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.

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