Hello everyone, I am starting this forum to get some help for a petition I am working on to get the FDA to approve the insulin pump I am currently wearing. It is the Medtronic Paradigm Veo insulin pump with CMS.
I am currently living in Germany with my husband. We were stationed her 5 years ago and because our base does not have an Endocrinologist, I was referred to a German Endocrinologist in our local area. I had been on a Medtronic insulin pump for years when we moved here. After my first visit with my Doctor I was switched to a German version of my Paradigm insulin pump because the European pumps run on a different frequency. Because of this my Doctor could not download my American pump. About three years in to my time here my Dr Braun got approval for me to use the CMS that went with my pump. At that point I had been a Type 1 Diabetic for roughly 20 years and had never been fully stable. I went through fazes of almost stable to totally out of wake from one appointment to the next. I know that most insurance companies refuse to cover the CMS because it is not "medically necessary", but that will be my next battle to get resolved. My Doctor and I found out slowly after I started using the CMS that there are certain things that vastly affect my blood sugar that do not usually affect others.
Fast forward to the fall of 2012. I had inquired with my Doctor about doing a clinical trial for patients with Type 1 diabetes. I wanted to do anything I could to help make a change for the better for other people dealing with this disease that were having the same problems that I was having or had in the past. On my next appointment Dr Braun asked me if I would like to be involved in a clinical trial for the newest insulin pump on the market. He said I would have to answer a questionnaire during some of my visits and would have to download the information from my insulin pump to the site once a month while the study was going on. "I would love to help!" is what I told him and then Dr Braun got me all set up with the insulin pump for the study. The clinical trial ended up going longer then originally planned because it was going so well and all the information that Medtronic was getting from the patients. I also saw a vast improvement in my blood sugars while doing the study. When the clinical trial ended I was put back on my original Paradigm insulin pump.
In the spring of this year my insulin pump started to break. The Act and Esc buttons did not always work which was causing a problem with the alarms on my pump. Because of this I was written a new prescription to get the upgraded insulin pump, which was the one I did the clinical trial for. I was ecstatic because I had had such good results while using this pump! My HbA1c was finally down to below 8.0 after 4 years of frustration, anger, and very hard work.
After I had been wearing the pump for a month or two I received a letter from my insurance company and a phone call from Medtronic that my insulin pump was not being covered because it was not FDA approved. The pump had not been approved by the FDA because of the automatic shut off feature that suspends the basal rate when the patients blood sugar has dropped below a certain number. Mine is set to suspend at 70 because when my blood sugar drops, it drops very fast. I also have hypoglycemia unawareness. I found out after speaking with the Medtronic, Deutschland representative that this insulin pump is now the only one provided in Germany.
I started my petition for FDA approval because this suspend feature saved my life earlier this year! My blood sugar dropped so fast while I was asleep one night that I didn't even hear my pump alarming that my blood sugar was low. When I finally woke up and checked my blood sugar it was 41! If my insulin pump had not suspended I could be dead or in a comma right now! How scary is that?! I still do not know why my blood sugar dropped so fast or so low that night because my daily routine the day before was the same as always (I really like my life to follow a schedule). I also know that I am not the only American that has problems with sever hypoglycemia or hypoglycemia unawareness. This pump could help save thousands of peoples lives!! I know I have a battle ahead of me but I am throwing my whole self in to this to try and help make life easier and safer for all Type 1 diabetic living in the United States! Thanks in advance for any support and help anyone can offer!!
United States Food and Drug Administration : Approve Medtronic Paradigm Veo insulin pump w/...www.change.orgMedtronic Paradigm Veo insulin pump, with continuous monitoring system, is the closest thing to the artificial pancreas on the market to date! The...
If this link does not work you can find my petition on www.change.org under Approve Medtronic Paradigm Veo insulin pump w/ Continuous monitoring system. Please share my petition on any forum you would like to to help bring awareness to this situation.