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Objective <p>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.</p> Methods <p>In this prospective observational study, patients with T2DM and secondary polycythaemia (<i>n</i> = 62) and T2DM controls with normal haematological indices (<i>n</i> = 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.</p> Results <p>Fasting plasma glucose and HbA1c were similar between groups (<i>p</i> = 0.352 and <i>p</i> = 0.816), while fructosamine (456.53 ± 90.18 vs. 404.18 ± 97.63 µmol/L; <i>p</i> = 0.001) and Home-CBG (207.23 ± 49.18 vs. 181.98 ± 55.31&#xa0;mg/dL; <i>p</i> = 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&#xa0;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&#xa0;mg/dL; 95% CI: −25.53 to − 8.07; <i>p</i> &lt; 0.001). Fructosamine-derived eMPG showed substantially better agreement with Home-CBG (bias: +7.68&#xa0;mg/dL). Overall, 60% of polycythaemia patients would have been assigned to a different glycaemic control category based on fructosamine versus HbA1c.</p> Conclusion <p>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.</p>

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Glycemic assessment in diabetic patients with secondary polycytheamia: limitations of HbA1c and the potential role of fructosamine—a prospective comparative study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月22日

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  • Sertas Erarslan,
  • Turkan P. Kilit,
  • Aycan Acet

摘要

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.