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FDA Approves Continuous Glucose Monitoring System with 90-Day Implantable Sensor PDF Stampa E-mail
Lunedì 25 Giugno 2018 05:56

By Kristin J. Kelley

Edited by André Sofair, MD, MPH

The FDA has approved a continuous glucose monitoring (CGM) system with a fully implantable glucose sensor that can be worn for up to 90 days, as opposed to 7 days like many other sensors.

The Eversense CGM system, approved for adults with diabetes, measures glucose levels using light-based technology and sends readings every 5 minutes to a mobile app to warn users if levels are getting too high or low. Approval was based on study data from 125 adults. The FDA compared readings from the Eversense system to those from a lab-based glucose analyzer. Less than 1% of study participants experienced serious adverse events from the implanted device.

Side effects related to placement of the sensor may include allergic reaction to adhesives; bleeding; bruising; discomfort; infection; skin discoloration, inflammation, or scarring.

Separately, the FDA expanded approval of an automated insulin delivery system — the MiniMed 670G hybrid closed looped system — to include younger pediatric patients (7 to 13 years old) with type 1 diabetes.

 

da NEJM