NCT07124923Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 7792 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 20 Jul 2025
- Primary completion date
- 20 Jan 2026
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Diseases
- Type 2 diabetes
- NCT number
- NCT07124923
What you commit to
- Study type: Interventional
- Planned participants: 7792
- From 20 Jul 2025 to the primary completion date, 20 Jan 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with systemic corticosteroids
Other illness
- Diagnosis of type 1 diabetes mellitus (T1DM)
- Active neoplasia (malignancy)
- Gestational diabetes
- Diagnosis of MACA (advanced chronic disease with life expectancy \<1 year)
- Diagnosis of dementia
- Severe psychiatric illness (e.g., psychosis, bipolar disorder, major depression)
- History of kidney transplant
- History of alcohol or drug abuse
Age
- Age over 90 years
- Age under 18 years
Other
- T2DM managed by a specialist at the time of inclusion
- Pregnancy or breastfeeding
- Complex chronic patients (CCP)
- Institutionalized patients or those residing in social healthcare facilities
- Undergoing dialysis
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.