Dexcom

Dexcom, Inc.
Public
Traded as NASDAQ: DXCM
Founded 1999 (1999)
Headquarters San Diego, California, USA
Key people
Kevin Sayer, CEO & President
Products Medical devices
Website http://Dexcom.com

Dexcom, Inc. is a company that develops, manufactures and distributes continuous glucose monitoring systems for diabetes management. It operates internationally with headquarters in San Diego, California, United States.

History

DexCom's roots stem from 1967 research on implanted glucose sensors at the University of Wisconsin, and started with a focus on creating an implantable sensor that the body would not reject and that would perform for a long period of time.[1] With over 40 patents,[2] Dexcom’s Sensor technology is based on this research.

Dexcom's history includes multiple generations of sensor technology coupled with partner development agreements. In 2006, Dexcom received U.S. Food and Drug Administration (FDA) approval and launched the Dexcom STS Continuous Glucose Monitoring System.[3] This was a three-day sensor that provided up to 288 glucose measurements every 24 hours. Dexcom received approval of the second generation product, the Seven Continuous Glucose Monitoring System in May, 2007. This device improved on accuracy as well as extending usage from three to seven days of continuous wear.[4] In 2008, Dexcom announced two consumer development agreements with Insulet Corporation[5] and Animas Corporation[6] as well as a development agreement with Edwards Lifesciences for a continuous glucose monitor in the intensive care unit hospital environment.[7] During February 2009, Dexcom received approval for the SEVEN PLUS Continuous Glucose Monitor, the third generation Dexcom continuous glucose monitoring system from the FDA.[8] This product received a CE mark in November 2009. In 2013, development to integrate with Insulet broke up. [9] Dexcom entered a non-exclusive agreement with Tandem Diabetes Care, Inc. in 2015 to allow the integration of next generation G5 and G6 continuous glucose monitoring systems into Tandem's insulin pumps.[10]

Dexcom Seven Plus Continuous Glucose Monitor

The Dexcom Seven Plus is Dexcom's third generation continuous glucose monitor. It can show a new glucose reading every 5 minutes for up to seven days of uninterrupted wear-time to show where glucose levels are, where they have been and where they are going.[11] The system is made up of three technologies: the sensor, transmitter, and receiver. The sensor is a flexible round wire that goes just under the skin to read glucose levels, and attaches to the skin with an adhesive patch. The transmitter snaps into the sensor; it wirelessly sends glucose information to the Receiver every 5 minutes. The receiver displays glucose levels and trends. It is about the size and weight of a cell phone.

The system features include:

While the receiver holds up to 30 days of data, the Dexcom Data Manager 3 (DM3) software allows data downloads from the Dexcom CGM systems to a computer. This provides users the ability to track their trends and progress over time. DM3 works with all versions of SEVEN Receivers. With the SEVEN PLUS, meal, insulin, health, and activity information entered can be reviewed later with the DM3 software. A1c values can also be entered in the software for tracking and viewing improvements.[19]

G4 Platinum Continuous Glucose Monitoring System with Share

On Jan 26, 2015, the FDA approved[20] this latest DEXCOM continuous glucose monitoring system which also

Like previous versions,

which are all displayed on both the DEXCOM monitor & linked cell phones.

G5 Constant glucose monitoring system with share and follow

Notes

  1. Česká Republika. "Continuous Glucose Monitoring Company - Learn More About". Dexcom. Retrieved 2015-12-03.
  2. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=DexCom,+Inc&FIELD1=ASNM&co1=AND&TERM2=&FIELD2=&d=PTXT
  3. "DexCom™ STS™ Continuous Glucose Monitoring System - P050012". Accessdata.fda.gov. Retrieved 2015-12-03.
  4. "STS-7 Continuous Glucose Monitoring System - P050012/S001". Accessdata.fda.gov. Retrieved 2015-12-03.
  5. "Insulet Corporation and DexCom Announce Development Agreement (NASDAQ:DXCM)". Investor.shareholder.com. Retrieved 2015-12-03.
  6. "DexCom™ Announces Joint Development Agreement with Animas Corporation". Investor.shareholder.com. 2008-06-10. Retrieved 2016-04-04.
  7. "Edwards Lifesciences and DexCom to Develop Continuous Glucose Monitoring Products for Hospital Market (NASDAQ:DXCM)". Investor.shareholder.com. Retrieved 2015-12-03.
  8. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm128040.htm
  9. "Insulet & Dexcom Break Up Over OmniPod Next Gen Plans". Diabetesmine.com. 2013-02-05. Retrieved 2015-12-03.
  10. "Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future... - SAN DIEGO, July 30, 2015 /PRNewswire/". Prnewswire.com. Retrieved 2015-12-03.
  11. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 10.1 Device Performance Characteristics: Number of Readings Provided, p. 119.
  12. "Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System - Full Text View". ClinicalTrials.gov. Retrieved 2015-12-03.
  13. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 10.1 Device Performance Characteristics, p. 109 - 121.
  14. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 5.1 Glucose Readings, p. 69 - 70.
  15. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 5.2 Glucose Trends, p. 71.
  16. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 5.3 Glucose Alerts and Alarm, p. 73.
  17. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 10.2 Product Specifications, p. 123.
  18. http://Dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 10.2 Product Specifications, p. 127.
  19. http://Dexcom.com/sites/all/themes/dexcom/node-files/DM3_Help_File.pdf, Data Manager 3 Help File
  20. Česká Republika (2015-01-26). "FDA Approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share". Dexcom. Retrieved 2015-12-03.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.