Diagnostic Accuracy of Glycated Haemoglobin and Average Glucose Values in Type 2 Diabetes Mellitus Treated with Premixed Insulin.

INTRODUCTION: Studies assessing the relationship between glycated haemoglobin (HbA1c) and average blood glucose (ABG) were conducted in small groups of patients on different treatments and may be biased for these reasons. The aim of the study was to assess the relationship between HbA1c and ABG in a large group of type 2 diabetes patients treated with premix insulin. METHODS: In 4257 patients treated with premixed insulin, the parallel point-of-care assessment of HbA1c and ABG from the preceding 90 days (ABG90), calculated automatically from all values measured by the glucometer, was performed twice. The regression formulas and respective values of HbA1c and ABG90 were calculated. RESULTS: The mean number of recorded glucose values/patient was 2.37 estimations per day. The regression formula calculated using data from the first assessment was HbA1c = 5.28 + 0.01487 × ABG90 and that using data from the second one was HbA1c = 4.78 + 0.01683 × ABG90. The slopes of the regression lines are lower than that in a similar analysis from the A1c-Derived Average Glucose (ADAG) study. The comparison of ADAG formula and the formula derived from the present study shows that both formulas give similar results at low HbA1c values, but differ at higher HbA1c values. Additionally, the 95% confidence interval is broader in the PROGENS study e.g. a 95% probability of certainty that the actual HbA1c value was greater than 7.0% (53 mmol/mol) was achieved only at an ABG90 value of 220 mg/dL. CONCLUSION: The relationship between HbA1c and ABG estimations may be different in various patients; therefore, it seems that the use of one equation in all populations may not be reliable. Broad assessment of ABG as a tool that may replace HbA1c measurements should be recommended only with caution, providing the possible limitations and confidence intervals. FUNDING: Bioton S.A.