Self-Monitoring Blood Glucose aCRF

Illustrates Domains

LB

Illustrates Variables

LBTPT
LBTPTNUM


Content

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Indicate whether or not SMBG was performed. Was SMBG performed?
LBPERF LBSTAT
Provide the name of the device used.
SPDEVID
_________________
LBTEST LBTESTCD Hidden/pre-populated
GLUCOSE

<From LBTEST codelist>

LBSPEC Pre-populated
PLASMA

<From SPECTYP codelist>

Record the date of measurement.
LBDAT LBDTC
_ _ / _ _ _ / _ _ _ _
LBTPT LBTPTNUM Pre-populated
Pre-Morning Meal
Indicate if the Pre-Morning Meal measurement was performed. Was Pre-Morning Meal measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

LBTPT LBTPTNUM Pre-populated
Post-Morning Meal
Indicate if the Post-Morning Meal measurement was performed. Was the Post-Morning Meal measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

LBTPT LBTPTNUM Pre-populated
Pre-Midday Meal
Indicate if the Pre-Midday Meal measurement was performed. Was the Pre-Midday Meal measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
LBTPT LBTPTNUM Pre-populated
Post-Midday Meal
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

LBTPT LBTPTNUM Pre-populated
Pre-Evening Meal
Indicate if the Pre-Evening Meal measurement was performed. Was the Pre-Evening Meal measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

LBTPT LBTPTUM Pre-populated
Post-Evening Meal
Indicate if the Post-Evening Meal measurement was performed. Was the Post-Evening Meal measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

LBTPT LBTPTNUM Pre-populated
Bedtime
Indicate if the Bedtime measurement was performed. Was the Bedtime measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

LBTPT LBTPTNUM Pre-populated
Overnight
Indicate if the Overnight measurement was performed. Was Overnight measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

Date of measurement. Should be a programmatic representation of Day, Month, Year and not entered by a user.
LBDAT LBDTC
_ _ / _ _ _ / _ _ _ _
LBTPT LBTPTNUM Pre-populated
Next Day Pre-Morning Meal
Indicate if the Next Day Pre-Morning Meal measurement was performed. Was the Next Day Pre-Morning Meal measurement performed?
LBPERF LBSTAT
Record the time in hh:mm format. 24 hour clock time.
LBTIM LBDTC
_ _ : _ _ : _ _
Record glucose measurement.
LBORRES
.__.__
Select the original unit in which glucose measurement was collected. What was the unit of the lab result?
LBORRESU

<From UNIT codelist>

View CRF Metadata

Columns whose headers are shaded blue are specific to the indication and/or form, and are not from the CDASH model or the CDASH domain metatable.

Field IDActivation TriggerQuestion TextPromptTypeCDASH VariableCDASH CoreCase Report Form completion instructionsImplementation InstructionsMaps to the SDTMIG VariableSDTMIG CoreMapping InstructionsControlled Terminology Codelist NamePre-defined valuesPre-specified valueHide?TA Specific Usage Rules
LBPERF_ALL Was SMBG performed?SMBG PerformedbooleanLBPERFHRIndicate whether or not SMBG was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.

A combination of SDTMIG variables ( e.g., LBCAT and LBSCAT, LBTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided. See SDTMIG Section 4.1.5.1.2.
     
SPDEVIDLBPERF_ALL = "Y"What was the device used?DevicetextSPDEVIDOProvide the name of the device used.Identifier for the device used to obtain the result.

This field applies to all timepoints on this CRF.
SPDEVIDPermMaps directly to SDTM.     
LBTESTLBPERF_ALL = "Y"N/AN/AtextLBTESTHRN/ARequired to identify which test the result is for.

This field applies to all timepoints on this CRF.
LBTEST;LBTESTCDReq;ReqMaps directly to SDTM. The SDTMIG variable LBTESTCD may be determined from the value collected in LBTEST. The SDTMIG variables LBTESTCD and LBTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.LBTEST GLUCOSEY 
LBSPECLBPERF_ALL = "Y"What is the specimen material type?Specimen TypetextLBSPECON/AThe type of specimen used for a measure (e.g., TISSUE, BLOOD, BONE MARROW).

This field applies to all timepoints on this CRF.
LBSPECPermMaps directly to SDTM.SPECTYP PLASMA Agreed on populating it with PLASMA as results are reported as concentrations in plasma - disregarding if the measurement is taken from blood or plasma.
LBDAT_1_8LBPERF_ALL = "Y"What was the date of the lab specimen collection?SMBG DatedateLBDATHRRecord the date of measurement.A complete date is expected. The SDTMIG variable LBDTC contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.

This field applies to timpoints 1-8 on this CRF
LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
LBTPT_1LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "1".   See SDTMIG for additional information on representing time points.  Pre-Morning Meal Label of test per protocol.
1_LBPERFLBPERF_ALL = "Y"Was Pre-Morning Meal measurement performed?Pre-Morning Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Pre-Morning Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
1_LBTIM1_LBPERF = "Y"What was the time of the lab specimen collection?Pre-Morning Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
1_LBORRES1_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
1_LBORRESU1_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_2LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "2".   See SDTMIG for additional information on representing time points.  Post-Morning Meal Label of test per protocol.

Post meal measurements are dependent on the study protocol.
2_LBPERFLBPERF_ALL = "Y"Was the Post-Morning Meal measurement performed?Post-Morning Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Post-Morning Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
2_LBTIM2_LBPERF = "Y"What was the time of the lab specimen collection?Post-Morning Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
2_LBORRES2_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
2_LBORRESU2_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_3LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "3". See SDTMIG for additional information on representing time points.  Pre-Midday Meal Label of test per protocol.
3_LBPERFLBPERF_ALL = "Y"Was the Pre-Midday Meal measurement performed?Pre-Midday Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Pre-Midday Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
3_LBTIM3_LBPERF = "Y"What was the time of the lab specimen collection?Pre-Midday Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
3_LBORRES3_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
3_LBORRESU3_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_4LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "4". See SDTMIG for additional information on representing time points.  Post-Midday Meal Label of test per protocol.

Post meal measurements are dependent on the study protocol.
4_LBPERFLBPERF_ALL = "Y"Was the Post-Midday Meal measurement performed?Post-Midday Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Post-Midday Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
4_LBTIM4_LBPERF = "Y"What was the time of the lab specimen collection?Post-Midday Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
4-LBORRES4_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
4_LBORRESU4_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_5LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "5". See SDTMIG for additional information on representing time points.  Pre-Evening Meal Label of test per protocol.
5_LBPERFLBPERF_ALL = "Y"Was the Pre-Evening Meal measurement performed?Pre-Evening Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Pre-Evening Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
5_LBTIM5_LBPERF = "Y"What was the time of the lab specimen collection?Pre-Evening Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
5_LBORRES5_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
5_LBORRESU5_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_6LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "6". See SDTMIG for additional information on representing time points.  Post-Evening Meal Label of test per protocol.

Post meal measurements are dependent on the study protocol.
6_LBPERFLBPERF_ALL = "Y"Was the Post-Evening Meal measurement performed?Post-Evening Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Post-Evening Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
6_LBTIM6_LBPERF = "Y"What was the time of the lab specimen collection?Post-Evening Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
6_LBORRES6_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
6_LBORRESU6_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_7LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "7". See SDTMIG for additional information on representing time points.  Bedtime Label of test per protocol.
7_LBPERFLBPERF_ALL = "Y"Was the Bedtime measurement performed?Bedtime Measurement PerformedbooleanLBPERFR/CIndicate if the Bedtime measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
7_LBTIM7_LBPERF = "Y"What was the time of the lab specimen collection?Bedtime TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
7_LBORRES7_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
7_LBORRESU7_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBTPT_8LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "8". See SDTMIG for additional information on representing time points.  Overnight Label of test per protocol.

This is a protocol specific timepoint and should follow what the protocol states for this measurement.
8_LBPERFLBPERF_ALL = "Y"Was Overnight measurement performed?Overnight Measurement PerformedbooleanLBPERFR/CIndicate if the Overnight measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
8_LBTIM8_LBPERF = "Y"What was the time of the lab specimen collection?Overnight TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
8_LBORRES8_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
8_LBORRESU8_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L   
LBDAT_9LBPERF_ALL = "Y"Next Date of MeasurementSMBG Next Day DatedateLBDATHRDate of measurement. Should be a programmatic representation of Day, Month, Year and not entered by a user.A complete date is expected. The SDTMIG variable LBDTC contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
LBTPT_9LBPERF_ALL = "Y"N/AN/AtextLBTPTON/APlanned time point are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text.LBTPT;LBTPTNUMPermLBTPT maps directly to SDTMIG variable LBTPT. LBTPTNUM = "9".   See SDTMIG for additional information on representing time points.  Next Day Pre-Morning Meal  
9_LBPERFLBPERF_ALL = "Y"Was the Next Day Pre-Morning Meal measurement performed?Next Day Pre-Morning Meal Measurement PerformedbooleanLBPERFR/CIndicate if the Next Day Pre-Morning Meal measurement was performed.This may be implemented for an Lab entire panel, or on a specific lab test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.LBSTATPermThis does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null.     
9_LBTIM9_LBPERF = "Y"What was the time of the lab specimen collection?Next Day Pre-Morning Meal TimetimeLBTIMR/CRecord the time in hh:mm format. 24 hour clock time.May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.LBDTCExpThis does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.     
9_LBORRES9_LBPERF = "Y"What was the result of the test?ResultfloatLBORRESHRRecord glucose measurement. LBORRESExpMaps directly to SDTM.     
9_LBORRESU9_LBPERF = "Y"What was the unit of the lab result?UnittextLBORRESUR/CSelect the original unit in which glucose measurement was collected. LBORRESUExpMaps directly to SDTM.UNITmg/dL;mmol/L