Implant Pump Seen as Boon for This Diabetic
James Lawson said he was a little sore Friday morning but happy to be the first West Coast recipient of an implanted insulin pump that doctors hope will revolutionize the treatment of diabetes.
Yes, the 39-year-old construction worker felt a little bit like a guinea pig.
“But I enjoy it,” Dawson said during a press conference at the American Medical International (AMI) Medical Center in Garden Grove. The Los Angeles resident added that he was eager to participate in a trial study of the new mechanism.
“The day I heard about it I was down here begging at the door. I first saw this pump in a display case four years ago and said, ‘That’s for me.’ ”
During an hourlong operation Thursday, doctors from UCI Medical Center and AMI implanted the pump--about the size of a hockey puck and weighing about 7 ounces--over Lawson’s abdomen, on the lower left side of his stomach.
The pump houses a reservoir containing about 2.5 teaspoons of concentrated insulin and delivers a computer-controlled dose triggered by a patient-operated radio transmitter.
A diabetic for 25 years, Lawson sent his first instructions to the pump Friday morning and said he feels comfortable with the process. He has been wearing an external pump inside a shirt pocket for the last 3 1/2 years.
Diabetes is a disease in which the pancreas does not produce enough insulin to properly metabolize sugar. Diabetics control the buildup of blood sugars with daily insulin injections.
An estimated 1.5 million Americans have diabetes and depend on insulin injections. Even with treatment, the disease can be lethal, and it is a leading cause of blindness, kidney failure and heart disease, according to Dr. M. Arthur Charles, clinical director of UC Irvine’s Focused Research Program in Diabetes.
Best Way to Control
However, Charles said, studies indicate that control of blood sugar levels is the best way to improve or prevent those complications and pumps appear to be the best way to achieve that control. “The problem with subcutaneous (below the skin) insulin injection is that it doesn’t really work on a general basis,” he said.
Thursday’s implant is part of a federal Food and Drug Administration-sponsored study in Garden Grove and at Johns Hopkins University in Baltimore in which 40 pumps will be implanted during the next two years. Four diabetics already have received implants in Maryland and about 20 others in Europe, according to Dr. Jean-Louis Selam, a French diabetes expert working with the Orange County research team.
Selam says early indications are that the pumps are successful but adds that more research has to be done. The pump has to be refilled by a doctor four or five times a year, and it holds a 3.6-volt battery with a minimum life expectancy of about 3 1/2 years, after which the battery must be surgically replaced, he said.
That life expectancy of the pump could be as much as six years, added Dr. Kenneth Waxman, who performed the surgery. Waxman said there were no pump failures during two years of research on dogs. He admitted that there may be less of a life expectancy for the catheter through which the insulin flows. In some animal tests, the catheter lasted less than a year, Waxman said.
A successful test period might make the pump available to the general public in 1989, he said, but the final decision on approval rests with the FDA.
Bulgy Nature
The only other problem is the pump’s bulgy nature, Selam said, adding that manufacturers probably will find ways to reduce the size slightly but, because of the need for an adequate reservoir of concentrated insulin, it can’t get much smaller.
Costs haven’t been accurately gauged, but John Livingstone, a vice president of research at Mini Med Technologies, the manufacturing company, guesses that the pump might be priced at about $7,500. Livingstone noted that the pump’s design is based on a mechanism used during the Viking spacecraft’s experiments on Mars.
Lawson, who will remain hospitalized for a few weeks and return to work shortly thereafter, said Friday that he didn’t expect any major changes in his life. However, he emphasized that “better control” of his insulin will be a blessing. With daily injections, he said, his blood-sugar level fluctuated wildly, which can cause side effects, including extreme thirst, fatigue and irritability. When he switched to the external pump, his blood-sugar levels improved considerably. The implanted pump, Lawson said, is another step forward.
With his children--Justin, 6, Danielle, 8--and wife, Eileen, at his side, the construction worker said he now has more freedom.
Although the external pump means he won’t have to inject daily, it still means some inhibitions. “You couldn’t go water-skiing with it,” he said. Diabetics who have no medical complications and have been insulin-dependent for a long period are candidates for insulin pump implants during the research project, Waxman said.
