Self-care habits in adults with type 2 diabetes
Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)
This project will see if self-care behaviors in adults with type 2 diabetes are linked to blood sugar control over time and what clinical or sociodemographic factors influence those behaviors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 2 sites (San Donato Milanese, Milan and 1 other locations) |
| Trial ID | NCT07042399 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling adults with type 2 diabetes who speak Italian and can give informed consent. Investigators will collect clinical and sociodemographic data from medical records and ask participants to complete questionnaires at the start or end of routine outpatient visits. The study will analyze how self-care behaviors relate to glycated hemoglobin (HbA1c) over time and which participant characteristics are associated with better or worse self-management. No investigational treatments are given; the project aims to describe patterns and associations to inform care.
Who should consider this trial
Good fit: Adults over 18 with a diagnosis of type 2 diabetes who understand Italian, can provide informed consent, and can complete questionnaires are ideal candidates.
Not a fit: People who are pregnant, have documented psychiatric or neurodegenerative disease, or have any condition that would limit adherence to study procedures may not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help target education and support to improve blood sugar control and reduce diabetes complications.
How similar studies have performed: Previous observational and interventional studies have found links between better self-care or self-management education and lower HbA1c, so this work builds on an established evidence base.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of type 2 diabetes; * Age over 18 years old; * Adequate comprehension of the Italian language; * Signed and dated informed consent. Exclusion Criteria: * Presence of documented psychiatric or neurodegenerative disease; * Pregnancy; * Any condition that, by the investigators' judgment, may limit adherence to study procedures
Where this trial is running
San Donato Milanese, Milan and 1 other locations
- IRCCS Policlinico San Donato — San Donato Milanese, Milan, Italy (Recruiting)
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Monza Brianza, Italy (Recruiting)
Study contacts
- Study coordinator: Davide LL Ausili
- Email: davide.ausili@unimib.it
- Phone: +39 0264488032
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.