I day in 3/1-a follow-up of my saga
Find a Conversation
| Sun, 02-22-2004 - 3:04am |
Hi everybody,
This is a follow-up to my "not good Doctor's visit" saga. I met with the new CDE and saw my "old" one who has become a friend when I went for the initial visit concerning going on insulin. I had a c-peptide test done and for some reason the people who are running the trial will not give my doctor the results of this test. I also had another A1C run. I will know the results early this next week. If my A1c remains above 7 I will be accepted into the GOTT trial.
The GOTT trial is a 4th level trial, which meals that all 6,000 subjects will get the treatment drug, in this case Lantus. The FDA has accepted doseage levels for using Lantus in type 1 diabetics but there is no such agreement for type 2 diabetics. So this trial will determine the appropriate doseage for type 2 diabetics who have been on oral meds and have an A1C above 7. The trial will go on for 7 months.
I was given a new meter and boy am I spoiled after using the one I was given last year. It is an Accu-Chek Advantage. You have to stick the testing strip in at the appropriate time, you have to calabrate the meter and you have to wait longer for the results. I have been using an Accu-Chek compac and it certainly is a much nicer meter. I am only given enough testing strips to test my blood sugar once per day before breakfast. So if I want to test more often than that I must use my own meter. This is quite a nuisense.
I will meet with the CDE and my doctor again on March 1st when I will be started on 10 units of Lantus every evening, probably 9 or 10 at night. Then I will need to record my morning blood sugar reading into some kind of a calculator which on a weekly basis will average my blood sugar readings and tell me if I need to increase, decrease or keep the doseage the same. This part at least should be interesting.
One interesting part is that I have to record the number of events when my blood sugar is 70 or less. I have to tell them if I needed to dial 911, had convulsions or seizures and what I did to treat my blood sugar. Let's hope this part of the reporting booklet remains absolutely blank. I begin to feel symptomatic when my blood sugar reaches the low 80's so I most likely will have already treated this unless it occurs during the midlle of the night. Ughhh!
I'll keep you informed as to what happens next. Wish me well on this new adventure!
Mary Frances
cl-maryfrances40

Pages
Wow, Mary Frances talk about a lot going on with you. I am glad to hear that if your A1c is above 7 that you will participate in the GOTT, because I have read so many good things about all the things they have been doing during this. How ever
You are absolutely correct! I would dance a gig to get out of there!
The C-peptide test measures if you are still producing insulin. I suspect that the drug comapny wants to know about this to correlate the amount of Lantus needed to bring the diabetic under control. But it is really strange that they won't tell my physician the results. Perhaps they will tell him when the study is over. If the Lantus doesn't control my blood sugar and drop my A1C reading the answer to the question must be that I am not able to produce enough insulin to control my blood sugar, especially if I have to go on short acting insulin as well as the long acting. We will have to see how all this works out and you and my other board friends will know as soon as I know.
Mary Frances
cl-maryfrances40
My experience has been that since I am under the close supervision of a CDE,
I, too, hope that you don't have readings under 70 that would prompt ER visits, and nasty events that you described. I'd be so shaken (figuratively and actually) that I couldn't record anything! I had an 81 last week (same evening as the 117 that made me happy), and ate too much which threw off my waking sample. Live and learn, I guess!
I think testing once a day with the study meter wouldn't be adviseable. I agree that to keep a good hand on your levels, you will need to test with your meter, also.
Well, keep us informed, ok? We care what happens to you!!!
Anyway, was going through some magazines I picked up at the diabetes education yesterday. In "Diabetes Interview" there was info regarding Novo Nordisk announcing that they'd rec'd an approval letter for insulin detemir, its long-acting insulin analog. This apparently is in response to the Lantus by Aventis Pharmaceuticals.
So...there's a big ad on the opposite page for Lantus--insulin glargine injection. So, I don't understand why you would be in a study when they've already released it. What do I know, anyway? It says that it's for adults with type 2 diabetes or adults and children (6-15) with type 1 diabetes. Side effects: hypoglycemia; injection site reactions, including changes in fat tissue at the injection site; allergic reactions; and itching & rash.
24 hour support line: (866) 263-5389
on-line: www.lantusconnection.com
At least my whole night wasn't wasted! I'm such a computer geekette. Just thought I'd pass the info to you. You probably know all this already.
:-)
Kathi,
My A1C came back at 7.1. Almost made it out of the study!
The reason for the study is that the FDA has not accepted the amount of Lantus necessary to treat type 2 diabetics with insulin resistance. So this study will be used to determine the guidelines for treatment. Everybody knows that it works for diabetics but often for type 2s it takes much more to be effective. 6,000 of us will get the drug and be put in different treatment arms. I won't know which arm I am in until March first.
I am little leary about the hypoglycemia possibilities but I don't think I will let them occur. Since my blood sugar is higher than desired, when it gets 90 or less I feel it. I intend to treat it and to check it as I always have. It is a nuisence to figure out which meter I want to use!
The recommendation of the American Acedemy of Clinicial Endocrinologists is 6.5 but unfortunately more than half of diabetic can't even meet the 7.0 guideline.
I'll continue to post as this goes along.
Mary Frances
cl-maryfrances40
I'm very interested in your progress. Guess since I was insulin resistant, I fit in that group, too. Thanks for the update.
By the way, why isn't the Wednesday 8PM working tonight? It's way past that time, and CL-charlotte311 doesn't receive emails for me to get the scoop. What good is a support chat if it's not working?
:-(
Pages