User's Manual
Table Of Contents
- Chapter 1
- Beginning Your Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System Journey
- Chapter 2
- Indications for Use and Safety Statement
- Chapter 3
- Risks and Benefits
- Chapter 4
- What’s the G5 Mobile?
- Chapter 5
- Set Up Your Display Devices
- Chapter 6
- Starting a Sensor Session: Inserting Sensor, AttachingTransmitter, and Starting Your Session
- Chapter 7
- Calibration
- Chapter 8
- Ending Your Sensor Session and Transmitter Session
- Chapter 9
- Home Screen, Rate of Change Arrows, and Errors
- Chapter 10
- Daily Events Affect Your Glucose Trends and Patterns
- Chapter 11
- Sensor Glucose Alarm and Alerts
- Chapter 12
- On the Go With G5: Customizing Your Alarm and Alerts
- EVERYTHING ELSE G5
- Chapter 13
- Warranty: The Fine Print
- Chapter 14
- How to Take Care of Your G5 Mobile
- Chapter 15
- On the Go With G5 Mobile: Getting Through Security
- Chapter 16
- Need Help? You’re Not Alone!
- Chapter 17
- Technical Information
- Chapter 18
- Troubleshooting
- Chapter 19
- Symbols on Package Labels
- SHARING IS CARING
Dexcom G5 Mobile System User Guide
Technical Information
304
Agreement and Accuracy Relative to SMBG
Agreement between the system and BG values is also characterized using
paired system and SMBG results (Table 11 to 12). The system and SMBG
values were compared by pairing the comparative SMBG value to a system
glucose reading that occurred immediately after the SMBG was collected.
These results characterize the performance that subjects expect during real-
time use of the system in their daily diabetes management when comparing
the system readings to their home BG meter results. For readings less than or
equal to 80 mg/dL, the absolute difference in mg/dL between the two glucose
results was calculated. For values greater than 80 mg/dL, the absolute
percent difference (%) from the SMBG values was calculated. The
percentages of total readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30
mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40% were then
calculated.
For example, if the system reads 100 mg/dL, it is between 81-180 mg/dL
range and you can expect the system readings to be within 20% of the SMBG
values 85% of the time for the
Software 505 Adult
Study, as seen in Table 11-
A.
Overall, the system in the
Software 505 Adult
Study reads, on average, 2.6%
lower (Mean Percent Difference) than SMBG values and 11.3% absolute
different (Mean Absolute Percent Difference) than the SMBG values. The
Median Percent Difference shows that half of the time the system reads lower
in 2.7% or less than the SMBG values and the Median Absolute Percent
Difference shows that half of the time the system reads about 8.6% or less
different than SMBG values, as seen in Table 12-A.
Adverse Events
No serious adverse events or device-related serious adverse events occurred
during the studies. Mild to moderate skin irritation, such as erythema or
edema, occurred at the sensor needle insertion area or around the adhesive
area. No infection, bruising, or bleeding occurred at the sensor needle
insertion area or the adhesive area.
17.2 Product Specifications