Truly Long Term Continuous Glucose Monitoring
The GlySens ICGMTM System
GlySens is developing a truly long term continuous glucose monitoring system (expected one year or longer life, demonstrated up to 18 months in preclinical studies) intended to dramatically improve the lives of people with diabetes. The basic system is comprised of two elements: (1) the fully implanted sensor (designed for long operational life) and (2) an external receiver with monitor. The external receiver is designed to offer a convenient means for continuous, at-a-glance glucose display, recording, and alerts regarding hypo- or hyperglycemic glucose excursions.
The GlySens ICGM System is Intended to Enable Easy, Worry-Free Glucose Monitoring
- The GlySens long term ICGM System needs only a brief outpatient procedure to insert the sensor, and then is designed to work continuously, for an expected period of one year or more, with only occasional need for calibration anticipated. Other continuous glucose monitor needle-sensor approaches must be replaced every 3-7 days and require frequent calibration during use.
- Because our ICGM sensor is fully implanted and is designed to achieve a stable tissue/sensor contact interface, it is not expected to be subject to many of the factors that can cause inaccuracies with other glucose sensor approaches where the sensor/tissue contact is not stabilized.
- By providing a continuous sensor that maintains proper contact with body tissues throughout its long lifetime, it is expected that the GlySens ICGM system will help take the worry out of not knowing glucose levels any time of the day or night. With built-in alerts designed to warn of abnormal glucose excursions, this may be especially welcome news to parents of children with diabetes or other caregivers of people with diabetes.
- Because the GlySens system does not utilize any through-the-skin or skin-adhered components, users will not need to worry about the sensor snagging, dislodging, or breaking due to movement (all of which can affect sensor accuracy) or affecting certain clothing choices or activities.
The GlySens ICGM System is Intended to Free Users from the Burden of Frequent Sensor Maintenance
- The GlySens ICGM system requires no needle insertion, or through-the-skin/skin-adhered components. There are no sensor elements that need to be changed every few days or every week. Other CGM approaches can require a painful needle insertion with every sensor replacement, can be physically obtrusive, and can present significant impediments to normally active lifestyles.
- With the GlySens ICGM system, there is expected to be a dramatically reduced need for calibration adjustment compared to other short term CGM approaches. The need for frequent attention and calibration with other CGMs can be significantly intrusive to users’ lifestyles.
The GlySens ICGM System is Intended to Enable Improved Glucose Management
- Continuous glucose monitoring has been demonstrated to improve outcomes. A major study by the Juvenile Diabetes Research Foundation (JDRF) showed that people who utilize continuous glucose monitoring on an ongoing basis achieve significant improvement in glucose control, which is known to lower their risks for serious complications (The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, “Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes,” New England Journal of Medicine. 359: 1464-1476, 2008). Use of continuous glucose monitoring has also been shown to durably improve outcomes for people with type 2 diabetes (Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM, “Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes,” Diabetes Care . 35(1): 32-8, 2012). Because the GlySens ICGM system is designed to provide 24/7 information over very long durations and is expected to be convenient and unobtrusive, it is anticipated that it will enable significantly more people with diabetes to benefit from the improved outcomes associated with long term continuous monitoring.
- Because our revolutionary ICGM system is designed to work for extended periods without user effort or inconvenience, it is expected that users will be more likely to take better care of their diabetes. The GlySens long term ICGM system will provide technology specifically designed to alleviate the user from product maintenance responsibilities, while providing the information they need to optimize their care. With other needle-sensor glucose monitoring systems, the user is burdened by an approach that can require the patient to work for the technology, instead of having the technology work for them.
The GlySens ICGM System is Designed to Offer These Significant Advantages:
- Long-lived (18 months preclinical), fully-implanted sensor, unobtrusive to patient lifestyle, automatic 24/7 monitor
- Glucose-specific, oxygen-based, dual-enzyme electrode technology, adapted from laboratory standard method
- Sensor is inherently stable and drift-resistant, resistant to interference, highly biocompatible
- Differential reference sensor technique compensates for tissue effects that have historically plagued other approaches
- Offers high-bandwidth data source potentially applicable to new diabetes-related health information technology applications