Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia

This randomized, parallel-group, cluster-randomized clinical trial evaluates the effectiveness of a continuity-of-care intervention to improve metabolic control in adults with type 2 diabetes mellitus (T2DM) in the Terres de l'Ebre health region. The intervention, led by the Endocrinology Service at Hospital de Tortosa Verge de la Cinta (HTVC), involves structured, multidisciplinary training and feedback provided by endocrinologists and nurse educators to primary care professionals. Training modules combine theoretical and practical content focused on current diabetes management. Eleven primary care centers were randomized to intervention (n=5) or control (n=6) groups. Eligible participants are adult patients with an active diagnosis of T2DM for at least 12 months as of January 2025, registered in the eCAP system. Primary care professionals in intervention centers are offered the training intervention. The intervention was conducted over one year (July 2025-July 2026). Quantitative data were collected at baseline, 6 months, and 12 months, with a further assessment planned at 24 months. The primary outcome is the between-group difference in mean HbA1c at 12 months, accounting for the cluster-randomized design. The 24-month assessment will evaluate the sustainability of the intervention effect. Six-month data are retained but are not included in the main effectiveness analysis. Secondary outcomes include cardiovascular risk factors, diabetes complication screening, healthcare utilization, medication changes, and organizational variables. A qualitative component gathers professional input before and after the intervention to inform future implementation. Patient data are processed using appropriate confidentiality and data protection safeguards.

Inclusion Criteria: Enrollment will begin in July 2025, aligned with the initiation of training sessions for healthcare professionals (physicians and nurses). Eligible participants must: * Be adults (≥18 years old) * Have an active diagnosis of T2DM documented in the eCAP primary care electronic health record system * Have a duration of T2DM of at least 12 months as of January 2025 Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus (T1DM) * T2DM managed by a specialist at the time of inclusion * Current treatment with systemic corticosteroids * Active neoplasia (malignancy) * Gestational diabetes * Pregnancy or breastfeeding * Diagnosis of MACA (advanced chronic disease with life expectancy \