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

NCT07285330 | Recruiting

• 1 other identifier: CSAPG-76
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes (DM)

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycate hemoglobin

  Glycated hemoglobin (HbA1c) levels three months after completion of the intervention

  three months after completion of the intervention

Study Arms (2)

Day Care Hospital

These patients received joint care from a nurse and an endocrinologist in the day hospital before 2024.

Other: Day Care Hospital

Nutritionist

These patients received joint care from a nutriotinist and finally an endocrinologist in ambulatory care unit after 2024.

Other: Nutritionist

Interventions

Day Care Hospital OTHER

Clinical follow-up under the joint care of a nurse and an endocrinologist at Day Care Hospital

Day Care Hospital

Nutritionist OTHER

Clinical follow-up with a dietitian-nutritionist and an endocrinologist at ambulatory care unit

Nutritionist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by diabetes mellitus type 2

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Hospital de Vilafranca

Vilafranca del Penedès, Barcelona, 08720, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Central Study Contacts

Noemí Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: June 30, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• 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.

Locations

ES (1)