Dexcom

Dexcom, Inc.

Type	Public (NASDAQ: DXCM)
Founded	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:

• According to a self-study by the manufacturer: excellent accuracy, especially in the "hypo-zone" and during rapid rates of glucose change^[12][13]
• 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour period trend graphs on the receiver^[14]
• Trend arrows to show where glucose is heading^[15]
• Alerts & alarms to notify the user when glucose goes either above or below a user defined level^[16]
• Water-resistant sensor & transmitter pod (The receiver is not water-resistant)^[17]
• Rechargeable^[18]

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

• links and shares glucose data, readout every 5 minutes, with cellphones via Bluetooth using a "free" display app, as of 04/18/2015 only available on Apple iPhones (4S & later; Android app pending), along with
• sharing this same data with up to 5 others, of the user's choice, via cell phone.

Like previous versions,

• each sensor element is rated for use of 7 days (some users achieving longer times)
• transmitter and display re-usable with many subsequent sensors (transmitter has an internal non-rechargeable battery that last 1 year)
• using a calibration check about every 12 hours serving as the calibration reference
• for a graph of glucose readings every 5 minutes, 288 readings/24 hours,

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

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.