STS-7 Continuous Glucose Monitoring System - P050012/S001
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: STS-7 Continuous Glucose Monitoring System
PMA Applicant: DexCom, Inc.
Address:5555 Oberlin Drive, San Diego, CA 92121
Approval Date: May 31, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050012s001a.pdf
What is it? The STS-7 Continuous Glucose Monitoring System is a glucose sensor for home use that reports glucose values every 5 minutes for up to 7 days before a new sensor must be inserted. These readings are used with fingerstick glucose measurements to detect trends and patterns in sugar (glucose) levels in adults age 18 and older with diabetes. These readings can help people with diabetes, and their healthcare practitioners to manage the disease.
How does it work?
- The sensor is inserted just below the skin on the abdomen with a disposable applicator. Once the sensor is in place, a transmitter is snapped into the sensor.
- After a 2 hour start-up period, the STS-7 Continuous Glucose Monitoring System is calibrated with 2 fingerstick glucose measurements read by a traditional glucose meter.
- After calibration, the STS-7 System provides a glucose reading and updated glucose trend information every 5 minutes that can be viewed on the wireless receiver.
- The STS-7 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 STS-7 Continuous Glucose Monitoring System is used with fingerstick measurements to provide additional glucose information to adults with diabetes and their healthcare practitioners. The Indications for Use are:
- The STS-7 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 STS-7 Continuous Glucose Monitoring System is intended for use by patients at home and in health care facilities. The device is for prescription use.
- The STS-7 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 STS-7 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-7 Continuous Glucose Monitoring 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 STS-7 System must be used with a blood glucose meter.
- Treatment decisions should not be based solely on results from the STS-7 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-7 System results.
- You should update the STS-7 System’s calibration every 12 hours at a minimum to ensure device performance. The performance of the STS-7 System when calibrated less frequently than the recommended minimum of every 12 hours, has not been studied.
- The STS-7 System must be removed prior to MRI
- Use of acetaminophen-containing medication when the STS-7 sensor is inserted may affect the performance of the device.
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=p050012s001