Date of Publication: 06-May-2026
INTELLIGENCE OVERVIEW
Agency: USFDA
The U.S. Food and Drug Administration (FDA) has released a new technical guidance document titled , providing industry recommendations for the standardized submission of continuous glucose monitoring (CGM) data in clinical studies.
Published in May 2026, the guidance outlines technical specifications for sponsors submitting CGM data to support marketing applications for drugs and biological products. The document focuses on the use of CDISC standards, including SDTM and ADaM datasets, to improve consistency, traceability, and regulatory review efficiency.
The FDA emphasizes the importance of structured handling of epoch-level glucose readings, missing data management, device-level traceability, and final analysis datasets used for evaluating CGM-derived endpoints such as Time in Range (TIR). The guidance also recommends standardized tables, figures, and paired glucose analysis datasets to support regulatory assessment.
Additionally, the document highlights considerations for digital health technologies (DHTs), including CGM device identifiers, software versions, sensor replacement tracking, and participant interaction data. Sponsors are encouraged to engage with the FDA early in development programs to align on CGM data strategies and analysis methodologies.
KEYWORDS: Digital Health Technology, Clinical Data Management, Data Standardization
REFERENCE: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-continuous-glucose-monitoring-data-clinical-trials