Friday, April 27, 2007

Then Again, Maybe I Won't ... Or Will I?

I was thinking about what to call this post, and it occurred to me that the title to the kid's 1971 novel by Judy Blume seemed appropriate, given my mixed feelings right now -- except my dilemma is not about masturbation as the lead character's was in that controversial book, but whether I should return to using an insulin pump.

Last Tuesday, I visited my endocrinologist. Nothing really eventful as it has become so routine over the last 30 years I hardly even give it a second thought, except that on Tuesday, my endo asked me if I would be interested in a continuous blood glucose monitor. My initial reaction was, "Sure, but it kind of depends if can we get insurance to cover it." He told me he's had some success in getting them approved for about 6 patients (all type 1's, few type 2 patients have physiological issues causing hypoglycemia unawareness that plague many type 1 patients) so far, and that the best luck has been with those who have problems with hypoglycemia-associated autonomic failure (HAAF), another way of saying hypoglycemia unawareness. While some journals have reported overconfidently that the condition can be reversed, more comprehensive work done by Philip Cryer at Washington University at St. Louis have suggested that such claims aren't true for all patients with type 1 diabetes. I'm naturally one of the exceptions to that rule, as I cannot recall having the described "symptoms" of hypoglycemia since I was about 10 years old (I'm 38 now). I've dealt with that for quite a while now, and rely almost exclusively on "external" clues as they refer to it in Blood Glucose Awareness Training (BGAT), consisting mainly of knowing the time and activity profile of insulin and when I am most susceptible to undetected lows. But that can easily be screwed up by being busy with other things, or any unusual activity. I also test about 18 times daily, often at the slightest hint that I might be low, as its better to be safe than sorry. I have found that when its dropping rapidly, I may have some weakened symptoms, but if my blood glucose levels drop slowly, there is no sign of it. It makes managing this condition a real walk in the park, I assure you. That also means my insurance company pays a boatload for test strips. So far, they only bothered me once when I got first the script for that many strips, but since then, they've never asked about it. I guess having to pay for EMT service makes the cost outlay for test strips (especially given the deals managed care providers cut with manufacturers) look inexpensive by comparison!

I also have a history with insulin pumping, I wore an Animas R-1000 (or was it R-1200?) -- I don't recall, but the pump is pictured here. I wore an insulin pump for 3 years only to determine that the time and effort associated with it delivered only little improvement in glycemic control (I had great A1C's pre-pump), and fundamentally, I really hated being tethered to that device, my infusion sets pulled out after my first shower, and the whole thing was more of a pain in the ass than a great experience. I also discovered that my basal insulin needs were incredibly small (less than 0.5 units per hour consistently, except overnight - more on that in a second). The big lie that insulin manufacturers claim is that insulin analogs do not last very long, yet Novolog kept working for an agonizing 8 hours, Apidra for about 4 hours, only Humalog had no tail of activity for me, and now, thats not a "preferred" drug on my insurance formulary. As a result, I went back to shots about 2 years ago, and I found the return very liberating.

As I noted, my only real issue was overnight, as I tended to wake with more highs than I cared to remember until my doctor recommended switching to NPH, the "old" insulin that was supposed to become outdated (if you listen to all these insulin salespeople) with the emergence of long-acting analogs. But my morning highs were not due to the much talked-about "dawn phenomenon" that seemingly every diabetes educator loves to talk about, but slow (6-8 hours) digestion of proteins, which had proven itself time and time again while I was on the pump. At least I discovered what the issue was. The morning after Thanksgiving dinner usually resulted in a horrible high if I did not increase my basal rate! Today, if I don't eat any (meat) protein for dinner (vegetarian meals, as well as fish and eggs don't seem to work the same way), then I need to cut my overnight dosage of NPH significantly. Unfortunately, I worry that NPH's time on this earth may be limited. Its no secret that Novo Nordisk intends to stop making it (at least according to their Chief Financial Officer). Unfortunately, all of the long-acting analogs are designed to work for 24 hours, not 12 or 8. Right now, Lilly continues to make the old stuff because many people still use it. Collectively, the old insulin formulations accounted for $226 million in sales for Lilly during Q1 2007 vs. $340 million for Humalog, and that is even more remarkable considering the price tag for Humulin sells for about one-third the price of Humalog, meaning the number of users is significant. I should note that Humulin sales declined 3% in the U.S. during Q1, but grew 8% on a worldwide basis. For the time being, Lilly remains a thorn in Novo's global ambition to eliminate all forms of human insulin, assuring me access to the old stuff for a while anyway.

If they stop making NPH, I will have no other choice to go on bionic beta cells, not because of glycemic variability, but because of manufacturer greed. In fact, the other day, there was news from the UK that Novo Nordisk's Velosulin insulin would be withdrawn from the market earlier than expected, not because the demand wasn't there, in fact, quite the opposite. Novo Nordisk already stopped making the old standby and expected that once announced, British consumers would rush for its "modern insulins" as the company likes to call them, but that did not happen at all, as a result, the existing supplies will run out much faster than the company predicted. I can only congratulate my British peers for their tenacity, but they ended up being screwed nevertheless because that tenacity. OK, can one of the many generics manufacturers step in to fill the void here? So far, blockbuster mentality in the pharmaceutical industry has prevented that from happening, but the tide may be turning.

But back to my pumping dilemma, the good news is that newer insulin pumps enable microscopic basal rates, unlike when I was pumping -- when a pump that delivered as little as 0.5 units per hour broke the mold of the 1 unit per hour minimum standard on the old Minimed 507/508 series (that was why I chose the pump I ultimately ended up with). But if I were to return to pumping, it wouldn't be for improved control or glycemic stability, it would be because it offered the benefit of continuous monitoring and alarms for movements in the wrong direction.

Right now, Medtronic MiniMed offers combination continuous glucose monitor (CGM) and insulin pump called the Paradigm REAL-Time System, or a standalone product called Guardian® REAL-Time CGM. But MiniMed's pumps have little appeal to me with all that annoying tubing and the company's crappy but proprietary infusion sets. If I were to return to pumping, I'd prefer something like the Omnipod, which has no tubes at all. But I've discovered that insurance will routinely pay for a more expensive pump that includes a CGM, but not a CGM by itself. I cannot figure the logic -- the Paradigm REAL-Time System sells for $5,000 to $6,000 vs. about $1,500 for the Guardian alone. I guess past experience has suggested that A1C's come down with pumps, but shouldn't that be based on the starting point rather than an average net reduction? What about for an A1C that really cannot come down any further ... safely?

At this point, I'd really prefer just the Guardian, as if I return to pumping, I don't want the tubing. I can always get the Paradigm combined CGM and pump and not use the pump element, but I wonder if insurance would question paying for the Omnipod system if I already had a pump? Of course, the whole thing would be irrelevant if I changed jobs and had a new insurance plan, so maybe I should get the thing and look for a new job! For now, I am in the information gathering stage, but would welcome hearing from any others who have tried various CGM's, what their experience was in terms of getting insurance coverage, etc.


Anonymous said...

your cat is SO cute and i love her name!

Scott K. Johnson said...

Hey Scott,

The logic of the insurance industry is very twisted from my uneducated perspective.

It is just simply not to be figured out sometimes.

I think that Medtronic recently released an upgrade to their Guardian line (?). If I remember, that was just the sensor and receiver component...

Chrissie in Belgium said...

Scott, I just HAD to reply about proteins and the dinner meal. I have exactly the same problem. First of all my basal is only 0.2U/hr. It does increase to 0.25U from 4AM to noon. I find that my "dawn phenomenon" shifts timing now and then. This MAY be related to the change in seasons and light! Does protein consumption affect all diabetics and the subsequent bg rise 6-8 hours is built into their basal or are some diabetics less sensitive to protein consumption? I have had arguments with my CDE when he wanted me to do basal tests. He suggested that I could do these tests and still eat protein, but no carbs! He orginally didn't believe the protein affected my bg values! Fish as well as meat increases my bg values. The problem is that the pattern of bg increase is irratic, both in timing and amount.This ould be b/c the liver sometimes produces glucagon to help digest the protein. Furthermore fasting during a basal test ALSO changes patterns. AND humalog DOES, at least sometimes, seem to have a tail beyond the 3.5 hours. Are you visiting Sweden this summer? BTW I have already tried changing bottles!

Unknown said...

I've been told that I should use the pump by all of my doctors, endos and pcp's alike. And I don't want to be tethered to something either.

The CGMs are the best invention for diabetes since insulin. I'd rather have one of those by itself, but I'm also looking at going on the Minimed Paradigm pump / cgm combo.

Like I told my doctor, though --what if the interactive tool breaks down? At that point, you won't have your pump NOR your glucose monitor.

Also, it's likely that the manufacturer of the best insulin pump won't be the same as the manufacturer of the best continuous glucose monitor (I'm hoping Abbott's will come out soon).