P121: Development of a 21 CFR Part 11 Compliant Dashboard for a Wearable Biosensor Device for Clinical Research

Poster Presenter

Mary Ann Moore

Senior Director, Project Management
PPD, part of Thermo Fisher Scientific
United States

Objectives

To describe the development of an interactive dashboard for the calculation, parsing, evaluation and visualization of biosensor-related data for near real time presentation, to facilitate medical review and analysis for clinical trial purposes.

Method

We utilize a multi-tier data architecture and an integrated API design pattern that is fit for purpose to support the extraction and processing of data from a commercially available continuous glucose monitoring (CGM) devices for analysis and visualization in a Spotfire dashboard.

Results

We successfully integrated data from intermittently scanned CGM devices (isCGM) (Freestyle Libre, Abbott) into an existing Spotfire dashboard that also contained data from electronic data capture (EDC) systems and central laboratory data. Data visualizations included lasagna plots, box and whisker plots and trending analyses. Calculations included common measures of glycemic variability including, but not limited to, time-in range (TIR), mean of daily differences (MODD), coefficient of variation (CV), glucose management indicator (GMI). Integration of vendor API endpoints with a multi-tiered cloud data lake supports both near real-time and retrospective batch data integration into our Spotfire system for monitoring and medical review. All data transformations were performed in Spotfire facilitating data safety review by Sponsors and CRO staff, while data transferred to biostatistics allows for analysis outputs.

Conclusion

Commercially available applications to store, access and review data from wearable biosensor devices such as CGMs are not always sufficient for clinical research needs and may not be compliant with the United States Food and Drug Administration Code of Federal Regulations, Title 21, Part 11 (21 CFR Part 11). This fit for purpose solution, which utilizes a multi-tier data architecture and integrated API design pattern to extract parse, calculate and visualize CGM-related data from a 21 CRF Part 11 compliant data source into an interactive Spotfire dashboard, simplifies data access and enables CGM data to be reviewed holistically in near real-time alongside clinical data from other sources facilitating review by medical and operations team members. The solution is device agnostic and can be applied to real-time CGM (rtCGM) devices (e.g., Dexcom) and isCGM devices. Following the successful completion of operational acceptance testing (OAT) and user acceptance testing (UAT), the dashboard was successfully implemented for a number of clinical studies, and this approach is being adapted to other wearable devices.