Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes (NUTRI-DIAB)

December 3, 2025 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Vilafranca del Penedès, Barcelona, Spain, 08720
        • Recruiting
        • Hospital de Vilafranca
        • Contact:
        • Principal Investigator:
          • Altea Pérez
        • Principal Investigator:
          • David Benaiges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients affected by diabetes mellitus type 2

Description

Inclusion Criteria:

  • Patients with a diagnosis of type 2 diabetes (T2DM) referred to endocrinology due to poor metabolic control.
  • Patients on insulin therapy

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Day Care Hospital
These patients received joint care from a nurse and an endocrinologist in the day hospital before 2024.
Other: Day Care Hospital
Clinical follow-up under the joint care of a nurse and an endocrinologist at Day Care Hospital
Nutritionist
These patients received joint care from a nutriotinist and finally an endocrinologist in ambulatory care unit after 2024.
Other: Nutritionist
Clinical follow-up with a dietitian-nutritionist and an endocrinologist at ambulatory care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycate hemoglobin
Time Frame: three months after completion of the intervention
Glycated hemoglobin (HbA1c) levels three months after completion of the intervention
three months after completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSAPG-76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

After publication of main results of the study.

IPD Sharing Access Criteria

IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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