CGM system approved for use without finger sticks
A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced.
The first continuous glucose monitoring (CGM) system that can be used by patients to make diabetes treatment decisions without calibration based on blood from a finger stick was approved by the FDA on Sept. 27.
The FreeStyle Libre Flash Glucose Monitoring System uses a small sensor wire inserted below the skin's surface that continuously measures and monitors glucose levels. Patients can determine glucose levels by waving a dedicated mobile reader above the sensor wire. The device is intended for use in patients 18 years of age and older. After a 12-hour start-up period, it can be worn for up to 10 days.
Approval was based on a study comparing readings from the device to those obtained by an established laboratory method, according to an FDA press release. Risks include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate, as well as mild skin irritations around the insertion site. The device 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.
A safety alert from the FDA also recently notified clinicians of a recall of certain lots of diabetes infusion sets because the vent membrane may be susceptible to being blocked by fluid, which can lead to overdelivery of insulin shortly after an infusion set change. The infusion sets are used with Medtronic insulin pumps.