This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Dexcom G4 PLATINUM Continuous Glucose Monitoring System
PMA Applicant: Dexcom, Inc.
Address: 6340 Sequence Drive, San Diego, CA 92121
Approval Date: October 21, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120005S018a.pdf
What is it? The Dexcom G4 PLATINUM Continuous Glucose Monitoring (CGM) System is an externally-worn system with an internal sensor that continuously measures and displays glucose values in the fluid between the body’s cells (interstitial fluid). In addition to reporting interstitial glucose values every 5 minutes, the system reports trending information in real-time for up to seven days (the life of each sensor). This new version updates the software that calculates the interstitial glucose values from the sensor signal.
How does it work? The Dexcom G4 PLATINUM CGM System includes several components: a sensor, transmitter and receiver. The sensor is a small wire that is inserted under the skin of the abdomen and measures interstitial glucose values. These values are sent through the transmitter to the hand-held receiver where they are displayed for the user.
When is it used? The Dexcom G4 PLATINUM CGM System is an interstitial glucose monitoring device used to detect trends and tracking patterns in people (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
The Dexcom G4 PLATINUM CGM System aids in detecting episodes of high blood glucose (hyperglycemia) and low blood glucose (hypoglycemia). The system helps with both short-term and long-term therapy adjustments, which may minimize these highs and lows in blood glucose. Interpreting the Dexcom G4 PLATINUM CGM System results should be based on the trends and patterns seen with several consecutive readings over time.
The Dexcom G4 PLATINUM CGM System does not replace the information obtained from a standard home blood glucose meter but rather, it is used to complement the information obtained from the blood glucose meter.
What will it accomplish? People with diabetes can use the tracking and trending glucose information to help understand patterns in their interstitial glucose values, and be alerted when interstitial glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) values. When used along with a blood glucose meter to obtain a more accurate reading of actual blood glucose values, the Dexcom G4 PLATINUM CGM can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose values in a safe range.
When should it not be used? The Dexcom G4 PLATINUM CGM System sensor, transmitter, and receiver should be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM CGM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the System so that it might not display sensor glucose readings or provide alerts; and a low or high interstitial glucose value may be missed.
Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.