A sensor for glucose monitoring in adults with diabetes with the ability to function for up to six months has received approval from the US Food and Drug Administration (FDA).
The continuous glucose monitoring system developed by the Senseonics company received FDA approval to market its Eversense E3 product. This device is implanted in the body of adults with diabetes and monitors their glucose for up to six months.
The implantable device is about the size of a fingernail and, according to the FDA, “provides real-time blood sugar (glucose) readings every five minutes for people with diabetes. The system consists of an implantable fluorescence-based sensor, a transmitter, and a mobile app to display glucose values, trends, and alerts on the patient's compatible mobile device."
The device must be implanted by a medical professional as it is inserted under the skin. Through bluetooth, it completely wirelessly sends glucose data to a mobile device. In addition, the Eversense mobile app alerts the user in the event of hyperglycemia or hypoglycemia, according to the levels configured by the patient.
The FDA also explains the importance of the system's data collection as it "can track long-term trends in glucose measurements and help patients and their providers make adjustments to treatment plans over time to maintain blood glucose levels in a safe range.
After Senseonics' application to the FDA was postponed due to the pandemic, they have finally received the yes, in order to provide their services to patients living with diabetes.
The medical director of Senseonics explained in a statement that this system is a great advance for the control and monitoring of diabetes in adults. Likewise, he thanked the researchers of the PROMISE study, and their participants, who were a vital part in achieving the development of the system. “We are excited to start making this next-generation product available in the US for people with diabetes,” he explained.
On the other hand, the American company has also announced that it will seek to carry out tests to develop a similar device, but that it extends its use for up to a year.
