Important Safety Information
The SEVEN PLUS is the next generation of the SEVEN Continuous Glucose Monitoring
System and is a version of the SEVEN System. The SEVEN and the SEVEN PLUS Systems
are compatible for use with SEVEN Sensors. The “System” as used in the below Indication
for Use, Contraindications, Warnings, and Precautions paragraphs refers to both
the SEVEN and the SEVEN PLUS Continuous Glucose Monitoring Systems.
Indication for use
The System is a glucose monitoring device indicated for detecting trends and tracking
patterns in adults (age 18 and older) with diabetes. The System is intended for
use by patients at home and in healthcare facilities. The device is for prescription
use only. The System is indicated for use as an adjunctive device to complement,
not replace, information obtained from standard home glucose monitoring devices.
The System aids in the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments, which may minimize these
excursions. Interpretation of the System results should be based on the trends and
patterns seen with several sequential readings over time.
Contraindications
The System must be removed prior to Magnetic Resonance Imaging (MRI). Use of acetaminophen-containing
medications during Sensor wear may affect device performance.
Warnings
This System is not designed to replace a blood glucose meter. Always 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 use
your blood glucose meter to check the System results. Calibration should be updated
every 12 hours at a minimum to ensure device performance.
Precautions
The SEVEN Sensor has currently only been tested in adult persons with type 1 and
type 2 diabetes. The System has not been tested in children or adolescents, pregnant
women, or persons on dialysis. For OpenChoice Calibration, you must enter the exact
fingerstick reading that your blood glucose meter displays. Enter all fingerstick
readings for calibration within 5 minutes.
Please note: The Performance Characteristics Section
of your new SEVEN PLUS User’s Guide has changed to reflect the recent study done.
The overall results of the trial showed that this next-generation SEVEN PLUS System
will provide you more continuous glucose readings, and you should expect more of
your Sensors to provide data for the entire 7-day use period. Note that the data
described in the Performance Section also showed a difference from this generation
in the SEVEN PLUS device to the original SEVEN System device in performance in the
low glucose region (40-80 mg/dL). Our study showed that at 50 mg/dL blood glucose,
the device reported glucose to be as high as 64 mg/dL and at 80 mg/dL blood glucose,
the device reported glucose to be as high as 90 mg/dL. Because the performance of
the Next-Generation SEVEN PLUS varies from the original, it is important that you
assess how the new generation device performs for you, especially in the low range.
You should review the performance of this device with your healthcare provider to
understand how well the SEVEN PLUS System performs. Contact DexCom Toll Free at
877-339-2664 for detailed indications for use and safety information.