The Risk of Not Knowing

It is important for people with diabetes to manage blood sugars and avoid high glycemic levels (hyperglycemia) to avoid dangerous and debilitating long term conditions including heart disease, stroke, high blood pressure, blindness, kidney disease, amputations, dental diseases, pregnancy complications, sexual dysfunction, and nervous system disease (1). It is also crucial to avoid dangerously low glycemic levels (hypoglycemia), which are associated with acute cognitive dysfunctions like blurred vision, irritability, dizziness, and even loss of consciousness or death.

Current treatments, which are based on conventional self monitoring blood glucose (SMBG) methods, only approximate the function of the normal pancreas and the blood glucose profiles of even the most diligent individuals can remain markedly abnormal. Studies of glycemic variability indicate that evenbrief hyper- and hypoglycemia may have profound detrimental effects. Without the means for reliable, convenient continuous glucose monitoring needed to optimize care, many individuals may experience periods of hyperglycemia and hypoglycemia, increasing both short term and long term health risks. Patients and caregivers face a delicate balancing act to maintain glycemic control. A constant dilemma is that their efforts to prevent complications by avoiding hyperglycemia can increase the risk for dangerous hypoglycemia. The GlySens ICGM system is intended to help alleviate the worries that can accompany such efforts to improve glucose control.

Continuous Glucose Monitoring is Knowledge

A 2008 major clinical trial funded by the Juvenile Diabetes Research Foundation concluded that patients using continuous glucose monitoring devices experienced significant improvements in glucose control. Over the long term, this improvement in control is expected to lower the risk of debilitating complications.(2,3)

But not everyone with insulin-dependent diabetes uses a CGM, because currently available CGM products have significant drawbacks:

They're short term

Current “needle-sensor” products last for up to 14 days before requiring at-home removal and reinsertion of a new sensor. Newly available implantable sensors only last up to 3 months, requiring a Health Care Professional and an office visit. In contrast, the GlySens fully implanted sensor is being designed to last for up to 2-years without user intervention and only require a brief outpatient procedure every 2 years. A truly Long-Term sensor enables individuals to worry less about their diabetes devices.

They impact body image

Through-the-skin and on-the-skin components like needle-sensors and transmitters, are viewed by many as problematic for daily as well as active lifestyles. They are uncomfortable, burdensome and can hinder daily activity. In contrast, the GlySens sensor is fully implanted and designed to eliminate the visible body burden of current diabetes technology thereby enabling individuals to live their most uncompromising and healthiest life.

They demand attention

Short-Term sensors require an individuals' constant cognitive attention to ensure success. Routine decisions like renewing a sensor after expiration, daily maintenance and reapplication of adhesive or multi-day finger stick calibrations often impact long-term use. On the contrary, the Eclipse 3 System is designed to eliminate these barriers and enable 100% adherence, thereby reducing the cognitive demands of diabetes devices and enabling positive health benefits.

The Eclipse 3 System is designed to shift the paradigm in blood glucose management

Momentum in the Continuous Glucose Monitoring market continues to accelerate with recent estimates valuing CGM device sales of $4+ Billion per year (4). This volume has outpaced the annual revenues of conventional “fingerstick” monitoring and will likely continue outperforming the long-standing technology for many years to come.

Supporting the economic accomplishment is a wealth of clinical literature that demonstrates advanced diabetes technology providing superior health outcomes when compared to traditional care (5).
Like other modalities of care today, millions of people with various chronic conditions are enjoying life with the use of implantable medical technologies, and the robust U.S. implantable device market is expected to grow to $124 billion by 2024. (6)

Because the GlySens ICGM System is designed to enable long term continuous monitoring with nothing worn on the skin, and with only minimal need for device interaction, it is expected that it will offer people living with diabetes a new level of empowerment to take better care of their health.

Citations
1. Centers for Disease Control and Prevention. “National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014.” Atlanta, GA: U.S. Department of Health and Human Services; 2014
2. The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. “Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes.” The New England Journal of Medicine. 359. 2008.
3. “JDRF Funded Clinical Trial Demonstrates Continuous Glucose Monitoring Improves Blood Sugar Control.” Juvenile Diabetes Research Foundation. September 2008.
4. Close Concerns Memorandum, 2019 Diabetes and Obesity Industry Roundup, March 24, 2020.
5. Maiorino MI, Signoriello S, Maio A, Chiodini P, Bellastella G, Scappaticcio L, Longo M, Giugliano D, Esposito K. Effects of Continuous Glucose Monitoring on Metrics of Glycemic Control in Diabetes: A Systematic Review With Meta-analysis of Randomized Controlled Trials. Diabetes Care 2020 May; 43(5): 1146-1156. https://doi.org/10.2337/dc19-1459
6. Research and Markets. “Implantable Medical Devices Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024,” June 2019.

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