Scientists say their mathematical
formula improves accuracy of standard blood screen. The study
appears in the Oct. 5 issue of Science Translational Medicine.
Industry-funded researchers say they have developed a way to improve
the accuracy of a standard diabetes test.
"We think our approach will
enable many patients and their doctors to do a better job controlling
blood sugar levels and reduce the long-term risks of heart attack,
stroke, blindness and kidney failure associated with diabetes,”
said Dr. John Higgins, associate professor of systems biology at
Harvard Medical School in Boston.
At issue is the HbA1c test, also known
as the A1c test, which is used to diagnose diabetes. It also
identifies people with prediabetes and provides insight into how well
blood sugar is controlled over a three-month period among those
monitoring their disease. “The A1c test measures how much sugar
a person's blood cells have soaked up since the time the cells were
produced," Higgins said.
"Before the test was available,
patients and clinicians only knew what a person's current blood sugar
level was. But effective treatment of diabetes depends on knowing
what the blood sugar level has been since the previous checkup,"
Higgins explained. "The HbA1c test provided the first
available estimate of a patient's blood sugar level over the past
several weeks."
For millions of diabetics worldwide,
the A1c test forms the basis of their treatment. In the United
States alone, more than 29 million Americans have diabetes, according
to the U.S. Centers for Disease Control and Prevention.
The test can be inaccurate, however.
How much that matters is up to debate.
Higgins said the errors are
significant. But another specialist, Dr. Joel Zonszein, said the
test is rarely inaccurate and "is a good test for the great
majority" of patients. "Patients with diabetes can be
properly monitored and treated with the tools we have," said
Zonszein, director of clinical diabetes at Albert Einstein College of
Medicine's University Hospital in New York City.
"In my experience, the main
issue is that individuals with diabetes don't often check their A1c
values," said Zonszein, who wasn't involved with the new
research.
For the new study, Higgins and his
colleagues used an advanced mathematical formula, or algorithm, to
analyze blood sugar levels through the HbA1c test. This enabled the
scientists to account for variations in the age of blood cells among
different people, Higgins said. Hemoglobin in red blood cells
accumulates sugar over time, and is a major reason for differences in
test results, he said.
In more than 200 patients included in
the study, Higgins said the new approach reduced significant errors
from about one in three to about one in 10. These were errors large
enough to affect treatment decisions, he said. Since people with
diabetes often get A1c tests every three months, Higgins said the new
approach could improve their monitoring and treatment.
Higgins declined to estimate how much
it would cost to add the new calculations to existing tests. But he
anticipates the extra expense would be less than the cost of the A1c
test itself. And in defense of any higher pricing, he added,
"diabetes becomes very expensive if blood sugar levels are not
well-controlled."
The study was funded by the U.S.
National Institutes of Health and Abbott Diagnostics, a company that
develops laboratory medical tests. The study authors, including
Higgins, are listed as inventors on a patent application linked to
the findings.
Higgins said the researchers are
looking for partnerships that would allow labs to use the algorithm
to improve HbA1c testing.
Zonszein said the study findings appear
valid, although the algorithm "has not been challenged and/or
compared with other possible mathematical models."
For now, however, "this is
research, and it is not a practical model that needs to be
implemented," he said.
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