Glycated haemoglobin and fasting plasma glucose tests in the screening of outpatients for diabetes and abnormal glucose regulation in Uganda: A diagnostic accuracy study.

ABSTRACT

BACKGROUND AND OBJECTIVES: To understand the utility of glycated haemoglobin (HBA1C) in screening for diabetes and Abnormal Glucose Regulation (AGR) in primary care, we compared its performance to that of the fasting plasma glucose (FPG) test. METHODS: This was a prospective diagnostic accuracy study conducted in eastern Uganda. Patients eligible for inclusion were consecutive adults, 30-75 years, receiving care at the outpatient department of a general hospital in eastern Uganda. We determined the sensitivity, specificity and optimum cut-off points for HBA1C and FPG tests using the oral glucose tolerance test (OGTT) as a clinical reference standard. RESULTS: A total of 1659 participants underwent FPG testing of whom 310 were also HBA1C and OGTT tested. A total of 113 tested positive for diabetes and 168 for AGR on the OGTT. At recommended cut-off points for diabetes, the HBA1C and FPG tests had comparable sensitivity [69.8% (95% CI 46.3-86.1) versus 62.6% (95% CI 41.5-79.8), respectively] and specificity [98.6% (95% CI 95.4-99.6) versus 99.4% (95% CI 98.9-99.7), respectively]. Similarly, the sensitivity of HBA1C and the FPG tests for Abnormal Glucose Regulation (AGR) at ADA cut-offs were comparable [58.9% (95% CI 46.7-70.2) vs 47.7% (95% CI 37.3-58.4), respectively]; however, the HBA1C test had lower specificity [70.7% (95% CI 65.1-75.8)] than the FPG test [93.5% (95% CI 88.6-96.4)]. At the optimum cut-offs points for diabetes [45.0 mmol/mol (6.3%) for HBA1C and 6.4 mmol/L (115.2 mg/dl) for FPG], HBA1C and FPG sensitivity [71.2% (95% CI 46.9-87.8) versus 72.7% (95% CI 49.5-87.8), respectively] and specificity [95.1% (95% CI91.8 97.2) versus 98.7% (95% CI 98.0 99.2), respectively] were comparable. Similarly, at the optimum cut-off points for AGR [42.0 mmol/mol (6.0%) for the HBA1C and 5.5 mmol/l (99.0 mg/dl) for the FPG test], HBA1C and FPG sensitivity [42.3% (95% CI 31.8-53.6) and 53.2 (95% CI 43.1-63.1), respectively] and specificity [89.1% (95% CI 84.1 92.7) and 92.7% (95% CI 91.0 94.1), respectively] were comparable. DISCUSSION: HBA1C is a viable alternative diabetes screening and confirmatory test to the FPG test; however, the utility of both tests in screening for prediabetes in this outpatient population is limited.