FDA approves Dexcom SHARE™, the first remote mobile communications device used for Continuous Glucose Monitoring (CGM)

October 21, 2014 | Reply More

Press Release

San Diego, CA, October 20, 2014 – Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE, an accessory to the Dexcom G4® PLATINUM Continuous Glucose Monitoring System, uses a secure wireless connection to transmit the glucose levels of a person with diabetes to the smartphones of up to five designated recipients, or “followers.” These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere via their Apple® iPhone® or iPod® touch. With Dexcom SHARE, parents and personal caregivers can monitor a child’s or loved one’s glucose data from a remote location, giving them peace of mind and reassurance when they are apart.

“Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar,” said Terrance H. Gregg, Chief Executive Office of Dexcom. “With Dexcom SHARE, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes.”

Dexcom SHARE enables glucose data to be securely shared with remote viewers:

  • The Dexcom SHARE consists of a small cradle device in which the Dexcom G4 PLATINUM is docked. The cradle also functions as a battery charger for the receiver and must be connected to an electrical outlet.
  • The Dexcom SHARE cradle is equipped with Bluetooth technology, enabling the device to wirelessly transmit glucose levels from the Dexcom G4 PLATINUM receiver to the Dexcom SHARE App on the patient’s Apple® iPhone® or iPod® touch.
  • The Dexcom SHARE App uploads glucose data to a secure server. Personal caregivers or parents can then remotely receive notifications about glucose levels and trends on their Apple® iPhone® or iPod® touch.

“Continuous glucose monitoring offers a unique opportunity for patients with diabetes to aim for glucose levels close to the reference range found in persons without diabetes,” said Lori Laffel, M.D., M.P.H., Chief of the Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, in Boston, MA. “The ability to share the continuous glucose data remotely, to almost any location, is a remarkable advance. This new device should help patients, families and care providers succeed with their overall efforts to improve diabetes control and prevent both short-term and long-term complications while preserving quality of life for patients with diabetes and their family members.”

Diabetes affects 25.8 million Americans and is the 7th leading cause of death in the United States.2 With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 79 million Americans over the age of 20 years old are at risk for developing diabetes, largely due to obesity, physical inactivity and poor diet.2 People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.3,4 Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years1. The traditional standard-of-care for glucose (blood sugar) monitoring has been a finger stick meter. CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and for guidance in making therapy and meal decisions. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high.

References

*Remote capabilities require internet, Bluetooth and electrical power supply connections

    1. Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci. 2012;(3)2:83-93.
    2. 2011 National Diabetes Fact Sheet. Centers for Disease Control and Prevention. http://www.cdc.gov/diabetes/pubs/factsheet11.htm. Updated October 25, 2013. Accessed December 3, 2013.
    3. Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.
    4. Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.

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