I have been thinking about test strips. Again - Still. Some of you may know this is a reccuring topic with me. It is, because.., well..., strips matter.
Test strips are the foundation of good diabetes self-care. People with diabetes, particularly those who use insulin, need to test frequently to manage their blood glucose and make care adjustments, particularly with the insulin. As simple as it sounds test strips are vital to avoiding dangerous low blood sugars from insulin.
Insulin can be a dangerous drug. An article in the Journal of the AmericanMedical Association estimates that ninety-seven thousand of Americans a year go to the emergency room due to low blood sugars caused by insulin.(1) The journal goes on to says most of those insulin ER visits are seniors, Medicare’s people and that one in three of the ER visits the person is hospitalized. When it is dangerious, it is expensive.
The ninety-seven thousand mentioned cited in that article is MORE than the government estimate of Americans who go to the ER for stimulants including methamphetamines.(2) It is shocking that insulin beats breaking bad as reasons Americans go to the ER. However, the comparison does help put good self-management in perspective. Clearly a goal is the safe use of insulin that helps keep America's, particularly seniors, well while preventing the need for emergency room and avoiding unnecessary hospital admissions cost to Medicare.
We all have heard of medical trials. Trials, because they can impact the participant's health, have strict rules. Some of those rules came about as the result of studies that were unethically done on people without their permission or knowledge.(3) It seems logical that if someone were going to introduce new means of accessing something as critical to maintaining health as test strips that they would follow the trails safety rules.
Unfortunately, that was not the case.
Medicare changed the rules for how beneficiaries get test strips. Medicare tested it in 2011 in nine pilot cities around the country. But they didn’t treat it as a clinical trial or follow safe trail protocols. Maybe because they judged the rules don't apply to them as a government agency. Medicare said it was a huge success, they saved money and there were few complaints and no disruption.
A poster presented at the American Diabetes Association scientific session in June 2015 by skilled academic scientists looked carefully at Medicare’s data. It showed that in the nine pilot cities(4) there was a disruption of patients access to test strips. How and how many strips people with diabetes acquired shifted. In some cases, people on insulin stopped receiving testing supplies. The researchers found an increase in hospitalizations, higher cost, and more mortality in people with diabetes using insulin in the test cities.
I don't know who is right, Medicare, who says there was no harm and extended the program nationwide or the researchers who found statistically significant increase in mortality, hospitalization, and costs in Medicare's data. I am not a scientist, a statistician or a bioethicist. I do want to know if people on Medicare are safe.
Congress is paying the bills. They authorized this experiment. They should find out what the truth and tell us is Medicare program safe? ACT NOW to ask Congress to get to the truth.
(1) Geller AI, Shehab N, Lovegrove MC, et al. National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations. JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136. https://archinte.jamanetwork.com/article.aspx?articleid=1835360
(2) National Institute on Drug Abuse. Drug-Related Hospital Emergency Room Visits Retrieved from http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits
(3) https://en.wikipedia.org/wiki/Belmont_Report
(4) Test sites included Charlotte-Gastonia-Concord (North Carolina and South Carolina); Cincinnati-Middletown(Ohio, Kentucky and Indiana); Cleveland-Elyria-Mentor (Ohio); Dallas-Fort Worth-Arlington (Texas); Kansas City(Missouri and Kansas); Miami-Fort Lauderdale-Pompano Beach (Florida); Orlando (Florida); Pittsburgh(Pennsylvania); and Riverside-San Bernardino-Ontario (California)
I wanted to let you know about a project we're working on and ask for your help with a short (2-question) survey. We're working on a Tier 1 PCORI Pipeline to Proposal project aimed at eventaually looking at the efficacy of peer support delivered online. You know, that thing that the DOC does.
I had the great privilege of joining Stacey Simms in a conversation about Diabetes, Advocacy and DPAC. Just click below to listen in.
Diabetes Connections with Stacey Simms
DPAC - Diabetes Patient Advocacy Coalition
Released: Sep 29, 2015
DPAC is a new effort to make it easier for people with diabetes to communicate with policy makers. Co-founder Bennet Dunlap explains how Diabetes Patient Advocacy Coalition works and how we can all take part.
Read more at https://html5-player.libsyn.com/embed/episode/id/3826551/height/360/width/640/theme/standard/direction/no/autoplay/no/autonext/no/thumbnail/yes/preload/no/no_addthis/no/#GHJpPi83EkwpAtB7.99
Famously, the painting of the Forth Bridge (an enormous railway bridge across the Firth of Forth in Scotland) took so long that by the time the workers finished painting this spectacularly beautiful collection of girders, steel, bricks and sweat, it needed to be started all over again. Apparently this is no longer the case and the painting has finally stopped, at least temporarily, but bear with me here as I indulge myself in a little cliched allegory.
Painting the Forth Bridge - I wonder what it would be like to be one of those people given that task.
Perhaps a young man, in his early twenties. Suddenly, unexpectedly, given this massive undertaking. A job for life. It must surely have been a daunting prospect. But perhaps there was something of a challenge about it too. Something to get stuck into. Something to work towards. And while the tools were, at first, unfamiliar and clumsy, he was determined to see the work done. To do it the best he could. To protect this beautiful structure.
And the days turn into weeks, and the weeks turn into years. And still it goes on. It is hard work. The schedule is punishing, but it has to be done. He pushes on. The tools are more familiar now - he's actually got pretty good at this painting lark. He has picked up some tips from others who have been painting far longer than him. He can even take some of the difficult corners in his stride, the awkward spots that he could never really manage before. Occasionally a new brush or a fresh pot of paint kindles some excitement and interest. Spurs him on. Improves his technique. And then back to the graft.
And some days... some days it is just beautiful. Way up there at the top of one of the arches, alongside friends and co-workers, with the wind gently cooling his face, as the sun beats down on his shoulders. The view stretching for miles and miles. The distant thrum of locomotives passing below. The faintest call of birdsong from the marshes. When he compares his work to others' he thinks, "You know, it's not that bad." He feels lucky. Yes there is work to be done. Yes he has to be careful to keep himself safe, but in comparison to some other working conditions he knows about - he could have done much worse.
There are scary times too. When storms lash and winds howl. This work is no place for the faint-hearted then. But even then... even then there is something to push against. Something to overcome. A battle to be fought. Something almost heroic about it. Those are not the hardest times for him.
It is the grey days he fears the most. The grey, unending, energy-sapping days. Where the fog rises up and obscures everything else.
The days when his paintbrush seems to weigh even more heavily than his heart. When the neverending nature of the task overwhelms him. No matter how hard he tries, no matter what he does. He will never finish. Stroke after pointless stroke. Hour after pointless hour. And still no nearer the end. There is no end. And if he slows down, he only gets further behind. The task goes on and on. Unrelenting. Inescapable.
He has an annual performance review with the HR department. They seem happy enough with his work, but can only talk about the rust and decay that constantly threaten the bridge. The rust... the rust... always the rust. He must not let up they say. He must keep up his workload. They come down pretty hard about Health and Safety too. Apparently, though he tries to be careful and is pretty diligent with his harness, hardhat and boots, he is not doing enough. He could slip at any moment and that would be it. They don't seem to understand the reality of what it's like up there. Sometimes you have to move from point 'a' to point 'b' and it's not always possible to be fully harnessed-up in between.
He ventures to ask about a new piece of painting equipment. It would make his work much easier, and much safer. He has even tried it and has seen what a difference it makes. Unfortunately 'the management' will not provide it. It is too expensive, and they are not sure they believe the promises in the brochure. The HR department are sympathetic, naturally, but the decision is out of their hands. He knows, of course, that his equipment is pretty expensive already. It's not a surprise that the newest and fanciest stuff is out of reach. But his head and his heart feel differently about it. Part of him aches for what might have been. Part of him wishes he'd never even heard of this new stuff.
And the grey days continue. He blunders on. Barely looking at what he is doing now. So tired. So tired of it all. Sometimes he looks at his brushes with loathing. He wants to throw them over the edge. Cast them into the broiling waters below. Just watch the bridge decay and fall. The rust... the rust... To surrender the bridge to the elements.
To stop.
But he can't. He WON'T stop. He pushes down the melancholy as an act of will. He knows so many people that love this old bridge. Who rely on it. Who need it. He wants it to be there for them.
Well, this is it. The last of my posts covering my time with the Medtronic MiniMed 640G. Thank you so much for bearing with me over the last few months. Normal wittering will be resumed shortly. However, as seems to be the way of things with blockbuster franchises (HA!) I have split this last episode into two parts. Part (i) covers all the little niggles and irritations I had while using the MM640G, while part (ii) looks at the things I loved, and reviews my results including reductions (if any) in hypoglycaemia and an HbA1c I had done at the end of my time using the pump. HbA1c is the test which measures how much of the glucose in your blood stream has stuck to red blood cells. It is often used as a measure of your likelihood of developing the long term complications of diabetes.
For those who really can't bear wading through all those minutes of video I will summarise the results below. The video gives a lot more detail though, and features a fluffy bunny. What's not to like?!
When it comes to the things I really liked/disliked about the MM640G you will need to bear in mind that I am comparing to a MiniMed Veo. All of the really good stuff about pumps generally - precise basal patterns, advanced dual and square wave bolus options for tricky meals, ease of use, bolus calculator, temporary basal rates, precision of doses and correction factors, blah, blah, blah... are already assumed to be present and correct. Some of the things I loved about the MM640G are precisely because they fixed annoyances I found with the Veo. But more on that later. First:
The worst of the Medtronic MiniMed 640G
Those who have read any of my reviews before will know that I can get unreasonably irritated by the slightest things. It will come as no surprise then, that while I generally loved the MM640G both with and without sensors, there were a few things about it that drove me nuts.
Pump lock After a few minutes the pump automatically locks and most interactions require you to play an annoying 'press the right button' game. This is no good if you are in a hurry, and is not an option that can be turned off.
Change of orientation It's now 'portrait' not 'landscape'. As someone who wears an insulin pump on my belt this is a bit awkward.
No small versions Medtronic have now abandoned plans to produce a smaller version of the pump. All MM640Gs will now have the little sticky-up bit to accept the larger reservoirs. The smaller reservoirs can still be used, but at present, with approximately 35u/day usage, the 'how full is my reservoir' icon on my status bar is pretty much permanently red.
Sensor overtape irritation The glue used on the sensor overtapes (and also the little patch that holds the sensor down initially) caused a red rash to appear after a couple of days of wear. Initially it was only toward the end of a sensor but in the end it began pretty much at day 2. I used an alternative dressing, but even that was pretty itchy. Weird - because I don't usually react to adhesives at all.
Sensor swap delays From start to finish swapping a sensor takes around 3 hours to begin providing new continuous data. That's a looooooong time!
Occasional sensor lag Mostly I found the sensor accuracy was brilliant. But sometimes, particularly if I treated a low to try to fix a below target BG reading, the sensor was a little slow in responding (perhaps 30 minutes behind reality). Additionally calibrations by BG meter do not necessarily reach up to match sensor glucose and BG fingerstick value, but often end up with some odd half-way house. If the sensor glucose value had drifted a little there were even occasions where calibration triggered an 'alert before high' which was doubly annoying.
Sensor Glucose Review The one-day graphs which allow you to flick back through previous days' results show no indication of SmartGuard interactions or insulin doses. Makes them about 10% as useful as they could have been.
Home screen without sensors For no apparent reason, the icons in the status bar do not align neatly when using the MM640G without sensors. There's a gap where one of the sensor icons(!) would go, which makes it look untidy and poorly considered. The enormous dotted line 'we have no BG information to show you' panel where recent meter BG readings go (when not using sensors) also irritated me more than strictly necessary. Just doesn't feel like the visual look of the home screen for most UK users, who will be using the MM640G without sensors, was given enough finesse.
Watch the video
The grumbles, gripes, and irritations - everyone will have their own, I'm sure.
The best of the Medtronic MiniMed 640G
Whether you use the MM640G with sensors or not there is a LOT to like about it. There are all sorts of little, pleasing improvements in the interface and options that make a massive difference. Add the wizardry of SmartGuard into the mix and things are taken to another level - but even without there are lots of tasty treats for non-sensor users.
Setting basals and temp basals There are now up to five basal patterns on the MM640G, and brilliantly you can copy entire patterns from one 'slot' to another to experiment with and then switch back if you need to later. The patterns also come with helpful names to keep track of which are which: Work Day, Day Off, Sick Day, Pattern 1, Pattern 2. Which pattern is set is not marked on the home screen, but thankfully setting any of them does not cause the 'alert circle' to appear like it did on the Veo.
Temp basals can now be set in 15 minute increments for more precision and alter up and down by 5% at a time making them much quicker and less fiddly to set.
No TBR 'chime' Setting a Temporary Basal Rate no longer causes the pump to issue a useless wittery alert tone every hour, which means you can ACTUALLY USE THEM OVERNIGHT! In even better news - the end of a TBR is now indicated by a single beep. Brilliant!
Different Alert Tones There are now a series of different alert tones to indicate different things. There were a few on the Veo, but so many overlapped with either 'pip-pip-pip' or 'naah-naah-naah' that I find it much easier to work out what is going on on the MM640G without having to check the pump for 'information' alerts and being alerted (ha!) to things that actually require action. The ability to increase volume has also significantly improved.
No lockout during bolus delivery It is possible on the MM640G to do rather more things during the time while a reasonable sized bolus is being delivered - for example you can set a TBR. The Veo made you wait until the bolus had finished before allowing you to do anything (other than stop the bolus!). This meant I could group my pump interactions together and then get on with life, rather than having to wait around tutting.
Screen visibility in sunlight Really, really good - especially compared to some other colour-screen diabetes gadgetry I have tried. Not perfect from every angle, but really easy to turn a little and see very clearly even in direct sunlight.
Remote boluses from BG meter Not a full remote control with bolus wizard, but a really useful standby when digging your pump out from within clothing is impractical or inconvenient.
Waterproof Now rated as IPX8 - up to 12 feet of water for up to 24 hours.
SmartGuard - overnight hypoglycaemia Unsurprising if you have watched my Overnight Hypoglycaemia post, but SmartGuard overnight for me was a real stand-out winner. No readings at all for 9 weeks below 3.5mmol/L overnight, and hardly any below 4.0mmol/L. Some nights almost no basal insulin required, and others requiring my more 'usual' 6-7 units at night. Looking at the results it's hardly surprising I had so many problems and so much Severe Hypoglycaemia during my years on Lantus!
SmartGuard - results overall When compared to averaged results from 10 weeks of Libre sensors (the only other 24 hour data I have) time in hypoglycaemia fell by 90% during my 9 weeks with the MiniMed 640G. At the same time my overall levels, as measured by HbA1c fell by 0.3%. And all this with less effort and very little 'alarm fatigue'.
Watch the video
Improvements to the pump (with and without sensors) and the all important results.
Conclusion
It has been a great privilege to experience the MM640G system, and for me the results were spectacularly good. The comparison with Libre data is an interesting one, particularly where hypoglycaemia is concerned. Times wearing a Libre sensor were previously my 'best ever' results-wise. The ability to spot hypos coming during the day and try to head them off (I generally scan a Libre sensor something like 30-40 times a day), plus the ability to spot low levels overnight and make hurried basal rate changes meant that I generally had fewer hypos on a Libre than I would normally. And yet when compared to these data, the MM640G system reduced my time spent in hypoglycaemia by 90%. To be clear, that means that for every 10 minutes I spent below 4.0mmol/L trying my very hardest with a Libre sensor, I would spend only one minute when using SmartGuard. That and my HbA1c dropped over the same period from 6.3% to 6.0%. 0.3% - it's not a huge margin, but those fractions are pretty tricky to shave off once you get down below 7.0 in my experience.
My only hint of melancholy about the whole experience is, of course, the eye-watering cost of full-time sensor coverage (approx £3,500 per year inc transmitter). It's not something we as a family can afford, and full time CGM on the NHS is reserved for those who really need it most - and rightly so.
It feels a little like being given a chance to live in a multi-million pound mansion and drive an Aston Martin for a few weeks to see how I like it. I may think it's brilliant - but the reality is that it's not really an option that is really open to me long-term.
I have a pump clinic coming up in a week or two and will see what they say about the results - particularly my unpredictable and occasionally lengthy periods spent below 4.0 overnight. These do nothing to help my efforts to keep my Imparired Awareness of Hypoglycaemia under control. I may ask about the possibility of part-time sensor coverage. Even a few months in a year would make a massive difference (as long as the transmitter continued to function, of course).
My Veo is nearing the end of its warranty period, so I am looking to the future. I have some thinking and some sums to do after this experience - depending on what my clinic say.
Final verdict (with sensors and SmartGuard): 5/5 Final verdict (without sensors): 4/5 Final verdict (considering self-funding sensors): 4/5*
* because of Dexcom's more 'stretchable' reputation when it comes to sensor life
Disclaimer: I was offered a trial of the Medtronic MiniMed 640G system for 64 Days with full sensor coverage so that I could share my opinion and experience good or bad. I was not paid to write this post, and if I had thought the pump was terrible I would have written that. I was encouraged (not required) to post video blogs about my experience, but Medtronic did not have any control over what I posted.
For all the times when SmartGuard has worked brilliantly for me (and there are - too many to count), there have also been a number of situations in which it seemed to make a bit of a mess of things. Overshooting and leaving my higher than I'd like... kicking in when a hefty carb load was just about to arrive and stopping basal for that 30 minute minimum (during which time I would be having a high glucose alert)... or cancelling various parts of dual and square wave boluses which I then may not spot until slightly too late.
I'm sure each user would have their own list - but these are my own #SmartGuardFails and some of the techniques I have tried to fine-tune the alerts and levels to work around them. It's interesting how irritating these odd occasions can be, and I suspect it is only because, well for me anyway, SmartGuard has worked so *brilliantly* for so much of the time that they really stand out.
If you have any MM640G SmartGuard tips and tricks of your own (or any other comments or questions), please leave a comment below.
