CDASH. Device Identification

Content

Title: Devices Used by the Subject to Manage Diabetes

	Collected Device Identifier CSPDEVID SPDEVID Hidden/pre-populated	Sponsor-defined
Indicate what diabetic devices the subject is using to manage their diabetes. Enter 1 device per page/line.	What diabetic devices is the subject using to monitor or treat their diabetes? SPDEVDSC_DIVAL DIVAL where DIPARMCD="SPDEVDSC" DXTRT	rtCGM isCGM Blood Ketone Meter Blood Glucose Meter Insulin Pump Insulin Pen (Smart/Digital) Insulin Pen Inhalation Device Other Diabetic Device
Record the name of the manufacturer of the device.	Who is the device manufacturer? MANUF_DIVAL DIVAL where DIPARMCD= "MANUF"	_________________
Record the device model number.	What is the model number of the device? MODEL_DIVAL DIVAL where DIPARMCD="MODEL"	_________________
	Visit Date VISDAT DXDTC DXSTTPT DXENTPT Hidden/pre-populated	Date of visit
	Start Relative to Reference Time Point DXSTRTPT Hidden/pre-populated	BEFORE
	End Relative to Reference Time Point DXENRTPT Hidden/pre-populated	ONGOING

View CRF Metadata

Order Number	TAUG Reference	CDASHIG Variable	CDASHIG Variable Label	Question Text	Prompt	Data Type	Case Report Form Completion Instructions	SDTMIG Target	SDTMIG Variable Mapping	Controlled Terminology Codelist Name	CRF Implementation Notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	TAUG-T1D-P&D	CSPDEVID	Collected Device Identifier	What is the collected device identifier?	Collected Device Identifier	text	N/A	SPDEVID			The sponsor assigns the device identification value. A identification code may be collected on the CRF. The SPDEVID is assigned by the sponsor when the SDTM datasets are created.		Sponsor-defined			Y
2	TAUG-T1D-P&D	SPDEVDSC_DIVAL	Collected Device Description Value	What diabetic devices is the subject using to monitor or treat their diabetes?		text	Indicate what diabetic devices the subject is using to manage their diabetes. Enter 1 device per page/line.	DIVAL;DXTRT	DIVAL where DIPARMCD="SPDEVDSC";DXTRT		The sponsor will determine the appropriate DIVAL for the device types listed on the CRF	rtCGM;isCGM;Blood Ketone Meter; Blood Glucose Meter; Insulin Pump; Insulin Pen (Smart/Digital) ; Insulin Pen; Inhalation Device; Other Diabetic Device			radio
3	TAUG-T1D-P&D	MANUF_DIVAL	Manufacturer Device Value	Who is the device manufacturer?	Manufacturer Device Value	text	Record the name of the manufacturer of the device.	DIVAL	DIVAL where DIPARMCD= "MANUF"
4	TAUG-T1D-P&D	MODEL_DIVAL	Model Device Value	What is the model number of the device?	Device Model Number	text	Record the device model number.	DIVAL	DIVAL where DIPARMCD="MODEL"
5	TAUG-T1D-P&D	VISDAT	Visit Date	What was the date of the visit?	Visit Date	text		DXDTC;DXSTTPT;DXENTPT					Date of visit			Y
6	TAUG-T1D-P&D	DXSTRTPT	Start Relative to Reference Time Point		Start Relative to Reference Time Point	text		DXSTRTPT					BEFORE			Y
7	TAUG-T1D-P&D	DXENRTPT	End Relative to Reference Time Point		End Relative to Reference Time Point	text		DXENRTPT					ONGOING			Y