This example shows how messages generated by the device might be represented in SDTM. In this case, there are several types of messages, including alarms and routine maintenance messages. It is probable that these data would be transmitted electronically to the sponsor rather than capturing them on a CRF. In addition, most devices currently have little data standardization, so it is likely that extensive mapping may be required.
Certain Expected variables may have been omitted in consideration of space and clarity.
|Row 1:||Shows when a high blood glucose alarm was issued by the CGM device.|
|Row 2:||Shows when the CGM device was calibrated. This calibration was performed 4 minutes after the high blood glucose alarm issued by the same device (as shown on row 1), which suggests that recalibration may have been performed in response to the alarm. However, both of these events were reported independently by the device so no causal relationship is recorded in the data.|
|Row 3:||Shows when a sensor-occluded alarm was issued by the CGM device.|
|Row 4:||Shows the period during which the CGM device was performing autocalibration. This information may be important because glucose levels reported by a CGM device during an autocalibration period may be less accurate.|
|Row 5:||Shows when a battery-low alarm was issued by an insulin pump. If it were important to record the time of battery replacement in response to this alarm, battery replacement could be recorded as an event in the DE domain. A battery replacement record is not included in this example because it was not an event reported by the insulin pump.|
|1||T004||DE||0001||CGM-A-1||1||BLOOD GLUCOSE HIGH||BLOOD GLUCOSE HIGH||DEVICE ALARMS||2019-01-15T08:16|
|2||T004||DE||0001||CGM-A-1||2||CALIBRATION PERFORMED||CALIBRATION PERFORMED||CALIBRATION||2019-01-15T08:20|
|3||T004||DE||0002||CGM-B-4||1||SENSOR OCCLUDED||SENSOR OCCLUDED||DEVICE ALARMS||2019-02-09T14:23|
|5||T004||DE||0004||IP-A-3||1||BATTERY LOW||BATTERY LOW||DEVICE ALARMS||2019-01-30T15:30|