The Juvenile Diabetes Research Foundation announced this week it will team up with Animas Corporation, a subsidiary of Johnson and Johnson, to create an "artificial pancreas."

The New York-based JDRF has pledged $8 million to develop the device, which would combine an insulin pump with a continuous glucose monitor (CGM), running algorithms that would automatically control the amount of insulin dripped throughout the day.

Although pump-and-CGM tandems already exist, such as the Medtronic MiniMed Paradigm REAL-Time System, they are not fully automated, JDRF says.

In type 1 diabetes, patients need one-time spikes of insulin around meals, but also a steady, constant delivery, the background or basal rate, to mimic the continuous supply given by the healthy pancreas. CGMs-and-pumps deliver this background rate through schedules plugged in by the user, who has to plan them based on trends that vary with physical activity, illness and other factors, when insulin needs fluctuate.

According to JDRF, this demands rigorously diligent compliance.

"If you think about someone with diabetes who is wearing an insulin pump, it 'runs' through their brain: they're thinking about their dosing decisions all the time," Aaron Kowalski, Ph.D., assistant vice president for glucose control at JDRF, tells DOTmed News. "They think about how much they're going to sleep, how much exercise they have, when they're eating."

Because of this, Dr. Kowalski says even the most motivated people with the best equipment only spend 30 percent of their day in the glucose ranges of those without diabetes.

"What we're trying to do here is, we have this continuous glucose information, and we have engineers developing algorithms - the sophisticated computer software coming into the the pump. Based on that information, the insulin dosing becomes automated," he says.

The goal of the new device, Dr. Kowalski says, would be to keep blood sugar within a target range. This means if blood sugar dips low overnight, the pump would shut off, preventing the continuing dosing of insulin which could lead to a dangerous hypoglycemic episode. And if during the day, say in the morning, blood sugar spikes, it could automatically turn the pump up to deliver more hormone.

Currently, glucose monitors will sound alarms if blood sugar levels become dangerously low, but Dr. Kowalski thinks auto-dosing would be better, especially if the drop happens while the patient is sleeping.

"We know from a lot of research, [people with diabetes] don't wake up from alarms, because the hypoglycemia, the low blood sugar, blunts their ability to do that. And they're asleep," he says.

The device will not be completely automated, though. The so-called bolus dose of insulin, a huge spike given around mealtimes, which is not automated in any device on the market, will still be manually controlled in this tool, too. The reason is simple: because of the large load of insulin delivered, if it's not set at exactly the right time, it can be dangerous, Dr. Kowalski says.

TO THE CLINIC

With pilot studies already done, Dr. Kowalski expects clinical trials to start soon. But there could be some obstacles. The FDA still recommends that patients use a finger-prick test to really determine their blood sugar levels, and only use CGMs as an adjunct.

"One of the reasons there are problems with using continuous monitors for replacement, is you have some degree of inaccuracy," Dr. Kowalski explains. "You don't want to be dosing insulin off a signal, if you're not confident the insulin's really high."

But he says their device could overcome these concerns, partly because the goal with the automation is less precise dosing, and more ensuring blood sugar levels don't stray beyond set safe limits. "If you could lop off the high and low blood sugar levels, you could be really clinically impactful," Dr. Kowalski explains.

And by the time the JDRF-Animas device, whose monitors are being made by Dexcom, makers of the Seven Plus CGM, comes to market, it might not be the first of its kind. Last year, Medtronic released its Paradigm Veo in Europe (it's not approved in the U.S. yet), which has an automatic shut-off when blood sugar levels drop too low.

"That's a great first step, but again it's not here in the States," says Dr. Kowalski.