Saw this in my Google news alerts today about a study taking place in the UK to test the effectiveness of insulin pumps. The study examines the benefits of insulin pump therapy compared to MDI to see if the expense of pump therapy is worth it.
I am curious to hear peoples' reactions to these studies. There have been some limited studies in the past looking at the effectiveness of insulin pump therapy, but these are two of the largest studies I've seen to date that will closely examine whether insulin pump therapy really results in better outcomes.
What are your thoughts? At this point, are such studies even warranted in your opinion?
Sometimes when I see these studies I just wonder why we don't take the money being spent to conduct these studies and buy everyone pumps and related supplies. But that's just me :-)
I can only comment in my particular case. I have been injecting for over 25 years. My A1C's were OK (6.8-7.0), but after 5 years on a pump my A1C's are 6.0-6.4. Believe me, I don't miss four injections a day and all that "stuff" you have to bring along. Going on a pump and now with a CGM is great. It's just so expensive. If I didn't have health insurance I would go broke....and back to MDI. The pump does require a lot more work, but well worth it . I think the pump vs MDI is an issue that concerns health insurance companies to control costs. In my case the pump has lowered my A1C by a point and it costs a lot to keep it there. The bottom line is that insurance companies want to keep costs down. This kind of "study" just gives more justification for the insurance companies to decrease benefits and premium costs to employers.
Of course these studies are important. In Germany a type 1 diabetic on MDI costs €6.50 per day. The same patient on pump therapy costs €12 per day and this is a huge difference. In Germany a T1 diabetic will get a pump if the medical team can proof that this treatment will have substantial health benefits for this patient that can not be reached on MDI: fewer lows, better A1c, better glucose control etc. This also means that the pump can be denied - even after years of using it - if there are serious doubts about the success of the treatment. I think it is fair that our compulsory health insurance system tries to find the right balance between the investment and its benefits. I also think that this regulation helps to make pumps available to those patients that really need them.
I think studies are good, but I also think that the pump has other benefits than just improved control, better A1C, less lows, etc. I was similar to Mike and didn't think I needed a pump because A) my A1C was fine (6.5) and B) I'm mostly retired and had time for the shots. But now on the pump my A1C is 5.7 and I feel my time is better spent than worrying about diabetes and taking shots all day long. For me, I don't feel that the pump is more work, though it does carry its own risks and obstacles. (With a shot you know you got the dose you injected even if it is poorly matched to your needs due to whole unit limitations, and with a pump your danger of going dangerously high in a short time is increased).
Bottom line is for me the freedom the pump gives me is worth even more than the improvement in A1C and I'm not sure that quality of life issues are easy to measure in studies.
I agree that it's important to know but I suspect that the "invisible hand" of insurance is there to try to use it against "us" or those of us who are pumping. It sort of astounded me how disinterested the surgeon, anesthesiologist, etc. were in my BG when I had surgery in October as I figured they'd want to check the CGM to make sure things were sailing along nicely. I guess they were sailing along nicely as I was in the 90s when I came to afterwards but none of them said "if the CGM starts bleeping at us, we will do _______" or whatever? It simply didn't matter to them as long as I was able to make myself ok for a few hours after fasting for about 10 hours.
This could also be big for T2 as it seems as if there are more barriers to getting pumps?
I am on MDI and my last A1C was 5.1 (with the one before that 4.9) but that came with lots of lows. Some members of my diabetes team think that a pump wouldn't make any difference to my control; others think that a pump would help to mitigate the lows.
The thought of being 'tethered' actually scares me a little. It is too much like the hospital cannulas and those *really* freak me out.
As Lila points out, it's how "effectiveness" is defined that scares me. My A1C is definitely better but this is largely because I am able to correct highs that I could not correct with MDI due to insulin sensitivity.
There are other benefits the pump gives me that I just don't see being captured in any study. For example, anything that is more "convenient" is going to result in better adherence. With MDI, there's always the issue of sneaking off to give yourself a shot. With a pump, it's so much easier to administer insulin wherever you are.
In addition, a pump for me has meant a much greater ability to exercise. On MDI, any physical activity had to be carefully timed and planned out. With a pump, I can just turn down my basal insulin an hour or so before exercising and I'm usually fine.
And how do we define who really "needs" or would "benefit from" a pump? For example, I've saw one study that was unable to positively say that children benefited from a pump, and the study also noted that certain characteristics (higher education level, higher income level, etc) meant that a person was "more likely" to benefit from pump therapy. And let's face it - this sort of makes sense because there is some data analysis required when using a pump to adjust basal and bolus rates. BUT, I could see how this could go down a really bad path of people being denied access to insulin pumps simply because they don't meet some requirement that one study deemed was critical for being "successful" on a pump. And the problem with studies is that there's always some other study that produces opposite results.
On one hand, I agree that in the face of scarce resources, we have to decide what is the best use of available dollars. But when I know that oodles of money are being dumped into potential cures that I will probably not see in my lifetime, into therapies that are even more financially out-of-reach (like the artificial pancreas project), and into research like this, I start to wonder whether we couldn't make better use of these all these funds by just ensuring that every person with diabetes has access to the currently-available tools needed to control the condition, including pumps if so desired.
It's the "invisible hand" that scares me the most. When pumps first became widely available, insurance companies had really bizarre requirements for covering insulin pumps. Some insurance companies required that you be "in control" of your diabetes in order to get a pump, as they felt you had to show that you could manage things on your own and were therefore doing well enough to get the benefit of the pump. Other insurance companies required that you be in "poor control," thus warranting the cost of the device.
Even now, it's virtually impossible to get any clarification from an insurance company regarding what their coverage requirements are and how they define "medical necessity." I will say that my last pump purchase was the best, as I was only required to submit a certificate of medical necessity and some blood work to obtain coverage. So I think things are getting easier, at least for those of us who have insurance.
1. I am a huge proponent of insulin pumps. While the technology helps, I think another element is entirely mental. While insulin pumps come with their own headaches, in a way they do make intensive insulin treatment easier and less of a burden. It's hard for me to put in words how.
2. I do believe such studies are warranted and good. Having a scientific study will allow people to convince insurance companies and state healthcare programs to make provision for the money necessary to help people afford insulin pumps and supplies.
Things are definitely getting easier. I got my first pump when I lived abroad, so I can't comment on the state of things in the mid-2000s. However, I came back to the States in 2009. I was lucky enough to get myself right into a university-affiliated teaching hospital that has a dedicated diabetes clinic. Through them, I upgraded my pump. It was seamless. Maybe because I'd already had a pump, there wasn't some crazy dance to get it approved.
I recently transferred into private insurance and, while it's insanely costly, they're really good and covering everything I need to pump effectively. I think now maybe insurance companies scrutinize add-ons like CGMs. My endo told me not to bother and, I think, it might be because he knows the process is a PITA to deal with. All of that stuff, including the expensive pump supplies diabetes supplies I get in 90 day supplies with a reasonable co-pay. I can't imagine how expensive it would all be without the expensive PPO I've currently got. (That's sad, but that's another thread.)
As for the studies, we need them and, thus far, the data and stats are on our side.
I was skeptical about CGMs too however I was intrigued enough by the idea of always having an idea, even if it's not 100% accurate, to try one out. I've been very pleasantly suprised with how useful it has been. The improvements in control haven't been huge but they are there too.
I think studies are warranted given pump expense & outrageous health costs. Pumpers get training on carb counting, I:C ratios, basal testing, etc. that MDI users don't. My belief is that accounts for some of the improvement experienced. Not that this is an option, but I'd rather funds, whether nationalized healthcare or private insurance, be spent towards more people getting the education they need on managing diabetes effectively.
There's a big difference between want & need.
I like the German system Holger outlined. If a pump isn't successful, then future use can be denied.
I don't know what education is like in the U.S., but I initially got almost no education because I was a kid (or, if I did, I don't remember it at all). Then when I switched to MDI, after 15 years of diabetes, I finally learned about carb counting. (I had actually read about it myself before I officially had training, but it was hard to implement using R and NPH, so I had to wait until Lantus came to Canada in 2005 to really use it.) When I went on a pump I didn't really get any additional training in regards to carb counting, it was all to do with the physical use of the pump, changing sites and cartridges, and fine-tuning basal rates which wasn't possible with Lantus.
For me a pump has made a huge difference because of the variable basal rates throughout the day and night. On Lantus this was impossible, and even if I ate nothing (I wasn't able to skip a meal) I would experience highs and lows just because my body sometimes had too much basal and sometimes had too little with Lantus. Also the ability to adjust settings over a matter of hours instead of days (for exercise, illness, hormones). In fact, when I told the pump nurse that I was switching to a pump for better control, she said I was the first person she'd heard with that reason (I guess for most it's convenience). I had no issues with MDI except that even doing everything I could (splitting Lantus, correcting between meals, getting up every night at 3 AM to take some Humalog for the dawn phenomenon) I still wasn't able to get my A1c to target.
I think studies like this are important. The one problem with studies is how do you define "effectiveness"? Not everyone is able to achieve the same level of control with the same tools. And is a pump "effective" if it doesn't improve control but does improve quality of life, as some here have mentioned?
I got zero education 3.5 years ago. In fact, what I got being discharged from the hospital was contradictory. I was given hand-outs on the old exchange system & carb counting. I spent many frustrated hours trying to reconcile the two not even knowing they were entirely different:) Went to a diabetes ed class & was the only T1, so that didn't help. I had to teach myself.
Read here from many people they didn't count carbs, or count them carefully, until they got a pump. They also didn't have ratios or know how to fine tune doses prior to pumping.
Studies should closely examine SD & not A1c to assess effectiveness. If both are improved, I'd say a pump has helped that person.
Quality of life is a can of worms. Medical outcomes should be the priority. .
Wow, that is crazy about the handouts. For me I got training on carb counting and got an I:C ratio and an ISF when I began using MDI, so I already had that information going into pump training. I think here that must be usual (at least here) because the nurse didn't really cover any of that stuff, the training was just about how to use the pump itself.
Yes, the "quality of life" factor is what worries me. Improving quality of life can mean that people feel better about taking care of their diabetes and are more responsive to it. Like you, the ability to adjust basal rates throughout the day has been the biggest benefit for me. Trying to eat on a rigid schedule to account for basal insulin is really hard - I mean, who wants to eat when they aren't hungry??
Also, "control" is a really relative term when it comes to diabetes. "Control" for one person may not mean an improvement in their A1C, but it could mean fewer BIG fluctuations between highs and lows. I can keep my BGs in tight range or fluctuate between 40 and 400 and my A1C might come out exactly the same. Those huge fluctuations are thought to cause about as much damage as sustained highs in Type 1s. I have a hard time when studies JUST focus on the A1C and not these other aspects.
Also, for me, the pump has really made it easier to log all my data in one place. This may seem like a small thing, but try to go around each day writing down everything you do (carbs, insulin, BG) in a log book. It's not as easy as one might thing especially when you oh, I don't know, HAVE A REAL JOB!! With my pump, logging all this info is effortless. And this means that I have more accurate data to work with. This was one of those "pumping benefits" that really surprised me and one that isn't talked about enough.
Exchange system?? Auughhh!! Just hearing those words makes me want to run away screaming with my hands covering my ears.
I agree that medical outcomes are important, but when it comes to something like T1 diabetes, even medical outcomes can be subjective. Could not agree more about SD as opposed to A1C as an important measure, though. While A1C might be a good measure for T2s, I really don't feel it's a good measure for T1s.
I do, however, think that quality of life is an important factor, one that is just as important as medical outcomes. In so many cases, quality of life can translate into better care provided by the patient. When I was on MDI, I could achieve a decent A1C in the 7s, but it came at a cost. My life was completely rigid with little to no flexibility in my exercise or work routine. This affected my job (I had to be so strict about when I took lunch, for example) and my personal life (couldn't sleep in on a Saturday morning, had to eat when I wasn't hungry, had to skip meals when I was hungry, had to pass up social opportunities that involved food, etc...even sex couldn't be spontaneous because I had to make sure I wasn't going to crash in the middle of things....). I consider all of these things "quality of life" issues. Sure, they may sound petty to some, but when you have to live such a rigid life 24/7, it can really start to burn you out. It affects relationships, work, everything. So yeah, my "medical outcomes" might have been ok, but my personal life often bordered on being a mess. I've found that I have less "burn out" on the pump because I can be more spontaneous. I have a better relationship with my spouse because we can be more spontaneous.
Trying to do a comparison between pump and MDI... I'm not sure any existing data could be used and it probably would take a study designed especially to do such a comparison.
It's not strictly true that pump users are a self-selected group but it's often true. I'm sure today you could compare those on the pump vs those not on the pump and find that those on the pump are better educated and better controlled... but that could be due entirely to self-selection.
MDI'ers would probably benefit from a lot of the stuff a pump user is taught. But they seem less likely to be taught it.
And then there's still a contingent out there doing 2 shots a day of R+N, or a basal/bolus routine with MDI but without any of the actual benefits of using bg readings and carb counting to make MDI work well.
It will be interesting to see how a supposedly objective set of studies will compare the cost vs benefit. No question that pumping is superior to MDI but cost is always a consideration. Few of us would opt for MDI if pumps were handed out for free! I hope that advancements in pump design and manufacturing technologies will make pumping more affordable, and then studies like these will be moot.
