Dietitian-led follow-up versus day-hospital endocrinology care for improving blood sugar in type 2 diabetes
Official title: NUTRI-DIAB: Impact of the Dietitian-Nutritionist Model vs. Day Hospital on the Metabolic Control of Patients With Type 2 Diabetes
Run by Consorci Sanitari de l'Alt Penedès i Garraf · NCT07285330 · Data updated 2026-11-12
This project will test whether follow-up by a dietitian-nutritionist or care in a day hospital leads to better three-month HbA1c in people with type 2 diabetes who are on insulin and have poor blood sugar control.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Vilafranca del Penedès, Barcelona) |
| Status | Recruiting |
| Started | June 30, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07285330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with type 2 diabetes on insulin who were referred to endocrinology because of poor metabolic control and who are independent in daily activities and able to attend outpatient visits.
✕Probably not a fit
Patients unlikely to benefit include those using rapid-acting bolus insulin, with acute diabetic decompensation, on systemic corticosteroids, with other diabetes types, with severe functional dependence or cognitive impairment, or with a language barrier.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study compares two care models for adults with type 2 diabetes referred for poor glycemic control and treated with insulin: a day hospital endocrinology program versus follow-up centered on a dietitian-nutritionist. It is an observational, non-randomized comparison carried out at Hospital de Vilafranca in Barcelona, with change in glycated hemoglobin (HbA1c) at three months as the primary outcome. Key exclusions include other diabetes types, rapid-acting bolus insulin regimens, acute decompensation, corticosteroid use, severe dependence or cognitive impairment, and language barriers. Routine clinical and laboratory data will be collected from participants in each care pathway to compare short-term metabolic control.
Why it matters
Potential benefit: If successful, the findings could identify a less resource-intensive care pathway that achieves similar or better short-term blood sugar control for insulin-treated people with type 2 diabetes.
How similar studies have gone: Previous work shows dietitian-led programs can modestly improve HbA1c, but direct head-to-head comparisons with day-hospital endocrinology care are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital de Vilafranca
Vilafranca del Penedès, Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Noemí Casaponsa
- Email: recerca@csapg.cat
- Phone: +34 938960025
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.