User error ?? I know of some with diabetes NOT on pumps and unfortunately are not here to tell the story !!!
This is a quintessential argument as to what is enough info and what is too much in managing diabetes. My tu friend Stuart calls diabetes a "beast". Reminds me of the old Eagles hit:
You can stab it with your steely knives
( our syringes, infusion sets, syringes, they are steely!!) but you just can't kill the beast!</< em>strong> Livin it up in the hotel diabetes, such a lovely place;... You can check out anytime you want ( ignore the difficulties): but you can NEVER leave".. LOL
God bless,
Brunetta
LOL that is great Brunetta.
Girl, I was "loopy" when I wrote that;and when I checked after posting, BG was 39... A swig of Sunny d has taken care of it and I am now at 74. Guess I better remember to lower my basals when shopping all afternoon.
God bless,
Brunetta
Loopy, but a rock star none the less. Shopping always does me in too, why is that?? LOL, thanks for the tune, the trip down memory lane and for making this post less scaremonger as it was intended. It is a beautiful thing to be in the midst of folks who know how to LIVE with this thing and even be able to laugh and poke back at it! You gals ROCK!!
hahahaha weekends always make me low, its cause my schedule is totally off and lol if I have it my way I wont get out of bed till 10. I need to create a pattern for weekends, and yeah shopping does it to me too. The thrill of the hunt for that uber good deal, lol.
PS a pumper since 2001 :)
Truthfully I work in the medical field and I see it a lot, people not accurately counting for carbs, or dosing based on what their blous wizard, (LOL maybe it IS magical) suggests, changing their recommended settings and running high because of fears of lows. Its not so much pump malfunction as just a lot of error on the users parts. While I can certainly appreciate the fear of going low, and NO ONE likes to go low unexpectedly,pump therapy makes getting out of lows MUCH easier and faster. No where in that FDA article does it state pumps malfunctioning. Im all for people receiving further education, but that I feel too should be based on the patients level of understanding and comfort level. We are not all the same. Me I really didnt even need the 3 hours it took me, I totally got it...I just needed help on where to set my basals at. But there are people out there who probably could benefit from additional training sessions, and yes others who just don't put forth the effort thinking the pump is an easy solution, its ONLY as good as the individual who is controlling it, and the amount of dedication they want to put into managing their disease. These pumps based on the FDA report are NOT miscalculating dosages, that is coming from human errror. Not to say it CANT EVER happen. But the OP is making it sound like it happens on a DAILY basis to THOUSANDS of pumpers, whatever, Im not seeing that in the FDA report at all.
I'm sensing a lot of push back because I've criticized the safety of pumps. However, all of the anecdotes everyone has mentioned confirm the dangers I'm talking about. We agree.
I agree that the pump is amazing and I'm not giving it up. The control it offers is fantastic, and the basic therapeutic model is much safer than MDI.
However, much of our therapy is filled with folk-lore and getting data out of the pump through carelink is actually fairly difficult. Does anyone remember when it didn't work on any new computers about a year and a half ago? Why is it some members here find it easier to share pictures of their device, than a link to a report somewhere with a nice narrative that software has helped to generate? Because it doesn't exist. Medtronic controls the data and refuses to allow us access to it.
I should probably mention at this point that by day I'm a software engineer specializing in human factors and usability. I don't know much about medicine, but in software we try not to blame the user when we give them difficult task, instead we figure out a way to make the impossible possible, and the difficult easy.
Since we all seem to be agreeing that pump therapy is an arduous journey, my argument is simply that we need access to our data. I bought the device, the data is generated by me, and I need access to it in case carelink doesn't work again or just doesn't fill my needs. Without close monitoring insulin therapy is dangerous, and without access to the data, the job of monitoring is difficult.
If so many users found it so easy to misuse or abuse the pump, I think it says more about the pump than the users. If you give me a choice of a faulty solution vs no solution, I'll take the faulty solution without complaint. However if it's faulty let us help make it better since our lives depend on it. No one has more motivation to create safe and effective technology than the people using it, regardless of the domain.
I'm sure you would benefit from having more access to your own medical data.
:-)
I never mentioned malfunctioning. I mentioned design faults that make the pump difficult to use, and difficult to understand what to expect during use, as well as bugs my own doctor has told me about, such as life time of active insulin, failure to alarm, button stickiness, etc.., anything potentially leading to side-effects from therapy is a bug of some kind, right?
With access to technical details, the diabetic community could solve a lot of these issues without any changes to the pump or the pump business. It starts with being able to independently access our data.
I'm not sure I agree so much that pumps are dangerous as I think that it's the insulin that's dangerous, no matter how you shoot it.
I haven't encountered any problems w/ CareLink since 2008. "Duration of insulin effectiveness" is adjustable too, so I'm not sure what access to the nuts and bolts of the software will do for you? I think too that many users would find recoding their pump, for whatever reason, would likely be more difficult than using CareLink. I think that Medtronics manages their pump business like IBM managed mainframes before the PC era, they owned and staffed them for companies. The user just rented the whole package. You can get the data out but only though the method that they support. If you start reprogramming it, no more warranty so that when an error arises, you are "out".
I'd also suspect that with any drug machine, letting a user recode it could be construable as negligence on the manufacturer's part should, for example, I reprogram my pump and then run my car into a crowd of people "insulin pump, what, it was reprogrammed...". It's probably more clear to defend such allegations by keeping them locked?
huh?? My pump is not a device I use to keep track of my medical data, it is simply a device to get insulin and it offers fine tuning ability. The most important medical data for me is actually on my meter (I don't use the link meter) and this is what I use to adjust pump settings. I am not one who agrees that pumping is an arduous jouney. So, allow me to suggest that since you are not giving it up, maybe just give up the expectation of the pump providing all that data you seek. Getting data out of the pump can be done the old fashioned way. I don't want my pump to be making changes, decisions, or recalculating anything...it is a machine.
The pump keeps logs of its behavior that can be used to analyze and improve your configuration. Getting access to these logs is vital to better understanding therapy. I'm not talking about making automatically making changes to the pump, simply devising ways for me to better understand therapy. I find the carelink software limiting in this regard and have chosen to improve things only to find the manufacturer actively preventing me from doing automatic analysis, not changes.
I'm glad you don't have problems with lows on Saturdays or while out shopping or exercising.
Your feedback has been incredibly valuable. I've tried to address some of the confusion in http://lists.participatorymedicine.org/scripts/wa-SPM.exe?A2=SPM-MEMBERS;4f8d7190.1206. Would you please let me know if this begins to clear things up? I understand it's a bit long, I've tried to simply describe the problems I'm trying to solve. I apologize that the technology is sufficiently confusing to distract away from the core issues at stake here, and for my inability to concisely communicate the benefits available.
You make assumptions that I have not introduced. I am a type one diabetic and have lived with this for most of my life. I get hypos now and then, and some software improvement is not going to "fix" that. I get high for no reason sometimes as well. My first pump did only one thing, it delivered insulin - that was in 1990 and it was a great improvement from shooting a mix in the morning and then feeding the peaks and valleys all day. Today I can have multiple basal sets, insulin to carb sets, bg range sets and so on. Awesome and carelink does not stop me from fine tuning these options. I have learned in my time with diabetes that no matter what settings I've made, I must always be ready for change. I don't need a report or software to help me understand this.
If you have lows while shopping or exercising, you can put your pump on a temporary basal set and you don't need the carelink, the manufacturer, or a report to do that. Logs are great, but they don't necessarily know what happened today so can't answer for everything.
I sure hope you can get whatever changes you are looking for incorporated into your pump therapy.
I apologize for making assumptions, it is a defensive response in the assumptions being directed my way as well. I am repeatedly accused of doing things or attempting to do things that are completely inaccurate.
I've repeatedly stated I'm not looking to make changes, simply contribute to making things better through stronger and more thorough analysis of all the data available. I don't understand your arguments against me doing this. Are you arguing we are better off without better analysis? Are you arguing that patients don't have the ability to do any better than what we've been given? I'm confused as to why we are better off without access to raw data. Can you explain?
It sounds to me as if there is lots of room for improvement and there are easy ways to prevent side-effects, and I'm eager to get the ball rolling.
I think I understand and agree withthe criticality of having the data however as a non-technical person I don’t actually want the raw data files, I want the data “collated” like Carelink does. I also work for an insurance company, investigating claims, many of which are extremely bizarre. I can imagine that from Medtronics perspective, they’d rather keep the keys to their kingdom. That way, when they get sued, they know what they are dealing with. If the information is “open sourced”, Medtronic will still be a defendant but the costs of litigation could be modeled to be higher, if only because of additional defendants and allegations!
Ok, I think we can begin to have an excellent discussion. I understand your desire to just have something that works, I feel the same way. Carelink is an excellent and elegant first effort! I don't actually want to be doing any of this, either, but we must all play our roles, it seems.
I agree there are legal concerns. The vendor is actually unable to separate the auditing use case from the therapy use cases if the protocol is indeed opened. I believe that you are correct in proposing that this is one reason to deny access! However the damages you mention remain a potential threat today, agreed? What about all the people who have already gone to the hospital or even died because they simply didn't understand what they were doing? Do we have an obligation to help the people already being hurt? If opening the protocol can potentially help them through better simulations, better communication, and better analysis, better education, then what role should a vendor's fear of potential lawsuits play? What if someone brought a lawsuit because they were denied access to the information they needed and wound up in the hospital?
My understanding is that there is already case law on the books setting precedents to protect Medtronic from being held responsible if some rogue patient does something crazy. Can anyone verify or reject this?
By the way, by making a technology open source, you can also prevent lawsuits by denying any fitness for any purpose. Because the source is open, the user is free to make their own judgement as to whether or not it is safe, or can choose to trust the word of an authority.
Having empirical access removes the liability of trusting an authority.