Continuous Glucose Monitoring Methods Evaluation and Recommendations for Reporting Guidelines

To evaluate the completeness of methodological reporting in continuous glucose monitoring (CGM)-based clinical trials, and based on our findings, to propose a standardized reporting framework to improve reproducibility and transparency.

We conducted a search to assemble a study sample of CGM-based clinical trials published between 2019 and 2024. Articles were identified via PubMed and screened based on predefined eligibility criteria. We measured the presence or absence of reporting elements across seven core methodological features essential for reproducibility, spanning CGM device characteristics, data platforms, data extraction processes, preprocessing and transformation methods, handling of missing data, CGM metrics, and analytic approaches. Data were manually extracted by trained reviewers, with quality assurance performed on a subset of records. Descriptive statistics were used to summarize reporting completeness.

A total of 248 studies met inclusion criteria. On average, studies reported 4.39 (SD 1.22) of the seven core methodological features. Reporting was highest for CGM metrics (100%), analytic methods (100%), and device make/model (96%). In contrast, key elements of the CGM data pipeline were frequently underreported, including data extraction processes (56%), preprocessing methods (43%), handling of missing data (32%), and CGM data platform (30%). Only 6% of studies reported all seven features. These findings demonstrate substantial heterogeneity and consistent gaps in reporting practices across CGM clinical research within the literature sampling frame.

Incomplete reporting of CGM data pipelines limits reproducibility, comparability, and the clinical and computational utility of CGM-derived outcomes. We propose a preliminary, candidate CGM-specific reporting checklist to standardize documentation of data acquisition, processing, and analysis. Adoption of a refined, consensus-based version of such a framework may strengthen methodological rigor, support regulatory and clinical interpretation, and enhance the reliability of CGM data for emerging digital health and artificial intelligence applications.