692-P: Development and Adoption of CDISC Clinical Data Standards for Type 1 Diabetes (T1D)

Abstract

Development and adoption of global, non-proprietary and platform-independent CDISC standards a) enables traceability from data collection through data analysis, b) improves data quality, c) reduces costs, d) streamlines processes facilitating data sharing, and e) enables reliable and accurate data reuse. CDISC collaborates with type 1 diabetes subject matter experts to lead a unique effort that brings academia and industry together to create T1D clinical data standards in the areas of pediatrics, devices, exercise, and prevention. The T1D team is tasked with developing standards for collection, tabulation, and analysis of the data by building on existing foundational diabetes standards. They will use a multiphase, consensus-driven process, that includes scoping key data concepts commonly used in T1D clinical studies. The Pediatrics and Devices team has identified several data concepts that would benefit from development of data standards: diabetic ketoacidosis, diabetes history, CGM data, insulin management, laboratory tests related to diabetes, and vital signs percentiles for pediatrics. The public review of the standards developed will be launched in Summer 2019. The Prevention and Exercise team has initiated the scoping process to identify the most urgent areas for standards development, which will be followed by modeling. The public review of these standards will commence beginning of 2020. As the project progresses, the T1D community is encouraged to participate in the informational webinars and public review stages, which will enable all-inclusive development and adoption of the resultant data standards. Factors involved in the adoption of clinical data standards within organizations will be discussed. Disclosure J.M. Owen: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust