The FDA has approved the use of a new glucose monitoring system that forgoes the need for a blood sample. Called the FreeStyle Libre Flash Glucose Monitoring System, it places a sensor beneath the skin and uses a mobile reader to read glucose levels.
Current diabetes health monitoring equipment requires the person to prick their finger and provide a blood sample (a process often called a “fingerstick”), which can become frustrating over time. For people who can’t stand the thought of doing that indefinitely, the U.S. Food and Drug Administration has something for them: a new glucose monitoring system that doesn’t require harming yourself.
The organization announced earlier this week it had given approval to the FreeStyle Libre Flash Glucose Monitoring System from Abbott Diabetes Care Inc. Instead of a fingerstick, it utilizes a small sensor placed underneath the skin, enabling it to continuously measure and monitor glucose levels; a mobile reader can be waved above the sensor to see if glucose levels are too high or too low.
The new system is intended for adults over the age of 18. The FDA explains it can be worn for up to 10 days after a 12-hour initialization period. However, it’s not capable of offering real-time alerts, or alerting the wearer of low blood sugar levels.
“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 FDA Deputy Director of New Product Evaluation Donald St. Pierre. “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.”
According to the Centers for Disease Control and Prevention, over 30 million people in the U.S. have diabetes, with 1 out of 4 unaware they have it. While there’s currently no cure, multiple vaccines are headed to human trials next year, while stem cell implants are also being explored as a potential cure. Healthcare startup Vitra, meanwhile, believes it can combat diabetes using nutrition and personalized diets.
Regardless of which method yields success, it’s clear that diabetes is a serious threat to a person’s health. Diabetes is the seventh-leading cause of death in the country, but the new FreeStyle Libre Flash and aforementioned treatments could significantly reduce the number of people living with the disease.