ADaM BDS for time glucose measurements in range

Illustrates Domains

ADEFF

Illustrates Variables

ABLFL

Illustrates Data Structures

BDS


Content

This is an example ADCGMTIR dataset. It is based on an SDTM LB dataset containing the observations per CGM value per visit per subject

adcgmtir.xpt


adcgmtir.xpt

 RowSTUDYIDUSUBJIDSPDEVIDTRT01PPARAMPARAMCDPARAMNAVISITN AVISITAVAL BASE CHG ABLFL  ASTDTMAENDTM A1LOA1HI
 1TD011001-001

CGM-001

Drug A

Time below range (%) 24 Hours Prior to  the End of the Analysis Interval

TBRGL24H1

0

Baseline 27.1 27.1
Y

07OCT2016:13:09:33


08OCT2016:13:09:33


70180
 2TD011001-001CGM-001Drug A

Time in range (%) 24 Hours Prior to  the End of the Analysis Interval

TIRGL24H2

0

Baseline 56.2 56.2
Y07OCT2016:13:09:33

08OCT2016:13:09:33

70180
 3TD011001-001CGM-001Drug A

Time above range (%) 24 Hours Prior to  the End of the Analysis Interval

TARGL24H3

0

Baseline 16.7 16.7
Y07OCT2016:13:09:33

08OCT2016:13:09:33

70180
 4TD011001-001CGM-001Drug A

Time below range (%) 2 Weeks Prior to  the End of the Analysis Interval

TBRGL2W4

0

Baseline 24.5 24.5
Y

24SEP2016:13:10:00

08OCT2016:13:09:33

70180
 5TD011001-001CGM-001Drug ATime in range (%) 2 Weeks Prior to  the End of the Analysis IntervalTIRGL2W 5 0Baseline 55.4 55.4
Y

24SEP2016:13:10:00

08OCT2016:13:09:33

70180
 6TD011001-001CGM-001Drug ATime above range (%) 2 Weeks Prior to  the End of the Analysis IntervalTARGL2W 6 0Baseline 20.1 20.1
Y

24SEP2016:13:10:00

08OCT2016:13:09:33

70180
7TD011 001-001CGM-001Drug A

Time below range (%) 24 Hours Prior to  the End of the Analysis Interval

 TBRGL24H1 52Week 52 23.4 27.1-3.7

07OCT2017:13:15:00

08OCT2017:13:15:05

70180
8TD011001-001CGM-001Drug A

Time in range (%) 24 Hours Prior to  the End of the Analysis Interval

TIRGL24H2 52Week 52 61.156.2 4.9

07OCT2017:13:15:00

08OCT2017:13:15:05

70180
9TD011001-001CGM-001Drug A

Time above range (%) 24 Hours Prior to  the End of the Analysis Interval

TARGL24H3 52Week 52 15.516.7-1.2

07OCT2017:13:15:00

08OCT2017:13:15:05

70180
10TD011 001-001CGM-001Drug ATime below range (%) 2 Weeks Prior to  the End of the Analysis IntervalTBRGL2W4 52Week 52 19.624.5-4.9

24SEP2017:13:15:00

08OCT2017:13:15:05

70180
11TD011 001-001CGM-001Drug ATime in range (%) 2 Weeks Prior to  the End of the Analysis IntervalTIRGL2W5 52Week 52 63.355.47.9

24SEP2017:13:15:00

08OCT2017:13:15:05

70180
12TD011 001-001CGM-001Drug ATime above range (%) 2 Weeks Prior to  the End of the Analysis IntervalTARGL2W6 52Week 5217.120.1-3.0

24SEP2017:13:15:00

08OCT2017:13:15:05

70180

The following is an example of the ADCGMTIR metadata for the analysis of the TIR as defined by the study protocol. A BDS structure was used. The BDS dataset contains 1 or more records per subject, per analysis parameter, per analysis timepoint.

ADCGMTIR Dataset Metadata

ADCGMTIR Variable Metadata

Parameter Value Level List - ADCGMTIR [AVAL]