My father and the numbers
I wish my father was still alive. For many reasons, of course. But tonight I wish I could take advantage of his extensive knowledge of a subject that I am grappling with. A subject he taught at some of the nations finest colleges and universities: statistics.
I've been trying to understand things beyond my normal experience. Beyond my education. And, perhaps beyond my intelligence.
Sensor number eight has been acting up. Running high. Too high. I’m back to being THE NEVROUS DIABETIC.
My first two weeks were wonderful. Like a fairy tale. But with the 7th sensor crapping out and number 8 not acting like the first six, I find myself becoming paranoid. I don’t trust the girl as much as I used to....and she’s a lot of work and money. If I can’t trust her, what’s the point?
Medtronic has provided me with 16 pages of clinical study data in the back of the manual. I'm looking through all of this to try to answer one question: were my first two weeks typical performance and the recent trouble an anomaly, or the other way around? I'm struggling to understand what the information is saying. I wish I could call my father and have him explain it to me.
Although I remember once, when I was in college, I called and asked him a stat question. A deep sigh in the phone. A pause, and then, finally..."Well, you do have a copy of my book, don't you?" Yes, Dad. "Well I cover this quite toughly in chapter two." I was told to read chapter 2 and THEN call back if I still didn't get it.
I've looked though both of the books my father wrote tonight, but his voice isn't speaking to me through them. I'm on my own with no one to call if I don't get it.
Here is what I think the data tells us. I may not have "gotten it." So don't treat this like it is carved in stone.
The help line’s official number is that the Guardian readings are plus or minus 13.8% of a finger stick, but looking over the clinical studies it is not that simple. The results are non-linear. That means that in some ranges it is better than the 13.8 and in other ranges worse.
Medtronic have compiled various data into an analysis to show how readings could effect real world situations. Overall, about 62 percent of readings can be considered "clinically accurate." Around another 35 percent of readings would lead to "benign" decisions. In other words, yeah, off a little, but you wouldn't hurt your self. So the machine is considered golden about 97% of the time. That's damn good. But what about the other 3%? Well yes, this is the zone where you can kill yourself.
Part of that number includes lows that are not detected. The system is not perfect. Is it still worth it? My feeling is the money is well spent catching 97% of my trouble. Besides, this is not the only game in town. I'm still using my BG meter and my brain. Even though I can't feel lows I can recognize when my behavior has put me into a situation where they are more likely and I can exercise more vigilance. Might it miss a hypo? Sure, could happen. Might I miss one on my test strips? Yes, and once pre-Guardian I had a real close call. Might the Guardian catch something I would otherwise miss. Yes, 97% of the time.
Might I have a "perfect storm" with me out to lunch and the Guardian in 3% town? Could happen. And what would happen then? Well, hopefully my wife would remember how to use the Glucagon kit. (My pharmacist had a good friend who died of hypo. His frantic mother injected the saline with out first pushing it into the vial and then drawing it back it. These ain't Epi-pens. My advice: have your loved once "practice" with expired kits before you toss them every six months.)
There is a ton of data. Tables. Charts. Columns of figures. It is late at night. My mind is muddled and I am depressed by all that has transpired. But I’m feeling encouraged. Tomorrow I’ll sleep in. Then I’ll get up and look at the data again and make sure I’ve got it right. After that I’ll look over the download of my data again carefully and try to figure out what’s going on.
SIX HOURS LATER...........
This morning I was planning to sleep in. I was up late last night studying the clinical studies data in the back of the Guardian manual, trying to divine how well it is supposed to work. But I woke up at 8. Laid there trying to get back to sleep with no luck. May as well check the BG. Cozmo has me at 65. Kinda low. I take the Girl off of the nightstand and flip open the case. Click. 90.
$#%&^*@ #%#%&% $^*&%##!!!!!!
Or words to that effect. I retest with Cozmo. Now 64. I take a half a cherry slice and roll over and try to get back to sleep. No luck. I’m too pissed off.
I get up. It is site change day for the pump, but not until tomorrow for the Guardian. The sensor that died threw us off the system. A normal site changes seems so simple. So little to do.
I gather up my notes and call Medtronic. The poor guy at the 24 hour help line really gets an ear full. Among other things I dump on him I tell him this is too damn expensive not to work right and what are my return privileges if I want to throw in the towel?
He is exceeding polite to me, even though I’m probably near the edge of being nasty myself. These Medtronic folks are professional. He doesn’t know why I'm so far off, and he doesn't know about the return policy on the Guardian, but he’ll find out.
As promised, he calls back within the hour with THE PLAN. First off, the Guardian has a 30-day return. As we are closing in on 30 days they want me to know they are going to extend that for me. They want the machine to work for me and we are going to work together to try and make that happen. However, failing that, they’ll take her back and refund my money. Cool. I’d much rather spend the rest of my life like I’ve lived the first two weeks, but if that was just beginners luck then I’d rather have the money back in my checking account.
They ask me to email all data from hook up until today. They’ll analyze it and with in 24 hours they’ll call back. We’ll conference call with tech, help line, and me. We’ll all be looking at the same data on our computer screens and try to figure out what’s going on.
Tomorrow: Good News for Wil and the girl
I've been trying to understand things beyond my normal experience. Beyond my education. And, perhaps beyond my intelligence.
Sensor number eight has been acting up. Running high. Too high. I’m back to being THE NEVROUS DIABETIC.
My first two weeks were wonderful. Like a fairy tale. But with the 7th sensor crapping out and number 8 not acting like the first six, I find myself becoming paranoid. I don’t trust the girl as much as I used to....and she’s a lot of work and money. If I can’t trust her, what’s the point?
Medtronic has provided me with 16 pages of clinical study data in the back of the manual. I'm looking through all of this to try to answer one question: were my first two weeks typical performance and the recent trouble an anomaly, or the other way around? I'm struggling to understand what the information is saying. I wish I could call my father and have him explain it to me.
Although I remember once, when I was in college, I called and asked him a stat question. A deep sigh in the phone. A pause, and then, finally..."Well, you do have a copy of my book, don't you?" Yes, Dad. "Well I cover this quite toughly in chapter two." I was told to read chapter 2 and THEN call back if I still didn't get it.
I've looked though both of the books my father wrote tonight, but his voice isn't speaking to me through them. I'm on my own with no one to call if I don't get it.
Here is what I think the data tells us. I may not have "gotten it." So don't treat this like it is carved in stone.
The help line’s official number is that the Guardian readings are plus or minus 13.8% of a finger stick, but looking over the clinical studies it is not that simple. The results are non-linear. That means that in some ranges it is better than the 13.8 and in other ranges worse.
Medtronic have compiled various data into an analysis to show how readings could effect real world situations. Overall, about 62 percent of readings can be considered "clinically accurate." Around another 35 percent of readings would lead to "benign" decisions. In other words, yeah, off a little, but you wouldn't hurt your self. So the machine is considered golden about 97% of the time. That's damn good. But what about the other 3%? Well yes, this is the zone where you can kill yourself.
Part of that number includes lows that are not detected. The system is not perfect. Is it still worth it? My feeling is the money is well spent catching 97% of my trouble. Besides, this is not the only game in town. I'm still using my BG meter and my brain. Even though I can't feel lows I can recognize when my behavior has put me into a situation where they are more likely and I can exercise more vigilance. Might it miss a hypo? Sure, could happen. Might I miss one on my test strips? Yes, and once pre-Guardian I had a real close call. Might the Guardian catch something I would otherwise miss. Yes, 97% of the time.
Might I have a "perfect storm" with me out to lunch and the Guardian in 3% town? Could happen. And what would happen then? Well, hopefully my wife would remember how to use the Glucagon kit. (My pharmacist had a good friend who died of hypo. His frantic mother injected the saline with out first pushing it into the vial and then drawing it back it. These ain't Epi-pens. My advice: have your loved once "practice" with expired kits before you toss them every six months.)
There is a ton of data. Tables. Charts. Columns of figures. It is late at night. My mind is muddled and I am depressed by all that has transpired. But I’m feeling encouraged. Tomorrow I’ll sleep in. Then I’ll get up and look at the data again and make sure I’ve got it right. After that I’ll look over the download of my data again carefully and try to figure out what’s going on.
SIX HOURS LATER...........
This morning I was planning to sleep in. I was up late last night studying the clinical studies data in the back of the Guardian manual, trying to divine how well it is supposed to work. But I woke up at 8. Laid there trying to get back to sleep with no luck. May as well check the BG. Cozmo has me at 65. Kinda low. I take the Girl off of the nightstand and flip open the case. Click. 90.
$#%&^*@ #%#%&% $^*&%##!!!!!!
Or words to that effect. I retest with Cozmo. Now 64. I take a half a cherry slice and roll over and try to get back to sleep. No luck. I’m too pissed off.
I get up. It is site change day for the pump, but not until tomorrow for the Guardian. The sensor that died threw us off the system. A normal site changes seems so simple. So little to do.
I gather up my notes and call Medtronic. The poor guy at the 24 hour help line really gets an ear full. Among other things I dump on him I tell him this is too damn expensive not to work right and what are my return privileges if I want to throw in the towel?
He is exceeding polite to me, even though I’m probably near the edge of being nasty myself. These Medtronic folks are professional. He doesn’t know why I'm so far off, and he doesn't know about the return policy on the Guardian, but he’ll find out.
As promised, he calls back within the hour with THE PLAN. First off, the Guardian has a 30-day return. As we are closing in on 30 days they want me to know they are going to extend that for me. They want the machine to work for me and we are going to work together to try and make that happen. However, failing that, they’ll take her back and refund my money. Cool. I’d much rather spend the rest of my life like I’ve lived the first two weeks, but if that was just beginners luck then I’d rather have the money back in my checking account.
They ask me to email all data from hook up until today. They’ll analyze it and with in 24 hours they’ll call back. We’ll conference call with tech, help line, and me. We’ll all be looking at the same data on our computer screens and try to figure out what’s going on.
Tomorrow: Good News for Wil and the girl
posted by Wil | 4:32 PM
3 Comments:
Ellen--thanks for the advice, but I'm not going to be returning her. Even with some of the headaches I'm far better off with this machine than without her.
Don't throw in the towel yet Wil - I'm rooting for you!
I'm 5 for 5 so far - no bad sensors yet, only a tendency to trend low in the first 6-12 hours. Results have been similar despite wide differences in sensor placement. I'm feeling comfortable with the stability of the readings and with placement on the upper thigh.
I may cut back on fingersticks slightly, but otherwise don't see this device having a huge impact on the daily routine. Its been worth the initial cost of the device to have an additional layer of security against lows, but unless I win the lottery, the high cost of the sensors may make this only a semi-continuous glucose monitor.
Congrats on the nomination!
Ellen--
I've been giving your comment a lot of thought. Let's talk about the Navigator first. Based on the advanced preview on the Abbott site it looks like a hell of a machine. Things I especially like: it is supposed to have a trend indicator; an arrow that shows if you are moving up or down. That's nice. The hypo alarm is also a different set up, which may prove superior. The Navigator senses rate and degree of change. By contrast the Guardian is set to alarm when the BG levels cross a certain threshold, set by the user. Navigator on the other hand seems "smarter" at recognizing impending hypo, or at least a situation that could lead to it. On the surface this seems like a good idea, although in practice this may cause a lot of post-meal false alarms depending on how fast a persons BG returns to normal.
I also like the idea that it has its own built in BG meter for calibration. Of course that would have me carrying two BG meters all the time, but at least the pump and the Navigator would share the same test strips. Speaking of which, the Freestyle test strips are probably the hardest to use of any made....It also looks to be a bit larger than Guardian.
All of the medical companies, I think, push the envelope a bit in getting products to market. But we all know that, and we all understand that being an "early adopter" means paying more than later folks will and getting a product that will not be as good as the cheaper version they'll sell next year.
But it all really comes down to availability. I honestly thought that the Navigator would hit the market first. But it didn't. And no one seems to know when it will. Will it be two months, six months, two years? Guardian may not be prefect, but she's here, today.
Will I be irritated if I keep her with all her joys and frustrations only to see Navigator hit the streets two weeks after I can no longer send the Guardian back. Yeah, probably so. Especially if it does turn out to be a better unit. But on the other hand, it could be another year before we see the Navigator and it may be no different than Guardian.
Guardian had an approval advantage at the FDA. It is simply the next generation of existing (and approved) technology. Navigator does not have that advantage. Abbott is in new and uncharted waters here, and they have a lot more to prove.
No doubt in five years we'll have a number of continuous devices to choose from, and hopefully at that point our $%@#$ insurance companies will be on board to help us out!
Meg!
Hello! So great to meet a fellow pioneer! We need to start a club! I got an email a few weeks ago from another Guardian user that also reported a trend towards low readings during the first day. I haven't really seen that, but it would not bother me. I just hate it when the girl clocks me in higher than my BG meter. Stress! I have not tried to wear the sensor anywhere other than on the stomach, but that's the only place on my body that I have any body fat left on at all. The rest of me is skin, bone, and a (sadly) small amount of muscle! Sensor cost is a bitch, and is causing some trouble for me too. I just keep telling myself that it is only for a while. Maybe six months, a year at the outside; before the insurance will help us out with sensors.
Post a Comment
<< Home