Background and Aims

Adoption of clinical data standards can transform otherwise incompatible and disparate data into useful and interoperable information that can enable impactful discoveries for T1D and clinical research more broadly. This project is developing T1D data standards for Pediatrics, Devices, Exercise and prevention data.

Methods

Following the CDISC consensus-based, clinical data standards process and with support from T1D clinical and standards development experts, the current CDISC diabetes standards are being expanded. The CDISC standards development process consists of five stages:

1) Scoping

2) Concept Modeling

3) Standards Development

4) Internal Review

5) Public Review

6) Publication

Results

September 2019 the T1D data standards for Pediatrics & Devices (P&D) became available for Public Review and will be published by end of Q12020 for the use of researchers and industry. The first implementation of the P&D is expected to be the T1DEXI observational study data that will be made available publicly.

T1D data standards for Exercise and Prevention (E&P) will be available for Public Review in Q12020. We encourage all ATTD attendees to contribute!

Conclusions

Required by US FDA and Japan PMDA for all drug submissions, CDISC standards enable the FAIR (findable, accessible, interoperable, reusable) data practices to be implemented by industry and academia. With the use of data standards, we can overcome the hindrance of “silo-ed” research data to find innovative solutions to diabetes treatments and therapies. CDISC’s vision is to expand the use of data standards to leverage and realize the full potential of research and clinical data.