This randomized, parallel-group 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.
Primary care centers are randomized to intervention or control arms. 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. All primary care professionals in intervention centers participate in the training.
The intervention is conducted over one year (July 2025-July 2026). Outcomes are assessed at baseline, 6, 12, and 24 months. The primary outcome is HbA1c; secondary outcomes include other health indicators, professional knowledge and engagement, and organizational variables. A qualitative component gathers professional input before and after the intervention to inform future implementation. All data are anonymized to ensure confidentiality.
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
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)
Parallel
Continuity-of-Care intervention
Other interventionThe intervention is a structured, multidisciplinary training and feedback program led by the Endocrinology Service at HTVC in collaboration with primary care centers in Terres de l'Ebre. Four endocrinologists and four nurses (three educators and one diabetic foot referent) will provide onsite training to primary care physicians and nurses. Training includes six modules with theoretical and practical components, covering T2DM management, cardiovascular risk reduction, and diabetic foot care. Sessions will be held biweekly and delivered by doctor-nurse teams rotating through the participating primary care centers from July 2025 to July 2026, with each center receiving a total of 15 sessions per year. The program also includes regular feedback to professionals on clinical performance and patient outcomes, adapting content to each center's needs. A qualitative component, involving focus groups before and after the intervention, will gather feedback and inform future implementation.
HbA1c
Evaluate the percentage improvement in HbA1c levels in relation to healthcare professionals' attendance at training sessions.
Change in total cholesterol and LDL cholesterol
Mean change in total and LDL cholesterol levels from baseline, measured in mg/dL.
Change in systolic and diastolic blood pressure
Mean change in systolic and diastolic blood pressure from baseline, measured in mmHg.
Change in smoking status
Change in smoking status (current, former, never) and number of cigarettes smoked per day.
Change in Body Mass Index (BMI)
Mean change in BMI (Kg/m2) from baseline. BMI will be calculated as weight in kilograms divided by height in meters squared.
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Institut Investigacio Sanitaria Pere Virgili
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborator
Institut Catala de Salut
Collaborator
