Insulin Exposure

This CRF was used to record both (1) insulin therapy used before the start of the study and (2) insulin used as background therapy during the study. The CRF uses CMSTRF and CMENRF, but could have used CMSTRTPT and CMENRTPT. See CDASHIG v2.0 Section 3.7, Mapping Relative Times from Collection to Submissions, and SDTMIG v3.2 Section 4.1.4.7, Use of Relative Timing Variables, for more information (available at https://www.cdisc.org/standards).

Title: Insulin Management Prior to Study/Background Therapy

CRF Instructions

Enter a separate record for each type of insulin that was used. If the frequency of use was changed, enter each frequency as a separate record.

	Concomitant Medication Category CMCAT Hidden/pre-populated	ANTIDIABETIC
	CM Number CMSPID Hidden/pre-populated	Sponsor-defined
Record the specific type of insulin used by the subject, 1 type of insulin per line. Refer to the protocol for a list of insulins to be recorded.	What was the medication? CMTRT	_________________
Provide the route of administration for the medication.	Route CMROUTE	RESPIRATORY (INHALATION) SUBCUTANEOUS <From ROUTE codelist>
Record the usual frequency of injections or inhalations per day, or choose "Continuous" if subject was using an insulin pump.	Frequency CMDOSFRQ	PRN QM QOD QD BID TID QID CONTINUOUS <From FREQ codelist>
If available, record the date the insulin was first taken using this format (DD-MON-YYYY). If the subject has been taking insulin for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior concomitant medications that are exclusionary should have both a start date and an end date.	Start Date CMSTDAT CMSTDTC	_ _ / _ _ _ / _ _ _ _
If a start date is not available, indicate if the concomitant insulin was started before the study.	Prior to Study CMPRIOR CMSTRF	Yes <From NY codelist>
Indicate if the insulin is ongoing (i.e., the subject has not stopped taking this type of insulin at the end of the study). The end date should be left blank.	Is the medication ongoing? CMONGO CMENRF	Yes <From NY codelist>
If available, record the date insulin stopped using this format (DD-MON-YYYY). If the subject has not stopped taking insulin, leave this field blank.	End Date CMENDAT CMENDTC	_ _ / _ _ _ / _ _ _ _

View CRF Metadata

Order	TAUG Reference	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	Controlled Terminology Code List Name	CRF Implementation Notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	TAUG-T1D-P&D	CMCAT	What is the category for the medication?	Concomitant Medication Category	Record the medication category, if not printed on the CRF.	Text	CMCAT		The category is sponsor-defined.		ANTIDIABETIC			Y
2	TAUG-T1D-P&D	CMSPID	What is the medication identifier?	CM Number		Text	CMSPID		If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.		Sponsor-defined	prompt		Y
3	TAUG-T1D-P&D	CMTRT	What was the medication?	Concomitant Medication	Record the specific type of insulin used by the subject, 1 type of insulin per line. Refer to the protocol for a list of insulins to be recorded.	text	CMTRT
4	TAUG-T1D-P&D	CMROUTE	What was the route of administration of the medication?	Route	Provide the route of administration for the medication.	Text	CMROUTE	(ROUTE)		RESPIRATORY (INHALATION);SUBCUTANEOUS;		prompt
5	TAUG-T1D-P&D	CMDOSFRQ	What was the frequency of the medication?	Frequency	Record the usual frequency of injections or inhalations per day, or choose "Continuous" if subject was using an insulin pump.	Text	CMDOSFRQ	(FREQ)		PRN; QM; QOD; QD; BID; TID; QID; CONTINUOUS		prompt	radio
6	TAUG-T1D-P&D	CMSTDAT	What was the start date?	Start Date	If available, record the date the insulin was first taken using this format (DD-MON-YYYY). If the subject has been taking insulin for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior concomitant medications that are exclusionary should have both a start date and an end date.	Date	CMSTDTC					prompt
7	TAUG-T1D-P&D	CMPRIOR	Was the insulin taken prior to prior to study start?	Prior to Study	If a start date is not available, indicate if the concomitant insulin was started before the study.	Text	CMSTRF	(NY)	Sponsors may collect this information rather than start dates. See CDASHIG v2.0 Section 3.7 and SDTMIG v3.2 Section 4.1.4.7 for more information.	Yes		prompt	checkbox
8	TAUG-T1D-P&D	CMONGO	Is the medication ongoing?	Ongoing	Indicate if the insulin is ongoing (i.e., the subject has not stopped taking this type of insulin at the end of the study). The end date should be left blank.	Text	CMENRF	(NY)	See CDASHIG v2.0 Section 3.7 and SDTMIG v3.2 Section 4.1.4.7 for more information.	Yes			checkbox
9	TAUG-T1D-P&D	CMENDAT	What was the end date?	End Date	If available, record the date insulin stopped using this format (DD-MON-YYYY). If the subject has not stopped taking insulin, leave this field blank.	Date	CMENDTC					prompt

This example CRF was used at each visit, including the baseline visit, to record the mean total daily dose of insulin over the previous 7 days for each type of insulin treatment that was ongoing.

Title: Insulin Management - Mean Total Daily Dose

	Visit Date VISDAT FADTC Hidden/pre-populated	Date of visit
Enter the medication identifier for the ongoing insulin treatment.	What is the identifier for the insulin treatment? FACMNO FALNKID	_________________
If insulin is ongoing, record the mean total daily dose of insulin taken in the last 7 days.	What was the mean total daily dose over the last 7 days? DOSTOT_FAORRES FAORRES where FATESTCD = "DOSTOT" and FAOBJ = CMTRT and NSFA.FACOLSRT = "MEAN" and FAEVLINT = "-P7D"	. __.__
	Unit DOSTOT_FAORRESU FAORRESU where FATESTCD = "DOSTOT" and FAOBJ = CMTRT Hidden/pre-populated	U

View CRF Metadata

Order	TAUG Reference	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTM Variable Mapping	CRF Implementation Notes	Pre-specified Value	Hidden
1	TAUG-T1D-P&D	VISDAT	What is the date of the visit?	Visit Date		Text	FADTC			Date of visit	Y
2	TAUG-T1D-P&D	FACMNO	What is the identifier for the insulin treatment?	Related Concomitant Medication ID	Enter the medication identifier for the ongoing insulin treatment.	Text	FALNKID		This does not map directly to an SDTM variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the associated Prior/Concomitant Medications domain.
3	TAUG-T1D-P&D	DOSTOT_FAORRES	What was the mean total daily dose over the last 7 days?	Mean Total Daily Dose	If insulin is ongoing, record the mean total daily dose of insulin taken in the last 7 days.	Float	FAORRES	FAORRES where FATESTCD = "DOSTOT" and FAOBJ = CMTRT and NSFA.FACOLSRT = "MEAN" and FAEVLINT = "-P7D"
4	TAUG-T1D-P&D	DOSTOT_FAORRESU	What was the unit?	Unit		Text	FAORRESU	FAORRESU where FATESTCD = "DOSTOT" and FAOBJ = CMTRT		U	Y

Insulin Exposure

Illustrates Domains

Illustrates Variables

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