The
U.S. Food and Drug Administration today approved the FreeStyle Libre Flash
Glucose Monitoring System, the first continuous glucose monitoring system that
can be used by adult patients to make diabetes treatment decisions without
calibration using a blood sample from the fingertip (often referred to as a
“fingerstick”).
The
system reduces the need for fingerstick testing by using a small sensor wire
inserted below the skin’s surface that continuously measures and monitors
glucose levels. Users can determine glucose levels by waving a dedicated,
mobile reader above the sensor wire to determine if glucose levels are too high
(hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing.
It is intended for use in people 18 years of age and older with diabetes; after
a 12-hour start-up period, it can be worn for up to 10 days.
“The
FDA is always interested in new technologies that can help make the care of
people living with chronic conditions, such as diabetes, easier and more manageable,”
said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics
and Radiological Health and deputy director of new product evaluation in the
FDA’s Center for Devices and Radiological Health. “This system allows people
with diabetes to avoid the additional step of fingerstick calibration, which
can sometimes be painful, but still provides necessary information for treating
their diabetes—with a wave of the mobile reader.”
People
with diabetes must regularly test and monitor their blood sugar to make sure it
is at an appropriate level, which is often done multiple times per day by
taking a fingerstick sample and testing it with a blood glucose meter.
Typically patients use results of a traditional fingerstick test to make
diabetes treatment decisions; however, fingerstick testing is not needed to
inform appropriate care choices or to calibrate glucose levels with this
system.
According
to the Centers for Disease Control and Prevention, more than 29 million people
in the U.S. have diabetes. People with diabetes either do not make enough
insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes).
When the body doesn’t have enough insulin or cannot use it effectively, sugar
builds up in the blood. High blood sugar levels can lead to heart disease;
stroke; blindness; kidney failure; and amputation of toes, feet or legs.
The
FDA evaluated data from a clinical study of individuals aged 18 and older with
diabetes, and reviewed the device’s performance by comparing readings obtained
by the FreeStyle Libre Glucose Monitoring System to those obtained by an
established laboratory method used for analysis of blood glucose.
Risks
associated with use of the system may include hypoglycemia or hyperglycemia in
cases where information provided by the device is inaccurate and used to make
treatment decisions, as well as mild skin irritations around the insertion
site. It does not provide real-time alerts or alarms in the absence of a
user-initiated action; for example, it cannot alert users to low blood glucose
levels while they are asleep.
The
FreeStyle Libre Flash Glucose Monitoring System is manufactured by Abbott
Diabetes Care
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