Denied by Cigna? or Gentiva?
Contact me at kweaver@kweaver.org if you've been denied by Cigna or Gentiva?
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Contact me at kweaver@kweaver.org if you've been denied by Cigna or Gentiva?
And for a scary reason.
Enforcement Report for September 22, 2004
PRODUCT
DANA Diabecare II insulin pumps. Recall # Z-1451-04.
CODE
Serial numbers: AEE001FC – AEE039FC, AEE041FC, AEE043FC - AEE048FC, AEE083FC – AEE132FC.
RECALLING FIRM/MANUFACTURER
Dana Diabecare USA LLC, New Orleans, LA, by email, letters and telephone on May 26, 2004. Firm initiated recall is ongoing.
REASON
There is a switch malfunction that may cause the unit not to respond when command key is depressed.
VOLUME OF PRODUCT IN COMMERCE
37 units.
DISTRIBUTION
AZ, WV, PA, FL, WI, MI, TN, and MD.
I currently way the least I have weight in a very long time. I think even since I was diagnosed with diabetes.
I've lost 35 pounds since February and around 10 pounds since school started. My goal is to lose about 1 pound a week, and I think I'm doing a tad faster than that, certainly I have since school started.
I also got rid of a bunch of old, too big pieces of clothing this weekend.
Ended up ending this trial after exercising and a bunch of skips. I think I dislodged the watch again.
The good news:
I have good data that tells good things.
The burn isn't as near as bad as before.
The watch was not painful, but a bit uncomfortable. You have to wear it in a place that you don't usually wear a watch.
The bad news:
I had to end early when I worked out. I think it will get better as I didn't lose the watch after I ran up the stairs and got a perspiration warning.
All in all, I think the watch is okay. I think it is a good choice for me, because basal tests are stressful for me. Keeping an eye on the clock and testing every hour isn't good, and is too hard to do at school. Wearing the watch works.
I don't think the watch is worth $1000. $300 isn't bad, but the reporting needs to be more flexible. I also think the new price point on the autosensors is much better. I am going to see about having Blue Cross Blue Shield cover the autosensors in the future.
It is going extremely well. I have good numbers, and good trends.
However, it's been a cool day in the classroom and relatively calm.
It went so well, I went ahead and ordered 2 boxes of autosensors since they are at the reduced rate.
I think I'll talk to my CDE about getting them setup with the insurance.
I think I have the watch in a better location this trip. Also Monday's burn is healing better and faster than the previous burns from the watch. I still have itching and visible marks.
Good news, though, Diabetes Forecast came out with a review (clinical trial) that shows that the watch works well at "normal" blood sugars, tracking trends.
Bad news, it doesn't do as well as it could with low blood sugars.
Another difference between the two types is gone.
Type 2 Diabetics Not Immune to Diabetic Ketoacidosis
A significant portion of diabetic ketoacidosis (DKA) cases occur in patients with type 2 diabetes, according to the results of a review of admissions published in the Sept. 27 issue of the Archives of Internal Medicine. There are subtle differences from DKA in patients with type I diabetes, but the treatment is the same.
"An episode of DKA was once considered a hallmark feature that would differentiate individuals with type 1 diabetes mellitus from those with type 2 diabetes mellitus," write Christopher A. Newton, MD, and Philip Raskin, MD, from the University of Texas Southwestern Medical Center at Dallas. "With the changes in the frequency of DKA and the increased incidence of DKA in patients with type 2 diabetes mellitus, the question may be posed of whether there has been any change in the clinical or laboratory characteristics of the patients with DKA who present to the emergency department."
I ended up stopping the watch and taking it off. I had dislodged it, and wasn't getting readings.
One thing I have learned from pumping -- these things take practice and adjustment.
The good news, is that I did get two hours of good data.
It's going well, in fact, the values on the watch are actually matching my meter values!
I'm experiencing some itching, and occasional pain, I'm not sure that the spray has helped much and think I'll see what the prescription solution is if I start using it more.
I'm not doing a basal test today, just watching trends for the day.
Today is my first daytime trial of the Glucowatch.
I put the spray they recommended on first. I can't decided if it helps yet or not. And I've gotten a few perspiration warnings during warm up period, so we'll see how it goes.
Teacher workshops have always been a problem. Typically they serve food that is guaranteed to throw me off and yesterday was no exception. Plus I have to sit in one chair all day.
I'm finally realizing that I HAVE to do a 20% temporary basis. And I have to bring and eat my own food.
All of which I did yesterday and ended up with not only perfect blood sugar at the end of the day, but again the next morning, in fact it was lower than it has been all week.
I also had more energy and got more out of this one that I have gotten out of a workshop in a long time. Of course, it helped that I learned a new skill and was working with a different application than I have before.
I wore the watch again last night, and got another good trial.
Do the readings coorespond to my glucose meter? No!? But do readings between two meters correspond? Not really.
But it does show the trend and does show what is going on.
What I've learned? You have to stay in a fairly cool and dry place. It's really only good for testing pump settings. However, its much better than fingersticks every hour. Or forearm sticks.
Cheaper and easier to deal with that the Minimed CGMS, since you can't get it wet, have to wear it for 3 days, and can't see what is going on until you return it to the doctor.
I just can't see how someone's diabetes is under control if they aren't under a regular doctor's care and aren't getting the standard tests.
Is Diet-Controlled Diabetes Really Controlled?
Some patients with type 2 diabetes are able to achieve good glycemic control with diet and exercise alone. However, for many patients, the term "diet-controlled" suggests more optimism than science. Physicians should heed this study's findings and confirm that, in patients whom they are treating without medication, diabetes truly is well controlled, and they should monitor such patients adequately.
The New York Times > Health > Fitness & Nutrition > High Blood Sugar Also Poses Risk to Heart
The A1c is not very expensive at all to do. I think the At Home kits all run around $10.00 a piece.
My mistake -- I stayed in my computer room and got too hot. I should have calibrated downstairs or I should have turned on the A/C before calibration time.
I'll remember that.
I called today, and I got information on a pre-treatment that's supposed to help the burns. It's a spray -- and I couldn't find it at my drugstore, but it was available for a "delayed" order from Drugstore.com. It's called Cortizone 10 Quick Shot Spray. You're supposed to alcohol the spot then spray with this stuff. It's around $7.00 by the time you pay shipping.
Newer insulins and easier blood glucose monitoring have greatly improved the ability to obtain excellent control of blood glucose levels with less risk of hypoglycemia. In type 1 diabetes, insulin pump therapy remains the optimal approach with the most flexibility, especially with the ultra-fast-acting analogs lispro or aspart. Otherwise, once- or twice-daily dosing with the long-acting analog glargine provides excellent basal coverage, and lispro or aspart at meals provides bolus coverage, all in the attempt to mimic physiological insulin secretion. For type 2 diabetes, although oral agents continue to be a mainstay of therapy, it is clear that many patients require insulin to attain the goal A1c of < 6.5%. Once-daily glargine is now used more commonly after 1-2 oral agents have failed, and it typically takes the place of sulfonylureas. The future will likely have better systems for continuous glucose monitoring and novel therapies to control glucose through agents that affect gut hormones.
Right now, continuous glucose monitoring really doesn't seem feasible, even in the very near future. It's also expensive!
This is a good article reviewing the state of technology though. I will say, as a Type 2 diabetic, I STILL hate any of the longer acting insulin. Their release just isn't as perdictable as the fast acting in a pump. Plus, if you get up and you end up running around the room all day, the only way to deal with the excess insulin is eating, thus incurring weight gain.
I don't like the way things have been going, and I'm going to concentrate on fixing some of that this week.
I'm losing 3-5 pounds during the week and then gaining back part of what I've lost. Part of the problem, is that I'm losing too much during the week.
I'm also tired all the time. And I'm having a lot of trouble with gastric reflux still, even though I've lost a lot of weight.
One of my students pointed out the main problem -- I'm up and perky in the morning, but by the end of the day, I'm just exhausted.
One change I'm going to make right away is when I eat. I'm going to eat a bigger breakfast, and try not to eat anything after 6:00 pm this week.
I'm also going to take a day off in the middle of the week if I feel stressed, especially since I have staff development on Saturday.
I've also got my schedule set up so I shouldn't have to be on my feet a whole lot.
The good news! This is the end of the first six week.
The bad news, I see the sleep doctor in about 3 weeks.
MSNBC - Are you ready for weight loss?
Very good article -- and gives quite a bit of insight into my behavior.
Right now, I do believe I can lose weight -- there was a time when I didn't believe I could, or there were more barriors to weight lose than there are at the current time.
Test 3 was successful -- while it alarmed for a low glucose event, and my glucose wasn't quite that low, it showed what was going on, and was even accurate at the end.
My assessment -- the device is something that takes getting used to -- I am definately going to call about the cream. However, I can sleep with it.
It is definately NOT for day to day use. It's too difficult and expensive to use for that. However, it's what I wanted -- something to take the stress out of basal tests. It's idea for basal tests.
Things to keep in mind -- and true for ALL blood glucose monitoring devices. It is NOT 100% accurate. It shows tends, and that is even true of finger stick devices.
It doesn't handle day to day monitoring. I doesn't handle exercise, food, or even insulin administration well.
However, it's ideal for basal tests.
Is it worth the price? It is certainly NOT worth the original price. At $400, it's still pricey, especially since the software isn't included. I also want to be able to export the data and do things with it. That's my next goal to look into.
At $4.00, it's not bad for basal testing. I would definately finger stick more than once though -- and be prepared to calibrate several times.
This one is going MUCH better. Pain from the watch itself isn't as bad as Trial 2, though I am going to ask about the cream.
Readings are much more accurate, so far.
I stopped this round when I started getting funky results and it still itched.
Going to try again tomorrow.
Got home from school and put on the watch.
Now, part of the problem is that I got eaten alive by mesquitos last night and everything itched already, BUT
I put the watch on my outer arm, and I swear it feels like I'm getting burned. I've been able to tolerate it, but it is very uncomfortable.
Got through the warmup phase and calibration and now am testing and so far the watch has skipped every reading -- the first two. If thing doesn't start giving readings soon, I'm taking it off. This is just too uncomfortable, to get no where.
Health Beat :: America has heartburn
Back when Prilosec worked for me, and it was a prescription drug, the pharmacy's would run out of Prilosec back then too. Makes me wonder if the manufacturer does it on purpose.
Skin irritation isn't bad, but you can definately tell where the watch was at.
I still don't know about the readings, but I was more comfortable going to bed with the lower blood sugar with it on.
So I don't know. I am going to try it again either during the day on Friday, or Friday night.
DB's Medical Rants ? Comparing drug pricing
Interesting, told me that 80 mg of Zocor runs around $100.00 a month, and that mail order it's around $86.00
I'm not sure what problems RCentor is having, but I didn't have any trouble
I honestly don't know what to think.
I've stopped the test, because I want to go downstairs and work out.
I did get a low alarm, I was experiencing low symthoms so I took 20 grams of carbohydrate, since my blood sugar via the meter was 118 at 11:30. Not REAL low, but the lowest my blood sugar has every been at night since I started measuring things.
I woke up with a meter reading of 98, and several soft alarms. The watch showed several very low readings.
I'm going to try again several nights before I do anything to affect my treatment. And it's all very odd.
And I just performed an interesting experiment.
The watch claims my blood sugar was 100 - 113.
Freestyle Flash claims it's 133.
One Touch Ultra 137
Accu-Check Compact 156
So 4 different numbers.
Does it matter?
Not really -- first remember there is some error inherent in any of these devices.
While doing this, got my third reading -- now at 120.
After a LONG wait. Okay the advertised 2 hours, I finger stuck and calibrated the watch. It was a successful calibration, so we'll see how the evening goes.
The biggest things to remember, is that the reading is 15 minutes off, because it's sucking up glucose, rather than getting it from blood. Trends are more important. I'll have my first reading in 10 minutes.
The tech support people are courteous. I was freaked out by the fact that when I put the glucowatch in the reader port, and then pulled it out, the battery flew out and the watch reset.
So I called, it was after business hours, so I left a message. Got a call fairly early today acknowledging that it was a known feature of the watch, and shouldn't be an issue. And that it would be easier to remove the watch for the port with the armband.
I called back, because I hadn't asked about the reset issue, but I did figure out what was going on with that. The watch was new out of the box, and the onboard lithium battery hadn't charged yet. When I left the watch alone for a couple of hours, I could get it out of the hardware port with no problem, even though the battery still flew out.
They confirmed during the call, that yes, the battery didn't come charged, and that it would store results for 2 days without an external AAA battery.
That was reassuring.
Tech support means a lot to me. I would grade them higher with they had 24 hour tech support -- Therasense seems to, and Animas does -- though the tech support person calls you back within a few moments of you calling them.
I've had the watch on for 15 minutes and it's already a tad itchy. I'm also afraid I don't have it glued down good, but we'll see.
One of the problems with the Glucowatch is price. Even at the new reduced price, the autosensors are $3.99 a piece. That's a lot out of pocket, but I'm going to see in the insurance will pay for them if I like the watch.
They arrived today -- though this time, didn't have an invoice, which I need to have them reimbursed by my Flexible Spending plan. So I called and asked for a duplicate.
I've got the watch on and calibrating. I'll let you know how things go.
I did fubar things, I had the straps and d-rings wrong, and my husband had to help me find a way to make it all work without disturbing the autosensor.
I'll do better next time.
I'm going to do a "basal" test. I ate around 4:30, exercised, took off my temporary basal and plan to calibrate and then not eat again until tomorrow morning and see how things are going.
One thing that was freaking me out, was that when I pulled the watch out of the hardware port, the battery flew out AND it lost all it's data.
I even left a message with tech support, about the battery flying out thing, which does bug me.
However, what is going on, is that the internal battery isn't charged so it was losing the data. It's charging now, and retaining data. I'll leave it in Power Save mode all night, and maybe it will get charged.
Which may be why the Glucowatch hasn't been successful.
I bet the blood sugar monitor required one too.
Warning -- you have to call a 1-800 number and answer a silly "test" to get a passcode to be able to use the Biographer.
It's goofy.
I did pass, and I did get a passcode.
I have seen some of the training video. It's well done.
I like the fact that they give you a card with an index, telling where each part begins.
Okay, I have a SERIOUS problem with this. When you fire up the program, you're presented with a user id and password login. The login information should be on the CD case, not in the help file.
Oh well.
So far, I'm disappointed as there doesn't seem to be a way to export data.
Oh well.
I'll figure out a way.
I just added a new Glucowatch category -- and will move the other entries on it to this category.
The software and watch arrived, the autosensors are due tomorrow evening.
I am currently installing the software.
It came in a box with a CD, and the CD case has a "quick install" and information on getting help for the CD. Personally, I like to keep the manuals to a minumum, so it's okay for me. Heck, I rarely read anything but the quick install these days.
New computer users might want more.
One of the absolute best articles I've seen on diabetes, and covers BOTH types.
GreenvilleOnline.com - Planning helps diabetic students cope at school
There are two points to this story -- to illustrate another way that apologizing isn't acceptable --
And to illustrate what happens when blood sugar is out of control.
A couple of years ago, right after being diagnosed with diabetes and
with a blood sugar of over 400 ... a teacher aide interrupted one of
my classes. I politely asked her to leave, and when she continued to
interrupt my class time by standing in front of the computer I was
doing the demonstration on, I yelled at her to get out of my room.
Probably a bit strong of a reaction, and if my blood sugar had been
lower, I might have not yelled as quickly. Woman never DID budge.
As a result, she complained to one of the administrators, and I
refused to back down. Geez, it was MY classroom, I was teaching MY
class, and she was interrupting. I ended up discussing it with the
principal, and no one ever did acknowledge interrupting me put her in
the wrong.
To mollify everyone involved, I agreed to let her come up to my
classroom, introduce her to my students, and apologize to her in front
of them. She wouldn't accept anything less.
My students were appalled! I told them what was happening the day before she came.
And after she left, I let them know that while the witnesses agreed she was in the wrong, third parties had determined that I needed to apologize and it wasn't a big deal for me. I truly
shouldn't have yelled, even if she wasn't listening.
Good things came of it. My students learned that apologizing for
misbehavior -- justified or not -- is not that big of a deal, and the
aide and I are at least cordial, and she sees things my way now.
She also hasn't interrupted a class of mine since.
UPS tried to deliver my glucowatch sensors this evening. It was weird, because it was just around UPS time so I decided to check to see if it had been dropped off -- they often drop the package off and ring the door bell -- but for some reason, usually we're in the backyard, we don't always hear them. And I'm not sure they always ring the bell.
Driver had just driven up, so I walked up to the truck and talked to the driver, and he showed me where it was dated 9/8 -- last Wednesday. I refused delivery, so we're all okay now.
And he admitted that it should have been delivered last week, and that it was marked all over "temperature sensitive". Sigh.
Well, here's the deal on the Glucowatch.
The guy who runs the insulin pumpers list (whom I have a problem with anyway) claimed he had a working Glucowatch that people could try.
So I told him to send it and ordered a minimum order of autosensors.
However, when it came, it was missing 5 components: the recharger, the self test unit, the autosensor press, and the batteries. Batteries wasn't a problem, it has two rechargable but takes a regular AAA.
The problem is, you can't make it work without the autosensor press.
It wasn't a complete waste, because I got to see the video tape, which was well done, and reasonable. I didn't open the other materials, as I figured out pretty quickly it wasn't going to work.
So I called the Glucowatch people and was going to cancel the autosensor order but they had shipped the day before. So then I decided to bite the bullet and buy the watch.
Friday arrives -- two days after the "temperate sensitive" auto sensors were supposed to have shipped and NO sensors. And Diabetic Promotions is out of the office at 4:00 pm Friday (EST). I don't even get off work until 4:00 pm Friday on (CST), so that was problematic.
I phoned first thing this morning, ready for a battle, but yes, they had shipped, and UPS lost the order! I wasn't completely convinced until UPS called, so now I'm waiting for both the watch and the reshipment of the autosensors.
And so far, Diabetic Promotions have been okay to deal with.
Going through the Glucowatch 1-800 is hookie, because they are on California time, and don't answer to 10, and Diabetic Promotions are on Eastern time, so I'm not even going to mess with the Glucowatch 1-800 from now on. Especially since before 8:00 am our time is an ideal time for me to mess with stuff like that.
As of today, I'm 28 pounds less than I was when I first went to their office!
I'm really thrilled to death with both the doctor and the CDE. We did have an interesting conversation, because the doctor didn't want me to waste my money on the Glucowatch, but they both decided -- like I did -- if anyone on the planet can get it to work, I can, and because I've done so well with everything else, we might as well give it a shot.
Believe me, I'll hammer the Glucowatch people with tech support requests. More on that, next.
Anyway, the CDE and I had an interesting conversation -- I'm one of her very few Type 2's on a pump (I might be the only one), and she's not sure if she would put me on the pump if I was a new patient. She acknowledged she would have to work with me for a while.
I also admitted I wasn't as anal about numbers until the pump -- but why be, if you aren't influencing the numbers by your behavior?
We also agreed that I will see her after I see my sleep doctor and that if he has anything negative to say about my part of my care, I'm walking out of the office!
This is an interesting article and I hope more doctors and hospitals see this information. And the good news, here is where a doctor involved in litigation has been something that may lead to some good. (Note that the cases were sent to him to review because they were in litigation, not that the researcher was sued).
Diabetes In Control News - Researchers Devise Way To Detect Brain Swelling In Diabetic Children
The Glucowatch people have reduced the price on their watch and on their sensors. I don't want to try it though, unless I have good reason to know it works, and works well for me.
The insulin pumpers group has shipped a Glucowatch G2 to me, and I'm going to order autosensors from them on Tuesday to try it out. I'll report here.
Though I have it on at least one user's advice that it caused serious skin irriation for him, and was always around 50 units off.
It would be nice if it worked.
The glucowatch samples every 10 minutes and produces a 20 minute average, alarms when low or high, and is downloaded. It would certainly solve the need for basal tests if it worked.
I'm doing very well on the weight loss, still losing around 1-2 pounds a week. Unfortunately it's so slow that the people who are around me all the time don't notice.
I did enjoy the ego boost when I returned back to school though. That's been nice.
And due to posts from the insulin-pumpers list, I believe they are starting to ship
FDA Approves Geodon, Alimta, Vioxx, and Others
On June 28, the FDA approved a blood glucose module (CoZmonitor, made by Smiths Medical MD, Inc., formerly Deltec, Inc.), intended for attachment to the back of the Deltec Cozmo insulin pump to create an "all in one" insulin pump and blood glucose monitoring system. The pump keypad and screen are used for all blood glucose testing functions and results.
I don't know if it was working before the upgrade, but finally the TypeKey commenting feature is working!