Level of Agreement and Correlation Between the Estimated Hemoglobin A1c Results Derived by Continuous or Conventional Glucose Monitoring Systems Compared with the Point-of-Care or Laboratory-Based Measurements: An Observational Study

Abstract

Introduction: Hemoglobin A1C (HbA1c) is an important marker for diabetes care management. With the increasing use of new technologies such as continuous glucose monitoring (CGM) and point-of-care testing (POCT), patients and their physicians have been able to monitor and continuously check their blood glucose levels in an efficient and timely manner. This study aimed to investigate the level of agreement between the standard laboratory test for HbA1c (Lab-HbA1c) with point-of-care testing (POCT-HbA1c) and glucose monitoring index (GMI) derived by intermittently scanned CGM (isCGM) or estimated average glucose (eAG) derived by conventional self-monitored blood glucose (SMBG) devices.

Methods: A cross-sectional study was conducted at the Diabetes Treatment Center, Prince Sultan Military Medical City, Saudi Arabia, between May and December 2020 with 81 patients with diabetes who used the isCGM system (n = 30) or conventional finger-pricking SMBG system (n = 51). At the same visit, venous and capillary blood samples were taken for routine HbA1c analysis by the standard laboratory and POCT methods, respectively. Also, for isCGM users, the GMI data for 28 days (GMI-28) and 90 days (GMI-90) were obtained, while for SMBG users, eAG data for 30 days (eAG-30) and 90 days (eAG-90) were calculated. The limits of agreement in different HbA1c measurements were evaluated using a Bland-Altman analysis. Pearson correlation and multivariate linear regression analyses were also performed.

Results: Based on the Bland-Altman analysis, HbA1c levels for 96.7% and 96.1% of the patients analyzed by the POCT and the standard laboratory methods were within the range of the 95% limit of agreement in both isCGM and conventional SMBG users, respectively. About 93.3% of the GMI measurements were within the 95% limit of agreement. Also, about 94.12% of the eAG-30 and 90.2% of the eAG-90 measurements were within the 95% limit of agreement. Moreover, the correlation analysis revealed a statistically significant positive correlation and linear regression among Lab-HbA1c, POCT-HbA1c, GMI, and eAG in both conventional SMBG and isCGM users (all p < 0.001). These positive results persisted significantly after adjusting for different factors (all p < 0.001).

Conclusion: GMI derived by isCGM or eAG derived by conventional SMBG systems, as well as the POCT-HbA1c measurements, showed a high level of agreement; therefore, we recommend them as potential methods for diabetes monitoring, especially when a rapid result is needed or with patients with uncontrolled diabetes or on intensive insulin therapy.

Keywords: Diabetes; HbA1c; POCT; Saudi Arabia; isCGM.