Response to Comment on Bergenstal et al. Glucose Management Indicator (GMI): A New Term for Estimating A1C From Continuous Glucose Monitoring. Diabetes Care 2018;41:2275–2280

We thank Pluchino et al. (1) from the U.S. Food and Drug Administration (FDA) Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, for their thoughtful and detailed commentary. They conclude that our proposed continuous glucose monitoring (CGM)–derived measure called glucose management indicator (GMI) (2) is appropriate for inclusion in CGM software to generate a metric conveying extended glucose exposure that may also prove to be a helpful additional tool to personalize diabetes management. In our estimation, this example of Dr. Lias and her colleagues from the FDA being willing to engage in a dialogue with the authors and the diabetes community focused on finding a solution to a clinical and regulatory quandary (in this case, the use of the potentially confusing term estimated A1C) is worthy of highlighting as a model for future productive …