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Clinical Trial to Evaluate GlySens Eclipse ICGM System

August 7, 2017 San Diego, CA GlySens® Incorporated today announced another series of successful insertions of the ICGM® sensor in the FAST Trial. This trial is a feasibility study designed to evaluate advanced sensor algorithms in a limited number of clinical participants. Individuals are enrolling at St. Vincent’s Hospital, in Melbourne Australia, with David O’Neal, MD.

According to the World Health Organization (WHO), an estimated 422M adults worldwide are living with diabetes, accounting for 8.5% of the global population.1 The staggering prevalence marks a significant public health problem with substantial economic burden as well as assorted health complications. The 2016 American Association of Clinical Endocrinologists (AACE) Consensus statement and the 2016 Endocrine Society Clinical Practice Guidelines both recommend CGM as a tool to benefit the health outcome of individuals whose A1C is ≥7%, for those with history of severe hypoglycemia, hypoglycemia unawareness and those willing and able to use the device. “CGM is a tremendous tool to reveal glycemic variability and aid in the daily management of diabetes” said Bill Markle, President and CEO of GlySens Incorporated. “However, it continues to be poorly adopted by clinicians and patients primarily due to modifiable device barriers, namely the discomfort, daily and weekly maintenance and burden of through the skin, adhesively applied, needle sensors. A broadly acceptable solution is greatly needed to enable all individuals to use the powerful tool and live their healthiest life.”

The GlySens Eclipse® ICGM system is a long-term, fully implantable Continuous Glucose Monitoring device that enables uncompromised and unobtrusive glucose management. This is intended to empower individuals with diabetes by providing the information they need, while freeing them to live life on their own terms.

The FAST trial is scheduled to capture data through early 2018. It is a collaboration between leading clinicians and researchers to develop and employ new technologies that advance patient care while enabling the broad adoption of continuous glucose monitoring amongst all individuals living with and managing diabetes.

About GlySens Incorporated

GlySens Incorporated is a privately held corporation devoted to developing the world’s first unobtrusive, truly long term continuous glucose monitoring system, intended to dramatically improve and simplify the lives of people with diabetes. The GlySens fully implanted sensor wirelessly communicates to an external receiver, designed to provide continuous, at-a-glance glucose reporting and alerts regarding hypo- and hyperglycemic glucose excursions. While other CGM approaches may require calibration multiple-times-per-day and demand continuous wearing of through-the-skin or skin-attached components, the calibration checks of the GlySens sensor are designed to be required only infrequently, freeing users from burdensome care and maintenance requirements. For people living with diabetes, the GlySens implantable continuous glucose monitoring system (the GlySens ICGM system) is intended to provide a means for easy, unobtrusive, worry-free glucose monitoring, and empower users by providing the information they need, while freeing them to live life on their own terms—“Live more, worry less.”
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Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
GlySens®, Eclipse®, and ICGM® are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
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