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RecruitingNCT07285330NUTRI-DIABUpdated Dec 16, 2025

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

An observational study in Diabetes (DM), sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes (DM)

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Keywords

  • Diabetes Mellitus
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected by diabetes mellitus type 2

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

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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDay Care Hospital

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

  • OtherNutritionist

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

05

What researchers measure

Primary outcomes

  1. Glycate hemoglobin

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

    Time frame: three months after completion of the intervention

06

Study locations

1 of 1 sites recruiting
  • Hospital de Vilafranca
    Vilafranca del Penedès, Barcelona 08720, Spain
    • Noemí Casaponsa · Contact · recerca@csapg.cat · +34 938960025
    • Altea Pérez · Principal investigator
    • David Benaiges · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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).

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07285330
Lead sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Jun 30, 2025
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Dec 16, 2025

Study contacts

Noemí Casaponsa
Contact
recerca@csapg.cat
+34 938960025 ext. 43197

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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