Acta diabetologica · 2026
Glycemic assessment in diabetic patients with secondary polycytheamia: limitations of HbA1c and the potential role of fructosamine-a prospective comparative study.
СтатьяСравнительное исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Erarslan Sertas, Kilit Turkan P, Acet Aycan
Аннотация
OBJECTIVE: This study aimed to evaluate the reliability of haemoglobin A1c (HbA1c) for assessing glycaemic status in patients with type 2 diabetes mellitus (T2DM) and secondary polycythaemia, and to determine whether fructosamine serves as a more reliable complementary glycaemic marker in this population.
METHODS: In this prospective observational study, patients with T2DM and secondary polycythaemia (n = 62) and T2DM controls with normal haematological indices (n = 40) were enrolled. HbA1c- and fructosamine-derived estimated mean plasma glucose (eMPG) were compared with structured home capillary blood glucose (CBG; 7 measurements/day × 5 days). Bland-Altman analysis and multivariate linear regression (adjusting for age, sex, diabetes duration, BMI, smoking, fasting glucose, haemoglobin, haematocrit) were performed.
RESULTS: Fasting plasma glucose and HbA1c were similar between groups (p = 0.352 and p = 0.816), while fructosamine (456.53 ± 90.18 vs. 404.18 ± 97.63 µmol/L; p = 0.001) and Home-CBG (207.23 ± 49.18 vs. 181.98 ± 55.31 mg/dL; p = 0.002) were significantly higher in the polycythaemia group. Bland-Altman analysis confirmed a systematic negative bias of HbA1c-derived eMPG (mean bias: -23.73 mg/dL; 95% LoA: -45.97 to - 1.48). On multivariate regression, polycythaemia group assignment was the strongest independent association with HbA1c underestimation (β=-16.80 mg/dL; 95% CI: -25.53 to - 8.07; p < 0.001). Fructosamine-derived eMPG showed substantially better agreement with Home-CBG (bias: +7.68 mg/dL). Overall, 60% of polycythaemia patients would have been assigned to a different glycaemic control category based on fructosamine versus HbA1c.
CONCLUSION: HbA1c systematically underestimates glycaemic status in patients with polycythaemia and may lead to clinically relevant misclassification. In contrast, fructosamine appears to provide a more reliable estimate of glycaemic control in this population.
METHODS: In this prospective observational study, patients with T2DM and secondary polycythaemia (n = 62) and T2DM controls with normal haematological indices (n = 40) were enrolled. HbA1c- and fructosamine-derived estimated mean plasma glucose (eMPG) were compared with structured home capillary blood glucose (CBG; 7 measurements/day × 5 days). Bland-Altman analysis and multivariate linear regression (adjusting for age, sex, diabetes duration, BMI, smoking, fasting glucose, haemoglobin, haematocrit) were performed.
RESULTS: Fasting plasma glucose and HbA1c were similar between groups (p = 0.352 and p = 0.816), while fructosamine (456.53 ± 90.18 vs. 404.18 ± 97.63 µmol/L; p = 0.001) and Home-CBG (207.23 ± 49.18 vs. 181.98 ± 55.31 mg/dL; p = 0.002) were significantly higher in the polycythaemia group. Bland-Altman analysis confirmed a systematic negative bias of HbA1c-derived eMPG (mean bias: -23.73 mg/dL; 95% LoA: -45.97 to - 1.48). On multivariate regression, polycythaemia group assignment was the strongest independent association with HbA1c underestimation (β=-16.80 mg/dL; 95% CI: -25.53 to - 8.07; p < 0.001). Fructosamine-derived eMPG showed substantially better agreement with Home-CBG (bias: +7.68 mg/dL). Overall, 60% of polycythaemia patients would have been assigned to a different glycaemic control category based on fructosamine versus HbA1c.
CONCLUSION: HbA1c systematically underestimates glycaemic status in patients with polycythaemia and may lead to clinically relevant misclassification. In contrast, fructosamine appears to provide a more reliable estimate of glycaemic control in this population.