pd01.jpg (13472 bytes)Stabbing one’s fingertips as a daily ritual is a far stretch from the ideal of preventive medicine. But for the millions of Americans suffering from diabetes, piercing their fingertips several times a day to monitor blood sugar levels is a necessary — and painful — evil.
(left to right: John Priest, PhD, Marcel Goetz, PhD, and John Gleisner, PhD)

Amira Medical of Scotts Valley, Calif., is trying to eliminate the painful finger-stick method of glucose testing with its AtLast System, a monitoring device that does not do away with puncturing the skin, but does move it away from sensitive fingertips. It also requires less blood for testing.

Instead of sampling blood from fingertips, the AtLast System measures glucose concentrations in blood drawn from capillary sites with a low density of nerve endings, such as the forearm, upper arm or thigh. The system requires only two microliters of blood, and results are displayed on a handheld monitor in as few as 15 seconds.

“We were looking for ways to get blood for glucose testing and figured there had to be a better way than through lancing the fingers,” said David Hasker, Amira’s director of new product planning, explaining how company founders — Karen Drexler, Joel Douglas and Jim Wilson — created the company around finding a less painful glucose monitoring system. “This can be quite painful with all the nerve endings in the fingertips. In the arm, there are fewer nerve endings, but the problem we encountered was that the wound can close up too quickly and doesn’t want to release a large amount of blood sample,” he said.

Amira developed a dual-ring sampling process, which features single-use disposable lancets and test strips. The handheld meter is held against the forearm, upper arm or thigh while a gentle press-and-release motion punctures the skin. The motion is used five times; the first pierces the skin, the lancet retreats, and subsequent up-and-down motions draw enough blood to the surface for testing.

Jan 1996 Company founded by Karen Drexler, Joel Douglas and Jim Wilson as Mercury Diagnostics, in Palo Alto, Calif.
Mid-late 1996 First prototype developed for AtLast System; sampler development
1997, 1998 Developed meter and diagnostic strips
End of 1998 FDA approval of AtLast System
1999 AtLast System is marketed to consumers

The test strip, attached to the monitor, is held to the blood sample on the skin which is absorbed using capillary action. The blood enters the reagent area only when the required volume is collected. The chemical reactions occur on the test strip and then results are displayed in plasma glucose concentrations consistent with the calibration method of the AtLast system. The meter software informs users if there is a system error.

“We were going to develop a separate analyzer, but we decided to keep the system together,” Hasker said. “This way, it’s more compact.”

The goals of the AtLast System were to make blood collection less invasive, less painful and to use less blood, according to Hasker. “Doctors want their patients to test three to five times a day, but most don’t, largely due to the pain of fingersticks. Your fingers can get awfully sore,” he said.

In a March issue of Parade magazine, the AtLast System was mentioned briefly in a health column. Amira was flooded with “thousands and thousands of phone calls” from diabetes sufferers wanting to know more, said Bill Feagin, Amira’s director of marketing.

If a first grader develops Type 1 diabetes, formerly known as juvenile diabetes, he or she is required to be tested four times a day, Hasker said. By high school graduation that child will have had to stick himself more than 17,000 times. The four-times-a-day mark is the standard, according to American Diabetes Association guidelines.

“With Type 1 diabetes, four times a day is minimum,” said Marian Parrott, MD, vice president of clinical affairs for the ADA. “With Type 2, you test as needed to maintain, but that might mean four times a day as well. “Many should be testing that much, but people do tend to test less than they should,” she said. Mary Beth Rausch, a nurse educator with the Joslin Diabetes Center in Boston agreed that “pain is definitely a factor” in why diabetics often don’t test enough. But they should test because it can be life-threatening, she said

“Type 1 diabetics are totally dependent on insulin, and they need to check four to six times a day,” she said. “With Type 2, it depends on the treatment regimen, but it is recommended they test four times a day.”

There are nearly 16 million diabetics in the United States, according to the ADA, and diabetes is the seventh leading cause of death in this country. Type 1, in which the body does not produce any insulin, occurs mostly in children and young adults. It accounts for 5 to 10 percent of all diabetes. Type 2, a metabolic disorder resulting from the body’s inability to make enough or properly use insulin, is the most common form of the disease. It accounts for 90 to 95 percent of all U.S. cases. Type 2 is nearing epidemic proportions, according to the ADA, due to an increased number of older Americans and a higher prevalence of obesity and sedentary lifestyles.

Efforts to eliminate the finger-stick portion of glucose testing are not new. A glucose watch, FDA approved for adults but not children, uses small electric currents to measure interstitial fluid just under the skin. But questions of accuracy have arisen when patients perspire too much. Also on the market are continuous glucose monitoring devices which work in much the same way as an insulin pump. However, these still require invasive methods to work.

A totally non-invasive method of testing blood sugar may not be that far away, according to the ADA’s Parrott. “The industry is probably no more than a few years away from a practical, non-invasive monitor that will give you a more thorough reading and a better idea of how you’re doing over a 24-hour period.”

“We’re continually looking at next generation type products,” Hasker said. “But our goal is to give diabetic patients something right away, and build on that platform for the next generation of products.”

The AtLast System, has a suggested retail price of $62.95, and a box of 50 test strips goes for $36.95, comparably priced with finger-stick testing devices. It is available for order through pharmacies, the company’s Web site ( www.amira.com ) or by telephone (1-877-282-1477).