Diabetes Self-Management Blog

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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Comments
  1. Very interesting. Techinology just keep moving right along. I don’t think I would qualify for this new machine. I’m sure it would be very helpful for people that would qualify for it. Keep up the good work.

    Posted by Tullah Smith |
  2. With the replacement of their CEO, I think Dexcom may see some improvement in their performance. We’re all waiting for the full details on June 23rd at the ADA conference.

    I can’t wait to get my hands on this and see just how many of the shortcomings they’ve actually fixed!

    http://blog.bernardfarrell.com

    Posted by BernardFarrell |
  3. I believe it would be useful to see a plot of a NORMAL person’s blood glucose over a day or two, with annotations indicating activities like eating, exercising, sleeping, etc.

    This could provide us all with something to aim for.

    Posted by charles king |
  4. My husband has to check his BS at least 8 times a day and a continuos monitoring device would be a God send. Please tell me how and where these devices are evailable.

    Posted by stinker |
  5. Hi stinker,

    To learn more about the manufacturers of continuous glucose monitors and how you can contact them, check out “Devices on the Market.”

    Posted by Tara Dairman, Web Editor |
  6. I am living in india,no.of people are type-1 diabetic and they need such device as early as possible. Please contact early when this product launched in market.Great thankful for your great news.

    Posted by virbhadra swami |
  7. Medicare is still slow about approving pumps for all insulin users.

    Posted by Buzzbird |
  8. im am glad to learn about STS-7 System. but the information is incomplete without kowing the cost of the disposable sensor

    Posted by sanjay khatri |
  9. Disposable sensors are expensive.
    The sensor transmitter can be held in place using a piece of waterproof surgical tape. Be sure to use an alchohol swab before plaing the tape over the sensor and skin for fout or five days or the skin will smell like old sneakers after you remove the tape. I can swim and shower with this surgical tape covering the sensor site and surrounding skin

    Posted by Tony |
  10. This unit sounds Great but at a cost of $800 and I read that some part of the meter (or all) only last 7 days isn’t this going to be very expensive? Also how much will your Health Ins. pick up? And lastly since this item is New and lets say your Health Ins. covers it when will this take effect by your Health Ins. carrier?

    Posted by Rosie |

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