Dietitian-led follow-up versus day-hospital endocrinology care for improving blood sugar in type 2 diabetes
NUTRI-DIAB: Impact of the Dietitian-Nutritionist Model vs. Day Hospital on the Metabolic Control of Patients With Type 2 Diabetes
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 |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Vilafranca del Penedès, Barcelona) |
| Trial ID | NCT07285330 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous work shows dietitian-led programs can modestly improve HbA1c, but direct head-to-head comparisons with day-hospital endocrinology care are limited.
Eligibility criteria
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 this trial is running
Vilafranca del Penedès, Barcelona
- Hospital de Vilafranca — Vilafranca del Penedès, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Noemí Casaponsa
- Email: recerca@csapg.cat
- Phone: +34 938960025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.