Diabetes Mellitus Type 2NCT07124923
Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia
A study testing Continuity-of-Care intervention in people with Diabetes Mellitus Type 2, run by Institut Investigacio Sanitaria Pere Virgili at 12 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Continuity-of-Care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,792 participants
- Where
- 12 sitesSpain
- Study dates
- 20 Jul 2025to 20 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Spain12 sites, 12 recruiting
- Recruiting
Abs Amposta
Amposta, Tarragona, 43870
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Deltebre
Deltebre, Tarragona, 43580
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Ametlla-Perelló
El Perelló, Tarragona, 43860
Marcel·la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
ABS FLIX
Flix, Tarragona, 43750
Marcel·la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Gandesa
Gandesa, Tarragona, 43780
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Ampolla-Aldea
L'Ampolla, Tarragona, 43895
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Mora La Nova
Móra la Nova, Tarragona, 43770
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs La Ràpita-Alcanar
Sant Carles de la Ràpita, Tarragona, 43540
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Tortosa Est
Tortosa, Tarragona, 43500
Marcel·la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Tortosa Oest
Tortosa, Tarragona, 43500
Marcel.la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Hospital de Tortosa Verge de la Cinta
Tortosa, Tarragona, 43500
Marcel·la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
- Recruiting
Abs Ulldecona
Ulldecona, Tarragona, 43550
Marcel·la Miret Llauradó, +34-977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Continuity-of-Care intervention
- Keywords
- HbA1c, Primary Care, Continuity of Care, Training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuity-of-Care interventionOther
The intervention is a structured, multidisciplinary training and feedback program led by the Endocrinology Service at HTVC in collaboration with primary care centers in Terres de l'Ebre.
Four endocrinologists and four nurses (three educators and one diabetic foot referent) will provide onsite training to primary care physicians and nurses. Training includes six modules with theoretical and practical components, covering T2DM management, cardiovascular risk reduction, and diabetic foot care. Sessions will be held biweekly and delivered by doctor-nurse teams rotating through the participating primary care centers from July 2025 to July 2026, with each center receiving a total of 15 sessions per year.
The program also includes regular feedback to professionals on clinical performance and patient outcomes, adapting content to each center's needs. A qualitative component, involving focus groups before and after the intervention, will gather feedback and inform future implementation.
| Study group | Role | What they receive |
|---|---|---|
| Continuity-of-Care Training for Primary Care Professionals | Experimental | A parallel-group randomized clinical trial will be conducted in 11 primary care centers of the Terres de l'Ebre area (Catalan Health Institute). Randomization was performed by the data extractor before pseudonymization using simple randomization (1:1 ratio), generating values 0 and 1. Centers scoring <0.5 were assigned to the control group; those ≥0.5 to the intervention group, resulting in 5 intervention and 6 control centers. Receives: Other: Continuity-of-Care intervention |
| Usual Care (No Continuity-of-Care Training) | No intervention | Primary care professionals provide care according to current local standard practices without receiving specific training on continuity-of-care strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Evaluate the percentage improvement in HbA1c levels in relation to healthcare professionals' attendance at training sessions.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Secondary outcomes (12)
Change in total cholesterol and LDL cholesterol
Mean change in total and LDL cholesterol levels from baseline, measured in mg/dL.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Change in systolic and diastolic blood pressure
Mean change in systolic and diastolic blood pressure from baseline, measured in mmHg.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Change in smoking status
Change in smoking status (current, former, never) and number of cigarettes smoked per day.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Change in Body Mass Index (BMI)
Mean change in BMI (Kg/m2) from baseline. BMI will be calculated as weight in kilograms divided by height in meters squared.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Percentage of participants adherent to screening protocol for T2DM complications
Percentage of participants who complete all recommended screenings for chronic complications of T2DM, including screening for retinopathy, nephropathy, foot examination, and cardiovascular assessment.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Referrals to the Diabetic Foot Unit
Evaluate the association between attendance at diabetic foot training and referrals to the Diabetic Foot Unit.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Emergency assistance for metabolic decompensations
Evaluate whether patients present to emergency care with a diagnosis of metabolism and nutrition disorder according to CIE-10 ( CIE-10 E00-E90)
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Number of hospital referrals from primary care
Evaluate the number of hospital referrals to endocrinology specialty consultation after primary care attendance.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Medication changes
Assess the association between professional attendance at training and medication changes.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Number of patient visits to primary care
Evaluate the number of patient visits to primary care, stratified by nursing and physician attendance.
Measured: At enrollment, 6, 12, and 24 months after enrollment.
Professional perceptions of relevance, feasibility and impact of the Continuity-of-Care intervention
Professional perceptions of the Continuity-of-Care intervention will be assessed through pre- and post-intervention focus groups. Focus groups will be conducted with professionals from different disciplines (primary care doctors and nurses). Transcripts will be analyzed using thematic content analysis to assess perceptions of relevance, feasibility, and impact of the intervention.
Measured: Pre-intervention and 1 month post-intervention
Professional experiences with implementing the Continuity-of-Care intervention, including perceived barriers and facilitators
Professional experiences with implementing the Continuity-of-Care intervention will be assessed through pre- and post-intervention focus groups. Focus groups will be conducted with professionals from different disciplines (primary care doctors and nurses). Transcripts will be analyzed using thematic content analysis to assess experiences related to implementation and perceived barriers/facilitators.
Measured: Pre-intervention and 1 month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 Jul 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7,792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Catala de Salut
- Responsible party
- Sponsor
- Investigators
- Marcela Miret Llauradó, MD, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124923
- Sponsor's protocol ID
- 009/2024
- Other IDs
- 2024 DI 00039
- Status last verified
- Sep 2025
- First submitted
- 16 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be upon request directly to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07124923
- Acronym / sponsor ID
- 009/2024
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- HbA1c, Primary Care, Continuity of Care, Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,792 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Catala de Salut
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuity-of-Care Training for Primary Care Professionals | Experimental | Other: Continuity-of-Care interventionA parallel-group randomized clinical trial will be conducted in 11 primary care centers of the Terres de l'Ebre area (Catalan Health Institute). Randomization was performed by the data extractor before pseudonymization using simple randomization (1:1 ratio), generating values 0 and 1. Centers scoring <0.5 were assigned to the control group; those ≥0.5 to the intervention group, resulting in 5 intervention and 6 control centers. |
| Usual Care (No Continuity-of-Care Training) | No intervention | –Primary care professionals provide care according to current local standard practices without receiving specific training on continuity-of-care strategies. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Enrollment will begin in July 2025, aligned with the initiation of training sessions for healthcare professionals (physicians and nurses).
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuity-of-Care interventionThe intervention is a structured, multidisciplinary training and feedback program led by the Endocrinology Service at HTVC in collaboration with primary care centers in Terres de l'Ebre. Four endocrinologists and four nurses (three educators and one diabetic foot referent) will provide onsite training to primary care physicians and nurses. Training includes six modules with theoretical and practical components, covering T2DM management, cardiovascular risk reduction, and diabetic foot care. Sessions will be held biweekly and delivered by doctor-nurse teams rotating through the participating primary care centers from July 2025 to July 2026, with each center receiving a total of 15 sessions per year. The program also includes regular feedback to professionals on clinical performance and patient outcomes, adapting content to each center's needs. A qualitative component, involving focus groups before and after the intervention, will gather feedback and inform future implementation. | Other | Continuity-of-Care Training for Primary Care Professionals |
Primary outcome
HbA1c
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Evaluate the percentage improvement in HbA1c levels in relation to healthcare professionals' attendance at training sessions.
12 secondary outcomes
Change in total cholesterol and LDL cholesterol
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Change in systolic and diastolic blood pressure
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Change in smoking status
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Change in Body Mass Index (BMI)
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Percentage of participants adherent to screening protocol for T2DM complications
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Referrals to the Diabetic Foot Unit
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Emergency assistance for metabolic decompensations
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Number of hospital referrals from primary care
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Medication changes
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Number of patient visits to primary care
Time frame: At enrollment, 6, 12, and 24 months after enrollment.
Professional perceptions of relevance, feasibility and impact of the Continuity-of-Care intervention
Time frame: Pre-intervention and 1 month post-intervention
Professional experiences with implementing the Continuity-of-Care intervention, including perceived barriers and facilitators
Time frame: Pre-intervention and 1 month post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. Data sharing will be upon request directly to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcela Miret Llauradó, MD principal investigator
Catalan Institute of Health
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuity-of-Care intervention in people with Diabetes Mellitus Type 2, run by Institut Investigacio Sanitaria Pere Virgili at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcela Miret Llauradó, MD (+0034977519100 ext. 2269, mmiretl.ebre.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: At enrollment, 6, 12, and 24 months after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.