GlySens today said the FDA approved the extension of a clinical trial of its implantable continuous glucose monitoring system from 6 months to a year.
The GlySens device’s implantable sensor is designed to need calibration no more than twice a month, the San Diego-based company said.
“We very much appreciate the timely review and approval by FDA of our request to extend the duration of this clinical evaluation, and are grateful for their thoughtful and collaborative working approach,” co-founder and CTO Joseph Lucisano said in prepared remarks. “We have been very encouraged by the human clinical experience with the ICGM® System and are pleased that the results of this testing have been suitable to support extending the trial.”
“This extension approval is excellent news and puts us in the enviable position to evaluate our CGM solution across its intended use duration and in real-life conditions,” added new president & CEO William Markle. “Additionally, it’s interesting to note that 100% of our currently eligible implanted subjects have independently consented to be part of the study extension and keep their sensor implanted for 12 months. Consistent with what we are routinely hearing from these subjects, the GlySens system appears to be unobtrusive and doesn’t impact their daily lives. Clearly if the sensor was uncomfortable, cumbersome, or even moderately bothersome, at least some portion of our currently implanted volunteer pool would have opted out; such has not been the case.”
