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Screening for diabetes mellitus is accomplished by measuring fasting blood glucose or HbA1C. The American Diabetes Association (ADA) guidelines recommend HbA1C for screening patients for diabetes or pre-diabetes, the U.S. Preventative Services Task Force (USPSTF) includes HbA1C only for monitoring and either glucose or HbA1C can be used for screening. This project sought to provide clinical laboratory evidence to support HbA1C as a diabetes screening test. De-identified electronic health record (EHR) patient data from individuals visiting a large medical center and its affiliated clinics that were tested for blood glucose (either alone, basic metabolic profile or comprehensive metabolic profile) and HbA1C ordered together on the same date of service were collected. 333,360 combined glucose and HbA1C requests were received in 2020. For further analysis, we included patients only with ICD-10 routine visit code Z00.00, excluding known diabetics, patients with elevated blood glucose and HbA1C below 5.7 %because this combination may indicate a non-fasting or inadequate fasting state. From the patients with diagnosis code Z00.00 and glucose within the reference interval, 73 %had HbA1C levels greater than 5.7 %. Among them, 65 %are of pre-diabetes [HbA1C between 5.7 and 6.4%] and 35% with HbA1C over 6.5%. Medical record review of patient charts with HbA1C over 6.5 % suggested a diagnosis of diabetes and were prescribed hypoglycemic medications. Elevated glucose and HbA1C complement each other in the initial diagnosis for diabetes and pre-diabetes; where as HbA1C alone is a good indicator in screening diabetes and pre-diabetes individuals that were previously not diagnosed with diabetes. We are currently collecting 2019 data to examine the differences and adjust for the sample volume due to effect of COVID-19 pandemic on patient visits in the early 2020. We are also evaluating if other variables such as insulin levels, insulin resistance status, and their correlation with HbA1C as a screening measure.

Combined utility of Glucose and HbA1C testing for screening diabetes mellitus