Intellectual property vs safety?

Think there are bigger battles to fight. How about BG meter accuracy? There inaccuracy is very easy to prove.

Please read the FDA report. Are you saying all the people who have been hurt by insulin pumps were hurt because of they believe in magic, were naive, or were doing things they weren't supposed to be doing?

I have not tampered with the device at all. Using the protocol is not tampering with the device any more than using a supported meter or using the remote control the vendor sells. This is misinformation and FUD that the vendor spreads among the technical ignorant.

I'm not talking about tinkering. I'm talking about using the scientific method as the basis for therapy and measuring therapeutic outcomes. Are you saying you believe the secrecy helps your therapy, or is it possible that more information will improve safety?

If a doctor wiped off the calibration markings on a syringe before giving it to you, what would you do? Would you ask for a syringe with all the calibration markings? I'm simply pointing out that the pumps as we use them are not much different from having someone wipe away all the calibration markings before you use it. Some people might be fine with that, but it doesn't mean that other people are not hurt from incorrect dosing. It also doesn't mean people should stop using it, rather that we have an ethical obligation to openly discuss safe dosing.

I'm glad your therapy is going well, but fail to understand why the success in your therapy should be used to justify the harm others receive? We just want information on how to recognize and avoid these safety problems without using folk-lore or magic.

LOL I agree Jim. Or how about making test strips and insulin and pump supplies and access to pumps more affordable so more people can have the resources to better control. AND if the calibrations on a syringe WERE wiped out, I'd ESTIMATE my dosage, we are not talking a 500 cc syrninge, at most 100 units. I think just about anyone of us who have used syringes could eyeball a dosage that is pretty close to what they take.

There are bigger battles out there to fight, and IF the FDA truly had a HUGE issue with pump safety, you can bet they would pull them off the market. It's a mechanical device and nothing is EVER going to make it 100% safe. I don't wish bad on anyone, BUT that being said, pumping is something that really does require dilligence, being dilligent in my opinion can help prevent or catch a lot of problems before they become something bad. That's just my opinion, I know since going on pump therapy the amounts of times I test has tripled compared to what I've done in the past, because I'm aware of what can and sometimes does go wrong.

Looks like to me from the FDA report it is PATIENT ERROR...that can be anything from miscalculating your carbs, entering the incorrect BG level etc that is causing problems. If that is the case than I can get behind the fact that yes additional patient education might be needed by some individuals and/or their family.

I looked at the report (finally!) and it appears to conclude that the problems were due to user errors? "patient errors in the use of insulin pumps appear to be the cause of the adverse events associated with these devices."

I think the big cause of patient errors is likely to be the "soft" targets many docs aim at and general tolerance of less than normalized results which wouldn't really be affected by pump safety or need to be reprogrammed? If anything, I've been sort of astounded by how reliably (*knocks on wood...*) my pump has worked!

and I quote this DIRECTLY from the FDA report

Peer reviewed and non-peered reviewed articles found in scientific journals and in newspapers collectively supported data of better or similar glycemic control with insulin pump therapy in pediatric and adult populations when the patient is motivated and willing to do the work of diabetes care combined with proper patient selection, education and training, and an effective support system. The studies substantiate safety and effectiveness of insulin pump therapy in selected children, adolescents, and adults with type I diabetes. (10, 12, 13, 14, 15, 17, 22) Several articles indicated psychological and emotional maturity, along with proper and thorough training in the correct use of the pump, significantly decreases patient vulnerability for misuse. (12, 13, 14, 15)

Appropriate education and training are paramount to successful insulin pump therapy, despite the different risk factors of youth and adult populations. (1, 2, 18) Regardless of treatment modality (multiple insulin injections or insulin pump therapy), greater risks for hypoglycemia are found in the pediatric, elderly, and people who have had diabetes for a long period of time. (15, 18) Some risks in adolescents with diabetes are unique to this group, but they share with adults common reasons for insulin pump misuse such as lack of motivation, inadequate education, and lack of appropriate support. (1, 18) Studies revealed similar medical complications between youth and adult populations, and similar adverse events occurred with multiple insulin injections compared to insulin pump therapy. (10, 13, 15)

Studies showed when suboptimal performance of the insulin pump occurred, the primary cause was patient error. (1, 16, 22) The causes range from youth missing mealtime insulin boluses, patients failing to adhere to treatment plans, to patients having inadequate familial, provider, or manufacturer support. (16, 17)

Many of the insulin pump studies revealed limitations that might have contributed to the data reflecting the number of adverse events noted. Such limitations included non­ randomization of patients and insulin pump devices, inappropriate patient selection - which included such factors as motivation, cognition and subjective assessment of parental/familial involvement. These factors were often not determined prior to conducting the study and affected the outcome. The exclusion of these patients would have made it easier to determine if the problems were with the device or the patient. Other studies were skewed because of patient selection, for only motivated, well­supported and high levels of cognition were determined prior to the study, therefore, reporting fewer adverse events. (11, 15, 18)


If anything, I've been sort of astounded by how reliably (*knocks on wood...*) my pump has worked!

Me too.

Are you arguing that the people who were harmed were too stupid or lazy to use the pump? That this is obviously true because it works for you?

I'm saying increased education on pump use will make it even safer. Are you disagreeing with this? Pump use is clearly a lot of work. If someone came along and could safely eliminate that work, especially the most dangerous bits, would you prevent them from doing so?

Diabetes is a lot of work regardless of which method of keeping a leash on it you use. I think the main reason that people have problems is that they're generally not encouraged to "go for it" and try to achieve normal BG levels as much as possible. I haven't hit it all the time but do ok but I'm always trying to figure out ways to do things more smoothly or whatever. I think education is good but, to me, it's not worth taking the pump or it's software apart to get at the nuts and bolts. I've been able to make it work as it is and can usully identify specific causes for deviant readings.

I need access to the logs in order to faithfully manage therapy. Easier access to logs means therapy is easier. Why should I be prevented from access to my own data?

I require access to my own data. Again, nothing is being taken apart. The technology to get access to the data is trivial. If we had access to it, we could build a solution so that you did always have time to do the right thing.

I dont get what you mean easier access to logs...are you talking about your BG levels? Carelink provides logs all your information from your pump is uploaded onto Carelink.

It might not be perfect I just dont see where Pumps are seriously dosing us incorrectly, or where the logs from Carelink don't provide adequate information. Follow the trends, its ALL an experiment, trial and failure of what works, what needs tweaking etc.

Ahhh, I have the CareLink gizmo too. I agree the data is awesome and has been one of my favorite things to have with it. If I didn’t have it, I’d want it for sure.

I LOVE my carelink it nice seeing where your averages are, so you can kinda get an idea of where your A1C will be, the graphs are wonderful for helping to determine where changes might need to be made. I second that if I didnt already have it, I'd spend the money to get it.

It's great that the existing products work for you guys. I don't understand why that should prevent others from empirically understanding their therapy. Especially when so many people are actively harmed.

Allowing others to understand their therapy as well as you understand yours won't change your devices or your therapy.

Were you aware that there was a period of time during which it was impossible to buy a new computer that worked with carelink? These kind of limitations are willfully put in place by Medtronic. I can make the usb stick work with any computer, for free, if they'd let me, so that no one has to go without access to it.

NO Im arguing what the FDA article says...its USER ERROR, and IF you had bothered to read what I had posted earlier Im all for people if they need it to have access to more education. BUT READ THE FDA ARTICLE IT SAYS USER ERROR...not pumps malfunctioning on their own. You want to mess with yours knock your socks off, you are the only one I see making an issue of this.

A person STILL has to know how to calculate the carbs correctly that they eat, and that just comes from practice and experience, and honestly I want to be the one in charge of my pump because if I screw it up I have NO ONE to blame but myself. Take that however you want to, its obvious you will. Machine can and do sometimes fail, I would rather have some control over my pump and make the decisions on how to act, than have it determine that for me.

This is what I posted on the other page but you must have not bothered:

Looks like to me from the FDA report it is PATIENT ERROR...that can be anything from miscalculating your carbs, entering the incorrect BG level etc that is causing problems. If that is the case than I can get behind the fact that yes additional patient education might be needed by some individuals and/or their family.

And yes I still stand by what I said earlier, if people have some misconception the pump is some easy fix, that they don't have to be dedicated to staying on top of thing, then MAYBE its NOT FOR THEM. I never once said people were stupid or lazy, but there ARE people out there that DO think pumps are a magic fix and don't require a LOT of effort on their part and THAT is a belief that will get you in a LOT of trouble.

I don't get too hung up about this nonsense. How much technology these days is accomplished through radio transmission? a lot, from opening garage doors to cell phone use to data transmission. If someone wants the information transmitted by my meter to my pump or visa versa; or they want the information transmitted to my clinic through Diasend, then they are entitled to it. What will they do with that information? It is unique to me. I am content with my life.

Hmmmm, intellectual property in this case is directly akin to the design of this very tested, proven, and well used insulin pump. I personally don't need access to documentation of the remote diagnostic protocol, and access to the firmware to fill my reservoir (you called it a syringe which is incorrect BTW!), or calibrate my ???. My pump(s) have provided me safe therapy for more than 20 years. As others have suggested, it is a mechanical device so there is surely the possibility of failure or malfunction. The company is quick to resolve any issue like this, and usually it is by sending a new pump to the user, not giving them technical coding instruction by phone! Since you can't abide allowing someone to give insulin without empirically investigating their method, I think you should stop pumping your insulin. MDI is an option that many folks do fine with, and ... oh wait - it is not without error or mishap. Good luck with your quest Ben.

I can safely say I have had MORE error and mishap on MDI than I ever have had on pump therapy. Trying to keep straight how much IOB I may have, when the last time I injected for something, how much I need to deduct because there is still active insulin. My pump takes ALL that into consideration, so yes far less error on my part.

I could not have said this better, Christy. Thank you!

Totally agree with you christy! I never had the amazing task of MDI, but my old regime of mixing was an accident waiting to happen at any given moment. We have the best tool available and are fortunate to wear them :)

I agree I remember the good old days of mixing R and NPH, lol I thought it was cutting edge when 70/30 came around...what I NO LONG HAVE TO MIX. LOL that junk was a nightmare to deal with. Yes I think we do have the absolute best tools available and I def consider myself fortunate to have it.