FDA Issues Dual Guidance on CGM Data in Clinical Trials and Postapproval Pregnancy Safety Studies

The FDA published two guidance documents: one standardizing Continuous Glucose Monitoring (CGM) data submissions in clinical trials using CDISC SDTM and ADaM data models, and another finalizing recommendations for postapproval pregnancy safety studies. The CGM guidance classifies CGM systems as Digital Health Technologies. The pregnancy safety guidance, finalizing a 2019 draft, recommends three study approaches: case reports, pregnancy registries, and complementary real-world studies using EHR and claims data.