Blood Glucose Monitoring Devices and Digital Biomarkers in Diabetes: Effectiveness, Utilisation and Challenges: A Systematic Review

Abstract

Abstract Introduction: Diabetes management has advanced with the introduction of digital biomarkers and blood glucose monitoring (BGM) devices, offering new avenues for improving glycemic control. This systematic review evaluates the effectiveness, utilisation, and challenges of these technologies in diabetes management.

Methodology: A comprehensive search was conducted in PubMed, Medline, and Embase for studies published between 2014 and 2024. Eligible studies involved adult patients (aged ≥18) with diabetes using wearable or body-mounted devices for glucose monitoring. The review included continuous glucose monitoring (CGM) systems (e.g., Dexcom, Medtronic), flash glucose monitoring (FGM) systems (e.g., Freestyle Libre), and self-monitoring of blood glucose (SMBG) devices. A total of 27 studies were included, comprising RCTs, observational studies, pilot studies, interventional studies, and quasi-experimental studies.

Results: CGM systems demonstrated significant improvements in glycemic control, with reductions in HbA1c ranging from 0.6% to 1.1% and improvements in time in range (TIR) from 43% to 59%. FGM systems showed an average HbA1c reduction of 0.44% and a significant decrease in hypoglycemic events, particularly nighttime hypoglycemia (a 0.29-hour reduction, p=0.0001). While SMBG proved effective for real-time glucose monitoring, it showed lower adherence rates and a limited impact on long-term glycemic outcomes compared to CGM and FGM. Across studies, CGM outperformed FGM and SMBG in minimising glycemic variability (GV) (27% vs 29%, p=0.05) and improving patient satisfaction. However, challenges related to device cost, accessibility, and adherence, particularly for SMBG, remain prevalent.

Conclusion: CGM and FGM offer substantial benefits over traditional SMBG, particularly in reducing HbA1c, improving TIR, and decreasing hypoglycemic events. While these advanced glucose monitoring systems provide significant clinical advantages, barriers such as cost and complexity must be addressed to ensure broader adoption and improved health outcomes for diabetes patients globally