How common severe diabetes-related distress is in adults with type 2 diabetes at Nice University Hospital
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
This project will measure how common severe diabetes-related distress is and try to find what clinical, social, and lifestyle factors are linked to it in adults with type 2 diabetes treated at Nice University Hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT07392437 on ClinicalTrials.gov |
What this trial studies
This is a single-centre observational project conducted in the endocrinology department of CHU de Nice enrolling adults with type 2 diabetes who receive usual care. Participants complete validated self-report questionnaires including the PAID-20 for diabetes distress, the WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire, while clinical data are extracted from medical records. The main goal is to estimate the prevalence of severe diabetes-related distress and to identify associated clinical, psychosocial, and lifestyle factors. Findings aim to fill a French data gap and could inform whether routine distress screening should be more widely adopted in local practice.
Who should consider this trial
Good fit: Adults (age ≥ 18) with type 2 diabetes who receive care in the endocrinology department at CHU de Nice, can read and complete self-report questionnaires, and are covered by the French social security system.
Not a fit: People under 18, pregnant women, those with types of diabetes other than type 2, patients not managed at CHU de Nice, or those unable to complete questionnaires are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this could reveal how common severe diabetes-related distress is locally and support routine screening and better targeted support to improve quality of life and diabetes control.
How similar studies have performed: International observational studies have repeatedly linked diabetes-related distress to worse glycaemic control, but comparable data from French adults with type 2 diabetes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (age ≥ 18 years). * Diagnosed with type 2 diabetes according to national (HAS) criteria, whether newly diagnosed or longstanding, with or without chronic complications, and with no restriction regarding HbA1c level. Managed for type 2 diabetes in the endocrinology department of Nice University Hospital (conventional hospitalization, day hospital, or outpatient consultation). * Able to understand the study information and to complete the self-administered questionnaires. * Affiliated to the French social security system. * Has not objected to participation in the study (non-opposition procedure). Exclusion Criteria: * Age \< 18 years. * Pregnant woman. * Any type of diabetes other than type 2 diabetes (e.g. type 1 diabetes, secondary or genetic diabetes). * Haemochromatosis. * Cystic fibrosis. * Current treatment with one of the following hyperglycaemic therapies: oral corticosteroids, immunosuppressive drugs, dopaminergic agonists, interferon-alpha, or protease inhibitors. * History of partial or total pancreatectomy. * Ongoing genetic work-up for atypical diabetes. * Non-French-speaking patient. * Major neurocognitive disorder or physical/mental disability preventing completion of the questionnaires. * Adult under legal protection (guardianship or curatorship). * Refusal or subsequent withdrawal of non-opposition. * Any later paraclinical result finally revealing a type of diabetes other than type 2 diabetes.
Where this trial is running
Nice
- CHU de Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: Philippe CAROLI-BOSC, Dr — Centre Hospitalier Universitaire de Nice
- Study coordinator: Philippe CAROLI-BOSC, Dr
- Email: caroli-bosc.p@chu-nice.fr
- Phone: +33 4 92 03 21 87
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.