I wish the World in general worked as well as you expect it to. I'll stick with the Omnipod, it works extremely well for me. And no the FDA does not need to remove it from the market at your bidding. I'm appaulled at your even thinking that you have even the slightest power of such magnitude. The World would probably be better of by removing people with your mentality.
Don't blame your failures on the pump. Think about it... I'm sure the FDA is having a good laugh at your letter.
I can understand frustration but this attitude is extremely selfish. You would like to deny Omnipod to the multitude of people who have had success with it by advocating that the device be discontinued just because you had an incident in your first week? Think about it. You didn't give the Omnipod a chance, there is an adjustment period.
We do understand, there are many of us who have come close to death and I'm one of them- more than once. I sounds like you are not a good pump candidate, any pump. No pump is that reliable and they all work in the same basic way. I would stick with MDI.
I've also had BS's go so high it wasn't read on my glucose monitor and so low I awoke in the hospital, all when on MDI. I have rolled a car, came to on the floor and awoken in the ER. There is a learning curve that you have to accept, if not then you should stick with what you are comfortable with. The pump isn't a simple magic cure but it certainly deserves longer than a 1 week test. After a month, if you're still this unhappy and angry then definitely go back to MDI, it's not for you and that's OK.
I have always tested 10 or more times a day and when first learning the pump it was even more. You must watch blood sugars very, very, very carefully when first learning to pump, and taking shots to get things under control is fine. This should have been explained to you and the fact that you didn't have support from either your doctor or trainer is sad and probably part of the problem.
My experiences with MDI (and DI) vs Omnipod are actually the opposite of yours. I was on DI then MDI for almost 40 years before I tried Omnipod about a year ago, I had HbA1C over 8%, I frequently have very high blood sugar; seeing a 500 was all too common and I also had frequent low blood sugar because, well, once the I has happened there's no way out!
Since being on Omnipod I've seen 500 I think once, my HbA1c has dropped to approaching 6%, I hardly ever have low blood sugars (my PDM target is 100, initially I targeted 80 and had episodes around 60 quite frequently, but the target 100 means I rarely go below 60).
Part of this is perhaps because 16 years is not long on MDI; those injections tend to destroy your subcutaneous fat and, after almost 40 years, enormous variability in adsorption rate of the insulin is, I suspect, to be expected. So Omnipod loses for you because sometimes it takes a high BS to become aware of problems with the injection site, but it wins for me because the problem disappears after a few hours. Like (I think) many Omnipod users I bolus like mad when my blood sugar starts to rocket after a pod change, it comes right because it's typically an adsorption problem so it self corrects at least so far as the basal is concerned.
Adhesive problems are, however, new to me. In my experience the adhesive is the last thing that detaches! I assume your ejected canula was because of the adhesive problems you referred to later and, curiously, today I have an adhesive problem! I'm seeing a detachment at the end of the pod, but what I did to achieve this was somewhat extreme (for a start I should have taken a shower before changing the pod ;-)
But this is only me; other people have various remedies to avoid detaching pods and it is widely discussed on this site. I see this as just one of those problems that diabetics can't avoid, like that weird effect where your subcutaneous fat disappears, but somewhat nicer.
John Bowler jbowler@acm.org
you keep saying you "nearly" went into the hospital...but you didn't end up there. IF you did it would have been ALL YOUR FAULT, not the OmniPod. Because despite what you say, you definitely DID NOT read all your training material. It's in there. So instead of consulting it, you QUIT and do something outrageous. You write the FDA. You could have read the literature again. You could have posted on here for help first, instead of writing to the FDA. You decide to write this HELP forum to blast the product we all rely on, instead of asking for help first. You get sympathy from me for your struggle, but none for your response to it.Shame on you.
When I first was diagnosed in 2008, I had a similar experience with MDI. I was very frustrated with high BGs and not having success with controlling it with MDIs. So... I talked with a friend who pumped on Minimed and loved it. My endo recommended checking out the OmniPod, and after checking both options out, I ended up on OmniPod. My experience was that it made things MUCH easier to manage. What you experienced with the cannula will be similar on any pump--they are all about the same length. I think OmniPod has an advantage because it inserts at a 45 degree angle which I would think would make it harder to bump out versus a 90 degree insertion. It's the nature of cannulas to not work 100% of the time either because of a bad insertion (pinching up is very useful to avoid this) or bumping on a doorway or seatbelt, etc. But even if you get a perfectly inserted cannula and never bump it, it can be at a site on your body which doesn't absorb the insulin for some reason (scar tissue, muscle, etc). I encourage you to give it some more time (I think you said you had 45 days...).
Best of luck to you.
What a reactions. Would it be an idea if some of us starts thinking it over for a few days before they post their comments. That takes the blood pressure down and makes people think more clearly. Newtopumping has had a bad experience and that's her truth. It happened and she feels very bad………… That is an emotion at level 10 at that time. A lot of the other reactions are also at a high level of emotion . Which I understand as Newtopumping tries to stop the Omnipod while there are many satisfied users who depend on the system.
I am also a satisfied Omnipod user and in the beginning had some bad experiences and said some, level 10, words. The first Pod I had to put on (training) started screaming. That gives real confidence.
After a few Pod’s a got the hang of it and now I do not want anything else.
So please think before you post a comment and do not use capital letters, it looks (sound) rude. Newtopumping I hope you give it a chance and wish you good luck and use this forum to ask questions and to get information.
I am so sorry this was your reality with pumping! Unfortunately, like others have said, bent canulas, malabsorption, and kinked tubing (as you find w/other pumps) are all part of pumping. A very frustrating part indeed. After being on a pump for 11 years these frustrations have lead me to consider MDI again. If your diet remains consistent and you have no other stressers/illness to account for-an MDI T1 can simply take a shot and expect a normal BS reading in 2-3 hours. A pumper has to examine all the other options for a high reading (those mentioned above) and decide "do I bolus and wait 2-3 hours to confirm my suspicion of a site issue or just change it out?" And, if you chose to wait to change it (and it is a site issue) you have added another 2-3 hours of high readings before the problem can be remedied. These situations seem to happen more frequently for me (at least 3x a month) after over a decade of pumping.
However, when pumping works (and clearly it does for many people)-the results are fantastic. What you have to weigh, newtopumping, is if your desire to wear a pump and possibly have tighter control can withstand the issues that will always occur with using this technology. It is definitely a very hard decision to make. Your experience with the pod sounds awful-DKA is terrifying! Living alone complicates this issue. What I find so frustrating with diabetes care is that it is highly personal. What works for you is unique to you and might not work for me. I hope after debating all the factors in your care you are able to make a choice that best suits your desires and reality. And please newtopumping-don't let the emotions of those that responded to you in this post disuade you from using this forum to gain insight. This community has been extremely helpful to me as I debate my future with pumping (I learn something new everytime I came here!)
Best of luck newtopumping!
If you check on the Internet, you will see there are a lot of complaints about the OmniPod. Mine is only one of many.
I have been on the Omnipod for awhile now and love it. I was on a MM pump for ten years before the Pod, so I have plenty of experience with that as well.
As others have indicated, pump failures, cannulas kinking and general pump "issues" are NOT mutually exclusive to the Omnipod. This is one of the problems I have with your post and letter to the FDA. I get that you are emotional, scared and most importantly, your expectations for the Omnipod were not met. However, when you only give it a week and you post something so emotionally charged, you are going to get an emotionally charged response from PWD's who love and use the Pod day in and day out. Newtopumping, you created the post and slammed the device that keeps us alive - did you not expect some backlash? You admit that you this is your first pump. Your letter to the FDA holds absolutely no water because you've never tried any other pumps. You can have similar issues with Medtronic, Animas etc. On various occasions I had high sugars with my MM pump. Don't get me wrong, the Omnipod is not perfect, but no pump is. After all, what the human body does is amazing, and we are trying to replicate it manually.
I've also had problems with a Humalog vial here and there. Did I rip off a letter to the FDA saying saying that Humalog was reckless and dangerous? Of course not.
Look, diabetes sucks sometimes and we are all just trying to do our best with all of the technology available to manage this disease. I'm happy we have choices. I'm happy we can choose between MDI's and Pumps. My guess is that pumping is not for you, or maybe it is. Your statements about the Omnipod to the FDA are misinformed. When a cannula kinks the PDM tells you and you replace the pod. No pump on the market will tell you if a cannula comes out. Why? Because the pump is still delivering insulin. No pump can tell you if the cannula is on the outside or inside of the skin. If you "expected" this then it's a problem you will have with every insulin pump on the market, not just the Pod. Maybe just the Omnipod wasn't for you - which is cool and completely understandable. It's all personal choice and what's best for you at the end of the day.
You get scared that you almost had to go to the hospital and I get that. I get scared when someone writes an emotionally charged letter to the FDA based off a very, very small sample about the device that keeps me alive.
I wish you the best, newtopumping, and hope if you give another pump a try that it works well for you. If pumping isn't for you, then I hope that MDI's keep you happy and healthy. Good luck.
p.s. when Insulet eventually releases the next gen pods, the cannulas will be a light blue color. This doesn't solve the problem when a cannula gets knocked out, or otherwise outside your body, but it should make it easier to see than the current clear tube. :)
I'm a relative newbie to the Omnipod - I've been using it a little under a year.
I've used just over 100 pods and only had to phone in 3 as failures. I'm happy with it so far and it has dramatically improved my control. 3% failure rate is not perfect, but it is acceptable for me given the advantages this pump gives me versus a tubed pump. I expect the failure rates to continue to improve with new generations of the technology, but as everyone has pointed out, pumping has its own unique failure modes.
Pump manufacturers have a daily check list that people can follow to deal with these.... for an example, see the Animas daily checklist here. If you aren't willing to deal with these kinds of things, perhaps pumping is not for you.
http://www.animas.com/about-insulin-pump-therapy/daily-pumping-checklist
There is an infusion set now that can HELP tell if a cannula is popped out or blocked.. Have you seen the Spring Infusion set.. basically it has a flap, if the cannula pops out, it will become occluded and cause a occlusion error on the pump. Not perfect but better than some.. Also for many people, it takes some time for an infusion set to work properly.. Did you make sure to fill the cannula? and sometimes a post-infusion change bolus (of a "little bit" of insulin can help things along..) I tend to use a temporary increse in basal for 4-8 hours... You might want to try a tubed device.. with those suggestions.. Wish you the best
_jake
If you check the Internet, you'll see a lot of complaints about ALL PUMPS! I'm sorry, but people like you really tick me off! Just because you failed, you have to write a letter to the FDA in an attempt to take away a good thing from others!!!!!! You must be one of those type that can't see beyond your OWN EGO!!! If the Omnipod doesn't work for you, just GO AWAY! Taking negative actions toward Insulet and it's happy customers is so self centered and self rightous, you really should be horse whipped!
You, sir, owe the Omnipod community here and elsewhere an apology for your actions.
Again you fail to take responsibility for your own actions. Instead, you choose to search the internet for complaints to give credibility to your claims. Why don't you just admit that you really did not read all the materials? ALL of your complaints scream loudly and testify that you did not read them thoroughly and did not follow procedure. When there was a problem you still did not refer to your material. AND instead of seeking help on this forum (btw that's what your profile says is the reason you joined this forum, for help) you didn't seek help. You chose instead to blast the device we all depend on. You want this to end? well just fess up to your error in judgement and admit you acted rashly. Why waste time defending your actions? Your criticism of OmniPod only points the finger back to you. Your own words testify to that. Read what you wrote...why in the world would you switch from MDI to a pump when ALL of your A1C's have been under 7 since 1996? I'm suspect to that statement. Is there anyone out there who has had ALL their A1C's under 7 for 16 years straight? If so, sign me up for the seminar.
No, writing a letter to the FDA is correct.
We *are* diabetics; we only live because we whine.
Newtopumping -
Sorry to read this. One of the frustrating things about pumping is that you never kno if the cannula falls out, no matter what system. You can't have a wire in that tiny soft material as it has liquid insulin going through it and it would be a real uncomfortable feeling for the user. That said calling and asking for a company trainer to visit with you might help. It is a great product but it is so different from other pump products that there is sometimes the need for more specific training. Especially within the first month or so. That is true for all pump user's but the CDE's are much more used to the tubed versions. That toll free number on the back of the pdm should help you get what you want and there used to be a 30 or 45 dauy money back option which would allow you to get some personal training and try it out.
As any change to pumping thee are so many variables that are different for all of us. Having pumped on and off for over 30 years now it always amazes me how much time I need to work out my personal kinks when I head back to a pump system. However, once you get in a groove ... it usually works spectacularly. Then again, reality id everything is not for all of us, right?
You make several good points and a local/regional sales rep or company CDE should be able to answer all of your concerns. The key is getting to the right person who will really take your issues to heart and they exist. Sorry this happened and I do hope that it can come around for you.
Then thre is always the chance you got some faulty product. Ask for it all to be replaced with different serial /lot numbers and see if you succeed with a new set up. You never know. sadly, these issues are so personal in the D world that what one of us does may not be good advice for another... I always say go wit your gut and do the right thing for you.
Good lcuk with your choice of options and continued success on those HBA1c's... that is the game changer for all of us!
Best wishes to you....
Erik, may I ask where you got this information from? Having worked in this industry for a decade the option of a "colored cannula" has always been gossip as inserting something under your skin with some sort of dye in it as ta would e a potential health concern for anyone with D. Not sure the FDA would ever allow this to happen quite honestly. they may develop such a thing but the FDA still needs to approve of it and that can take .... a significant amount of time.
I can hear them now... ",,,will this be used by a child..." , "what are the potential implications?" , "why doesn't every system have this" or " how can we see the insertion needle through the cannula coloring?" ... Sounds good but to many "if's" on this one. Just my two cents of course, it might be out tomorrow and then egg on my face but it would sure shock me if it did
Erik -
Sorry, I just read your link to the new brochure.. WOW!! Very exciting with a light blue cannula. I am so impressed by this as it is not a simple issue to tackle. Great for the Insulet engineers on this milestone!
Thanks, btw , for that link in one of your posts... great information to have.
Continued success ....