TRENTON, N.J. —An experimental artificial pancreas will soon be tested in diabetes patients, potentially sparing them the hormonal disorder's most dangerous complications and frequent blood sugar checks and insulin injections.
If all goes well, a commercial model could be on the market in four years, said Aaron Kowalski, research director of the Juvenile Diabetes Research Foundation's artificial pancreas project.
The device, being developed by the foundation and health care giant Johnson & Johnson, potentially could help about 6 million diabetics in the U.S. alone who use insulin, Kowalski said.
It could prevent the life-threatening seizures that can occur when blood sugar drops too low, as well as blindness, amputations and organ damage caused by years of too-high blood sugar. And it would end having to track carbohydrate intake and then calculate the insulin doses needed all day long. That's because the device would constantly measure blood sugar and its computer would decide when to give the patient more insulin.
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The research partnership, which also includes glucose monitor maker DexCom Inc., was announced Wednesday.
"It's been a goal for 40 years" at the foundation, Kowalski said. "The pieces of the puzzle are in place.... I'm confident this is going to work."
The foundation has been working with researchers at major universities in recent years testing the components of what will be the artificial pancreas — different types of insulin pumps, continuous blood glucose monitors and software — in various combinations to see what works best, Kowalski said in an interview Tuesday.
Johnson & Johnson's Animas Corp. unit, which sells the OneTouch Ping insulin pump, and DexCom will use data from that research to produce a commercial model. A device about the size of a cell phone would be worn outside the body, linked to a tube under the skin to hold insulin for release as needed. The first patient testing could begin in less than a year, Kowalski said.
"Four years is probably doable," given the project's "running start" and J&J's skill and experience in developing new products and working with regulators, said Erik Gordon, a professor and analyst at University of Michigan's Ross School of Business. "It sounds promising."
Analyst Steve Brozak of WBB Securities also expects approval because the Food and Drug Administration has been "exceedingly friendly" in reviewing diabetes products because the disease's complications are so severe and better treatments to prevent them are needed.
Currently, patients with Type 1, or insulin-dependent diabetes, and many with advanced Type 2 diabetes must inject themselves with insulin in the stomach two, three or more times a day to keep their blood sugar in a safe range. Some patients have an insulin pump tethered to their waist so they can avoid the injections. But even those patients must calculate how much insulin they need before each meal, based on how many grams of carbohydrates they expect to eat.
The experimental artificial pancreas would not cure diabetes, which has exploded along with obesity into an epidemic — dubbed diabesity — in the U.S. and other developed countries. But the device could enable patients to control diabetes much better, preventing complications that can lead to frequent hospitalizations and sometimes early death.