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Background  Glycated hemoglobin A 1c  (HbA 1c ) has been used as an index of glycemic control in the management, guidance, and clinical trials of diabetic patients for the past 35 years. The aim of this study was to validate the HbA 1c  model in patients with type 1 and type 2 diabetes and to use it to support interpretation of HbA 1c  in different clinical situations.    Methods  The HbA 1c  model was identified in 30 patients (15 with type 1 diabetes and 15 with type 2 diabetes) by estimating the overall glycation rate constant ( k ), based on results of continuous glucose monitoring. The model was validated by assessing its ability to predict HbA 1c  changes in cultures of erythrocytes  in vitro  and to reproduce results of the A1C-Derived Average Glucose (ADAG) study. The model was used to simulate the influence of different glucose profiles on HbA 1c .    Results  The mean  k  was equal to 1.296 ± 0.216 × 10 −9  l mmol −1  s −1  with no difference between type 1 and type 2 diabetes. The mean coefficient of variation of  k  was equal to 16.7%. The model predicted HbA 1c  levels  in vitro  with a mean absolute difference less than 0.3% (3.3 mmol/mol). It reproduced the linear relationship of HbA 1c  and mean glucose levels established in the ADAG study. The simulation experiments demonstrated that during periods of unstable glycemic control, glycemic profiles with the same mean glucose might result in much different HbA 1c  levels.    Conclusions  Patients with type 1 and type 2 diabetes are characterized by the same mean value of  k , but there is considerable interindividual variation in the relationship of HbA 1c  and mean glucose level. Results suggest that reciprocal changes in glycation rate and the life span of erythrocytes exist in a wide range of HbA 1c  values. Thus, for an average patient with diabetes, no modifications of parameters of the glycation model are required to obtain meaningful HbA 1c  predictions. Interpreting HbA 1c  as a measure of the mean glucose is fully justified only in the case of stable glycemia. The model and more frequent tests of HbA 1c  might be used to decrease ambiguity of interpreting HbA 1c  in terms of glycemic control.

journal of translational medicine

Validation of a hemoglobin A1c model in patients with type 1 and type 2 diabetes and its use to go beyond the averaged relationship of hemoglobin A1c and mean glucose level