Dexcom

Dexcom, Inc.

Type	Public (NASDAQ: DXCM)
Founded	1999
Headquarters	San Diego, California, USA
Key people	Terrance H. Gregg, President & CEO
Products	Medical devices
Website	http://www.dexcom.com

DexCom, Inc. (NASDAQ: DXCM) develops, manufactures and distributes continuous glucose monitoring systems for diabetes management. It operates internationally with headquarters in 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 Lifescinces 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.

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.^[9] 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^[10][11] However, one peer reviewed study on the Dexcom STS showed that out of 168 hypoglycemic alarms, only 14 were actually in the hypoglycemic range. Out of 30 real hypoglycemic events, the Dexcom STS detected half.^[12]
• 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour period trend graphs on the receiver^[13]
• Trend arrows to show where glucose is heading^[14]
• Alerts & alarms to notify the user when glucose goes either above or below a user defined level^[15]
• Water-resistant sensor & transmitter pod (The receiver is not water-resistant)^[16]
• Rechargeable^[17]

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.^[18]

Notes

1. ^ http://www.dexcom.com/about_dexcom
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. ^ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p050012
4. ^ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p050012s001
5. ^ http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=285480
6. ^ http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=286182
7. ^ http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=346852
8. ^ http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm128040.htm
9. ^ http://www.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.
10. ^ http://www.clinicaltrials.gov/ct2/show/NCT00722241?term=NCT00722241&rank=1
11. ^ http://www.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.
12. ^ . PMC 2769942. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2769942. 
13. ^ http://www.dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 5.1 Glucose Readings, p. 69 - 70.
14. ^ http://www.dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 5.2 Glucose Trends, p. 71.
15. ^ http://www.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.
16. ^ http://www.dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 10.2 Product Specifications, p. 123.
17. ^ http://www.dexcom.com/sites/all/themes/dexcom/node-files/SEVEN_Plus_Users_Guide.pdf, SEVEN PLUS Users Guide, 10.2 Product Specifications, p. 127.
18. ^ http://www.dexcom.com/sites/all/themes/dexcom/node-files/DM3_Help_File.pdf, Data Manager 3 Help File