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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorInstitut Investigacio Sanitaria Pere Virgili

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Continuity-of-Care intervention

Treatment groups

7,792 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Institut Investigacio Sanitaria Pere Virgili

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborator

Institut Catala de Salut

Collaborator