FDA Extends Clinical Trial of GlySens’ Continuous Glucose Monitoring System
GlySens announced that the FDA has approved an extension for the clinical trial of the company’s continuous glucose monitoring system from six months to a year.
The GlySens ICGM system is an implantable system that has demonstrated an 18-month in vivo performance in a preclinical setting, according to the company.
The implanted sensor enables an undisturbed body image, and is expected to need calibrations no more than semimonthly.
GlySens is a San Diego-based company devoted to developing the world’s “first unobtrusive, truly long term continuous glucose monitoring system,” to help simplify the lives of those with diabetes. — Michael Cipriano