Kitty Hawk revisited

I just got an interesting press release (picture William Randolph Hearst spinning in his grave—bloggers getting press releases???). Anyway, our cousins in Europe will be the ones to go down in medical history as advancing the cause of Type-1 diabetes treatment, not us yanks with our pokey slow FDA. It seems that Kitty Hawk has been moved to Denmark, or wherever.

Yep, the artificial pancreas takes flight over there, not here were it was developed.

Pfffffttttt! I just heard the sound of 800 diabetics and 2,000 mothers of Type-1 children spit out their morning coffee in shock. Artificial pancreas?! But that’s supposed to be decades away, you say.

Well, no. Or yes. Depends on how you cut the sugar-free pie.

Med-T has a new pump. No big surprise, they are overdue. Any student of Med-T’s leap-frog approach over the last few years of stand-alone CGMs and pumps with CGMs would easily surmise that the next gen pump would have guardian-like predictive alarms and the like.

But Med-T went one leap further. They added a feature they call “the low glucose suspend feature,” to be called LGS in Med-Speak.

What is LGS? Basically, if you don’t respond to a low alarm, the pump shuts down basal delivery. So how big a deal is this? Again, it depends on your prespective.

Pragmatically, if you are already too low to respond to an alarm, your basal is the least of your problems. You are most likely toast anyway. Still, nice not to add a squirt of lighter fluid on to a forest fire. Dr. Francine Kaufman (famous Endo, former head of ADA, author, diabetes advocate—and now, according to some, a member of the evil empire as Chief Medical Officer for Med-T) is quoted in the press release as comparing LGS to a car’s air bag; offering “added protection, greater confidence and may lower the risk of injury” from hypos.

Politically, this was a clever move. The FDA is very conservative. Letting the pump go on auto-pilot in a low is a no brainer—a safe move that can really do no harm to the user or to the FDA. If the CGM detects a low that doesn’t really exist, the wearer will acknowledge the alarm. If you are down and out, turning off the insulin won’t hurt. And while CGMs are far from perfect; I have a hard time believing that one would give a low alarm when you were really DKA high.

Looking at it from a $$$ point of view, Med-T desperately needs something fresh to win back their rapidly eroding market share. Given the choice of an OmniPod or a tethered pump that steps up to the plate during a mother’s worst nightmare, I know the pump choice the mothers of our little brothers and sisters will make. I’m betting many of us grownup T-1s will make the same decision. Or our wives will make it for us. For many, LGS will be a Royal Flush feature that trumps all others.

My take is that this is a really big deal. A very, very, big deal. Advanced apologies to you creationists out there, but I have a deep respect for evolution. Great progress takes place one step at a time, and I have no doubt at all that this is, and will do down in history as, the first step in the long road to the artificial pancreas.

For the first time ever, the pump and the continuous glucose monitor will CONTROL one function of insulin delivery—independently of the user’s actions. That is huge. Beyond huge. It is ginormous.

So on fragile wings of canvas and wood, the artificial pancreas really takes flight. Like Kitty Hawk, not a long flight, but never the less a first flight that will change the world.

Lucky European bastards…. Hmmmmmm… who do I know in Europe that would be willing to buy me a pump and smuggle it over to me? Let’s see….yep, not a single soul.

Damn. That’s one pump I’d sure love to get my diabetic paws on.