May 18, 2010
One man’s quest to outfit diabetics with robotic pancreases.
A personal quest. Jeffrey Brewer was the founder of net-ad company GoTo.com, now Overture.com. In 2002 his son Sean was diagnosed with type 1 diabetes (aka “Juvenile Diabetes”), in which the victim’s own immune system attacks the pancreas leaving it unable to produce insulin. Patients are forced to monitor their blood-sugar levels and administer insulin as needed; Processes that involve lots of poking from needles…
… or as some would say, “like a heroin addict.”
Brewer wanted something better. Something that didn’t require the constant needling. Something… automated…
They learned a simple algorithm: If their son’s blood sugar was this high, give him so many units of insulin; if it was this much higher, give him that much more. It’s a crude scale that every one of the more than 1 million type 1 diabetics in the US makes do with daily.
Tall, thin, and intense, Brewer was shocked by the antiquated approach. “I had this logbook,” he says. “I’m testing Sean every few hours, and I’m thinking, this is crying out for automation. A computer should do this and would do it better. Why didn’t this exist, with all that we can do?”
So began Brewer’s quest: To create an artificial, cybernetic pancreas.
The pieces come together. Surprisingly, it wasn’t hard to find the parts needed to make a robotic pancreas, as most of them had already been out on the market:
An insulin pump had been approved back in the late 1970s, and a continuous glucose monitor that read the output of a sensor implanted under the skin was nearing approval. (The first one would hit the market in 2005.) The trick was to connect the two via software, letting the monitor’s information on blood-sugar levels — high or low, rising or falling — serve as the basis for calculating exactly how much insulin to release.
In 2005, the Juvenile Diabetes Research Foundation approved the development of the device.
Input, please. Human testing began in April 2009. The results for the device proved its worth, but the Food and Drug Administration (the FDA) began dragging its feet:
Among the 10 diabetics he personally tested during overnight stays, he says, there were 17 episodes of mild hypoglycemia when the patients controlled their own insulin pumps, compared with just two when the device was in control. That’s an eightfold reduction — for most typical situations, computers really are better than humans at dispensing insulin in response to shifting blood-sugar levels.
Now the main challenge is getting the FDA to recognize that fact. In June 2009, Medtronic, a leading maker of diabetes treatment devices, announced the approval in several European countries of an integrated pump and sensor with a “low glucose suspend” feature that shuts off the pump when sugar levels are dangerously low. While only a baby step toward a fully self-regulating unit, it represents a milestone. But the FDA was still demanding that Medtronic conduct a clinical trial of the automatic shutoff before the agency would approve the device.
It would appear that the FDA, like the US Military, is nervous about letting machines make all the decisions and insist that some form of human input is present. Diabetes 1 patients want the convenience of not having manual, error-prone, human input and “Some have begun whispering about hacking their pumps to control them wirelessly. The likelihood of someone actually doing that increases with each passing day of bureaucratic paralysis.”
Brewer expects a semi-automatic version of his robot pancreas to be approved in five years. Then the only problem to be expected are repo-men.