Dr. M. Arthur Charles, clinical director of the UC Irvine Focused Research Program in Diabetes, praises Barbara Ficker for being a "highly motivated" research volunteer "and well educated with regard to diabetes."
Ficker, a diabetic who for nearly six years had been unable to control her blood sugar levels, is having dramatic success with an experimental insulin delivery system that was implanted just beneath the skin of her abdomen last November at the University of Utah. (See accompanying story.)
According to Charles, it is the opportunity to be involved with the latest kinds of research in insulin and insulin delivery systems that motivates the majority of the 150 diabetic patients participating in UCI's diabetes research program.
Among its half-dozen clinical research projects, the program is studying an implantable, programmable peritoneal insulin pump that would require only two shots of insulin a month.
The bottom line for all diabetic patients who volunteer for the research program, Charles said, is "they want to be able to give themselves insulin so they can keep their blood sugar levels at a normal range and avoid or minimize the complications of diabetes."
Citing U.S. Department of Health and Human Services statistics, Charles said 5 million to 6 million Americans have diabetes and know it, and an equivalent number of people are unaware they have the disease. Diabetes patients spend an estimated $15 billion a year in health care, and diabetes is the third leading cause of death in the United States, behind cancer and heart disease.
The real problem with diabetes, Charles emphasized, is the complications associated with the disease.
'A Horrible Disease'
Diabetes, he noted, is the leading cause of blindness, kidney failure and kidney transplantation in the United States. Excluding accidents, he said, it is the leading cause of amputations of the feet and legs, oftentimes associated with gangrene. And excluding alcoholism, it is the leading cause of peripheral nerve disease.
"It is a horrible disease," Charles said. "Almost nobody gets out alive. Most everyone sooner or later will develop complications of the disease. For young people under age 40, chances are almost for sure you're going to develop some complications."
The disease, he said, "can be insidious in that a patient may have a blood sugar level above 140--normal is less than 115--and not really know it and that can go on for several years."
"A patient may urinate once or twice a night and not think much about it," Charles said. "A patient may have blurry vision and not think much about it or lose weight and not think much about it. Those are all subtle signs."
Type 2 Most Common
Charles said 90% of diabetic patients have Type 2 diabetes--"they have insulin but it doesn't seem to work properly. They're the ones walking around with blood sugar in the 200s and don't know it." Although some Type 2 diabetic patients may need insulin injections, Charles said, they often can be helped through diet and exercise modification and oral medications.
Charles said that the chronic complications of the disease appear to be related to good metabolic control. "If you can stabilize the blood sugar in the near normal or normal range, all the available evidence suggests we can prevent the onset of complications and improve them if they're very mild."
To help achieve that goal, patients in the UCI research program who require insulin undergo a regular procedure involving a number of stages. Stage one involves two or three insulin injections a day, using short- and intermediate-acting insulin. Patients are able to measure their own blood sugar levels at home with the aid of a home blood glucose monitor. Based on their blood sugar levels, they can adjust the amount of insulin they're receiving on a daily basis.
Next Procedure Tried
If that doesn't work, Charles said, patients move on to stage two, in which they receive short- and long-acting insulin. "We give each stage a maximum of two months or so until we move on to the next strategy," he noted.
Those who still have not been able to stabilize their blood sugar levels go to stage three: They use a pocket-sized, programmable portable insulin pump that steadily infuses insulin 24 hours a day. The external pump has tubing that transfers the insulin from the pump to a small needle placed under the skin, usually in the abdominal wall.
"These," noted Charles, "have been very successful for most patients."
Charles said, however, that only about 30% of the research program's insulin-dependent diabetes patients have been helped by the first three stages of the program.
Many Not Helped
"In other words, all these spectacular technologies still leave a lot to be desired," he said. "The other 70%--we're not sure why we can't normalize their blood sugar. We think it has to do with a lack of predictability of insulin absorption. That's why we're setting up this implantable insulin pump research program. We hope that we can take a big percentage out of that 70%."
Three of the program's patients, including Ficker, who have not been helped by multiple injections or the insulin pump, have gone on to stage four: treatment with special peritoneal devices.
In fact, Charles said, two of the patients were much worse off than Ficker: In the two years prior to joining the UCI program they had been hospitalized more than 80% of the time, suffering from ketoacidosis, a potentially fatal condition in which the patients are deprived of insulin and their blood sugar goes to extremely high levels. "They were dying," Charles said.
These two patients, however, have shown dramatic improvement with the aid of a German-made peritoneal insulin delivery system--an external pump with a tube that goes directly to the abdominal cavity. Charles said these patients now spend less than 1% of their time in the hospital and "they're doing very, very well. Both of these patients are basically miracles."
Although the external German device has been used in Europe for seven or eight years, it is approved for use in this country only in life-threatening situations. Because she was not considered a medical emergency, Charles said, Ficker did not qualify for using the system.
And that's why Charles told Dr. Robert L. Stephen, research associate professor at the University of Utah's Institute of Biomedical Engineering, "I have just the patient for you," when the two met at an international meeting on insulin delivery systems last September and Charles learned that the University of Utah was getting much better results with its implantable peritoneal device.
'Very Pleased' With Results
"To date, we've been very pleased with it," said Charles, referring to Ficker's improvement. "We're looking forward to this device's success so we can use it in larger numbers of patients."
As for Ficker, it appears her years as a volunteer have paid off.
"Yes, oh, yes!" she said with a laugh. "Thank goodness. I'm so glad Dr. Charles found Dr. Stephen. It was a wonderful meeting."