DexCom™ STS™ Continuous Glucose Monitoring System - P050012
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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: DexCom™ STS™ Continuous Glucose Monitoring System
PMA Applicant: DexCom, Inc.
Address: 5555 Oberlin Drive, San Diego, CA 92121
Approval Date: March 24, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050012a.pdf
What is it?The DexCom STS Continuous Glucose Monitoring System is a glucose sensor that reports glucose values every 5 minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults with diabetes, age 18 and over.
How does it work? The sensor is inserted in the abdomen. After a 2 hour start-up period, the STS System is calibrated with 2 fingerstick measurements taken by a traditional glucose meter. After calibration, the STS System provides a glucose reading and updated glucose trend information for viewing every 5 minutes. The STS System also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low and pre-set high levels.
When is it used? The DexCom STS Continuous Glucose Monitoring System is used with fingerstick measurements to provide additional glucose information to adults with diabetes, age 18 and over, and their healthcare practitioners. The Indications for Use are:
- The DexCom STS Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The DexCom STS System is intended for use by patients at home and in health care facilities. The device is for prescription use.
- The DexCom STS Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
- The DexCom STS Continuous Glucose Monitoring System aids in the detection of episodes of high blood glucose (hyperglycemia) and low blood glucose (hypoglycemia), facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the STS System results should be based on the trends and patterns seen with several sequential Sensor readings over time.
What will it accomplish? Additional glucose information may help people with diabetes and their healthcare practitioners to better manage their disease by providing more information on glucose trends and patterns than can be obtained with fingerstick glucose measurements alone.
When should it not be used?
- This device is not designed to replace a blood glucose meter. The DexCom STS System must be used with a blood glucose meter.
- Treatment decisions should not be based solely on results from the DexCom STS System. You must confirm with a blood glucose meter before making therapeutic adjustments.
- Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the STS System results.
- You should update the STS System’s calibration every 12 hours at a minimum to ensure device performance. The performance of the STS System when calibrated less frequently than the recommended minimum of every 12 hours, has not been studied.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050012