Abstract
INTRODUCTION: The aim of this study was to investigate the relationship between actual measured glycated hemoglobin (HbA1c) and estimated glycated hemoglobin (EA1c) in the flash glucose monitoring (FGM) system in Chinese patients with type 2 diabetes. METHODS: This study was conducted in Nanjing First Hospital. Each patient used FGM twice in a 3-month period (during the first 14 days immediately after baseline and during a second 14-day period from days 76 to 90 after baseline). HbA1c measurements were made using a high-performance liquid chromatography assay before the start of the first FGM period (baseline) and at the end of the second FGM period. RESULTS: A total of 74 patients (35 men; mean age ± standard deviation [SD] 67.6 ± 5.2 years) were enrolled in the study. The mean (± SD) duration of diabetes was 11.9 ± 7.8 months. The first and second HbA1c measurements were both higher than the EA1c (both p < 0.001). Mean glucose (MG) gradually decreased over time and was the lowest on day 14. Linear regression showed that only HbA1c at baseline affected the gap between HbA1c and EA1c (β = 0.319, p = 0.01) when the educational level, age, gender, duration of diabetes, body mass index, HbA1c at baseline, and number of scans daily were included as independent variables. The best model for calculating EA1c was EA1c% = MG mmol/L × 0.669 - 0.213 × 8th MG + 3.351 when MG > 9.7 mmol/L, and EA1c % = (MG mmol/L + 2.590)/1.590 when MG ≤ 9.7 mmol/L. The correlation coefficient for EA1c and HbA1c in this model (model 7) is higher than that reported the original model in the FGM system 1 (0.955 vs. 0.822, respectively; p < 0.001). CONCLUSIONS: The EA1c used by FreeStyle Libre™ is lower than the actual measured HbA1c. Improvement in the glucose levels during FGM in these patients may contribute to the lowering of EA1c. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov, number NCT03785301.