The Incidence of Diabetes is Increasing Worldwide

Diabetes prevalence is growing at a staggering pace

  • Diabetes currently affects more than 382 million people worldwide and is expected to affect 592 million by 2035 (1).
  • 29.1 million Americans (9.3% of the population) have diabetes (both types) and as many as 2.5 million Americans currently live with type 1, insulin-dependent diabetes.  86 million Americans aged 20 or older are classified as prediabetic, including 51% of those aged 65 or older (2).
  • Diabetes results in $245 billion annual U.S. healthcare costs, growing 8% each year and driven by complications of poor glucose control (3).  Worldwide, costs of diabetes are estimated to account for 11% of total healthcare expenditures (1).
  • Nearly 1 in every 400 children in the U.S. has type 1 diabetes and is insulin-dependent.  26% of the U.S. population aged 65 or older has diabetes (2).
  • Diabetes is a major cause of heart disease, stroke, kidney disease, blindness, and numerous other debilitating diseases and afflictions.  It is the seventh leading cause of death in the U.S (2).

The Risks of Not Knowing

It is important for people with diabetes to avoid high glycemic levels (hyperglycemia) to prevent dangerous chronic conditions including heart disease, stroke, high blood pressure, blindness, kidney disease, amputations, dental diseases, pregnancy complications, sexual dysfunction, and nervous system disease (2). It is also crucial to avoid dangerously low glycemic levels (hypoglycemia), which are associated with acute cognitive dysfunction.

Current treatments  however, which are based on conventional monitoring methods, only approximate the function of the normal pancreas, and the blood glucose profiles of even the most diligent patients can remain markedly abnormal. Studies of glycemic variability indicate that even brief hyper- and hypoglycemia may have profound detrimental effects.  Lacking the means for reliable, acceptable continuous glucose monitoring needed to optimize care, many patients frequently experience periods of hyperglycemia and hypoglycemia; hypoglycemia can lead to loss of consciousness, coma, permanent brain damage, or death. Further associated with inevitable periods of hyperglycemia are serious and debilitating long term complications, including accelerated degeneration of the kidneys, retina, microvasculature, nervous system, large blood vessels, and other organs.  Patients and caregivers face a continuing dilemma that their efforts to prevent complications by avoiding hyperglycemia can increase their risk for dangerous hypoglycemia; the GlySens ICGMTM system is intended to help alleviate the worries that otherwise 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 (4, 5).

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

  • They’re neither long term, nor viewed as convenient by many potential users:   Current “needle-sensor” products only last for 3-7 days and require repeated recalibration by fingerstick glucose measurement during use.  In contrast, the GlySens fully implanted sensor (requires only a brief outpatient insertion) is wirelessly linked to a receiver, and designed to provide continuous 24/7 glucose measurement with an expected sensor life of one year or longer.
  • They can be physically obtrusive: through-the-skin and on-the-skin components are viewed by many as problematic for typical as well as active lifestyles.  In contrast, the GlySens sensor is fully implanted, and designed to allow users to be unencumbered by the device and free to do what they want, when they want. It is anticipated that the system will require only occasional calibration, and users will be able to forget about maintenance for extended periods of time.

The GlySens ICGM system is designed to shift the paradigm in the way people with diabetes monitor their glucose

Conventional “fingerstick” monitoring, while offering none of the advantages of continuous approaches, has estimated worldwide expenditures of $7 to $10 billion, with half of the sales occurring in the U.S. Even with the numerous limitations of current “needle-sensor” CGM products, growing interest and reimbursement confirms the market appetite for a more acceptable CGM.  What’s more, millions of people living with chronic conditions now use implantable devices, and the robust U.S. implantable device market is expected to grow to $74 billion by 2018 (6).

Because the GlySens ICGM system is designed to work with minimal user effort and present minimal inconvenience, it is expected that it will offer people living with diabetes a new level of empowerment to take better care of their health.

  1. International Diabetes Federation.  “IDF Diabetes Atlas Sixth Edition“.
  2. 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
  3. American Diabetes Association. “Economic costs of Diabetes in the U.S. in 2012,” published 3/6/2013.
  4. 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.
  5. “JDRF Funded Clinical Trial Demonstrates Continuous Glucose Monitoring Improves Blood Sugar Control.” Juvenile Diabetes Research Foundation. September 2008.
  6. Transparency Market Research. “Implantable Medical Devices Market (Reconstructive Joint Replacement, Spinal Implants, Cardiovascular Implants, Dental Implants, Intraocular Lens and Breast Implants) U.S. Industry Analysis, Size, Share, Trends,  Growth and Forecast 2012-2018,” published 1/23/13.