Translating CGM Regulatory Performance Metrics Into Clinical Interpretation: An Exploratory Expert Consensus Framework

Continuous glucose monitoring (CGM) performance is characterized by technical metrics that are inconsistently standardized across regulatory frameworks and variably connected to clinically meaningful outcomes, complicating interpretation and cross-device comparison.

To develop an exploratory framework translating CGM performance characteristics and derived metrics into clinically interpretable domains while distinguishing empirical evidence from expert judgment.

Candidate metrics were extracted from contemporary clinical, technical, and regulatory sources and organized into six functional domains. Targeted PubMed searches in ambulatory adults with diabetes evaluated domain-specific technical-to-clinical questions. Evidence was classified as direct device-performance, direct between-device comparative, or indirect/contextual. Five experts participated in two private voting rounds using a virtual Nominal Group Technique and prespecified RAND/UCLA agreement criteria. The study was conducted from November 2025 to January 2026.

More than 30 metrics and attributes were mapped across analytical accuracy and performance, glycemic exposure, glycemic variability, clinical safety, adherence and device use, and device reliability. Direct evidence was most clearly identified for device-level analytical performance and between-device differences in analytical accuracy and glycemic exposure; evidence in other domains was predominantly indirect, contextual, or device-specific. Twenty-four of 25 statements achieved consensus after round 1 and all 25 after round 2. The panel considered dynamic accuracy, alert functionality when available, and monitoring continuity potentially clinically meaningful, but these ratings did not establish category-wide superiority of FDA-designated integrated CGM systems.

The framework provides an exploratory structure for interpreting CGM technical performance and derived metrics. Regulatory designation and individual device characteristics should be considered separately, and purpose-designed comparative studies are required to determine whether specific attributes produce reproducible clinical benefits.