Observational studyActa diabetologica2026
Glycemic assessment in diabetic patients with secondary polycytheamia: limitations of HbA1c and the potential role of fructosamine-a prospective comparative study.
Observational study in Acta diabetologica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThis 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.
methodsIn 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.
resultsFasting 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.
conclusionHbA1c 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.
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