Aug 18 2015
GlySens Incorporated announced today that it has secured FDA approval for extending the current human clinical evaluation of its fully implantable continuous glucose monitoring system (the ICGM® System) from the originally approved six-month duration to the system's commercially-intended operational duration of twelve months.
"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," commented Joseph Lucisano, PhD, Co-Founder and CTO of GlySens. "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," continued Dr. Lucisano.
The GlySens ICGM® system is the world's first fully implanted CGM system to demonstrate 18 month in vivo performance in a preclinical setting. The current clinical trial is being performed under an FDA-approved IDE in the greater San Diego area. Key attributes of the GlySens system include a fully implanted sensor, which enables an essentially undisturbed body image and an expected need for only infrequent calibrations, currently anticipated to be no more frequently than twice monthly.
"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," commented William Markle, President and CEO of GlySens. "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 twelve 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," continued Mr. Markle.
Source: http://www.glysens.com/