Feasibility of Using a Factory-Calibrated Continuous Glucose Monitoring System to Diagnose Type 2 Diabetes

Context: Plasma glucose or A1C criteria can be used to establish the diagnosis of type 2 diabetes (T2D). Objective: We examined whether continuous glucose monitoring (CGM) data from a single 10-day wear period could form the basis of an alternative diagnostic test for T2D. Design: We developed a binary classification diagnostic CGM (dCGM) algorithm using a dataset of 716 individual CGM sensor sessions from 563 participants with associated A1C measurements from seven clinical trials. Data from 470 participants were used for training and 93 participants for testing (49 normoglycemic [A1C <5.7%], 27 prediabetes, and 17 T2D [A1C ≥6.5%] not using pharmacotherapy). dCGM performance was evaluated against the accompanying A1C measurement, which was assumed to provide the correct diagnosis. Results: The dCGM algorithm's overall sensitivity, specificity, positive predictive value, and negative predictive value were 71%, 93%, 71%, and 93%, respectively. At other clinically relevant A1C thresholds, dCGM specificity among normoglycemic participants was 98% (48/49 correctly classified), and for participants with suboptimally controlled diabetes (A1C ≥7%, above the American Diabetes Association recommended A1C goal) the sensitivity was 100% (8/8 participants correctly diagnosed with T2D). Conclusions: Classifications based on the dCGM algorithm were in good agreement with traditional methods based on A1C. The dCGM algorithm may provide an alternative method for screening and diagnosing T2D, and warrants further investigation.