Abstract
Background: This study aims to evaluate the multidimensional implications of introducing glycated albumin (GA) into Italian clinical practice as an innovative glycemic marker for monitoring type 2 diabetes mellitus (T2DM) in patients with stage IV–V chronic kidney disease (CKD), compared with the current gold standard, glycated haemoglobin (HbA1c). Methods: A Health Technology Assessment (HTA) was conducted from the perspective of the Italian National Health Service (NHS), adopting the EUnetHTA Core Model framework and using a comparative approach to assess the clinical and non-clinical domains of clinical pathways with and without the inclusion of GA. The analysis integrated evidence from a systematic literature review, health economics evaluations, and stakeholder perceptions gathered through validated questionnaires. Results: The systematic literature review demonstrated that GA more accurately identifies poor glycaemic control than HbA1c alone (52% vs. 19.2%), with benefits in reducing adverse events, in T2DM patients with advanced CKD. From an economic point of view, GA would lead to an overall economic saving equal to 2.02%, on annual basis, thus representing the strategy with the most favorable trade-off between costs and effectiveness. Healthcare professionals’ perceptions (collected using a 7-point Likert scale, ranging from −3 to + 3), confirmed these findings, with higher ratings for GA in terms of safety (1.60 vs. 1.01) and effectiveness (2.12 vs. 1.02). Improvements were also reported in perceived quality of life for both patients and caregivers (2.00 vs. 0.88). Organizationally, although minimal investments would be required for training and equipment updates, the adoption of GA was associated with a significant enhancement in the management of the patient care pathway (2.25 vs. 0.63). Conclusions: The results highlight the strategic value of GA as a complementary biomarker in the monitoring of glycemic control among T2DM patients with advanced CKD, offering clinical benefits and potential efficiency gains for the healthcare system.