in my head from the weekend but it may take me a while to convert them into typed words. As this one is more factual than opinion and as the news is fresh I was keen to get it out quickly.

I won't be the only one sharing this information today so please ask any of us the questions that pop up and we'll answer the best we can.

On the final morning we visited West Pharma near Dublin. The facility creates parts of the device and inserter and then builds and packages the final devices before they are boxed onsite and sent to distribution centres. The West facility is one of two manufacturing plants in Ireland that have automated the assembly process since January 2016. The implanted sensor parts are still manufactured in Witney, Oxfordshire. The West plant works 24/7/365.

Following the tour there was a presentation and question and answer section from Jared Watkin (Senior VP, Diabetes Care) and Scott House (VP of Operations).

Currently their are over 42 countries with the Libre, 5 with the Libre Pro and one with the Libre H (see below).

There are 800,000 people using the Libre every month. Current growth is at around 50,000 new customers per month.

The Dublin site is a sister facility to the one in Cork which both produce the finished product. Late last year and earlier this year investment was secured from the board for further manufacturing expansion of a 9000m sq. manufacturing plant being built in North West Ireland. They aim to do in 2 years what took them 5 years the first time around. This new facility will manufacture the sensor part of the device to duplicate what is done in Witney. This preparation was started at the beginning of June this year.

There are three devices are currently in production:

• Libre – the normal 14 or 10 day sensor used by patients independently.
• Libre Pro – a device used by healthcare professionals (HCP) where the person with diabetes has the sensor attached for 14 days but is not able to scan the Libre. The HCP downloads all the data after 14 days to spot trends etc.
• Libre H – this device is only used in hospitals in China. It allows Chinese HCPs to scan multiple patients in very large wards to reduce finger prick testing.  This products works well in China where data is written down rather than automatic downloads. We were told that automated systems and GDPR mean it is not expected this will be rolled out into Europe at the moment.

Keeping up with demand is a big headache for them and they are continually returning to the Abbott board to ask for more manufacturing investment. Unfortunately getting the green light, then finding locations and building the manufacturing devices takes time. All the machinery is custom made but having made them elsewhere already helps a little for future expansion.

By the end of 2019 production will have been increased by 50% from today’s levels and it will increase in further in each quarter of 2020.

The existing plants reached full capacity last month and this should mean the current restriction for new customers will be lifted but controlled in the next couple of months. Priority for new customers will be those who have registered an interest and have joined a waiting list. Order restrictions of 2 sensors per month (outside of US) will probably continue to be in place to try to limit stockpiling by users. Their focus is to ensure current customers can get hold of a required supply of sensors before adding new customers.

Feedback is actively welcomed. To quote Jared, "None of us can sit here and pretend the Libre is the perfect product and we don't need to do anything else." Feedback was key question for me. Abbott monitor both the official email / telephone help routes to spot patterns and recurring errors. This includes things such as where devices fall off within three days. Abbott are also now tracking through social media reports of problems to try and find patterns. Where a recurring problem is identified this will be researched. The take-away message here is to report all errors and problems when the sensor becomes ineffective.

The product is constantly being developed. The adhesive has been changed three times so far to try to reduce the instances of skin reaction and poor adhesion. The LibreLink and LibreView apps are also being improved and tweaked based on feedback. The use of apps instead of dedicated readers is beneficial as they can roll out software updates much more easily than to the standalone readers.

Now for the big ones:

• Yes CGM is being worked on but you'll need to be patient. The desire is to keep the same shape and design with any product change. This will allow costs to be kept down and therefore help the price charged to the users. They are also very conscious of alarm fatigue and see this as a benefit of the Libre over CGM. They are also keen that any integration with other products that includes injections and pumps. eg Bigfoot Biomedical
• They are moving towards joining the JDRF initiative on open protocol and see risks but also benefits in doing so.
• R and D is constantly being done. Cost reduction is a key driver for everyone there. A key driver is to lower the cost to consumer. This is more likely to be through extended sensor life rather than a reduced sensor cost. i.e. if a sensor can be made to last 20 days this will cost the same to manufacture as one that lasts 14 days. The biggest problems to overcome seem to be skin reactions and longer adhesion times needed.
• They expect competition to arrive. Can't avoid it forever. But Abbott believe that by investing in efficient manufacturing they can lead the field on sensor accuracy and cost. Production volumes are already far than the competition and they expect this to remain the case. This may sound arrogant but they are willing to be challenge.

If you've got this far, thanks. You'll have skimmed through the disclosure at the top and possibly taken everything I've written with a big pinch of salt. As I said, Abbott demanded nothing of me. I will say however, after looking into the eyes and listening to all Abbott paid employees I met, I have 100% confidence their desire is to make the Libre the best product they can and also doing it in the best way for the consumer / buyer. It's up to you to judge my impartiality.

I was one of many there this weekend so please seek out their blogs and thoughts as they will have detail I missed and also different views on bits too.