Rise of the Machines

So it’s the RotM (Rise of the Machines) day coming up this weekend and I’ve been looking forward to it. In typical fashion, there has been a little snag though!  

 The roads up here have been closed. To get to the event on time means a 68-mile diversion to get to the train station (and the same to get home). So that means a very silly hour start to get there with a lift. If I went by bike I could avoid most of the diversion, but that still leaves 22-miles. Thus meaning starting at about 4am, maybe sooner to be safe due to darkness/weather. Taking Lancet (the bike) would be a good thing as she is my APS system and quite frankly the sexist APS builds out there (in a Marty McFly voice “You built a APS out of a bicycle?!” Yep, I did as it has the additional sensors such as power output, heart rate, calorie burn, environment etc.)! So, it would solve both things but would require a silly hour ride in -3C/-4C temperatures through a Met Office weather warning just to get to the train station in pitch black darkness. Yes, I have lights, good lights but night riding isn’t going to be fun in those kinds of conditions. So after a fair bit of considering, sod that for a plan, I ain’t going! 

 This could have been got around by going down a day earlier and coming back on Sunday. Snag on that would mean this would soon become a £250-300 trip and I would be losing a day off work as well. So yes, a possible but a bit of a hmm is it really worth it?! 

 Anyhow, I had a few questions and points of discussion for the event though, which I’m going to throw out there so anyone can pick up and try and answer for me. Yes, in my inevitable style some sound like I’m treading on toes again but not intending to do so, would just like to know the answers to these is all and throw the ideas out there since I can’t make it… 

 

Real-world v Certified Usage 

 This is an interesting one as it’s one questioning how the NHS thinks things through. I can remember the first time I got to play with a CGM back in 2010, the *shudder* Medtronic harpoon. Evil thing that it was! It was certified for 6 days but my DSN said straight off, if it fails on day 5 give Medtronic a call and get a new one and if it gets to the end of the 6 days, restart it and see how long you can get out of it. I liked it for it being ohh looksee what my BG is doing, but soon saw the issues it had with dehydration and other problems. It was an interesting starting point though. But even in those early days a good DSN knew it’s limitations and how to flex them past their manufacturers certified boundaries also. 

 It has been shown recently that part of the issue with getting the NHS to provide CGM is money. Yes I know it was only September when we were told money wasn’t an issue as the Diabetes budget is so vast it doesn’t matter and being able to spend on the Libre wasn’t a concern. Well now it is and thus the reason why we can’t fund CGM. What was it I said at that time? Something about how the Libre would actually hinder our care by stopping us getting devices which can provide a far greater benefit (CGM as needed for use with APS systems) by stopping the budget for CGM? Anyhow, that is the past even if my Nostradamus thoughts have all come to pass or are skipping along quickly towards them. 

Part of the issue with certified usage is a Libre sensor is certified for 14 days. A Dexcom sensor is certified for 7 days. Therefore, in certified usage the Libre is a more economical device. Snag is being that the Libre isn’t restartable, at all while the Dexcom G4/G5 sensors are, multiple times. It’s not certified for this but every diabetic using one, every online forum and most health care professionals all know it. How many times? This comes from how it is used but depending on how clean the site was before the sensor was added and if some good fixing tape is used when it is applied most users get anything from 3-5 weeks with some getting up to 8 weeks from a single sensor! I know myself I average 4-5 weeks (only had once last a poor 3 weeks) on a sensor and when it comes to comparing pricing of the systems that actually alters matters greatly! 

  • The Libre using certified usage costs £1060 for the first year.
    Outside of certified usage it still costs £1060 for the year (costs include original starter kit, £990 per year in following year).  
  • The Dexcom G4/G5 for certified usage is £2900 for the first year.
    Although if you go outside of certification and restart sensors and change transmitter batteries yourself, that cost reduces to £820 for that year (price includes original starter kit £620 for the following year without this). Even if you don’t change transmitter batteries yourself and purchase new ones this equates to £925 per year. 
  • Medtronic Enlight certified usage is £3440 for the first year (excluding cost of a pump which is also necessary as it needs a Medtronic pump to display readings).
    Outside of certification this does drop to £2200 (no starter kits etc to not need calculating for further years). 

Outside of certified usage, in real world conditions a
Dexcom 
G5 is considerably cheaper than a Libre! 

The Dexcom sensor technology is considerably the cheaper option to run. Yes, I know manufacturers and the NHS can’t use anything not certified for their calculations and as such need to ignore how users actually use them. But the reality is, the Dexcom G4/G5 is the cheapest solution available, and the soon to launch G6 is expected to work out even cheaper due to sensors lasting even longer (without costs of sensors at this time pricing can’t be done).   

 

Software 

There is a lot of discussion these days about AndroidAPS, and OpenAPS which is where it all comes from. There has also been talk of a possibility of the NHS certifying it in some way. While yes, a wonderful idea it worries me in certain regards. I keep hearing the argument that the release version of the software should be the one certified by the NHS. This is an opensource piece of software, releases can come every few days or weeks. Certification takes testing, extensively, and could never keep up with that. That alone would require some considerable resources by the NHS. Simply put, never going to happen!  

The “we do testing in the dev release, the release one is perfect” argument is total utter crap! Yes, I totally understand, you spend weeks, months, years working on your code and feel it’s utterly perfect. You and your friends have spent weeks testing it and it works perfectly as you send it to become the release version. It then fails, often! It happens to all big software companies; how many times has Apple screwed up a patch? or Microsoft? Or even huge opensource projects like WooCommerce? Only a few weeks ago it’s latest release version crashed and burned (a lot!) of websites which needed rolling back until it got fixed. This was after a lot of testing also. I know myself, I’ve just earlier this month released a major project for work which I’ve spent the last 18 months on. We’ve been testing it in house and with third parties for the last few months, it was great…I spent the first few nights up to silly hours sorting all kinds of issues which came up once the general public got their hands on it. 

We all take great pride in our work, we all think it is wonderful, but we all make mistakes and when that work we are doing is put into the hands of people whose lives depend on it, we need to get it right! My proposal recently for this was a simply one, basically something akin to a LTS (Long Term Support) build for AndroidAPS and OpenAPS. This is used on mission critical software often, you have the development version, the release version, and the LTS. The LTS is older but has been tested to hell and back and everyone knows it works and works well. In regards to NHS certifying software, this is the one which should be the one it certifies. Yes, compared to the current release build it is dated, lacking features, but everyone, the NHS and those who choose to use it know it works and work well. Over time a trusted release build would get certified again annually or six-monthly and become the new Certified Build (not calling it LTS as support wise it doesn’t fit this example).  

 

Libre 

First off, I hate the Libre. Always have and no matter what people say about it probably always will. You are probably asking why shortly followed by the usual spiel about it being innovative, but I have to ask where is it innovative? I love innovation and the Libre has none. The whole it’s “innovative” thing really winds me up. So, firstly I’m going to explain why I dislike it so much. 

It’s a none real-time CGM. And before people start whining that it’s not a CGM, it is. End of, it has the same sensor technology as all the rest, the only difference is it doesn’t transmit that information real-time. That’s THE ONLY difference. You can call it Flash, or anything else, I’ll call it NFC (Near-Field Communication) because that’s what it. Some call this an innovation, but is it? Simple answer to that is no. It is actually a work around to bypass other problems with the design, mostly that on the power usage of the device. If it used a proper wireless system like Bluetooth it would need a larger battery as the chipset available at the time (no longer though) would result in more power being necessary and a larger device and also a higher price tag. This would produce a far better device as it would make the Libre a real-time CGM like those from Dexcom and Medtronic, but due to the power requirements necessary a design decision was made not to have Bluetooth in the current version (as said above about why). For those of you following the development of the Libre II, it has Bluetooth and as such the NFC chip and aerial have been removed from the design. The lack of Bluetooth (or ZigBee or any other wireless system) has resulted in the Libre being unable to do alarms. This is not some “innovative” idea to make it less intrusive or anything else, this was a decision forced onto it due to power requirements and as such in the Libre II alarms are a major “innovative” feature being added.  

Another major issue I have with it has been how it’s been released. Basically unfinished. The initial Libre when they came out have test points still on the mainboards, not something normally found unless it was a test device (which it was). Since release, the mainboard has been swapped, the aerial design has also changed, the sensor has been modified, and they’ve tried three different glues (at last count) on the pads. The supply of the device has also been massively limited which raises some large questions. The device is pretty much a beta device released early and being modified as it goes. Production limitations are aiding that for being done in smaller runs so modifications can be made to it as production can be scaled up later once the final design (the Libre II is worked out). As well as the limitations, there has been a lot of people experiencing failing sensors and failing glues even after the numour changes so far. All round, the Libre smells as pre-release testing which took off rather too well so the company went with it as best they could when in reality it was intended as an early in the wild test bed for the true CGM the Libre II. 

Why was it chosen first? Was it because it was “innovative”? Surely not as it’s dated technology lacking true innovations. So why? Was it because of their blinding marketing campaign paying off bloggers with trips to lovely places which got them wittering word for word marketing spiel and making the masses believe it? In doing so resulting in the masses sending endless streams of I want letters to decision makers? Highly likely. 

The Libre II is going to be a very interesting device. Still stuck to a set time use for a sensor which could prove interesting when it’s compared to the Dexcom G6. Both of these will have integration into various APS systems coming out “soon” so it’ll be very interesting how they work out cost wise. But as mentioned above, on cost when you go outside of the certifications the Dexcom will probably have it so it’ll all depend on that as to how the bean counters measure things. Whats said on paper or what occurs in reality. 

Taking on the World

Recently (ok maybe not so recently) I’ve managed to tick off a few folks, which let’s face it is something I am pretty good at. I did get criticised for supposedly a lot of wild speculation which I think we’ll see in the next few years more as predictions than simply speculation or possibly pretty good looks at reading the market. Anyhow, I wanted to get back onto one of my main loves and that’s tech (even after leaving the industry), or in this case again diabetic tech and let my “speculations” run wild!

Earlier this year it was asked to the diabetic community what it was that we would be willing to give up to be able to fund what we wanted. Partly in regards to the upcoming costs of CGM use with modern APS systems since every new pump from now on is going to be using them for this (which is long overdue and generally fantastic news). So I read it as pretty much one of the main things many Type-1’s want as it’s as near as dammit we get to a cure in a box that’s attached to us! Now if we believe that such systems would ever be able to be used with every Type-1 diabetic in Britain (yes a very broad statement), and that CGM sensors lasted only as long as the manufacturers claim (we all know they can last far longer but we can’t sadly use that for doing costings) than the cost to the “diabetic budget” for this would be a third of its entire budget per year! Basically, an utter shedload of money that is not exactly easily covered from anywhere. Would we prefer to have one of these systems but be willing to only see a DSN and Consultant once every 10 years? Would we be willing to massively reduce who has access to this technology to only the children who would have to give it up when they move to adult clinics? Hard choices would have to be made as the funds available sadly aren’t what a friend recently said in another argument discussion that funds are supposedly infinite. So where do we find a solution? What are even the problems which really need addressing?

Part of the problem when discussing these new shiny devices is we have manufacturers playing to the masses of the diabetic online community using some pretty old school tech. product marketing strategies (along with extensive social media marketing campaigns, sheesh the number of them on Facebook!). The good ol’ make this scarce, throw in lots of freebies to friendly bloggers and getting them raving about the device, it doesn’t matter how old or primitive the tech is, as long as you claim in your press release its new and innovative they’ll keep wittering it until everyone believes it actually is. Then all their followers go queue around the block for it no matter how much it costs or how limited in features set is. It might not even work fully but if you have the following, it’ll sell! Add some limited availability due to “excess demand” when it launches and it’ll make even more people want it! Phone companies, computer companies, and games companies have used this same tactic for well over the last decade and to see medical companies using it now is nothing short of irritating. We are even seeing it with lancets in recent months and insulin! Part of the problem with this consumer-driven market is the pressures it is putting on our healthcare professionals and the NHS as a whole for it to be able to provide all these shiny new devices every five minutes when the manufacturer launches its latest with a new go faster stripe.

This results in patients screaming for the latest technology and putting huge pressure on health care professionals and the NHS as a whole. In a recent discussion about tech use with a large group of diabetics it quickly became apparent the system the clinic I am under whose policy of only upgrading pumps when they fail, thus allowing their resources to stretch to allowing more patients on pumps as some patients (like mine is well over 7 years old now) can make them last. If a patient can make one last eight years, that has funded a further pump for another patient! This system sadly seemed totally alien concept for many with most immediately chasing a new pump when their current was approaching the end of its warranty. One had received eight pumps in ten years by screaming and shouting for the latest tech! It frankly sickened me the utter waste and abuse of the system, and again draws out something that really needs to be addressed if only to save the earache of our HCP’s.

One way of solving this greed of the diabetic community for the latest shiny device is to simply not have any of them. Problem solved! This does cause problems with our care slipping significantly though and many of the problems these devices solve sadly come back to bite us hard, and the end result would never look good in government statistics. Alternatively, we could just have one chosen device in each area chosen by the NHS as a whole and that’s it for us all to use. The NHS sets up a four-year contract with manufacturers to buy x number of z pump/meter/CGM and that is the one pump/meter/CGM available for all on the NHS. The result would be far lower costs due to being able to negotiate large deals (or should with the companies competing heavily for the exclusive contract). It also makes decision making and what knowledge HCP’s need to learn on devices much easier and less costly as there are far fewer devices to learn. Yes, the diabetic community would whine like hell as they couldn’t have the latest shiny device of their choice, but personally, I feel this is a far better acceptable trade off even though many would probably want my head on a pole for suggesting it. Is that the only possible solutions though?

WARNING: I’m about to go off on an 11073-10417 tangent!

What can be done to solve some of these problems we face and do the make the world a better place thing too? This is going to sound odd but ISO/IEEE 11073! You are no doubt wondering what the hell am I on about with this or are busy Googling it up out of curiosity. As always with ISO and IEEE things, these are international standards. This one was created about a decade ago to make any and all personal medical devices communicate together, namely things like blood glucose meters (specifically IEEE 11073-10417) pumps, CGM’s etc. Hang on a moment, yes I am saying that there is an international standard to enable us to use a Medtronic pump which can talk to a Dexcom CGM which uses an Abbott blood glucose meter?! Yes, I am!

How is that going to stop the problems of the NHS from greedy companies, bloggers and a shiny device obsessed diabetic community?

Why don’t companies do this then? Quite simply it’s not in their interest to do so if they can keep a patient on one of their devices locked into their own “ecosystem” of devices. It’s not like any government agency or anyone in a position of power would dare stand up to them and force them to play by an international standard when they can have their own lovely closed eco-systems locking in patients, medical professionals, hospitals, trusts, even countries into their closed market and being forced to use their consumables and services.

What would occur if they all worked on the same playing field (the international standard)? First off we would have an open competition and that prospect along scares them senseless! We would (eventually) end up with a market for medical devices along a similar market to mobile phones where it doesn’t matter what device you buy, all would be able to call each other and connect to any Wi-Fi hotspot anywhere. The best device for the best job and for that right patient would win! It forces development. It forces companies to strive to improve and not stagnate the market into the usual status quo (but without the good riff) we’ve all had to live with. Different price points should immerge with differing feature sets to meet markets to fit patient needs. Yes, initially they will complain like hell about it and no doubt throws around the usual excuses of security of patient data, it’s not profitable, they can’t provide the same care talking to an unknown device, it simply won’t work and probably a dozen or more excuses. But in the end, the result would be a far more competitive market in price and range of solutions for us all.

So a huge win?!

A huge win in the long run yes. It also benefits smaller companies and also homebrew technologies like OpenAPS (an open source design and software to make a homemade artificial pancreas out of computer components and various pieces of diabetic technology) as open standards for things to work each other would allow development far easier and on a par (frankly it already is if you don’t mind some tinkering) with solutions from medical companies. Part of my scheming dreaming has always been that given a list of compatible devices every T1 in the UK with a pump could be retrofitted out with an NHS own brand artificial pancreas (running OpenAPS) built around a custom manufactured Raspberry Pi Zero (reverting to the Pi as it was used in earlier versions and since Intel killed the Edison that many current OpenAPS systems use it makes an easy solution) from a company like Element 14. Costs would be peanuts (in the grand scheme of things, under £40 per device on back of envelope calculations) and also a huge PR thing for the NHS (dare I say it) in the post Brexit era for having something manufactured in the UK (Wales counts right?). Development to reach the final “product” could be run through UK Universities. Heck, the NHS could even sell them abroad as kits if it wanted to make some cash on the side?!

We also have recent developments in the US, which while we may believe won’t affect us at all, let’s be honest about things that in reality will actually have a much larger than any policy change by the British government or decision by the NHS. The decision in the US relates to how devices are funded, or not in regards to diabetic medical equipment which talk to smartphones. The problem is that a smartphone has become an integral component talking to pumps, CGM and some blood glucose meters and since only 77% of patients have a smartphone than surely it should be funded by insurance/Medicaid as well? As expected with people clambering for a new $1000 iPhone they now all want that “free” paid for via the medical provider. And so came the decision this week that due to such costs the insurance/aid companies involved will no longer fund any device which talks to a smartphone. This result hits the CGM market very hard and effectively overnight makes the market for the Dexcom G5, Eversense, SugarBeat and the upcoming Abbott Libre 2 pretty much devices without a market. While this might be an issue for the US at the moment the same issue can easily be put to the NHS which in a similar situation and cannot afford to even consider funding smartphones to patients. Hopefully, many of us will sensibly say why would we ask for such a thing? 80% of the UK already have one so what’s the issue? Well, there is that 20% who don’t. We hope it won’t impact equipment availability in this country but in reality, it will as once device makers move away from smartphones/watches which will be driven primarily by the US market’s change in direction we will simply have to see what devices remain for us to use. Yay for bulkier future D tech!

Yes, this is a huge flight of fantasy for now and I hope I’ve given a few of you some thoughts. I admit sadly I can’t see any of this occurring anytime soon, if at all but I hope it doesn’t stop me underlining a few of the points I’ve been trying to put across recently in regards to technology choices I hope. Keep tinkering with what we have and please remember try not to be greedy with pursuing our equipment requests!