FDA Approves Game Changing New Blood Sugar Testing System For Diabetics
September 28, 2017
Part of the Freestyle Libra Flash Glucose Monitoring System. Sensor at left, worn on body. At right, dedicated, mobile reader that is waved over the sensor to read blood glucose levels.
(NATIONAL) -- In September of 2014 the medical device and pharmaceutical giant Abbott received European approval to market its revolutionary new Freestyle Libra Flash Glucose Monitoring System.
For diabetics in Europe, this has been a game changer. Now that same life-changing product will be available to diabetics in the US.
On Wednesday The U.S. Food and Drug Administration approved for use in this country the FreeStyle 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 taken via needle from the fingertip (often referred to as a “fingerstick”).
The system reduces the need for diabetics to stick needles in their fingers to draw blood by using a small "sensor wire" that is inserted below the skin’s surface that continuously measures and monitors glucose levels.
Users of the product can, "Then 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," said the FDA announcement.
The system 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
Abbott first introduced this new glucose monitoring technology in 2013 at a medical conference. The product is intended to be a replacement for the long traditional blood glucose meters, but is also designed to overcome some of the limitations of constant glucose monitoring -- cost and the need for daily fingersticks with a needle.
“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's 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 make informed care choices or to calibrate glucose levels with this system.
29 million diabetics in America
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.
In making its decision to allow the product to be sold in he US, 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.
The FDA says there are some risks associated with use of the system. The risks 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.
The system 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 way it works
The Abbott system includes a tiny glucose sensor (0.2 inches in length, about the thickness of a hair) worn under the skin connected to a water resistant on-body patch the size of a one-dollar coin.
The sensor remains inserted in the skin for 14 days and does not require fingerstick calibrations. After putting it on the upper arm and waiting one hour, it begins reading glucose and trend information.
To use the system, users take a "touch screen reader device," hold it up to 1.5 inches above the sensor patch, and in less than a second can see their real-time glucose value (e.g., 102 mg/dl), a glucose trend arrow, and a trend graph showing the last eight hours of data.
The sensor can also be scanned through clothing. The reader device also has a number of reports available to the user, including a valuable graph that shows "time-in-target" (the amount of time the body is in the target range for glucose) right on screen.
FreeStyle Libre downloads to PC and Mac compatible software, which includes a traffic light approach to identify problematic times of the day. The system is approved for people with both type 1 and type 2 diabetes.
STORY TAGS: Freestyle Libra Flash Glucose Monitoring System, Food & Drud Administration, diabetes, glucose monitoring, type 1 diabetes, type 2 diabetes