Seeking to End
the Devastating Health and Economic Impacts of Diabetes

Diabetes — the Biology

People with diabetes have a metabolic disorder that affects the way the body processes digested food for growth and energy. In people with normal metabolism, the digestive system converts food into chemicals, including the most basic source of cellular nutrition and energy — a simple sugar called glucose. Glucose couples with a hormone called insulin, produced in the pancreas, which enables the glucose to be metabolized for growth and energy. Without insulin, the glucose cannot be metabolized and the body attempts to rid itself of the glucose by urination. In a healthy person, the pancreas' clusters of cells, called the islets of Langerhans, or Beta cells, produce insulin. This process results in the output of insulin being tightly regulated and correlated to food consumption.

In people with diabetes, the islets in the pancreas either produce no or too little insulin, or the body cells do not respond to the insulin produced by the pancreas islets. Consequently, in diabetics glucose builds-up in the blood, but the body loses its ability to consume it. Ironically, an untreated victim of Type I diabetes, though eating, will starve to death.

Two Major Types of Diabetes

Type I diabetes mellitus — Insulin-dependent diabetes (IDDM) — often referred to as Juvenile Diabetes. In patients with Type 1 diabetes, the insulin-producing pancreatic islets are destroyed by an autoimmune reaction. Type I victims are entirely dependent on multiple daily insulin hypodermic injections to sustain life. Insulin, as an oral medication (unlike some hormones), does not survive the digestive process — and therefore cannot be administered in tablet form. Injection of insulin does not precisely restore normal glucose homeostasis because it is nearly impossible to replicate the natural process of detecting blood glucose levels and increasing or decreasing insulin to match those levels.

Over time, the "blood test, estimate-and-inject" process which attempts to match insulin to glucose levels invariably leads to higher blood glucose levels which, in turn, leads to loss of blood flow in smaller capillaries and serious complications such as nephropathy, retinopathy, neuropathy and cardiovascular disease. About 5 percent of all diabetic patients in the U.S. have Type I diabetes.

There is no effective treatment for children with Type 1 / Juvenile diabetes, other than constant parental or adult supervision for testing, injections and tightly regulated food and drink intake.

Type II diabetes, also historically referred to as Adult Onset Diabetes. Type II diabetes afflicts approximately 95 percent of those in the U.S. diagnosed with diabetes. This form of diabetes is most common among adults over 45, and in half of the cases it may be treated with protocols involving diet, exercise programs, weight loss and oral medication. In approximately half of all Type II case, insulin therapies are required.

Diabetes — Public Health

According to the U.S. Centers for Disease Control and Prevention, seven percent of Americans have some form of diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. Diabetes is the primary cause of new cases of blindness, non-traumatic amputation, and kidney failure. In the U.S. alone there are 80,000 amputations annually and more than 23,000 new cases of blindness due to diabetes-induced complications. Diabetics are also at significantly higher risk for heart disease.

According to the American Diabetes Association, there are an estimated 21 million people in the United States who have diabetes. In 2006, 1.5 million new cases of diabetes were diagnosed in people age 20 years or older. Since 1987 the death rate due to diabetes has increased by 45 percent, while the death rates due to heart disease, stroke, and cancer have declined.

Clearly, treating and curing diabetes has enormous implications for public health in the U.S. According to the American Diabetes Association:

Direct medical and indirect expenditures attributable to diabetes in 2002 were estimated at $132 billion, with $23.2 billion for diabetes care, $24.6 billion for chronic complications attributable to diabetes, and $44.1 billion for excess prevalence of general medical conditions;

Per capita medical expenditures averaged $13,243 for people with diabetes and $2,560 for people without diabetes;

After adjusting for differences in age, sex, and race/ethnicity, people with diabetes had medical expenditures that were 2.4 times higher than expenditures incurred by non-diabetics.

The estimated $132 billion total annual cost of treating diabetes in America likely underestimates the true burden of diabetes because it omits intangibles, such as pain and suffering, care provided by unpaid caregivers, and several areas of health care spending where people with diabetes probably use services at higher rates than people without diabetes (e.g., dental care, optometry care, and the use of licensed dietitians).

Encapsulated / Transplanted Beta Cell Solution to Curing Diabetes

Successful transplantation of encapsulated islets reverses diabetes, obviates the need for insulin injections and, in restoring normal blood glucose levels, removes the long-term risks of devastating secondary diseases caused by prolonged high-glucose levels — hyper-glycemia, or high blood glucose. Hyper-glycemia can result in damage to small capillaries and damage to organs and body parts dependent on capillaries for nutrition. High blood glucose levels can also lead to high ketone levels and ketone poisoning. In addition, the immediate risk of erratic short-term swings of glucose levels — hypo-glycemia, or low blood glucose levels from too much insulin — can result in coma and severe shock and death.

Functional Cure — A Two-Part Process

In the last three years, there have been numerous scientific discoveries and research successes that validate a clear and promising strategy to provide a functional cure for diabetes. The strategy has two parts:

A scalable source for islet cells that can be encapsulated and transplanted into diabetic patients. Encapsulation technologies are NOT the limiting factor for bringing a functional cure for diabetes within the reach of an estimated 180 million victims worldwide. The source of islets is the greatest current limiting factor for full scalability of allotransplantation — and xenotransplantation is viewed as the best near-term solution for providing large numbers of islet cells. Encapsulife has extensive experience in xenotransplantation research through various U.S. and international collaborations and access to significant supplies of islet cells.

A means for protecting the transplanted islets cells from the new host's immune system and rigors of daily life and exercise; protection enables the transplanted islet cells to function and produce insulin in response to glucose produced by the host's digestive system.

When these two components are joined in a medical protocol that ensures both safety to the patient and efficacy (reversal of diabetes) at a reasonable cost, a functional cure for diabetes is achieved.