Continuous care program in primary care to improve type 2 diabetes control in Terres de l'Ebre
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 program will test whether giving structured training and feedback to primary care teams in Terres de l'Ebre helps adults with type 2 diabetes lower their HbA1c and improve metabolic control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7792 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili Academic / other |
| Locations | 12 sites (Amposta, Tarragona and 11 other locations) |
| Trial ID | NCT07124923 on ClinicalTrials.gov |
What this trial studies
This is a cluster-randomized, parallel-group intervention where primary care centers in the Terres de l'Ebre region are assigned to either a continuity-of-care program or usual care. The intervention delivers structured, multidisciplinary training and audit-and-feedback from endocrinologists and nurse educators to all primary care professionals at intervention centers over one year (July 2025–July 2026). Eligible adult patients with at least 12 months of documented T2DM in the eCAP electronic health record are followed with outcomes measured at baseline, 6, 12, and 24 months. The control arm continues routine primary care management while the intervention arm implements the training modules and feedback loops.
Who should consider this trial
Good fit: Adults (≥18 years) with an active primary care–documented diagnosis of type 2 diabetes for at least 12 months, registered in the eCAP system at participating Terres de l'Ebre centers, are ideal candidates.
Not a fit: Patients managed by specialists, those with advanced or terminal conditions, on systemic corticosteroids, pregnant or breastfeeding, institutionalized, or with severe psychiatric illness are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the program could help patients achieve better blood sugar control (lower HbA1c) and improved overall metabolic and cardiovascular risk management through strengthened primary care practices.
How similar studies have performed: Previous trials of structured training, audit, and feedback in primary care have produced modest but meaningful improvements in glycemic control, particularly among patients with poor baseline control, though results vary by setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amposta, Tarragona and 11 other locations
- Abs Amposta — Amposta, Tarragona, Spain (Recruiting)
- Abs Deltebre — Deltebre, Tarragona, Spain (Recruiting)
- Abs Ametlla-Perelló — El Perelló, Tarragona, Spain (Recruiting)
- Abs Flix — Flix, Tarragona, Spain (Recruiting)
- Abs Gandesa — Gandesa, Tarragona, Spain (Recruiting)
- Abs Ampolla-Aldea — L'Ampolla, Tarragona, Spain (Recruiting)
- Abs Mora La Nova — Móra la Nova, Tarragona, Spain (Recruiting)
- Abs La Ràpita-Alcanar — Sant Carles de la Ràpita, Tarragona, Spain (Recruiting)
- Abs Tortosa Est — Tortosa, Tarragona, Spain (Recruiting)
- Abs Tortosa Oest — Tortosa, Tarragona, Spain (Recruiting)
- Hospital de Tortosa Verge de la Cinta — Tortosa, Tarragona, Spain (Recruiting)
- Abs Ulldecona — Ulldecona, Tarragona, Spain (Recruiting)
Study contacts
- Principal investigator: Marcela Miret Llauradó, MD — Catalan Institute of Health
- Study coordinator: Marcela Miret Llauradó, MD
- Email: mmiretl.ebre.ics@gencat.cat
- Phone: +0034977519100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.