DexCom’s real time continuous sensor burst on the scene in March. Everyone, including CEO Andy Rasdal, seemed pleasantly surprised by the Food and Drug Administration’s quick approval exactly one year after their request. I too was surprised, even though I had bought some stock in the company before the FDA acted.
Still, DexCom, a small company in San Diego, responded to the FDA’s go-ahead with incredible speed. The company began shipping the first sensors to people with diabetes within a week of approval.
This is the DexCom STS, which stands for short-term sensor that the FDA approved for 72 hours of usage. Many users, however are already using it longer, saving them money at the expense of accuracy. DexCom is asking the FDA to approve its seven-day sensor.
Adults, but not children, at home or in health care facilities can use the DexCom STS to detect trends and to track patterns. Approval is for the STS to complement — not replace — episodic (regular) blood glucose meters, which calibrate the STS and confirm blood glucose readings that are especially low or high. Buying an STS requires a prescription from a doctor at a site where DexCom has trained health care professionals in its use.
Two of the first people to jump on the DexCom bandwagon are Aaron Kowalski, director of strategic research projects for the Juvenile Diabetes Research Foundation, and his brother Stephen. Aaron, 34, and his brother, 31, have each had type 1 diabetes since they were 3.
“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 telling 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 1, 3, and 9-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.” What a pleasant surprise to have all this information.
Sidebar: What it Costs
For some people the problem with the DexCom STS will be its cost. “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. He was formerly an official of Cygnus, which developed the GlucoWatch, the first real time continuous sensor.
The STS starter kit, which includes a receiver, a transmitter, two sensors and applicators, a carry 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 us for the STS or its sensors yet.
This article originally appeared in Diabetes Health, September 2006, p. 48.
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 The New Glucose Revolution: What Makes My Blood Glucose Go Up...And Down? (New York: Marlowe & Co., July 2006, and other publishers in the U.K., Australia, and Taiwan).
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