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

Effectiveness of a Continuous Care Intervention by the Endocrinology and Nutrition Service in Primary Care to Improve the Control of Type 2 Diabetes Mellitus in Terres de l'Ebre, Catalonia

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.

T2DM is a highly prevalent chronic disease, accounting for approximately 90% of all diabetes cases, and is primarily managed in the primary care setting. The complexity of optimizing metabolic control in T2DM has increased, as current guidelines recommend a multifactorial approach that addresses not only glycemic control but also cardiovascular risk and multimorbidity. Glycosylated hemoglobin (HbA1c) remains the principal marker for assessing glycemic control and predicting diabetes-related complications.

Despite the availability of evidence-based clinical practice guidelines, their implementation in routine care is often suboptimal due to factors such as limited time, resources, clinical inertia, and challenges with patient adherence. Interventions targeting healthcare professionals and organizational processes-such as structured training, audit and feedback, and system-level changes-have shown promise in improving metabolic outcomes, particularly among patients with suboptimal glycemic control.

This study is a randomized, parallel-group clinical trial designed to evaluate the effectiveness of a continuity of care intervention led by the Endocrinology Service at HTVC, in collaboration with primary care centers in the Terres de l'Ebre health region. Primary care centers will be randomized to either the intervention or control group.

The intervention consists of structured, multidisciplinary training and feedback provided by endocrinologists and nurse educators to primary care physicians and nurses. Training sessions are delivered in modules that combine theoretical and practical content, with a focus on up-to-date diabetes management strategies and the needs of each primary care center. The endocrinology team includes endocrinologists, nurse educators, and a specialist nurse from the Diabetic Foot Unit. Training will be delivered onsite at intervention centers in scheduled sessions over a one-year period.

A qualitative component is integrated into the study, involving focus groups with participating primary care professionals before and after the intervention. This aims to gather insights on professional perspectives, identify barriers and facilitators, and inform the adaptation and future implementation of the intervention.

The primary outcome is improvement in HbA1c, with secondary outcomes including additional patient health indicators, professional knowledge and engagement, and organizational variables. Data collection will occur at baseline, 6, 12, and 24 months. All data will be anonymized to ensure confidentiality.

This study aims to provide evidence on the effectiveness of a multidisciplinary, continuity of care intervention in improving metabolic control for adults with T2DM in a real-world primary care setting.

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 <1 year)
• Complex chronic patients (CCP)
• Diagnosis of dementia
• Institutionalized patients or those residing in social healthcare facilities
• Age over 90 years
• Age under 18 years
• Severe psychiatric illness (e.g., psychosis, bipolar disorder, major depression)
• History of kidney transplant
• Undergoing dialysis
• History of alcohol or drug abuse