A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials
Elias K. Spanakis, Curtiss B. Cook, Kristen Kulasa, Joseph Aloi, Lia Bally, Georgia M. Davis, Kathleen Dungan, Rodolfo J. Galindo, Carlos E. Mendez, Francisco J. Pasquel, Viral N. Shah, Guillermo E. Umpierrez, Rachel E. Aaron, Tiffany Tian, Andrea M. Yeung, Jingtong Huang, David C. Klonoff
Abstract
Diabetes Technology Society organized an expert consensus panel to develop metrics for research in the use of continuous glucose monitors (CGMs) in a hospital setting. The experts met virtually in small groups both before and after an April 13, 2023 virtual meeting of the entire panel. The goal of the panel was to develop consensus definitions in anticipation of greater use of CGMs in hospital settings in the future. Establishment of consensus definitions of inpatient analytical metrics will be easier to compare outcomes between studies. Panelists defined terms related to 10 dimensions of measurements related to the use of CGMs including (1) hospital hypoglycemia, (2) hospital hyperglycemia, (3) hospital time in range, (4) hospital glycemic variability, (5) hospital glycemia risk index, (6) accuracy of CGM devices and reference methods for CGMs in the hospital, (7) meaningful time blocks for hospital glycemic goals, (8) hospital CGM data sufficiency, (9) using CGM data for insulin dosing, and (10) miscellaneous factors. The panelists voted on 51 proposed recommendations. Based on the panel vote, 51 recommendations were classified as either strong (43) or mild (8). Additional research is needed on CGM performance in the hospital. This consensus report is intended to support that type of research intended to improve outcomes for hospitalized people with diabetes.