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Third-Generation Meters

By David Mendosa

Last Update: January 18, 2006

If meters that painlessly test on alternative sites are the second generation of blood glucose meters, as I wrote on the ADA website earlier, meters that will test continuously and automatically have to be the third generation.

The third generation is well underway.

Medtronic Diabetes in Northridge, California, introduced a whole new generation of glucose monitoring devices in June 1999 when the Food and Drug Administration approved its Continuous Glucose Monitoring System. The CGMS system can record a glucose measurement every five minutes for up to three days. Currently with the CGMS you can’t read directly from the device. Every three days you have to go to your doctor’s office to download the data. But if and when the FDA approves it for direct readout, the CGMS will provide quick recognition of blood sugar trends and a complete picture of control. The company has a Web page about the CGMS meter.

Cygnus in Redwood City, California introduced the second glucose monitoring device last April. The diabetes community has expressed great interest in these devices, but the GlucoWatch Biographer and its successor the GlucoWatch G2 Biographer both have serious limitations in terms of cost, ease of use, and skin irritation. But they are a tremendously important first step. You can read more at the company’s Web site.

Next on the horizon is probably TheraSense in Alameda, California. This company is one of the pioneers in alternative site meters, the second generation of blood glucose meters. The TheraSense approach is somewhat similar to that of Medtronic Diabetes. Its Continuous Glucose Monitoring Device will utilize a disposable, miniaturized electrochemical sensor that can be easily inserted under the skin by the user using a spring-loaded insertion device. The sensor is inserted across the outer skin to monitor glucose levels every five minutes, with the ability to store results for future analysis. A major difference between the CGMD and CGMS is the size of the needle. The TheraSense needle is less than 10 percent the length of Medtronic Diabetes’s. TheraSense designed its system to measure interstitial fluid. This requires a needle only long enough to cross the outer layer of skin and makes the needle essentially pain-free. One hurdle faced by the company is making the glucose readings accurate using a small sample size. TheraSense anticipates submission of a Premarket Approval Application to the Food and Drug Administration in the second quarter of 2003. Its Web site has more.

Sontra Medical Inc. in Cambridge, Massachusetts, is developing the Symphony Diabetes Management System for continuous glucose monitoring. It consists of a hand-held device called the SonoPrep, which permeates the skin, and a sensor/patch that can detect glucose levels and transmit continuous data wirelessly to a glucose meter. The company expects to start human clinical trials this quarter.

SpectRx in Norcross, Georgia, and Abbott Laboratories in Abbott Park, Illinois, have been working together to develop a continuous glucose monitor. But a few days ago SpectRx announced that it it is taking action to terminate its research, development, and license agreement with Abbott. That leaves the future of this work much in doubt. The SpectRx technology measures glucose levels in interstitial fluid. The company describes its work online.

Pendragon Medical in Zurich, Switzerland, says that it is developing a continuous sensing device, the Pendragon NI-CGMD, to provide frequent non-invasive blood glucose measurements. Pendragon's glucose sensor is based on radio wave impedance spectroscopy.

Sensors for Medicine and Science Inc. (SMSI) in Germantown, Maryland, says that “SMSI's glucose sensor will be implanted under the skin in a short outpatient procedure. The sensor is designed to automatically measure interstitial glucose every few minutes, without any user intervention. The sensor implant will communicate wirelessly with a small external reader, allowing the user to monitor glucose levels continuously or on demand....The target operational life of the sensor implant will be 6-12 months, after which it would be replaced.” The company says that pre-clinical studies are underway.

I list and link five other companies that say they are developing continous monitors on my Web site. They are Animas in Frazer, Pennsylvania, Bioject in Portland, Oregon, DexCom in San Diego, Institut für Chemo- und Biosensorik in Münster, Germany, and a joint venture between Hypoguard in Suffolk, England, and Elan Corporation in Dublin, Ireland.

Two of these devices are already here, so the third generation is well underway. When will the other devices become available for us to wear? Nobody knows. Yet is it clear that this is future direction of blood glucose testing. 


The American Diabetes Association originally published this article on its Web site as one of my “About the Internet” columns.

Update

Full disclosure: I own stock in Dexcom (ticker symbol DXCM).


    David Mendosa is a freelance journalist and consultant specializing in diabetes and lives in Boulder, Colorado. When he was diagnosed with type 2 diabetes in February 1994, he began to write entirely about that condition. His articles and columns have appeared in many of the major diabetes magazines and websites. His own website, David Mendosa’s Diabetes Directory, established in 1995, was one of the first and is now one of the largest with that focus. Every month he also publishes an online newsletter called “Diabetes Update.” Twice weekly he writes for his blog at http://blogs.healthcentral.com/diabetes/david-mendosa. He is a coauthor of What Makes My Blood Glucose Go Up...And Down? (New York: Marlowe & Co., August 2003, and second American edition coming July 10, 2006, and other publishers in the U.K., Australia, and Taiwan).


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