Devices Used by Subjects to Mange Diabetes

Illustrates Domains

DI
DX

Illustrates Variables

DIVAL
DIPARM
DIPARMCD
DXSTRTPT
DXENRTPT


Content

Title: Devices Used by the Subject to Manage Diabetes 

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
Record the name of the manufacturer of the device.
MANUF_DIVAL DIVAL where DIPARMCD= "MANUF"
_________________
Record the device model number.
MODEL_DIVAL DIVAL where DIPARMCD="MODEL"
_________________
VISDAT DXDTC DXSTTPT DXENTPT Hidden/pre-populated
Date of visit
DXSTRTPT Hidden/pre-populated
BEFORE
DXENRTPT Hidden/pre-populated
ONGOING
View CRF Metadata
Order NumberTAUG ReferenceCDASHIG VariableCDASHIG Variable LabelQuestion TextPromptData TypeCase Report Form Completion InstructionsSDTMIG TargetSDTMIG Variable MappingControlled Terminology Codelist NameCRF Implementation NotesPermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
1TAUG-T1D-P&DCSPDEVIDCollected Device IdentifierWhat is the collected device identifier?Collected Device IdentifiertextN/ASPDEVID

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
2TAUG-T1D-P&DSPDEVDSC_DIVALCollected Device Description ValueWhat diabetic devices is the subject using to monitor or treat their diabetes?
textIndicate what diabetic devices the subject is using to manage their diabetes. Enter 1 device per page/line.DIVAL;DXTRTDIVAL where DIPARMCD="SPDEVDSC";DXTRT
The sponsor will determine the appropriate DIVAL for the device types listed on the CRFrtCGM;isCGM;Blood Ketone Meter; Blood Glucose Meter; Insulin Pump; Insulin Pen (Smart/Digital) ; Insulin Pen; Inhalation Device; Other Diabetic Device

radio
3TAUG-T1D-P&DMANUF_DIVALManufacturer Device ValueWho is the device manufacturer?Manufacturer Device ValuetextRecord the name of the manufacturer  of the device.DIVALDIVAL where DIPARMCD= "MANUF"






4TAUG-T1D-P&DMODEL_DIVALModel Device ValueWhat is the model number of the device?Device Model NumbertextRecord the device model number.DIVALDIVAL where DIPARMCD="MODEL"






5TAUG-T1D-P&DVISDATVisit DateWhat was the date of the visit?Visit Datetext
DXDTC;DXSTTPT;DXENTPT



Date of visit

Y
6TAUG-T1D-P&DDXSTRTPTStart Relative to Reference Time Point
Start Relative to Reference Time Pointtext
DXSTRTPT



BEFORE

Y
7TAUG-T1D-P&DDXENRTPTEnd Relative to Reference Time Point
End Relative to Reference Time Pointtext
DXENRTPT



ONGOING

Y