NCT07124923 Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia
| NCT ID | NCT07124923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili |
| Condition | Diabetes Mellitus Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,792 participants |
| Start Date | 2025-07-20 |
| Primary Completion | 2026-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 7,792 participants in total. It began in 2025-07-20 with a primary completion date of 2026-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Marcela Miret Llauradó, MD
PRINCIPAL INVESTIGATOR
Catalan Institute of Health
Frequently Asked Questions
Who can join the NCT07124923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Diabetes Mellitus Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07124923 currently recruiting?
Yes, NCT07124923 is actively recruiting participants. Contact the research team at mmiretl.ebre.ics@gencat.cat for enrollment information.
Where is the NCT07124923 trial being conducted?
This trial is being conducted at Amposta, Spain, Deltebre, Spain, El Perelló, Spain, Flix, Spain and 8 additional locations.
Who is sponsoring the NCT07124923 clinical trial?
NCT07124923 is sponsored by Institut Investigacio Sanitaria Pere Virgili. The principal investigator is Marcela Miret Llauradó, MD at Catalan Institute of Health. The trial plans to enroll 7,792 participants.
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