
March 13, 2004
Blood Tests and Insulin Injections, Research: Monitoring
Question from Pennsylvania, USA:
I read recently that TheraSense has a noninvasive blood glucose meter and is waiting for FDA approval in order to market it. Have you heard anything about when this product might be available? Will it eliminate the need for finger sticks? Are there any other companies that are close to marketing something that will give blood sugars in real time? I’ve given up on closed-looped pumps but I would love for my daughter not to have to worry about being low when I am not around.
Answer:
At the Diabetes Technology Meeting in November 2003, Ben Feldman, Ph.D., from TheraSense presented a session entitled “The FreeStyle Navigator Continuous Glucose Monitor: Complete Results from a Home-Use Trial.” The Navigator required slightly more than a one hour warm up period, with finger stick calibrations at one, three, and 24 hours. No additional calibration was needed for the rest of the 72-hour period during which the Navigator can be worn. The Navigator consists of a sensor component, worn on the arm (for example), and a receiver/display unit that is worn on the belt (or carried in a purse). The display unit shows current blood glucose reading, as well as a trend arrow. Low and high alarms are user configurable.
TheraSense has submitted the FreeStyle Navigator to the FDA for approval.
There are many other companies working on continuous glucose sensors, though none have products currently before the FDA for immediate marketing approval.
JSH