Diabetes Technologies, Inc.

Thomasville, GA.,-- (August 2, 2002)- Diabetes Technologies, Inc., (DTI) announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing a new over-the-counter diagnostic test kit (AccuBase A_1c^™ Test Kit) developed by DTI for monitoring long-term mean blood glucose levels in individuals with and/or suspected of having any form of diabetes. The AccuBase A_1c ^™ Test Kit, will allow individuals to monitor their A_1c levels in the privacy of their home without the need for a prescription. The AccuBase A_1c ^™ Test Kit is Level 1 certified by the National Glycohemoglobin Standardization Program (NGSP). Kits are available now and can be ordered directly from DTI by calling 888.872.2443 for under $20.00.

The AccuBase A_1c ^™ Test Kit, will enable individuals diagnosed with diabetes or those considered at risk for developing diabetes to collect a non-fasting, finger stick blood sample at-home, and mail-in to a designated testing laboratory for analysis. The AccuBase A_1c^™ Test Kit provides improved technical precision and accuracy over traditional veni-puncture, at the same time improving convenience, economics and reduced patient anxiety.

A_1c measures the relative concentration of glucose attached to erythrocytes (red blood cells) during their life span of approximately 3 - 4 months. A_1c (glycohemoglobin) is formed when glucose is bound (attached) to erythrocytes, cells responsible for carrying oxygen to, and removing metabolic waste products from the tissues of the body.

Elevated levels of A_1c represent a proportional increase in the risk for developing diabetes and/or its chronic complications such as blindness, kidney, stroke, nerve and cardiovascular disease. A_1c testing does not replace daily blood glucose monitoring which helps determine daily medication and therapy. The A_1c test measures blood glucose as if you monitored your blood glucose constantly 24 hours per day over a 60-90 day period of time.

The A_1c test is considered extremely useful in determining optimal individual therapy and treatment, as well as judging the efficacy of current medical intervention. The AccuBase A_1c^™ Test Kit normal assay range is 4.3% to 5.5% (70 – 108 mg/dl). Normal A_1c ranges may increase slightly by each decade of age over 30 by .1%. A_1c measures the mean blood glucose (MBG) in the body over the life of the RBC. A_1c levels indicate the amount of glucose bound to red blood cells in response to glucose loads and other factors during their life span. Any A_1c test result reported over the upper normal limit of the A_1c assay range (5.5%) should be explained by a physician. Target A_1c goals should be set by a physician and/or health care professional.

Elevated and sustained levels of A_1c levels as small as .5% over the upper normal range can represent a potential threat to future health. A_1c levels should be maintained as close to normal levels as possible in accordance with physician directed targets. "Routine measuring of A_1c in individuals diagnosed with diabetes is a critical component of any diabetes management program," said Arthur G. Williams, Chief Scientific Officer and President of Diabetes Technologies, Inc.. Williams also stated that; "Everyone with diabetes should know their A_1c. The AccuBase A_1c^™ Test Kit can help improve the quality of life for millions of individuals with or suspected of having any form of diabetes when used as part of a comprehensive assessment and/or treatment plan. This is a simple, highly accurate and affordable test that can help prevent blindness, strokes, heart, kidney disease, and other diabetes complications."

The AccuBase A_1c^™ Test Kit was developed and cleared for OTC marketing through the FDA by Diabetes Technologies, Inc., a closely held, innovative bio-technology company located in Thomasville, Georgia, dedicated to developing technology to improve diabetes care. The company is developing unique products in several areas of diabetes care including alternate site sample collection technology, glycated protein analysis, Interactive Data Management Systems Independent Verification Systems for self-management, patient and professional education materials.

According to recent scientific papers (Diabetes Care February 2000), any A_1c test used for diabetes screening should have a coefficient of variation (CV) of less than 2.0 SD. The AccuBase A_1c^™ Test Kit is the only test kit that meets this criteria.

This exceptional level of accuracy of the DTI kit makes it ideal for screening for elevated mean blood glucose, often represented by impaired glucose tolerance. The clinical utility of the A_1c test was documented in the landmark, 8 year, Diabetes Control and Complications Trial (DCCT). The NGSP certification ensures its traceability to the DCCT data.

The DCCT demonstrated that "tight control matters." The trial established a direct relationship between A_1c levels and specific types of complications such as eye, kidney and nerve disease. The DCCT also documented that by lowering A_1c levels, complications could be reduced by as much as 76%. It is currently estimated that Medicare spends approximately 27% of all health care dollars on diabetes associated complications. Diabetes affects over 16 million Americans, and is the number one cause of blindness, non-traumatic lower limb amputations, kidney disease, stroke, and cardiovascular disease. The incidence of Type 2 diabetes in children is now considered an epidemic (especially in ethnic minorities).

Routine monitoring of A_1c in individuals diagnosed with diabetes can help improve patient compliance and clinical outcomes while reducing the associated economic costs and burden to the patient and health care delivery system. Currently, less than 25% of physicians routinely order the A_1c test for their patients with diabetes. The same technology used in the AccuBase A_1c^™ Test Kit also has the capability of detecting Sickle Cell Anemia, a disturbed erythrocyte kinetics blood condition.

The AccuBase A_1c^™ Test Kit is designed to reflect a highly accurate history of the mean blood glucose levels over the past 60-90 days. This insight provides a meaningful dialogue between the physician and the patient regarding their diabetes management and/or diabetes at-risk assessment. When monitored on a routine basis in individuals with diabetes, the A_1c test can provide a timely assessment of the effectiveness of current diabetes therapy. In addition, the A_1c test provides an early indicator of the need to modify or change current diabetes therapy.

Monitoring and recording daily blood glucose levels is considered very important for anyone with diabetes. Monitoring and recording daily blood glucose values helps establish a direct cause and effect between food, exercise, diet, and medication and other variables. The A_1c test provides a two-three month average of blood glucose levels for the same period, providing the health care team with an overview of individual diabetes control.

Any elevation in A_1c levels in non-diabetic individuals indicate the need for further clinical and diagnostic evaluation by a physician including but not limited to additional diagnostic tests, individual history and physical examinations.

The American Diabetes Association (ADA) recommends that individuals with diabetes have their A_1c tested at least every 120 days, more often if directed by a physician. Clinical studies have demonstrated that maintaining A_1c levels as close to the upper normal range as possible, significantly reduced or prevented the incidence of diabetes related complications. "Williams says, because of the highly accurate HPLC analytical method (< 2.0% CV’s) used to measure the DTI test, A_1c can be used to assess mean blood glucose in non-diagnosed individuals". Those with slight to highly elevated A_1c levels can be identified for determination of cause and appropriate levels of intervention such as; diet, exercise, dietary supplements, oral medications and/or insulin can be implemented. Early diagnosis of IGT and/or Diabetes can prevent acute and/or chronic complications that could otherwise cause significant health risks and a diminished quality of lie.

The AccuBase A_1c^™ Test Kit includes all necessary supplies to collect and mail-in an individual A_1c sample to a designated testing laboratory for analysis and test results reporting. The test results can be reported to the patient within five -seven days (interpretation of A_1c test results should be done by a physician and/or health care professional). Individuals interested in evaluating their mean blood glucose can contact DTI to order a test kit. Individuals with diabetes can enroll in an automatic shipment of A_1c kits in accordance with recommended testing frequency. The AccuBase A_1c^™ Test Kit has a 2-year shelf life and samples are stable for up to 30 days un-refrigerated once collected.. DTI maintains a toll-free technical support line to answer questions on the test procedure and/or diabetes in general.

AccuBase A_1c^™ Test Kit is a convenient and inexpensive test that has proven highly accurate and reliable since its release by the FDA (prescription use only) in 1998. With the recent FDA approval (January, 2002) as an OTC test kit, millions of individuals considered at-risk for developing diabetes and/or those diagnosed with diabetes can obtain the test kit with out the need for a prescription. Individuals diagnosed with diabetes should consult their physician before making any changes to their treatment plan. Williams says, "with the availability of this highly accurate and reliable test for the physicians office and home use, we hope to provide a new tool to help prevent and/or reduce the incidence of complications typically associated with sub-optimal diabetes control".