Bethesda, MD – November 10, 2016 – GlySens Incorporated executives, Bill Markle and Joseph Lucisano, PhD presented separate findings at the 16 th annual Diabetes Technology Society meeting. This conference brings together leading scientific researchers and health care professionals from around the world to focus on applying science and new technologies to the fight against diabetes. The presentation entitled “Market Opportunities and Customer Preference Data for a Fully Implanted Long-Term CGM Solution” was given by Mr. Markle, the Company’s President and CEO, while an “Update of Clinical Experience with a Long-Term Fully Implanted CGM System” was presented by Dr. Lucisano, the Founder and CTO. The clinical update was accompanied with a scientific poster presentation.
From the GlySens Presentation Abstract:
Joseph Y. Lucisano, PhD
Recent human experience with a second generation long term fully-implanted (no skin-attached elements) continuous glucose monitoring system (the GlySens Eclipse™ ICGM ® System) includes the launch of same-pocket reimplantations of new sensors in six adult human subjects, following completion of a 12-month initial sensor implant period.
At the end of an initial 12-month subcutaneous implant period, the GlySens Model 100 ICGM Sensor in each of six human subjects was exchanged for a new replacement sensor in a minor outpatient surgical procedure utilizing local anesthesia. Following sensor replacement, subjects are to self-monitor blood glucose four times per day and meter-stored fingerstick values are to be downloaded during monthly clinic visits that also include meal-based glucose excursions with YSI plasma glucose measurements and, in some cases, Dexcom G4 CGM recordings. Monthly subject interviews including a standardized survey questionnaire are conducted to assess tolerance of the device.
There were no significant adverse events associated with the sensor replacements. All sensors were easily extracted, with no significant adherent capsular tissue. Early performance measurements of the replacement sensors suggest feasibility of the approach for sensor replacement/renewal as part of an extended long term monitoring regimen.
Use of the fully implanted ICGM Sensor requires an annual user decision (whether to implant/reimplant or not) and an occasional decision to recalibrate; no maintenance of body-worn components or other regular user intervention is required to receive glucose readings. This combination of features offers minimal barriers for adherence to treatment modalities requiring continuous glucose monitoring.