Dexcom

Last updated
DexCom, Inc.
Company type Public
Founded1999;25 years ago (1999)
Headquarters San Diego, California, U.S.
Key people
Kevin Sayer (chairman, president & CEO)
Products Medical devices
RevenueIncrease2.svg US$3.62 billion (2023)
Increase2.svgUS$598 million (2023)
Increase2.svgUS$542 million (2023)
Total assets Increase2.svgUS$6.26 billion (2023)
Total equity Decrease2.svgUS$2.07 billion (2023)
Number of employees
c.9,600 (2023)
Website dexcom.com
Footnotes /references
[1]

DexCom, Inc. [2] is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.

Contents

History

Dexcom was founded in 1999 by Scott Glenn, John Burd, Lauren Otsuki, Ellen Preston and Bret Megargel. [3] [4] In 2006, Dexcom received U.S. Food and Drug Administration (FDA) approval and launched the Dexcom STS Continuous Glucose Monitoring System, which is a three-day sensor that provides up to 288 glucose measurements for 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 and extended use from three to seven days. 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, its new continuous glucose monitoring system, from the FDA. This product received a CE mark in November 2009. In 2013, development work for integration with Insulet was discontinued. Dexcom entered a non-exclusive agreement with Tandem Diabetes Care, Inc. in 2015 to allow the integration of its forthcoming G5 and G6 continuous glucose monitoring systems into Tandem's insulin pumps. [8] The G5 was approved in 2016 by the FDA for use as a standalone device, while the G6 gained approval in 2018. [9]

Dexcom's first G-series CGM, the G4 Platinum, received a CE mark [10] and FDA approval in 2012 [11] for adults ages 18 and over. This device improved hypoglycemic accuracy by 30%. [11] It also offered a longer range of transmission between the sensor and receiver, as well as a color LCD. [11] The G4 Platinum was approved by the FDA for use in patients ages 2–17 in February 2014. [12] Dexcom received FDA approval in January 2015 for the G4 Platinum with Share, which enabled the sharing of CGM data with up to five other people using the "Share" and "Follow" smartphone apps. [13]

The Dexcom G5 was approved in August 2015 by the FDA for use as a standalone device, [14] the G5 has Bluetooth integrated into its transmitter, enabling it to send data to a mobile device. [15] This allows for use of the device without the standalone receiver. The Dexcom G5 received a CE mark in September 2015. [16]

The Dexcom G7 was approved in December 2022 by the FDA for use as a standalone device and is the most accurate currently approved CGM in the U.S. [17]

Partnerships

Related Research Articles

<span class="mw-page-title-main">Insulin pump</span> Medical device to administer insulin

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:

<span class="mw-page-title-main">Blood glucose monitoring</span> Use of a glucose monitor for testing the concentration of glucose in the blood

Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose, whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals, each of which informs diagnosis or monitoring in different ways.

<span class="mw-page-title-main">Glucose meter</span> Medical device for determining the concentration of glucose in the blood

A glucose meter, also referred to as a "glucometer", is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of glucose testing, including home blood glucose monitoring (HBGM) performed by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained from slightly piercing a fingertip with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dL or mmol/L.

JDRF is a nonprofit 501(c)(3) organization that funds type 1 diabetes (T1D) research, provides a broad array of community and activist services to the T1D population and actively advocates for regulation favorable to medical research and approval of new and improved treatment modalities. It was initially founded as the JDF, the Juvenile Diabetes Foundation. It later changed its name to the Juvenile Diabetes Research Foundation and is now known as JDRF.

Inhalable insulin is a powdered form of insulin, delivered with an inhaler into the lungs where it is absorbed. In general inhaled insulins have been more rapidly absorbed than subcutaneous injected insulin, with faster peak concentration in serum and more rapid metabolism.

Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.

<span class="mw-page-title-main">Insulin (medication)</span> Use of insulin protein and analogs as medical treatment

As a medication, insulin is any pharmaceutical preparation of the protein hormone insulin that is used to treat high blood glucose. Such conditions include type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulin is also used along with glucose to treat hyperkalemia. Typically it is given by injection under the skin, but some forms may also be used by injection into a vein or muscle. There are various types of insulin, suitable for various time spans. The types are often all called insulin in the broad sense, although in a more precise sense, insulin is identical to the naturally occurring molecule whereas insulin analogues have slightly different molecules that allow for modified time of action. It is on the World Health Organization's List of Essential Medicines. In 2021, it was the 179th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

<span class="mw-page-title-main">Minimed Paradigm</span> Insulin pumps

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.

Wireless health is the integration of wireless technology into traditional medicine, such as diagnosis, monitoring and treatment of illness, as well as other tools that can help individuals improve their personal health and wellbeing. Wireless health differs from mHealth in that wireless health solutions will not always be mobile and mobile health solutions will not always be wirelessly enabled. Mobile broadband connectivity is useful in reaching new patients in remote areas while improving productivity and convenience through data transmission.

<span class="mw-page-title-main">HP ZBook</span> Brand of mobile workstations

HP ZBook is a brand of mobile workstations made by HP Inc. Introduced in September 2013, it is a successor to HP's previous mobile workstations in the HP EliteBook series. The ZBook mainly competes against PCs such as Dell's Precision and Lenovo's ThinkPad P series.

<span class="mw-page-title-main">Verily</span> Life sciences research organization

Verily Life Sciences LLC, also known as Verily, is Alphabet Inc.'s research organization devoted to the study of life sciences. The organization was formerly a division of Google X, until August 10, 2015, when Sergey Brin announced that the organization would become an independent subsidiary of Alphabet Inc. with restructuring completed on October 2, 2015. On December 7, 2015, Google Life Sciences was renamed Verily.

Tandem Diabetes Care is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.

Ambulatory glucose profile (AGP) is a single-page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard, with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for the representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24-hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980s. Since then, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting.

GlySens, a biomedical technology company, is a privately owned corporation developing a long term internal continuous glucose monitor in order to effectively manage and observe glucose levels in real time. The GlySens ICGM system is the world's first surgically implanted continuous glucose monitoring system to demonstrate an 18-month performance in a preclinical setting. GlySens Incorporated was founded in 1998 by David A. Gough and Joseph Lucisano, a bioengineering graduate at the University of California, San Diego. The implanted continuous glucose monitoring system uses an internal sensor equipped with electrochemical detectors to measure glucose readings via a chemical reaction between enzymes and oxygen.

Bigfoot Biomedical Inc. is a medical technology start-up headquartered in Milpitas, California, founded by a team of people with personal connections to type 1 and type 2 diabetes.

Insulin glargine/lixisenatide, sold under the brand name Soliqua 100/33 among others, is a fixed-dose combination medication that combines insulin glargine and lixisenatide and is used to treat diabetes.

Nightscout is a free and open-source project, and associated social movement, that enables accessing and working with continuous glucose monitor (CGM) data. Nightscout software aims to give users access to their real time blood sugar data by putting this data in the cloud. In addition to browser-based data visualization, Nightscout can also be used to review data from a phone or smartwatch, or to remotely monitor CGM data for individuals with type 1 diabetes. Associated with Nightscout software is a broader "CGM in the Cloud" social movement, supporting individuals seeking to access and use realtime CGM data through commercial and DIY approaches.

The Open Artificial Pancreas System (OpenAPS) project is a free and open-source project that aims to make basic artificial pancreas system (APS) technology available to everyone. The OpenAPS project was designed with the idea of quickly getting the APS technology to more people using a direct approach, rather than waiting for clinical trials to be completed and regulatory approval to be granted.

<span class="mw-page-title-main">Continuous glucose monitor</span> Blood glucose monitoring device

A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.

Nemaura Medical Inc. is a UK based Medical Technology company developing a wireless non-invasive blood glucose monitoring system called SugarBeAT.

References

  1. "2023 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. February 8, 2024.
  2. "DexCom Showcases Expanded CGM Portfolio at International ATTD Conference, Offering More Choice to People with Diabetes" (Press release). 26 April 2022.
  3. "Dexcom adding 500 jobs in Mesa". www.bizjournals.com. Retrieved September 19, 2019.
  4. "Freedom Meditech raises $7 million". San Diego Union-Tribune. August 7, 2013. Retrieved September 19, 2019.
  5. "Insulet Corporation and DexCom Announce Development Agreement (NASDAQ:DXCM)". Investor.shareholder.com. January 7, 2008. Archived from the original on December 8, 2015. Retrieved December 3, 2015.
  6. "DexCom™ Announces Joint Development Agreement with Animas Corporation". Investor.shareholder.com. June 10, 2008. Archived from the original on March 18, 2016. Retrieved April 4, 2016.
  7. "Edwards Lifesciences and DexCom to Develop Continuous Glucose Monitoring Products for Hospital Market (NASDAQ:DXCM)". Investor.shareholder.com. November 10, 2008. Archived from the original on December 8, 2015. Retrieved December 3, 2015.
  8. "Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems". PR Newswire. July 30, 2015. Retrieved December 3, 2015.
  9. "FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices" (Press release). FDA. March 27, 2018. Retrieved March 27, 2018.
  10. "FDA Nod for Dexcom G4 Platinum - Analyst Blog". Nasdaq. Zacks. 11 October 2012.
  11. 1 2 3 "DexCom Stock History". 13 June 2018.
  12. "FDA Approves Pediatric Use for Dexcom's G4 Platinum CGM". 19 February 2014.
  13. "Dexcom G4 Platinum With SHARE Gets FDA Approval". DiabetesInControl. January 29, 2015. Retrieved March 2, 2023.
  14. "Dexcom wins FDA nod for G5 CGM". 25 August 2015.
  15. "FDA approves Dexcom for Bluetooth-enabled CGM G5". 25 August 2015.
  16. "Dexcom gets CE Mark for G5 continuous glucose monitor". 14 September 2015.
  17. "Dexcom G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S." 8 December 2022.
  18. "Fierce Biotech". fiercebiotech.com. Retrieved 2015-08-11.
  19. "Verily Life Sciences". verily.com. Retrieved 2017-02-15.
  20. "Dexcom G7 CGM - Powerfully simple diabetes management". Dexcom. Retrieved 2023-06-28.
  21. "FDA Approval of Tandem's t:slim with Integrated Dexcom G4 Platinum CGM Expected in 2015". 7 August 2015.
  22. "FDA Approves New Insulin Pump-Continuous Sensor Combo".
  23. "FDA approves new closed-loop insulin delivery system for people with Type 1 diabetes". 13 December 2019.
  24. "DexCom and Companion Medical Collaboration to Support CGM". yahoo!finance. June 7, 2019. Retrieved March 2, 2023.
  25. "JPM20: Livongo strikes deal with Dexcom to integrate continuous glucose monitoring data". 14 January 2020.
  26. "Insulet Partners With Dexcom for Automated Insulin Delivery". Yahoo Finance. February 24, 2020.
  27. "Insulet's Omnipod to integrate with Dexcom, Abbott CGMS for automated, smartphone-controlled dosing". 20 February 2020.
  28. "Dexcom G6 integration enables insights from Welldoc BlueStar, Apple's rumored video workout app and more digital health news briefs". 12 March 2020.