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First continuous glucose monitoring technology for diabetes approved by FDA




The US Food and Drug Administration (FDA) has approved the first continuous glucose monitoring system for adult patients with diabetes. The FreeStyle Libre Flash Glucose Monitoring System enables patients to make decisions about their treatment without needing to calibrate using fingerstick testing.  

Fingerstick testing is the monitoring method used by most patients with diabetes. Glucose levels are tested by taking a blood sample from the finger, an often painful and uncomfortable method that may need repeating a number of times each day. This data enables patients to administer the correct amount of an insulin product, such as Amaryl (glimepiride) or Glucophage (metformin).

Patients using the newly approved system have a small sensor wire inserted below the surface of the skin on the back of the arm. This continuously measures and monitors the glucose levels in the blood and users can get a reading at any time by waving a reader over the sensor. The sensor is water resistant, so patients can still swim, shower and exercise without removing it, and it lasts for up to ten days before a replacement is required. The system, manufactured by Abbott Diabetes Care Inc, was approved following a clinical study of individuals aged 18 or over with diabetes, which examined the readings given by the device and compared them with an analysis of blood glucose obtained using an established laboratory method.  

However, the new system is not without limitations; it does not feature an alarm for particularly low or high blood sugar levels; is only for use in patients over 18 years of age; will not work with other brands of control solution or test strips; and can only be placed on the back of the arm. Furthermore, patients are also warned about taking ascorbic acid (vitamin C), as this may falsely raise the blood sugar reading, while salicylic acid may lower the reading. 

Despite this, the new system has been praised by many experts for providing Americans with diabetes with an easier way to manage and monitor their condition. Commenting on the technology, the American Diabetes Association’s (ADA’s) chief scientific, medical and mission officer William T Cefalu MD said: “Continuous glucose monitoring devices, by providing such in-depth information on daily glycemic profiles, can serve a vital role in improving health outcomes and quality of life for people with diabetes.”

More than 30 million adults in the United States have diabetes, around 9.4 percent of the population, according to National Diabetes Statistics Report 2017. Of these, more than nine out of ten cases are type 2 diabetes, a condition that inhibits the body’s ability to utilize insulin properly. The FreeStyle Libre Flash Glucose Monitoring System is not yet in pharmacies but is expected to be available in the United States in the coming months.  

For more information on the FreeStyle Libre Flash Glucose Monitoring System, visit https://www.myfreestyle.com/provider/