FDA Approves Remote Glucose-Monitoring Technology

On October 20, the U.S. Food and Drug Administration (FDA) approved the Dexcom SHARE, a first-of-its-type mobile communications device, for use with the Dexcom G4 Platinum continuous glucose monitoring system[1].

The Dexcom G4 Platinum is composed of a sensor, a transmitter, and a monitor. The sensor, which is approximately the diameter of a human hair, is inserted under the skin of the abdomen, where it continuously monitors the glucose level of the interstitial fluid (the fluid between cells). These values are sent to the monitor via the transmitter every five minutes for up to seven consecutive days.

The Dexcom SHARE uses a secure wireless network to transmit the glucose levels measured by the Dexcom G4 Platinum to the smartphones of up to five designated recipients, or “followers,” such as parents or other caregivers of people with diabetes. Using their iPhone or iPod touch, these followers can remotely monitor the glucose data and receive alert notifications from almost anywhere.

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The Dexcom SHARE device consists of a small Bluetooth-enabled cradle into which the Dexcom G4 Platinum is docked. (The cradle also functions as a battery charger for the receiver and must be connected to a power outlet; it can receive data from the transmitter from up to 20 feet away.) The cradle wirelessly transmits glucose data from the receiver to the Dexcom SHARE app on the user’s iPhone or iPod touch. This data is then uploaded to a secure server from which each follower can remotely receive information on the user’s glucose levels and trends on his iPhone or iPod touch.

The Dexcom SHARE, which does not[2] require a prescription and is not covered by insurance, is available now on the Dexcom website[3] for $299.

For more information, see the press release on the Dexcom[4] website or view a promotional video on the product here[5].

Endnotes:
  1. Dexcom G4 Platinum continuous glucose monitoring system: https://www.diabetesselfmanagement.com/Blog/Diane-Fennell/dexcom-g4-platinum-cgm-approved/
  2. which does not: http://www.tudiabetes.org/forum/topics/dexcom-share-approved-by-the-fda
  3. available now on the Dexcom website: http://dexcom.com/faq/dexcom-share/welcome
  4. Dexcom: http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=876992
  5. here: https://www.youtube.com/watch?v=fFBvR9UtOCU

Source URL: https://www.diabetesselfmanagement.com/blog/fda-approves-remote-glucose-monitoring-technology/


Diane Fennell: Diane Fennell has been an editor at Diabetes Self-Management magazine since 2003. She is currently the Editorial Director. (Diane Fennell is not a medical professional.)

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