The Food and Drug Administration (FDA) approved the first-ever continuous blood sugar monitoring device that doesn’t require the painful finger prick test to collect samples. It was granted to Abbott Diabetes Care, Inc. on Wednesday.
The device is called the FreeStyle Libre Flash Glucose Monitoring System, which uses a small sensor wire that is inserted below the skin’s surface and gauges and monitors the glucose levels. Meanwhile, the users can identify their glucose levels by waving a specialized mobile reader above the sensor wire, according to FDA.
Those with glucose levels that are too high (hyperglycemia) might be diagnosed with Type 1 and Type 2 diabetes. On the other hand, those who have too low glucose levels (hypoglycemia) may lead to various symptoms such as confusion, clumsiness, loss of consciousness, seizures, trouble talking, or death.
The new blood sugar monitor device can be used by people age 18 years and older with diabetes. It has a 12-hour start-up period and can be worn for up to 10 days. It does not require the traditional and painful fingerstick tests that diabetics regularly endure to determine their glucose levels to treat their diabetes. This could be absolutely a relief for them.
Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health, said that FDA is always interested in new technologies that could be helpful in caring for people with chronic conditions. These include diabetes, cancer, and heart disease, among others. He further said that the system allows people with diabetes to prevent the fingerstick calibration with a wave of the mobile reader.
Meanwhile, Dr. Carol Levy, director of the Mount Sinai Diabetes Center in New York City described the new system. She said that the pros of the new device are that it is a 10-day wear, it is low-profile, and that no calibration is needed. She further said that the cons of the device are that it has no alerts for either high or low BG levels for patients with hypo-unawareness. She added that it needs a separate receiver to see data.
CBS News reports that Abbott’s device could be available in pharmacies within months. On the other hand, it did not reveal yet the price of the new reader.
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