Therapeutic Area Data Standards User Guide for Diabetes Version 1.0 (Provisional) Prepared by the CFAST Diabetes Team CDISC Therapeutic Area Data Standards User Guide for Diabetes (Version 1.0) Notes to Readers • This is version 1.0 of the Therapeutic Area Data Standards User Guide for Diabetes. It makes use of domains and assumptions which are not final as of its publication, and is therefore a provisional, rather than final, release. • This document is intended to be used in conjunction with the SDTM v1.4 and SDTMIG v3.2, and with the CDASH Standard v1.1. • The TAUG-Diabetes v1.0 includes a user guide, a set of proposed SDTM variables, a set of draft SDTMIG assumptions, four draft SDTMIG domains, five sets of CDASH metadata tables with example CRFs, and six workbooks of somewhat simplified, prototype SHARE metadata displays. Revision History Date Version Summary of Changes 2014-08-01 1.0 Provisional Release 2014-04-03 1.0 Draft Draft for Public Review See Appendix F for Representations and Warranties, Limitations of Liability, and Disclaimers. Page 2 © 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved September 1, 2014 Provisional CDISC Therapeutic Area Data Standards User Guide for Diabetes (Version 1.0) CONTENTS 1 INTRODUCTION................................................................................................................... 5 1.1 PURPOSE .................................................................................................................................................................5 1.2 ORGANIZATION OF THIS DOCUMENT .......................................................................................................................6 1.3 CONCEPT MAPS .......................................................................................................................................................7 1.4 CONTROLLED TERMINOLOGY ..................................................................................................................................7 1.5 RELATIONSHIPS TO OTHER STANDARDS ..................................................................................................................8 1.6 KNOWN ISSUES .......................................................................................................................................................8 2 SUBJECT AND DISEASE CHARACTERISTICS ........................................................... 10 2.1 DIABETES HISTORY ............................................................................................................................................... 10 2.1.1 Examples for Diabetes History .................................................................................................................. 11 2.2 DIABETES COMPLICATION HISTORY ...................................................................................................................... 12 2.2.1 Examples for Diabetes Complication History ........................................................................................... 13 2.3 TREATMENT-NAÏVETÉ ........................................................................................................................................... 14 2.3.1 Examples for Treatment-Naïveté ............................................................................................................... 15 3 DISEASE ASSESSMENTS .................................................................................................. 17 3.1 LABORATORY TESTS .............................................................................................................................................. 17 3.1.1 Glucose Homeostasis and Diabetes Related Markers ................................................................................ 17 3.1.2 Lipid Panel ................................................................................................................................................. 20 3.1.3 Kidney Function ........................................................................................................................................ 21 3.1.4 Liver Function ........................................................................................................................................... 22 3.1.5 Miscellaneous ............................................................................................................................................ 23 3.2 GLUCOSE MEASUREMENTS ................................................................................................................................... 23 3.2.1 Self-Monitoring of Blood Glucose ............................................................................................................ 24 3.2.1.1 Examples for Self-Monitoring of Blood Glucose ................................................................................. 27 3.2.2 Tolerance Tests .......................................................................................................................................... 29 3.2.2.1 Meal Data in a Meal Tolerance Test ..................................................................................................... 30 3.2.2.2 Examples for Tolerance Tests ............................................................................................................... 31 3.3 HYPOGLYCEMIC EVENTS ....................................................................................................................................... 34 3.3.1 Classification of Hypoglycemia in Diabetes .............................................................................................. 35 3.3.2 Examples for Hypoglycemic Events .......................................................................................................... 38 3.3.2.1 Event and Symptom Data ..................................................................................................................... 39 3.3.2.2 Blood Glucose Concentration Data ...................................................................................................... 40 3.3.2.3 Last Meal and Last Diabetic Study Treatment ..................................................................................... 41 3.3.2.4 Precipitating Factors, Third Party Assistance, Adverse Event .............................................................. 42 3.3.2.5 Treatment for the Hypoglycemic Event ............................................................................................... 43 3.4 CARDIOVASCULAR EVENTS/OUTCOMES ................................................................................................................ 44 4 ROUTINE DATA .................................................................................................................. 45 4.1 CONCOMITANT MEDICATIONS ............................................................................................................................... 45 4.2 VITAL SIGNS .......................................................................................................................................................... 46 4.2.1 Waist & Hip Circumference, Waist/Hip Ratio ........................................................................................... 46 APPENDICES ............................................................................................................................. 48 APPENDIX A: PROJECT PROPOSAL ................................................................................................................................ 48 APPENDIX B: CFAST DIABETES TEAM ........................................................................................................................ 48 APPENDIX C: GLOSSARY AND ABBREVIATIONS ............................................................................................................ 49 APPENDIX D: METADATA ............................................................................................................................................. 50 Appendix D1: CDASH Metadata ............................................................................................................................ 50 Appendix D2: Prototype SHARE Metadata ............................................................................................................ 50 APPENDIX E: REFERENCES ........................................................................................................................................... 52 © 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 Provisional September 1, 2014 CDISC Therapeutic Area Data Standards User Guide for Diabetes (Version 1.0) Appendix E1: Further Reading ................................................................................................................................ 52 APPENDIX F: REPRESENTATIONS AND WARRANTIES, LIMITATIONS OF LIABILITY, AND DISCLAIMERS .......................... 53 FIGURES Figure 1: CDISC Industry Wide Data Standards ...........................................................................................................5 Figure 2: Coding Key for Concept Classification ..........................................................................................................7 CONCEPT MAPS Concept Map 1: Diagnosis of Diabetes ....................................................................................................................... 10 Concept Map 2: Diabetic Retinopathy