Click the Reports tab in the navigation panel to open the Reports window, then click the Create Report tab.
Study Reports are reports that can be generated on demand for your protocol.
To access CGM Reports:
Click the Reports tab in the navigation panel to open the Reports window, then click the Create Report tab.
Scroll down until you see the CGM Reports set. Use the down arrow icon to expand the view.
Click the Create Report icon to open the list for each report. CGM has several report categories:
CGM Calibrations Report
CGM Daily Trend Report
CGM Data Capture Report
CGM Data Capture Summary Report
CGM Device Status Report
CGM Trend Overview Report
You access each CGM report the same way. We use the CGM Daily Trend Report as an example.
Click a Subject No. in the Subject column and the Visits open below it.
Click the Visit in the Visit column.
Click the PDF file in the PDF Export column. The Report PDF opens for you to save to your local drive. The CGM Reports do not show in the My Reports area as other reports do.
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For the Device Status Report, you will click the Subject, and then click the PDF. |
CGM Daily Trend Report
This report shows daily CGM profiles.
The CGM profiles show trends or patterns which could indicate whether additional plasma glucose measurements may be needed.
The CGM Daily Trend Report should be reviewed upon upload of CGM data.
The CGM Daily Trend Report should be printed, dated and signed, and filed as a source document.
Important! The CGM Daily Trend Report must not be shared with the subject prior to End of Treatment visit.
CGM Data Report
This report shows how compliant the subject has been while wearing the CGM.
The CGM data capture in percentage shows whether the subject has kept the CGM receiver within the required transmission range of 6 meters (20 feet) from the CGM transmitter and that the wireless communication between the transmitter and receiver has worked well. Deviation from this requirement should lead to re-training of the subject or technical troubleshooting.
The daily SMPG calibration values show whether the subject has entered his/her SMPG value twice per day (every 12 hour) into the CGM receiver. Deviation from this requirement should lead to re-training of the subject.
The CGM Data Capture Report should be reviewed upon upload of CGM data.
The CGM Data Capture Report should be printed, dated and signed, and filed as a source document.
CGM Device Status Report
The CGM Device Status Report shows the device’s status; for example, the blinding mode and the measurement unit of the CGM Receiver.
According to protocol this report should be generated before the CGM device is handed out. However this is not possible. You have to complete the first CGM upload before the CGM device Status Report can be generated.
Each CGM Device Status Report should be printed, dated and signed, and filed as a source document.
CGM Trend Overview Report
The CGM Trend Overview Report shows a 24 hour average CGM profile.
The CGM profiles show trends or patterns which could indicate whether additional plasma glucose measurements may be needed.
The CGM Trend Overview Report should be reviewed upon upload of CGM data.
The CGM Trend Overview Report should be printed, dated and signed, and filed as a source document.
Important: The CGM Trend Overview Report must not be shared with the subject prior to End of Treatment visit.
See Also
How Do I Generate Reports on Demand?
