BBI Contributing Editor

NEW ORLEANS, Louisiana A recurrent theme at the 63rd annual scientific sessions of the American Diabetes Association (ADA; Alexandria, Virginia), held here in mid-June, was the association of obesity with diabetes. Nearly two-third of Americans 64% are overweight or obese and are growing heavier every year. Being overweight or obese is a leading risk factor for developing Type 2 diabetes. An estimated 90% of all newly diagnosed Type 2 diabetics are overweight. The ADA has initiated an education program, "Weight Loss Matters," which seeks to help millions at risk of diabetes and those who have diabetes to lose weight.

Diet and exercise are being promoted by the ADA as a means for reducing risk of cardiovascular disease among the pre-diabetic population. Analysis of data from the Diabetes Prevention Program showed that diet and exercise can be more effective than pharmacologic therapy at warding off cardiovascular disease in patients with impaired glucose tolerance. Individuals that lost 10 to 15 pounds and exercised just 30 minutes a day five times a week reduced their risk of developing diabetes by almost 60%.

Diabetes is the fifth-leading cause of death in the U.S. and the leading cause of end-stage renal disease. According to the Centers for Disease Control and Prevention (Atlanta, Georgia), the incidence of diabetes has jumped nearly 50% in the past 10 years. There are presently 16 million Type 2 diabetics and 16 million pre-diabetics. Two out of every three people entering a hospital with a heart attack are diabetic or pre-diabetic.

Roche Pharmaceuticals (Nutley, New Jersey) presented clinical trial data which showed that use of its prescription weight loss medication, Xenical (orlistat), in combination with changes in lifestyle habits resulted in reducing the incidence of Type 2 diabetes in obese patients at greater risk of developing diabetes - those with impaired glucose tolerance or metabolic syndrome (a clustering of cardiovascular risk factors). Abbott Laboratories (North Chicago, Illinois) featured its prescription drug for treating obesity, Meridia (sibutramine HCL monohydrate). Abbott also promoted its Glucerna shakes and bars, which have been clinically shown to lower postprandial glycemic response and to be effective in a weight-loss program.

McNeil Nutritionals (Fort Washington, Pennsylvania), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey), markets Splenda (chlorinated sucrose), a non-nutritive sweetener that is stable at elevated temperatures. It appeared as an ingredient in many of the low-calorie food products and drinks on display by several exhibitors.

Nutrition 21 (Purchase, New York) presented data from clinical trials conducted at the University of Vermont Medical School (Burlington, Vermont). Diachrome, which contains chromium picolinate and biotin nutritional supplements, was shown to have a beneficial effect on intracellular metabolic functions that enhance blood sugar control. Zenergen, a combination of chromium picolinate and linoleic acid, was shown to increase muscle glycogen levels which is a measure of the body's ability to process stored glucose. Nutrition 21 presented papers last April on the diverse health benefits of chromium at a conference sponsored by the Council for the Advancement of Diabetes Research and Education (New York).

Innovations abound in pumps, monitors

Technological advances continue to be made by marketers of insulin pumps such as downloading data from the glucose monitor, integrating information from the pump and glucose monitor into a personal digital assistant (PDA) and control via a wireless connection.

Deltec (St. Paul Minnesota), a subsidiary of Smiths Medical (London), displayed its CozMore Insulin Technology System, an all-in-one system that combines Deltec's Cozmo insulin pump with the FreeStyle blood glucose monitor from TheraSense (Alameda, California). Blood glucose data is automatically sent from the attached CoZmonitor blood glucose monitoring system to the Cozmo insulin pump, thereby enabling more accurate regulation of insulin usage. Patients will no longer need to manually enter blood glucose data and make their own insulin calculations. Deltec has submitted a 510(k) application to the FDA for its CozMore system and expects to introduce it in 1Q04.

Nipro Diabetes Systems (Miami, Florida), developer of the Amigo insulin pump, has world headquarters in Osaka, Japan. The pump uses an icon-driven program. It has market clearance from the FDA, and its U.S. launch was scheduled for last month and in early 2004 in Europe. Negotiations with potential distributors are under way.

Animas (Frazer, Pennsylvania), marketer of the IR 1000 insulin pump, just received from the FDA market clearance for its ezManager Plus that integrates data downloaded from a glucose meter and an insulin pump with a personal digital assistant for better management of diabetes and for more effective communication with the user's healthcare team. Introduction of this improved software program is planned for this month.

Medtronic Minimed (Northridge, California), the leading marketer of insulin pumps, presented its strategy for its Paradigm pump Pathway Program which allows for product upgrades as advances are made in its platform technology over the next four to five years. This approach is intended to overcome the situation wherein shortly after purchasing a pump, a new model is introduced. The Paradigm 512 pump will be introduced at the end of this summer. It links the pump to the BD Logic blood glucose monitor from BD Consumer Healthcare (Franklin Lakes, New Jersey). This "intelligent" wireless pump-monitor system recently received market clearance from the FDA. It takes the guesswork out of insulin dosing by displaying the recommended insulin dose needed by the patient.

Medtronic Minimed launched the CGMS System Gold, its most advanced subcutaneous continuous glucose monitoring system, which allows healthcare providers to view a continuous pattern of blood glucose activity retrospectively. This system is for use by physicians and a consumer model is expected to be available by the end of this year. Dr. Eric Renard from Montpelier University (Montpelier, France) presented clinical data that supported the safety and accuracy of using a venous sensor connected to an implanted insulin pump for long-term blood glucose monitoring in a closed-loop system in Type 1 diabetic patients.

DANA Diabecare USA (Metairie, Louisiana), the U.S. distributor for Sooil Development Co. (Seoul, Korea), markets the DANA Diabecare II insulin pump which is claimed to be the smallest and lightest insulin pump. It also is claimed to be less costly, $4,600 vs. $6,000 for competing pumps, and is reimbursed by Medicare. The company is waiting for FDA clearance to market a remote control feature for the pump.

A recent survey conducted by Worthlin Worldwide (New York) showed that 98% of patients believe that self-monitoring helps keep their diabetes under control, yet one-half of the patients don't monitor their glucose levels as frequently as they should. The principal reasons for not monitoring are that the process is too cumbersome, inconvenient or requires too much effort. Self-monitoring was seen as having a greater impact on health than regular visits to a healthcare provider.

A need for differentiation

The market for blood glucose monitors is becoming more crowded with new entrants. Innovations in this product category are mainly directed at improving the patient's management of diabetes, although enhancements are still being made in ease of use and pain reduction.

BD (Franklin Lakes, New Jersey), a leading supplier of syringes and lancets used by diabetics, is a new entrant into the glucose monitoring marketplace. The BD Consumer Healthcare division introduced the BD Logic blood glucose monitor that displays results in five seconds from a 0.3 microliter blood specimen and records insulin doses as well as blood glucose test results. The meter data can be downloaded into the BD Diabetes Software. Also featured were the BD Latitude Diabetes Management System that features a built-in pen and needle storage. It links with the BD Diabetes Software and the BD lancet device with six adjustable-depth settings. Nova Biomedical (Waltham, Massachusetts) is the contract manufacturer of the BD Logic blood glucose monitor.

TheraSense featured its FreeStyle Flash, which it plans to launch by the end of this year. It claims to be the smallest blood glucose monitor and incorporates a backlit panel for testing under dark conditions and four customized daily alarms to remind the user to take a measurement. Test data can be downloaded to FreeStyle's personal computer and Internet-based data management system. TheraSense disclosed in two posters at the ADA meeting preliminary clinical results of its development of a continuous glucose monitor. The monitor consists of a subcutaneous sensor using wired enzyme technology and is wirelessly coupled to a hand-held display/alarm.

Bayer Diagnostics (Tarrytown, New York) launched the Ascensia Breeze blood glucose meter and highlighted its simple design, which includes single-function buttons and automatic calibration for ease of use. The meter uses the 10-test Ascensia Autodisc, eliminating the need to handle individual strips and can be used for alternate-site testing.

Lifescan (Milipitas, California), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey), featured its recently launched OneTouch UltraSmart combination meter and electronic logbook for improved patient management of diabetes. The company's OneTouch Ultra is claimed to be the leading blood glucose meter recommended by diabetologists, endocrinologists and diabetes educators.

Allmedicus, a South Korean supplier of the GlucoDr blood glucose meter, markets its product in many foreign countries and is seeking a partner in the U.S. to assist in obtaining market clearance from the FDA and to distribute the meter. The company is developing additional diagnostic applications for the meter, including the measurement of A1C and cholesterol. A1C is a measure of the body's average glucose metabolism over the past two to three months and is the preferred standard for assessing a diabetes patient's overall glycemic control. The ADA recommends that diabetic patients get an A1C test two to four times a year.

Metrika (Sunnyvale, California) exhibited its A1cNow diabetes test, the only single-use, quantitative test available for both professional and consumer use to measure glycated hemoglobin (HBA1c or A1C).

Roche Diagnostics (Indianapolis, Indiana) introduced the Diabetes Assistant Program, which creates colorful graphs showing trends of blood glucose results that were downloaded from an Accu-Chek blood glucose meter. By transmitting these results through the Internet, physicians can make needed adjustments in the patient's management plan. The Diabetes Assistant Program allows for data to be transmitted from the Accu-Chek meter directly to a PDA (a Palm-based system) or to a personal computer. Roche has broadened its line of products for diabetics with its recent acquisition of Disetronic Medical Systems (Burgdorf, Switzerland), but the FDA recently issued an embargo on importation of new Disetronic insulin pumps into the U.S. because of problems with documentation of the manufacturing processes.

The pain and inconvenience of lancing to obtain a blood specimen for measuring glucose has led to many research programs aimed at developing a non-invasive glucose measurement. To date, the only commercial product that approaches this objective is the GlucoWatch from Cygnus (Redwood City, California), which uses an electric signal to remove a specimen of interstitial fluid through the skin for making measurements. The second-generation GlucoWatch G2 Biographer was the subject of several posters at the ADA meeting. It measures and automatically displays glucose levels up to every 10 minutes and creates an electronic diary, storing 8,500 glucose values that can be reviewed at the touch of a button or uploaded into the GlucoWatch Analyzer software program.

LifeTrac Systems (Biddeford, Maine) anticipates receipt from the FDA by year's end of authorization to market its patented SugarTrac noninvasive glucose monitor. It is a hand-held, battery-operated device that uses near-infrared to measure blood glucose content through the ear lobe. The product requires an initial calibration with a fingerstick reading of blood glucose. Calibrations are repeated on a monthly basis. The meter's sales price is targeted for $250, with an additional $20 for the ear clip, which can be used for 150 readings. The company plans to obtain FDA market clearance for the SugarTrac monitor via a 510(k) submission on the basis that the product is adjunctive to a fingerstick measurement. The SugarTrac monitor has been clinically tested by Ronald Arky, MD, at Brigham & Women's Hospital (Boston, Massachusetts). LifeTrac Systems is negotiating with potential distributors.

Glucon Medical (Petach-Tikva, Israel) reported on its development of a continuous non-invasive venous blood glucose monitor. The system employs a photoacoustic effect using ultrasonic waves created by absorption of light. The ultrasonic waves are generated by illuminating tissue with laser pulses at selected wavelengths that are specific to glucose. The company's desktop prototype is undergoing clinical trials. Glucon Medical said it intends to complete the development of its desktop device by the end of 2003 and to submit for FDA approval by mid-2004.

Pelikan Technologies (Palo Alto, California) has developed and has market clearance from the FDA for the Pelikan Sun electronic lancing device. It contains a cartridge that holds 50 lancets and allows a patient to do the entire lancing process with the push of a button. The product is currently in the advanced prototype stage. The company plans to further miniaturize the device prior to its launch during the first half of 2004. A key feature of the device is its ability to repeatedly attain a designated depth. There are 30 different depth settings that will be determined by the degree of callus, hydration and thickness of the stratum corneum. A second-generation product is planned that will incorporate a glucose meter. Pelikan is in discussion with potential marketing partners.