Thomas Brobson remembers the first morning he awoke after being equipped with an artificial pancreas. After years of fitful nights, he slept soundly and opened his eyes feeling great.
No waking up at 3 a.m. in a cold sweat with extreme low blood sugar. And no having to counteract those effects by getting something to eat in the middle of the night.
“I felt like I was getting a glimpse of what a cure would be like,” said Brobson, 53, a Type 1 diabetic.
What enabled Brobson to feel so good was a new computer algorithm that is able to link an insulin pump and glucose sensor in a delicate communication to mimic the work of a healthy pancreas. When working properly, the pancreas is an exquisitely sensitive organ that calibrates the correct blood sugar and insulin levels needed to fuel the body.
The technology holds the promise to be the biggest breakthrough for treating Type 1 diabetes since the discovery of insulin a century ago, scientists say. The advance could translate into a $15 billion market for the devices, priced at about $10,000 each, according to medical device analyst Thomas Gunderson at Piper Jaffray & Co. in Minneapolis.
Brobson, who is the national director of a diabetes advocacy group called JDRF, was outfitted with the experimental system during a three-day trial last year. Similar devices are in development by companies including Medtronic Inc. (MDT:US) and Johnson & Johnson (JNJ:US), as well as models from university researchers.
For type 1 diabetics with damaged pancreas that don’t produce insulin -- a group that consists of about 5 percent of the 18 million Americans diagnosed with the disease -- a fully automated artificial pancreas has the potential to let them “set and forget” a device for days at a time.
“You have a computerized brain that is looking at your insulin history, what’s been delivered during last week, the last day, the last 10 minutes,” said Gunderson. “It can do this without the user, the diabetic, having to figure out the calculations. That seems to be technically feasible now, where it wasn’t five years ago.”
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Insulin pumps made by Medtronic, J&J and others are about the size of a pager and store the hormone. A plastic tube with a needle to infuse insulin is attached to the body, and it must be moved to a new injection site every three days. Insulet Corp. (PODD:US) makes a tubeless, waterproof pump that is inserted painlessly, while Tandem Diabetes Care makes the first touch screen device.
The continuous glucose monitors, made by Abbott Laboratories, DexCom Inc. (DXCM:US) and Medtronic, include a tiny sensor inserted under the skin and left for up to a week. A transmitter sends the readings to another device, again the size of a pager or a deck of cards. Some units, such as the one Brobson tested, are coordinated with an Android phone.
Bruce Buckingham, a pediatric endocrinologist from Lucile Packard Children’s Hospital and Stanford University School of Medicine, in California, and his colleagues tested two approaches at diabetes camps for children this summer, including a system from Medtronic.
“The night is significant because people aren’t awake,” with 75 percent of seizures occurring overnight, Buckingham said. “Diabetes camp has a higher risk of seizures because of the activities during the day.”
The device eliminated low blood sugar levels, a feared complication that is trigged by too much insulin. It also increased the amount of time the campers were within the target range for good blood sugar control to about 85 percent of the night, up from 50 percent.
Studies show that reducing and controlling high blood sugar can slash the risk of health problems, including amputations, blindness, kidney and heart damage. On the other hand, the danger of blood glucose that goes too low is seizures, coma and sometimes, though rarely, death.
Medtronic has all the pieces of an artificial pancreas in-house. They’ve tested the device in hospitals. Now they’re aiming for easy, personal use.
“We know it’s good enough to improve glucose control,” said Francine Kaufman, Medtronic’s vice president of global medical affairs in the diabetes business. “Now it’s about making it safe enough to use at home.”
Johnson & Johnson, whose diabetes care division generated $2.6 billion in 2012, plunged headlong into the race for an artificial pancreas in 2010. It already makes insulin delivery devices, plus traditional glucose monitoring with one-use test strips.
“As with any technology like this, sometimes you feel the momentum building,” said Ramakrishna Venugopalan, director of the Artificial Pancreas Program, a partnership between J&J’s Animas division and the JDRF. “Researchers are on the verge of a breakthrough.”
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