Drugs

Guide on Submitting Continuous Glucose Monitoring Data

FDA has issued a new technical guidance document outlining how sponsors should submit continuous glucose monitoring (CGM) data collected during clinical trials for drugs and biologics, reflecting the growing role of digital health technologies in clinical research. The guidance, titled Submitting Continuous Glucose Monitoring Data in Clinical Trials, provides technical specifications to standardize how CGM data are organized and transmitted to the agency for regulatory review.

FDA describes CGM systems as digital health technologies that continuously and passively measure glucose levels in interstitial fluid, providing near real-time glucose readings and trend information throughout the day. The agency notes that CGM data can include raw “epoch-level” measurements, intermediate summary datasets, and final analysis datasets used to evaluate study endpoints.

According to the guidance, epoch-level data refers to the granular glucose readings captured at intervals determined by the device’s sampling rate, such as every one, five, or 15 minutes depending on the manufacturer and model of the CGM system.

The document also details how sponsors may structure data flows from raw CGM readings to summarized analytical datasets. FDA explains that intermediate summary datasets can serve as a bridge between raw readings and final analyses used in statistical evaluations. For example, a trial measuring “time in range” over a two-week period could include five-minute glucose readings in the epoch-level dataset, daily or weekly totals in intermediate summaries, and aggregate endpoint metrics in the final analysis dataset, it says.

FDA also says some studies may bypass intermediate summaries altogether, allowing raw epoch-level data to flow directly into final analysis datasets.

In addition to glucose readings, the guidance recommends submission of supplemental CGM-related information, including device manufacturer details, model specifications, software versions, and participant interaction data.

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