Jun 15, 2007

Seven-Day Continuous Glucose Monitor Approved

Tara Dairman

The U.S. Food and Drug Administration (FDA) has approved a continuous glucose monitoring system that measures a person's glucose levels for seven consecutive days with a single sensor. The other continuous glucose monitoring devices currently on the market are approved for no more than three consecutive days of use with a single sensor.

The newly approved STS-7 Continuous Glucose Monitoring System (also known as SEVEN) is manufactured by DexCom, Inc., of San Diego, California. DexCom's three-day device, the STS Continuous Glucose Monitoring System, was approved by the FDA in March 2006. Like the three-day model, the "second generation" STS-7 System consists of a pager-size receiver and a disposable sensor that is inserted under the skin of the abdomen, where it measures glucose levels in the body's interstitial fluid (fluid that surrounds the body's cells). Updated data about the body's glucose levels are transmitted from the sensor to the receiver every five minutes. This information allows a person to track patterns in his glucose levels over the course of a week.

In a webcast announcing the product's launch, DexCom's CEO said that the STS-7 System will feature improvements in design over the original three-day system: The new sensor will be waterproof, eliminating the need for a shower patch, and will feature a smaller needle for more comfortable insertion.

FDA approval for the STS-7 System was based on a study published in the journal Diabetes Care in December 2006, which showed that the device functioned well and helped users improve their blood glucose control.

The FDA's press release on June 4 stated that the STS-7 system is approved for people age 18 and older and that it is meant to supplement, not replace, traditional fingerstick blood glucose monitoring. While a continuous glucose monitor can help people see trends in their glucose levels and, with the help of built-in alarms, alert them to dangerously high or low glucose levels, fingerstick blood glucose checks must still be used to confirm blood glucose levels before making treatment decisions, such as calculating insulin doses.

DexCom also received approval from the FDA for new computer software, called the DM2 Data Manager, that analyzes data from the continuous glucose monitor. According to the company, this new generation of software will feature improved tools and analytical capabilities over its current DM Consumer Data Manager software.

DexCom plans to begin to roll out the STS-7 System and the DM2 Data Manager together in early July, with a larger launch to follow later in the year. The STS-7 System is expected to cost around $800, with additional costs for the disposable sensors.

In other continuous glucose monitoring news, Abbott Diabetes Care announced on June 6 that it had won approval in Europe for its FreeStyle Navigator Continuous Glucose Monitoring System. This system, which is currently being considered by the FDA for approval in the United States, measures glucose levels once every minute and features a sensor that can be worn continuously for five days.

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