International Consensus Statement Outlines Appropriate Metrics for CGM in Clinical Trials

International diabetes experts recently collaborated to provide recommendations on how to optimize CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These consensus recommendations have been endorsed by key professional organizations, including the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, Diabetes India, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. This recommended standardized approach to CGM data collection and reporting in clinical trials will encourage the use of uniform metrics and enhance the interpretability of CGM data. Managed care and payer professionals should note that these metrics offer a body of useful information beyond HbA_1c to inform therapeutic and treatment decisions, particularly related to hypoglycemia, postprandial hyperglycemia, and glucose variability.

Battelino T, Alexander CM, Amiel SA, et al. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023;11:42-57.