The real time shoot-out begins

The dry wind blows a tumbleweed across the dusty street. It is high noon. To the clink of spurs and the creak of leather the two hired guns ease out onto the street, squinting in the bright light, eyeing each other carefully, fingers hovering over the handles of their holstered weapons. Each wait for the other to make a move. The townsfolk scatter for cover.

It is time for a shootout. Diabetes style.

OK, enough fun, it’s time to get down and dirty. I got my mitts on a FreeStyle Navigator. I’m eager to try it out. To see what it is made of. To compare it to the Guardian. To wear the two units simultaneously. To see in real time how they each handle the very same highs, lows, and the occasional fudge-fudge walnut brownie Sundays from the Elephant Bar (in the name of science of course).

And like in any other shootout, there can be only one winner. Of course in a shootout between Med-T and Abbott I’d be very hard pressed to say who is wearing the white hat and who has the black hat.

This blog was originally created to report on Continuous Glucose Monitoring (CGM) back when CGM was just a baby. Since then, we’ve been all over the Diabetes Map together, but now I think it is time to get back to our roots for a time and re-visit CGM.

So before we get started, I want to review the LifeAfterDx ground rules. Like the knife fight scene in Butch Cassidy and the Sundance Kid (Rules? There’s no rules in a knife fight!), the rules are there are no rules. This is an influence free-site. I say what I think with honesty that has been described as both refreshing and brutal.

Right now I am holding a in my hands the much anticipated and much delayed Abbott/FreeStyle Navigator. Well….OK, that’s a lie, ‘cause I’m typing right now. I am metaphorically holding in my hands the FreeStyle Navigator, it is actually sitting on my desk right in front of me.

Now I confess, I did not buy it. And it did not come from Abbott either. The folks at Abbott didn’t even know I had it until this very second (picture the folks in the PR office running around in panicked circles like mice on LSD). This unit came from a Health Care Provider in an undisclosed location (yep, Dick Cheney’s poker bunker). The Provider is a fan of my writing who wanted to know how I thought Navigator stacked up against the other options out there. I’ve actually had the Navigator on my desk long enough for it to gather dust. That’s how long it took me to scrounge up a sufficient number of sensors from various users across the country to wear the system long enough to give it a fair shake; to overcome the euphoria that sometimes comes with new gadgets, or to work through the problems that also sometimes plague new gadgets—a more common experience with Continuous Glucose Monitoring systems.

In the interest of full disclosure, you also need to remember I’ve been wearing a Guardian since, well… forever. I’m used to it. There are a lot of things I like about it. I find it very accurate, but at the same time there is a least one HUGE flaw in the device; and that is its petite little voice. The damn thing is too quiet. CGM alarms are the difference between life and death for me. Literally. I want them loud. Real loud. The original garage-door guardian was not only loud, but had personality too. It made different types of noises for different types of alarms. My co-workers at the clinic learned her language. When my trusty box let loose with a low alarm they’d come running with glucose. When she signaled a high they’d laugh and tease me, “what did you eat this time?”

So, where I was going with this before I got distracted, is that I’m aware I may have a Guardian bias, having worn one so long and having adjusted to it. Still, I decided the best way to compare Navigator and Guardian was to wear the two devices simultaneously. My belt will be crowded with the Cozmo, Guardian, Navigator….thank God I never bother to carry my cell phone.

Before we get started with the shootout, let’s cover the basics for the CGM virgins. If you’ve been with me for a while this will be your refresher course.

First and foremost, Continuous Glucose Monitoring isn’t continuous at all. It also doesn’t read your blood sugar, nor does it replace the need for fingersticks. More on all of that in a moment.

CGM systems, for the most part, share some common elements. They all have a sensor. The sensor is a disposable needle-like miracle of modern technology that is placed under your skin, where it stays anywhere from three-to-seven days. Using assorted Voodoo and Sorcery, this needle magically determines what your blood sugar is without ever consulting your blood at all. Attached to the sensor is a transmitter, whose job it is to send sensor data wirelessly to a receiver. The receiver is the brains of the system and the interface with the user. It has a screen to display a variety of data, has controls to program the system, and contains alarm systems to alert the wearer to dangerous blood sugar levels.

The receivers vary a great deal between makers, in terms of features. All systems also have the ability to download data to a computer, and again, the quality of the software that displays the data varies quite a bit between makes.

The sensor needle actually reads interstitial fluid, basically the water that exists between your cells. There is a close correlation between interstitial glucose and blood glucose, but they are not one in the same. For convenience’s sake, I often will use the generic “blood sugar” when talking about the readings from CGMs even though they don’t really read blood sugar at all. None of the systems are continuous either. They read anywhere between once per minute and once every five minutes. Still, even at once every five minutes we are talking about the equivalent of 288 fingersticks per day. Just as movies are made by rapidly projecting a series of still images at the rate of 24 frames per second; these closely spaced blood sugar checks give us the illusion of continuous movement.

There are currently three companies in the CGM biz with five different systems. The first player to market was Medtronic. They now market three different devices using their sensor. One is a “blind” system that health care providers can place on a patient to monitor 24-hour blood sugar for three days, then download and study the data. Next up Med-T has a CGM system that talks to Paradigm model pumps. It is pretty primitive, having only threshold alarms (alerting the wearer when a certain high or low number is crossed) and the ability to only show a 3-hour and 24-hour graph of the glucose. The CGM uses the pump as the receiver, but in no way interacts with the operation of the pump. Last in the Med-T line up is the Guardian, a standalone unit that features some pretty sophisticated features including predictive alarms that actually work, and the ability to leave the system set on an active real-time graph. Not only can you scope out your current BGL, but you can put that into perspective while viewing your choice of 3-hour, 6-hour, 12-hour, or 24-hour graphs.

On Med-T’s heals was the Dark Horse Dex Com, the second player to win FDA approval, and the first to get a seven-day wear indication. They came to market with a Gillette Razor approach with a relatively inexpensive monitor and competitively priced sensors.

Abbott, who originally expected to be first to market languished for years. They waged a brilliant guerilla campaign of media “leaks” to keep the D-world salivating for the Navigator. I honestly don’t know why it took them so long to win FDA approval. I heard it said they were paying for sins of the past. I also know they took the courageous but fatal path of attempting to get an indication for replacing fingersticks. That was too big a leap of faith for the FDA. Med-T and Dex had applied as “investigational devices.” That made it easier to get FDA approval, but also made it easier for insurance companies to say “no.” Eventually Abbott actually withdrew their original application and started over, eventually winning the same indication the rest of the pack has. It was interesting to watch Abbott change the appearance of the prototype on their web site over the years this process took.

Tomorrow we’ll look at the nuts-and-bolts of the Navigator in its final incarnation, and make some comparisons to the Guardian. But for today I have a final thought: Med-T has given us the Guardian, to protect us, to watch over us. Abbott has given us the Navigator to help guide us. Maybe it’s just a coincidence. Or maybe it tells us something of the nature of the companies, a look into their corporate souls, a sense of their self image and perhaps more importantly; their image of us.


Tomorrow: judging a book by its cover