By Nicholas Borgert

Diabetes, for the most part, is a disease of the overweight and the aging, two of the fastest growing populations in the United States. Naturally, glucose testing is among the fastest growing segments of the IVD market.

Point-of-care (POC) glucose (diabetes) testing represents a substantial share of that segment. Performed in healthcare settings — hospitals or physician’s offices — or personally by diabetics, POC glucose testing delivers near instant results.

The 2000 Merrill Lynch market analysis places the worldwide POC glucose monitoring market at $4.1 billion and the U.S. market at $2.5 billion. Of the estimated 16 million Americans with diabetes, nearly one-third remain undiagnosed. One American Diabetes Association report put the direct and indirect cost of diabetes in the United States at close to $100 billion. In 1997, about 8 percent of U.S. healthcare dollars went toward treating diabetes, according to an ADA study. The same study found that the direct cost of medical care for an individual diabetic in 1997 was $10,071, compared to $2,669 for a non-diabetic.

Worldwide POC Glucose Monitoring Market Share (est.) Worldwide Glucose Monitoring Sales (est.)
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Roche Diagnostics
    $1.065 Billion
    $975 Million
Bayer Diagnostics
    $675 Million
    $495 Million

Market drivers
The POC glucose market is driven by the need for reduced sample size, less invasive methods that eliminate frequent, painful fingersticks and a growing interest in hemoglobin A1c (HbA1c) testing. The ADA recommends that diabetics have an HbA1c test at least twice a year, but studies show most do not comply.

An aging population, better diagnostic tools and more people predisposed to diabetes, are a few of the reasons Roche officials expect the U.S. glucose market to grow 7 to 8 percent annually over the next few years.

According to Tom Prigmore, Roche Diagnostic’s product manager for Hospital Systems, self-blood glucose monitoring (SBGM) represents 10 to 20 percent of the total U.S. IVD market. He pegs the total U.S. HbA1C market at about $77 million.

Of the total glucose strip market, Prigmore said, the hospital POC glucose strip testing represents 12 to 15 percent. “Hospital POC glucose analyzers essentially share the same strip technology as the consumer meters,” he said. “The primary difference is that hospital POC analyzers have much more sophisticated data management capabilities to meet regulatory requirements.”

The $77 million (POC and in-lab) HbA1c market is growing at about 10 to 12 percent annually due to HEDIS initiatives that went into effect in 2000, expanded physician awareness and growth of the diabetic population. Of that estimated $77 million, about 20 to 30 percent is represented by POC HbA1c testing. Roche offers HbA1c testing on its chemistry analyzers but not in a point-of-care platform. Reagent cost for a glucose test on a chemistry analyzer averages about 20 cents, about half the cost of a point-of-care test, Prigmore said.

photoRoche’s Accu-Chek Advantage

Roche currently offers four POC glucose analyzers — the Accu-Chek Advantage, Accu-Chek Complete, Accu-Chek Simplicity and Accu-Chek Voicemate — for patient use but none that are designed for healthcare professionals.

The Accu-Chek Advantage provides results in 40 seconds and houses a 100-value memory to store results, time and date information, which can be downloaded to a computer. A snap-in code key takes care of calibration. Accu-Chek Complete also provides results in 40 seconds, but it contains a 1,000-value memory to store results, time and date and a push-button selection displays reports in chart or graph form without a computer. Accu-Chek Simplicity provides results in 25 seconds, uses the snap-in code key for calibration and houses a 30-value memory for storing results, time and date. Accu-Chek Voicemate, which provides results in 40 seconds, uses voice prompts to help the visually impaired perform testing. It also uses the snap-in key code for calibration and has a 100-value memory storage.

In addition to the four analyzers, Roche offers diabetic patients its Accu-Chek Compass Windows-based software to help them manage and trend the course of their disease with charts and graphs. The Accu-Chek Sofclix Lancet with 11 depth settings and precise linear action helps minimize fingerstick pain.

photoLifeScan’s One Touch II

Less invasive methods
Johnson & Johnson’s LifeScan division, which is devoted to point-of-care diabetes testing, emphasizes less invasive, less painful day-to-day solutions in glucose testing for diabetes. The company does not offer HbA1C testing. Jeff Christensen, U.S. communications manager, said LifeScan’s handheld One Touch Ultra system provides a glucose result in five seconds with just one microliter of whole blood. The One Touch Ultra provides for alternate site testing, uses a capillary action strip and operates under the widest temperature range (45-111ÞF) of any glucometer. Its 150-test memory can be downloaded to a computer.

During the 2001 American Diabetes Association annual meeting, LifeScan introduced the first combined blood glucose monitor and insulin doser. The FDA-cleared InDuo System, developed in partnership with Novo Nordisk Biotech Inc. of Davis, Calif., is expected to be available this fall. The monitor/doser provides less painful, alternate-site arm testing, one microliter sampling, five-second glucose readings and insulin doses that are dialed and injected.

Connectivity challenges
In addition to patient testing concerns, LifeScan is addressing point-of-care data connectivity challenges inside the hospital with its DataLink systems. Integrating point-of-care data with an HIS or LIS remains a major hurdle. In its analysis of POC testing, a Johns Hopkins study found that more than 80 percent of 1,295 U.S. hospitals surveyed still recorded POC results manually. Only 43 percent of POC users expressed satisfaction with their data connectivity.

Bayer Diagnostics offers six glucometers for patients and healthcare professionals in addition to its Microlet and Microlet Vaculance automatic lancing devices. Both its handheld Glucometer Elite and Elite XL require just a two-microliter blood sample and no button pushing for test activation. The Glucometer Elite is Bayer’s easiest self-testing system to learn and use. It provides blood glucose monitoring with a 20-test memory. Automatic Sip-In Sampling provides fast accurate results in just 30 seconds.

The latest addition to the Elite line is the automatic Glucometer Elite XL, which combines testing with result storage and data management. A single button manages data: scrolls through up to 120 stored results and their average; sets the time and date; units of measure; and turns the beeper on or off. For data management, it can be connected to a computer through WinGlucofacts software.

WinGlucofacts Software is available for the Dex and Esprit glucometers while WinGlucofacts Software XL is available for the Glucometer Elite XL for healthcare professionals.

Alternate site testing
Abbott Diagnostic’s (Abbott Park, Ill.) Medisense division makes four glucometers, the Precision QID and the Precision Xtra for home use and the Precision PCx for hospital bedside use. In June, Medisense debuted its Sof-Tact alternate-site blood glucose monitor, which integrates all sampling and testing steps on one palm-sized device. Diabetics load a test strip and lancet inside the meter, place the device on the desired alternate skin site and press the “start” button.

In addition to the glucometers, Abbott has a marketing and distribution partnership with point-of care pioneer i-Stat Corp. of Bedford, Mass. i-Stat recently launched its i-Stat I Analyzer which uses a single platform to perform glucose strip testing along with all i-Stat test cartridges.

The Medisense Precision Link Data Management software, when used at home or under the guidance of a healthcare professional, helps manage the treatment of diabetes. Precision Link uploads test results from Precision QID, Precision Xtra and Sof-Tact to a computer and converts results into graphs, charts and reports. This information is useful in making decisions about diet, exercise and medication. The system provides a complete and accurate history of blood glucose test results.
In addition to Precision Link, the company’s Windows-based QC Manager Point-of-Care Data Management System, which is compatible with the Precision QID home meter, automatically collects, analyzes and reports QC information in a statistical format. It automatically collects data once the computer is connected to a glucose monitor. All data can be correlated with equipment, operators and patients.

Abbott projects that glucose monitoring will grow 15 to 18 percent annually, primarily in physician offices and handheld testing. For Abbott, hospital-based POC is 15 percent compared to 85 percent for home testing.

According to Medisense Worldwide Marketing spokesman Brett Fulton, the average cost of a glucose test done on a lab analyzer is about 5 cents compared to 45 cents on a POC analyzer. “However, the true cost, taking into account the cost of the analyzer, lab time report generation and more would be two-to-three times that of a POC test,” Fulton said.

Rise in patient self testing
ADA officials applaud the continuing rise in the number of patients performing their own glucose testing. “Our statistics indicate that 39.6 percent of people who have diabetes perform regular self-monitoring of blood glucose levels,” said Sherrye Landrum, ADA associate director for consumer books. “We want to see that keep going up.”

Two private companies, Amira Medical of Scotts Valley, Calif., and TheraSense of Alameda, Calif., are making inroads in alternate-site testing technology. Amira’s AtLast lancing meter system is in its second year, and the Freestyle lancing device by TheraSense requires a mere 0.3 microliter sample that gives results in 15 seconds. Freestyle allows patients to obtain blood samples from their arm or thigh rather than their fingertip. “Freestyle is especially helpful for the kids,” Landrum said.

Redwood City, Calif.-based Cygnus received FDA approval this year for adults to wear its GlucoWatch Biographer, a transdermal sensor device that non-invasively measures interstitial fluid glucose rather than blood glucose. It is currently undergoing trials on younger patients and offers great promise for needlestick-weary diabetics. According to the Journal of Family Practice and Pediatric News, as many as 33 percent of diabetics are needle phobic.

Nicholas Borgert is a Charlotte, N.C.-based freelance writer.