116-LB: iCoDE Project Final Recommendations for CGM-EHR Integration

Background: he Integration of Continuous Glucose Monitoring Data into the Electronic Health Record (iCoDE) Project is a consortium whose purpose is to facilitate efficient integration of continuous glucose monitor (CGM) data into the Electronic Health Record (EHR) through standards and best practices. Methods: A Planning Committee, Steering Committee, and six Working Groups (Data Standards; Account Linkage; Integration and Interoperability; Analytics and Visualizations; Clinical Workflows; and Partnerships and Business Models) were organized to tackle different technical, clinical, and operational aspects of CGM-EHR integration. Participants were recruited from industry, academia, healthcare, government agencies, and patient advocacy groups. Groups met regularly and got feedback from the Steering Committee. Each Working Group created a final summary of their group's thoughts, research, and recommendations. The iCoDE Co-Chairs then synthesized the six summaries into a final report, and derived formal Recommendation Statements (RS). These RS were then sent to the iCoDE Steering Committee for feedback and revisions. The feedback was incorporated, and a ballot was sent to all voting members. Results:130 individuals from more than 60 organizations participated in iCoDE over the course of 11 months. 54 RS were developed (7 Introductory RS, 27 Technical Standards RS, 20 Clinical Implementation RS). 93.8% of eligible steering committee members submitted their ballots. After the first round of voting, 13 statements underwent minor revisions and 2 underwent major revisions. A revised and final ballot was prepared and sent out to the Steering Committee. All 54 RS were adopted as Strong Recommendations (defined as >80% approval); average approval rate was 98%, range 91%-100%. Conclusion: The 2022 iCoDE Report and Recommendations provide comprehensive yet practical standards-based guidance for manufacturers and healthcare organizations interested in CGM-EHR integration. Disclosure J. C. Espinoza: Consultant; Sanofi, Research Support; NIH - National Institutes of Health, FDA, Speaker's Bureau; Glooko, Inc. A. Yeung: None. C. Huang: None. D. C. Klonoff: Consultant; EOFlow Co., Ltd., Fractyl Health, Inc., Integrity, Lifecare, Inc., Rockley Photonics, Thirdwayv Inc. Funding U.S. Food and Drug Administration (P50FD006425 to J.C.E.)