DexCom’s real-time continuous sensor—the DexCom STS—burst on the scene in March 2006.
Everyone seemed pleasantly surprised by the U.S. Food and Drug Administration (FDA)’s quick approval. Just one year earlier, San Diego-based DexCom had asked the FDA to let it sell the sensor in the United States.
The FDA approved the DexCom STS for 72 hours of usage. Many people with diabetes, however, are already using it longer, saving them money at the possible expense of accuracy.
DexCom is now asking the FDA to approve its seven-day sensor.
For Adults Only
Adults, but not children, at home or in healthcare facilities can use the DexCom STS to detect trends and to track patterns. Approval is for the DexCom STS to complement—not replace—regular blood glucose meters. Buying a DexCom STS requires a Statement of Medical Necessity or a prescription from a trained Site/Clinic.
Brothers Jump on the DexCom STS Bandwagon
Two of the first people to try the DexCom STS are Aaron Kowalski, 34, director of strategic research projects for the Juvenile Diabetes Research Foundation, and his brother Stephen, 31. Both brothers have had type 1 since they were 3 years old.
“My experience has been fantastic,” Aaron told me recently. “Today, I hit eight weeks of use. After only six weeks, my A1C came down from 7.2 to 6.5, and I have no doubt that it can go even lower. The beauty of it is that it was so easy to get there.”
Aaron says that he now feels in control of his diabetes for the first time in his life. In addition to giving Aaron his glucose values every five minutes, the STS also gives him “high” and “low” alerts and a low-glucose alarm. But he especially values the trend data.
“The one-, three- and nine-hour trend information is the most powerful feature for me,” Aaron says. “With one click I can, for example, see the point-in-time number and also the last hour.”
By knowing how their blood glucose numbers are trending, Aaron and others are able to minimize their highs and lows.
Editor’s note: The author owns stock in the company that manufactures the DexCom STS.
What About the Cost?
For some diabetics, the problem with the DexCom STS will be its cost in the absence of insurance reimbursement.
“Insurance approval is even more important than FDA approval,” says Tim Cady, president of Advanced Diabetes Supply, a division of North Coast Medical Supply in San Diego, California. Cady was formerly an official of Cygnus, which developed the GlucoWatch, the first real-time continuous sensor.
The STS starter kit (including a receiver, transmitter, two sensors and applicators, carrying case for the receiver and a charger) lists for $800. Additional sensors cost $35 each. Few if any health insurance companies have said that they will reimburse users for the DexCom STS or its sensors yet. But this has to be one of DexCom’s highest priorities now.
Bayer Acquires Metrika
On July 6, 2006, it was announced that Bayer Diabetes Care acquired Metrika, Inc. Details of the purchase agreement were not disclosed.
A few years back, Metrika made headlines in the diabetes community for its A1CNow—a pager-sized device for people with diabetes to use both at home and with their healthcare provider for monitoring A1Cs.
Source: Bayer Diabetes Care