Robotic Pancreas: Diabetes 1 Solution Waiting for Bureaucrats and Experts

"Robotic Pancreas: One Man's Quest to Put Millions of Diabetics on Autopilot"
Wired Magazine (April 19, 2010)

[stay with me on this, please: These paragraphs are long, but they've got a lot of information in them - The Lemming]

"Jeffrey Brewer was on top of the world. For years he had put in 100-hour workweeks as cofounder of two early Internet juggernauts: local guide Citysearch and the online advertising pioneer GoTo.com (later renamed Overture). But by 2001, with more than enough money to live on for the rest of his life, the 32-year-old handed off control of Overture and set out on a yearlong trip to Australia with his wife and two kids. Upon their return to the States, though, they noticed something odd. Seven-year-old Sean was unquenchably thirsty and urinating far more often than usual. On September 19, 2002, they took him to the pediatrician. The doctor gave him a urine test and announced without hesitation, 'Your son has type 1 diabetes.'

"Previously known as juvenile diabetes because it is usually diagnosed before adulthood, type 1 is the 'other' kind of diabetes, the kind no amount of dietary adjustment will hold at bay. It develops rapidly, due to a mysterious autoimmune reaction that attacks the insulin-producing beta cells in the pancreas. Treatment requires insulin injections and relentless hour-by-hour diet control. Short-term, the main risk is hypoglycemia — low blood-sugar level caused by too much insulin — which makes patients exhausted and confused, leading to unconsciousness and death if not treated immediately with something sweet. But the opposite problem, high blood sugar, raises the long-term risks of kidney failure, blindness, amputation, and heart disease. Either way, type 1 diabetics live on the edge, a cupcake away from a coma...."

Summarizing:

• Jeffrey Brewer
  • Co-founded
    • Local guide Citysearch
    • GoTo.com AKA Overture
  • Took a year off to be with his wife and kids
    • One of the kids developed type 1 diabetes
• Type 1 diabetes means your body can't process sugar without help
  • Good news:
    • Can be controlled
    • With a lot of effort
  • Bad news:
    • If you make a mistake, you'll
      • Die quickly
        • As your body runs through its supply of sugar
      • Die slowly
        • Because your body contains too much sugar
          • But first, you'll probably experience
            • kidney failure
            • Blindness
            • Amputation
            • Heart disease

Bottom line? type 1 diabetes isn't fun.

I've got diabetes - the type 2 kind. Compared to what young Sean Brewer's going through, it's a cakewalk. Back to the Brewers:

"...Nurses taught the Brewers how to inject the insulin and how to prick Sean's finger for the drop of blood to test his blood-sugar level with a little meter. 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...."

Simple, right? Actually, yes. But it's a lot of work. Including periodic checks during the night, while most people are sleeping. Most of us don't think about blood sugar levels because our bodies regulate it automatically. Since I've got type 2 diabetes, my control system is faulty - but drugs, diet and changing my lifestyle are bringing blood sugar levels near normal levels.

Folks with type 1 diabetes? Not so much.

"...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?'..." [emphasis mine]

We've had insulin pumps - internal ones - since the seventies. We've had implanted glucose monitors since about 2005: You don't have to prick your finger at regular intervals. I will, since I only need to do so once or twice a day - but like I said, I've got it easy.

As far as software that can handle the relatively simple feedback algorithm needed? Good grief: We've got robot spaceships exploring our corner of the cosmos. Something to pump more insulin if blood sugar is above one number, pump less if it's below another number - and routines to take into account the lag between changes in insulin levels and blood sugar readings?

My guess is that high-end games involve more complicated AI.

So, why don't we have it?

My summary would be: experts, bureaucrats, and lawyers.

Here's how the Wired article put it?

"...Everyone, Brewer soon found out, had an excellent reason for not letting Sean and other diabetics fly on autopilot. Manufacturers were afraid of liability, academics were bent on achieving perfection, and the Food and Drug Administration was downright jumpy at the thought of letting a computer control a mechanism with life-and-death responsibilities...."

I recommend reading the rest of the article.

And, although The Lemming is, in a sense, apathetic: this is something that I think calls for folks educating themselves about an issue - and (metaphorically speaking) lighting a fire under the FDA's collective butt.

I understand very well that it's necessary to study - carefully - new medical technology. I remember the thalidomide babies. But this is a case where we've got both ends of the new technology: implanted insulin pumps that are regulated through external controls; and monitors that take blood sugar readings from another implant.

All that's missing is an automated control system between the two.

Attack of the Crazed Killer Computers?

Oh, the horror? What if the computer decides to kill me? In the movies, this would be a real issue. And that's another topic, in another blog.

Out here in the real world, not so much.

Yes, there can be problems with automated systems.

Careful is Good - To a Point

Right now, I think the risk is that somebody's going to figure out a way of hacking into their insulin pump and monitoring equipment: and cobble together a makeshift prototype before the FDA gets through studying learned discussion about how many corpuscles can dance on the head of a pin.

If one person figures out how to make a crude-but-generally-effective feedback system - I give it about a week before just about every interested person with internet access knows how to, too.

I'm not going to call that hypothetical inventor reckless. There are very good reasons for someone with type 1 diabetes having an automated system controlling his insulin levels.

An Insulin Pump That You Control Yourself? What Could Possibly Go Wrong?

There's a problem with today's insulin pumps. They keep pumping at the same rate, until someone changes the setting.

Let's say you've got an internal insulin pump. You're pretty sure that you've figured out how much insulin your body will need for the next eight hours. You re-set the pump and go to sleep. Then, a few hours later, you die because just a little too much insulin was getting into your system.

Sure, you could set the alarm to wake you every hour or so - and hope that your blood sugar level was high enough for you to regain consciousness.

No Diabetes is Good, But if That's Not an Option:

All things considered, I think it'd be preferable to not have type 1 diabetes. For people who do, however, an automated system that monitors your body - and regulates your blood sugar levels more-or-less like your own system should - is probably better than interrupted sleep or risking death in the night.

Mr. Brewer seems to think that we don't need to wait for the perfect system:

"...Brewer flung himself into the challenge with the same passion he had brought to his Internet startups. Less than a month after his son's diagnosis, at a meeting of the Diabetes Technology Society, he was ready to shake things up. After listening to an arcane academic debate about which algorithm would be best for the pump, Brewer stood up in the audience and began berating the scientists for dithering over details. 'We have all the pieces,' he said. 'We need to start commercializing these technologies, because people living with the disease need it.'..."

Being careful makes sense. Not waiting for perfection also, I think, makes sense.

Vaguely-related posts:

• "Metabolic Syndrome, Wii Fit, and Mii"
  (November 20, 2009)
• "Lemming Tracks: The Lemming's Cooling Down"
  (January 12, 2009)
• "Not-So-Silly Science: Women Who Look Like Women are Healthier"
  (January 7, 2009)

More:

• "Type 1"
  American Diabetes Association
• "Type 1 diabetes"
  Mayo Clinic
• "Type 1 Diabetes"
  WebMD
• "FDA's Proactive Role in the Development of an Artificial Pancreas for the Treatment of Diabetes Mellitus"
  United States Food and Drug Administration