Showing posts with label research study. Show all posts
Showing posts with label research study. Show all posts

Thursday, June 18, 2009

The Placebo Effect

"Come in!" Ginny, the research coordinator, greeted me with enthusiasm(first requirement of the job, you have to LOVE people) as I cracked open a door, seeing if anyone was in that room.

The place. The place where history will either be made, or broken, was buried so deeply in the most obscure part of the multi-billion dollar sprawling medical complex that it had taken me a good ten minutes of wandering around, asking various people where the Surgical Endocrinology Lab was and THEY even not having a clue. Employees, who've worked on that floor for years.

I entered, peeling off my jacket as the warm air hit various body parts,instantly making it feel like a sauna, despite the coolness of the outside air. Ginny liked her haven on the warmer side of things.

It appeared much like the setup of the other research lab, recliners,racks of tubes, tables, several people running the lab tests and a short-white-coated-incredibly-young-looking medical student helping out. It's truly scary that there are now doctors younger then I..and that most people my age are now residents. Ack-I am old.(when did that happen?) Signed papers, had IV put in, drank 2 cans of chocolate Boost, and watched the CGM drift up from 114.

Research doctor wandered in. Ironically, his last name was the same as the research doc down in Virginia. I swear I can't get away from that last name, its too weird how it worked out. Another 2 people came in, they were pre-pancreatic (perhaps a Whipple?)surgery. They drank the Boost/glucose tolerance thing but of course they weren't getting the hormone. Research doc patiently answered all my questions,and asked a bunch of me(to make sure I passed the "should be in" test). Their drug is actually made in the lab and has had no effects in either rats, or humans.(and they make it in their lab so its not from some animal) There will be 4 visits, 4 weeks apart. (2 this week, 2 4 weeks from now)

Visit #1
-100 carbs of Boost
-IV blood draw every 15 minutes for 3 hours
-Get hitched up to study pump that contains either placebo saline or the pancreotic polypeptide.

Said pump, is a Disetronic T10 Panomat insulin pump probably from the 1980's, it is dirt-old and HUGE. Twice the size of my little Ping. They use this pump, because its the only pump out there that can deliver pre-programmed boluses and not have a basal rate. My job, is to do absolutely nothing at all. Do not press any of the buttons, check out the various screens, or drop it in the toilet. It also isn't waterproof, nor does the set detach, so I have to put it in a little baggie and hang it around my neck while showering.(and swimming for 3 days=OUT). I feel like I'm back in the dark ages.
-get payed for first visit($50)
-Recheck bg, (530) correct blood sugar
-Get Meal Voucher, wander on down to cafeteria where everything looks incredibly unappealing and I spend most of it on diet drinks because I'm that thirsty.

(pump return on Friday)


I really think I got the placebo this go-around, the research doc said I likely wouldn't be able to tell the difference but bgs have stayed their normal wackiness(perhaps from getting strep again,who knows,3rd time in 3 months,I'm a strep magnet) so either I'm not getting Wonder Drug or being sick is just minimizing the positive effects. Who knows. Next time I would get the real thing, if I got the placebo this time. Wonder Drug is supposed to make the highs not so high and the lows non-existent. Also got to meet the researcher who has been doing this for the past 20 years,that was pretty neat,drug company sponsorship might actually happen.

That evening, went to pump club, the guest speaker was an ophthalmologist from JH.(one of the members asked her doc to be the guest speaker) JH docs tend to think they are the cream of the crop and other places are 2nd rate or don't even deserve mention. I happen to think the place I got my eye care was pretty great(and cutting-edge) too, so the attitude of said doctor annoyed me a bit. He took our questions/talked about all things eyes for two hours.
Some points he made:
-new treatments are in the works, but lasars are the sole means of treating retinopathy and the lasers of today are very much more precise then those of 20 years ago.
-smoking ups your risk of macular degeneration by 400%. Besides upping glaucoma and retinopathy.
-Teenagers are walking into his office with severe proliferative retinopathy, and most going blind. Freaky scary.
-the goals isn't a cure, its to give you another 40 years with minimal damage. D is going to inflict damage, no two ways about it, the goal should be to limit that damage. He then looked around the table, demonstrating his point by saying that X,X,X you have eye disease, kidney disease, nerve damage(for the record, he gave me till age 84. I was ecstatic,84 sounds pretty good in my book,my a1cs are not longevity material). Apparently we're all disasters, waiting to happen. It was bothering, because thinking of yourself as half-dead and just waiting for the other half to fall apart as well is not really how one should be approaching life.
-young people who have cataract surgery are much more likely to need a lasar-capsulotomy to clear up hazing but I got lucky.
-sunglasses are really not that benifical in terms of reducing UV damage, they did a study on Bay crabbers (those who wore sunglasses vs those who didn't) and damage was the same.
-eyeballs actually shrink when the retina has detached(I'm not sure if this means they get smaller in the socket?)

(at that point, my own eyes were probably as round as saucers-freaky piece of info)

Bottom line is, there's no Plan B for blindness.(when they've done all they can do) You've got to do everything in your power to keep your body, and your eyes, healthy.

Tuesday, June 16, 2009

On Top of Mount Everest

Today, I'm going to talk about Mt.Everest. Apologies if you were expecting an earth-shattering post about CGMS, pumps and polypeptide hormones.(today) I'll be getting to that.(if you want earth-shaking, may I recommend Southern California)

I'm not a big fan of heights, mountains, or the Disney Ride. But my diabetes loves it.


This is today's reading, reaching its lovely 538 mg/dl peak about 11:30 am. (From 114 initially) Not surprisingly, from the 100 carb Boost-Fest with no bolus allowed(except for basal). Fortuantly, I was allowed to correct 15 min after that, and fortunately, it didn't go over 600. That would have been even more of a pain. I will just point out some mountain climbing, bg similarities.

-Going down is easier then coming up. MUCH easier.

-Hydration is important. Diet Coke and water are your best friends. They will save you from certain disaster.

-Mountain Climbing isn't fun. Unless you're a masochist, and feeling tired,cranky, and incredibly thirsty is really your thing.

-Everything looks different from the top. It's like being in a brain fog, if not a natural one.

-Don't do it alone. Call someone, buddy up. The mountain will kick your Gluteus Maximus faster then you can say "Leaping Lows!" In mountain climbing, as in life with diabetes, you need friends to help you out sometimes.

More to come..

Saturday, June 13, 2009

Last of the Type 1's

I've done the guinea pig thing before. It was an intensive, grueling experience; not for those who love A. their sleep or B. their (real, or illusion) state of being in control. Because in diabetes research, your goals are not their goals and vice versa. You sign your rights over to them, going into it you realize ADA type control will not likely be your lot because they tend to have an un-natural fear of anything under 100, trying to keep you more like 180. For a brief period, you just accept it and move on. (you don't have any choice about it sometimes)

The last study I did, I experienced the joys of the Medtronic CGM for the very first time. I hated it, it was off from the One Touch Ultra and the hospital meters by 50 (mostly 70-100) points at all times. NO amount of calibration could make it come back into line. But it was beyond coolness, to be able to see your blood sugar info without testing. So while I played with it(I sure hope they've improved the accessibility of it, because it was good and confusing) the endo fumed with minuscule doses and five minute blood tests. The CGM, was not very useful during the process, so it was largely ignored. (why they even incorporated it into the protocol beats me)

Fastforward almost 2 years later. The CGM I use(Dexcom) is pretty accurate, most of the time. Another research study is in the works, with the "guinea pig" aspect of it for real, with a non-FDA approved substance. Apparently, it hasn't killed/maimed/had any side effects in rats, or of any of the other 9 type 1's to have tried it.(it is a substance produced by the pancreas) Said CGM, will be instrumental in determining whether the stuff really works. I'm both nervous and excited, I've never done anything of this nature. I realize this is something most type 1's would NOT do,its still experimental but to me,I'm a sucker for research studies. And this one, will be pretty weird. (I'm the last person to have to complete the study,before they analyze the results/reproduce on a larger scale-hence, the "Last of the Type 1's" post title.) Hopefully,I won't be the one fatality.
Further details next week.

(when it all starts, bright and early Tuesday morning)

Monday, September 24, 2007

#1 with a Bullet(A girl, a Guardian, and the GCRC)

"Sorry I'm late," I mumble, as the RC's face lights up and she exclaims,"There she is!"(telephone in hand) It's 6:15, and I'm pushing the limits of having to reschedule the entire thing.
"Well, you are coming from far away-it's ok."
"Traffic was bad..."
"Don't worry about it."
Uncerimoniously dump overnight bag on floor, go off with nurse to have vital signs checked. 10 minutes later, time for blood sugar test(and supper). Sign RC's second consent form and she takes off for 3 weeks of blissful undisturbed solitude somewhere in the country of Spain. Well deserved(I might add), if I had to work nights and weekends I'd be ready for such a vacation too. Nurse puts in IV access #1, draws blood, lets me know my bg(167) and supper arrives.
Lemon pudding
1/2 baked potato
broccoli
steak strips
diet lemon lime soft drink
"I've got to see you bolus for it," the nurse announces, firmly.
"WhaaaTTTT? You mean, all at once? Can't I split it up?"
"No, Dr. A. said you've got to bolus for all of it at one time."
This isn't good, my body isn't going to take to well to 9 units hitting En Masse,Immeadiente. I would do it if the endo were here, but she's not. I don't know if this nurse can handle hypoglycemia-I envision getting low,overeating,and skyrocketing from all the supper carbs catching up. I don't really need that (on the eve of the research study).
But I can't very well refuse. I bolus, she nods her approval, and I proceed to inhale my supper at warp speed. Pudding, potato,broccoli, steak. And juice, because I still think I'm going to get low.
At 9 pm, the resident doc comes in, gives me my black Cozmo, inserts the Guardian sensor into my abdomen, enters the first bg.(124) At 11:15, she enters the 2nd bg(130) and the numbers start appearing on the screen. I watch them march steadily upward till 12(170), and fall asleep.
3 am- "Wake up, you're high. Dr. A. wants you to bolus 2 units."
4 am- Something is shrieking, and I know its not my pump.(or rather, their pump)It sounds very simular to a dead battery alarm(on the Cozmo), but it has to be the Guardian. Flip light switch. Yeah, my sensor is having connectivity problems.(I forget the exact term) Notify nurse, turn off the alarm somehow.Clip the Guardian directly over the abdominal sensor. Sleep well, little one.
6 AM-"Wake up, you're still high.Dr. A wants you take another unit."
I bolus, resume slumber.
6:30 AM- More blood, another IV access put in. Give up on getting any more sleep.
7 AM- BG check(160)
7:15 AM-150
7:30 AM-142
7:45 AM-136
8 AM- Everyone's there by now: the endo,2 vampire nurses, blood runner, person running bg machine, and the graduate student.
"Morning, Heidi.You were sort of high last night- what's your basal?"
"O.6."
"The nurse has got 0.5 on here." She glances down, puzzled. "Are you sure?"
"That's what its supposed to be since 6 AM- 0.6. I haven't checked it on this pump."
"Give me your pump." She reviews the basal profile. "Oh, this is programmed for PM, not AM."
"You mean I've been getting the wrong rates since 9 PM?? No wonder I'm high, 0.2 units/hr is NOT me at 1 AM. I have pretty strong dawn phenomenon."
"She must have got them mixed up."
Great. Thank you, Dr.K.
"You're fine now, 130. We're going to try to keep you at that till exercise. We'll turn off your basal rates, and give you frequent boluses based on the algorithms."
This incites a small pandimonium as everyone has to adjust their timing to the time of the caught mistake. Takes a good 30 minutes to get straight.
Bg stays a nice 120-130 till 9:30, when the breakfast(1/2 bagel,a few scrambled eggs) sends it up to 190(despite an adequate bolus)
The nurse slides the needle into the port, fills a tube, discards that, fills another one-squirts it into small vial,caps it off, and yells "Bullet!" to the runner. That's my blood, headed to the bg machine. A bullet of blood. (Weird what they call some things)Two more tubes, get stuck in a container of ice to test endogenous and exogenous insulin levels. Every five minutes, till 1 am.
Time to calibrate the Guardian.
One Touch Ultra-170
Hospital machine-130
Guardian-80
Lovely, it's at least 50+ points off.I'm not sure what I am, now-I leave it to the endo to decide that. She feels that putting the One Touch bg in the Guardian, will at least get it closer to the actual bg.
The hours pass, and "Top Chef" marathon fills the time. Unfortuantly, my bg isn't going down(stays near 200) and I have the urge to shoot a good 3 units but I'm not allowed to do that. It is stress that keeps at that range, despite frequent small boluses of 0.2-0.4 units.I'm not sure that Dr.A realizes that IOB isn't accurate,I don't think there's any insulin left(based on my bg not going down). I sure won't go low doing this. El Guardian has me in the 110-130 range, I want to shoot the thing.(I know I'm near 200,heck,I'm thirsty) Dr.K.shows up. I try not to think about food, but the food on "Top Chef" looks SO good. When my 4-H group took a tour of the Washington DC Culinary Arts School(and were subsequently cooked an exquisite dinner, I couldn't tell that it was cooked by students(it was all awesome). I know I have an untrained palate, but I think the judges on those shows are pretty rough on the contestants(it doesn't taste like compost,I'm sure).
1 pm- blood draws decrease to every 10 minutes.
1:30 pm-Exercise prep time. Strap on STS polar moniter, chest leads. Go down the hall to exercise room.Exercise physiologists show up.Attach leads to machine.
2 pm-2:45 pm.Ride exercise bike. Somehow survive.(the seat is hard,the moniter tight, and the room is about a million degrees)Definatly the worst part.
3 pm- Just an hour remaining. Graduate student leaves. Bg checks every 10 minutes. We continue watching Hour #6 of "Top Chef", having run out of things to talk about.(Weather, Weddings, and Whatever Else having been discussed Ad Nauseum)
4 pm- Dinner arrives.(salad,fruit salad, rice/mixed veggies, chicken, diet Lemon Lime) Despite being starved, its still way too much food! Food person asks me if I'd like some dessert. I cast a wary glance in the direction of the medical professionals and reply that fruit is a perfectly fine dessert. No one believes me, so they ask again later on, but I don't particurally like pound cake so I decline. Finish dinner, review discharge sheets, remove hardware.(it wasn't so hard giving up a Guardian that wasn't very accurate).
I'm not an expert, but I think if it had be calibrated more often it would have been closer to the actual bg. I also expected to see more numbers, not just a line and one bg on the screen. I think I'd like to try a Dexcom(I have no idea how, though,my D clinic doesn't have any) The Guardian, didn't exactly live up to my expectations.
The amount of blood taken(overall) was as much as a standard blood donation, so I can't give for a couple of months.