Title of project

Continuous Glucose Monitoring derived metrics for predicting long-term cardiovascular risks, Chronic complications, and severe outcomes.

Abstract

Diabetes, a􀆯ecting 537 million of individuals globally, presents escalating health and economic challenges due to its prevalence and the difficulty many patients face in achieving optimal HbA1c levels, thereby increasing the risk of severe complications. Continuous Glucose Monitoring (CGM) has emerged as a pivotal tool in diabetes management, offering real-time glucose data to aid in the prevention of adverse health outcomes. The significance of CGM-derived metrics, particularly Time-in-Range (TIR), is gaining recognition due to its association with diabetes complications, including retinopathy, nephropathy, and cardiovascular diseases. As the clinical focus shifts from HbA1c to TIR, regulatory bodies are considering CGM metrics for inclusion in therapeutic labelling, though guidance on the evidence required for TIR’s acceptance as a surrogate endpoint remains unclear. The aim of this project is to evaluate if CGM metrics correlate with cardiovascular risk factors as well as chronic complications and severe outcomes in individuals with diabetes. The project consists of three studies aiming at answering the following research questions:
– Do CGM derived metrics correlate with cardiovascular risk factors in individuals with T2D?
– Can derived Time in Tight Range (TITR), Time Above Tight Range (TATR) and Glycaemic Variability (GV) predict Major Adverse Cardiovascular Events (MACE), microvascular events, and severe hypoglycaemia in individuals with T2D?
– Do CGM derived metrics correlate with cardiovascular risk factors in individuals with T1D?

The evidence generated in this project, combined with existing data, can endorse the use of CGM-derived metrics as clinically significant endpoints. Additionally, it can support the inclusion of CGM-derived metrics in product labelling to assist patients and their healthcare providers in making clinical decisions and selecting individual treatment plans.