Continuous glucose monitor accelerates development of artificial
31 March 2006
New York, USA. US government approval of another medical device that
continuously monitors glucose is an important step in the development of an
artificial pancreas. It also has the potential to greatly improve the
quality of diabetes care and lower the risk of complications such as
blindness, heart attack, kidney failure, and amputation, according to the US
Juvenile Diabetes Research Foundation (JDRF).
"Continuous glucose sensors represent a giant leap forward in care for
people with diabetes, allowing them to monitor their glucose levels and
precisely dose their insulin based on that real-time information," said
Aaron Kowalski, PhD, Director of Strategic Research Projects at JDRF. "This
technology should greatly improve glycemic control -- which research has
shown to be the key to reducing or even eliminating both short and long-term
complications of diabetes."
The new device, called the STS Continuous Glucose Monitoring System, from
San Diego-based DexCom, Inc., was approved by the Food and Drug
Administration on Friday for use in people with diabetes. It's the latest
product in what is expected to become a competitive market for continuous
glucose monitoring products.
"By helping people with diabetes prevent serious and costly
complications, continuous glucose sensors can greatly improve the health
care system," said Cynthia Rice, Director of New Technology Access at JDRF.
She noted that total diabetes-related costs exceed $132 billion a year, and
32 percent of Medicare expenditures are spent on people with diabetes.
Nearly 21 million Americans have diabetes and one in three children will
someday develop the disease. Diabetes is the leading cause of kidney failure
and adult-onset blindness, increases the risk of heart attack deaths by
two-to-four times, and leads to more than 80,000 amputations each year.
Dr. Kowalski noted that research continues to confirm that current
diabetes technology is inadequate. Some studies, he said, have found that
even those patients who were intensively managing their disease — measuring
their glucose an average of nine times a day — spent less than 30% of the
day in normal glucose range. The rest of the time their glucose was either
too high (which can cause eye, heart, kidney, and nerve disease), or too low
(which can cause seizures, comas, and death). But studies have also found
that patients using continuous glucose sensors spent 26 percent more time in
normal glucose range, and have statistically significant improvements in
HbA1c levels, an important measure of longer-term glucose control.
Monitors such as these are the keys to the eventual development of a
closed-loop glucose testing and insulin delivery system, or an "artificial
pancreas." Continuous glucose sensors read glucose levels on a
minute-by-minute basis using a small sensor that is inserted under the skin,
which transmits data to a hand-held device. These devices not only provide
actual glucose readings, but can tell a patient whether their glucose level
is trending upwards or downwards, allowing them to continually adjust their
medication, diet and exercise to prevent high and low glucose levels.
Closed loop technology will provide patients and their doctors with far
more information about their daily glucose fluctuations and trends, and
allow for far tighter control. Patients who aggressively manage their
diabetes typically test their glucose up to eight times a day, and provide
insulin injections based on that information. The artificial pancreas will
test glucose approximately 1,400 times a day, and make insulin dosing
information based on that real-time information.
"The development of an artificial pancreas has been one of JDRF's top
research goals, and we are cautiously optimistic that these new products
will be as successful and beneficial to people with diabetes as we hope,"
added Dr. Kowalski. "The next critical steps are for Medicare and private
sector insurers to provide reimbursement for these technologies."
About the Juvenile Diabetes Research Foundation (JDRF)
JDRF was founded in 1970 by the parents of children with juvenile
diabetes — a disease that strikes children suddenly, makes them insulin
dependent for life, and carries the constant threat of devastating
Since inception, JDRF has provided more than $900 million to diabetes
research worldwide. More than 80 percent of JDRF's expenditures directly
support research and education about research.
JDRF's mission is constant: to find a cure for diabetes and its
complications through the support of research. For more information about
JDRF please visit http://www.jdrf.org/