Diabetes (DM)NUTRI-DIABNCT07285330
Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes
An observational study of Diabetes (DM), run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
The present study aims to compare the effects on glycated hemoglobin (HbA1c) at 3 months of two care models in patients with type 2 diabetes referred due to poor glycemic control: a day hospital endocrinology care model versus a care model centered on follow-up by a dietitian-nutritionist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM)
- What is being tested?
- Day Care Hospital and Nutritionist
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2025to 30 Apr 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by diabetes mellitus type 2
Who may be able to join
- Patients with a diagnosis of type 2 diabetes (T2DM) referred to endocrinology due to poor metabolic control.
- Patients on insulin therapy
Who cannot join
- Referred from primary care for other reasons such as hypoglycemia.
- Patients with other types of diabetes mellitus or with uncertainty in diagnostic classification.
- Patients on rapid-acting insulin bolus therapy.
- Patients with acute decompensation of diabetes.
- Patients receiving corticosteroid treatment.
- Dependent individuals for activities of daily living (ADL) with a Barthel index score below 60 or with cognitive impairment.
- Language barrier.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Vilafranca
Vilafranca del Penedès, Barcelona, 08720
Noemí Casaponsa, +34 938960025 ext. 43197, recerca@csapg.cat
Altea Pérez
About this study
Official title: NUTRI-DIAB: Impact of the Dietitian-Nutritionist Model vs. Day Hospital on the Metabolic Control of Patients With Type 2 Diabetes
The present study aims to compare the effects on glycated hemoglobin (HbA1c) at 3 months of two care models in patients with type 2 diabetes referred due to poor glycemic control: a day hospital endocrinology care model versus a care model centered on follow-up by a dietitian-nutritionist.
- Conditions
- Diabetes (DM)
- Being tested
- Day Care Hospital, Nutritionist
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day Care HospitalOther
Clinical follow-up under the joint care of a nurse and an endocrinologist at Day Care Hospital
NutritionistOther
Clinical follow-up with a dietitian-nutritionist and an endocrinologist at ambulatory care unit
| Study group | Role | What they receive |
|---|---|---|
| Day Care Hospital | These patients received joint care from a nurse and an endocrinologist in the day hospital before 2024. Receives: Other: Day Care Hospital | |
| Nutritionist | These patients received joint care from a nutriotinist and finally an endocrinologist in ambulatory care unit after 2024. Receives: Other: Nutritionist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycate hemoglobin
Glycated hemoglobin (HbA1c) levels three months after completion of the intervention
Measured: three months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285330
- Sponsor's protocol ID
- CSAPG-76
- Acronym
- NUTRI-DIAB
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRI-DIAB: Impact of the Dietitian-Nutritionist Model vs. Day Hospital on the Metabolic Control of Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07285330
- Acronym / sponsor ID
- NUTRI-DIAB / CSAPG-76
- Conditions
- Diabetes (DM)
- Keywords
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 Dec 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.
The present study aims to compare the effects on glycated hemoglobin (HbA1c) at 3 months of two care models in patients with type 2 diabetes referred due to poor glycemic control: a day hospital endocrinology care model versus a care model centered on follow-up by a dietitian-nutritionist.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day Care Hospital | – | Other: Day Care HospitalThese patients received joint care from a nurse and an endocrinologist in the day hospital before 2024. |
| Nutritionist | – | Other: NutritionistThese patients received joint care from a nutriotinist and finally an endocrinologist in ambulatory care unit after 2024. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by diabetes mellitus type 2
Key inclusion criteria (2 listed)
- Patients with a diagnosis of type 2 diabetes (T2DM) referred to endocrinology due to poor metabolic control.
- Patients on insulin therapy
Key exclusion criteria (7 listed)
- Referred from primary care for other reasons such as hypoglycemia.
- Patients with other types of diabetes mellitus or with uncertainty in diagnostic classification.
- Patients on rapid-acting insulin bolus therapy.
- Patients with acute decompensation of diabetes.
- Patients receiving corticosteroid treatment.
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 |
|---|---|---|
| Day Care HospitalClinical follow-up under the joint care of a nurse and an endocrinologist at Day Care Hospital | Other | Day Care Hospital |
| NutritionistClinical follow-up with a dietitian-nutritionist and an endocrinologist at ambulatory care unit | Other | Nutritionist |
Primary outcome
Glycate hemoglobin
Time frame: three months after completion of the intervention
Glycated hemoglobin (HbA1c) levels three months after completion of the 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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM), run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site 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 2 inclusion and 7 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Noemí Casaponsa (+34 938960025 ext. 43197, recerca@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycate hemoglobin (time frame: three months after completion of the intervention). 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 27 Oct 2026.