Information about the device description, manufacturer, and model number collected on the example CRF is shown in the following DI dataset. The appropriate device type was assigned for each pre-specified or collected device. A unique SPDEVID value was then assigned by the sponsor for each unique combination of assigned device type and collected device description, manufacturer, and model. Each uniquely identified device is then referenced via SPDEVID in other subject-related data.
|1||T001||DI||RTCGM-0001||1||DEVTYPE||Device Type||Non-Invasive Continuous Glucose Monitors (CGMs)|
|2||T001||DI||RTCGM-0001||1||SPDEVDSC||Sponsor Device Description||rtCGM|
|5||T001||DI||BGM-0002||1||DEVTYPE||Device Type||Self-monitoring meters|
|6||T001||DI||BGM-0002||1||SPDEVDSC||Sponsor Device Description||Blood Glucose Meter|
The Device Exposure (DX) domain is used to show which subjects in the study were using which devices. Each SPDEVID value in the DX dataset indicates which of the devices identified in the DI dataset were used by the subject. No timing information was collected about use of these devices apart from an indication that they were currently in use at the screening visit. This is represented using timing variables:
- The values of the VISITNUM and VISIT variables indicate that the information was collected at the screening visit.
- The DXDTC variable indicates the date on which the information was collected. The date of collection is also used as the value for the DXSTTPT and DXENTPT variables.
- The values of the DXSTTPT and DXSTRTPT variables indicate that exposure to the device had started before the date on which the information was collected.
- The values of the DXENTPT and DXENRTPT variables indicate that exposure to the device was ongoing when the information was collected.
|2||T001||DX||0002||BGM-0002||1||Blood Glucose Meter||SUBJECT DEVICES||1||SCREENING||2019-03-01||BEFORE||2019-03-01||ONGOING||2019-03-01|