NCT07392437Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Diabetes-related distress is not mentioned in the current French national guidelines on the management of type 2 diabetes, whereas international societies such as the ADA and, more recently, the EASD now recommend its regular assessment. This single-centre observational study conducted in the endocrinology department of Nice University Hospital aims to estimate the prevalence of severe diabetes-related distress in adults with type 2 diabetes receiving usual care, and to identify associated clinical, psychosocial and lifestyle factors. Participants complete validated self-report questionnaires (PAID-20 for diabetes distress, WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire), and clinical data are extracted from electronic medical records. The study does not modify usual medical management and participation consists only in completing the questionnaires and receiving feedback on the results.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- First submitted
- 8 Jan 2026
- Start date
- 15 Apr 2026
- Primary completion date
- 15 Jan 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Type 2 diabetes
- NCT number
- NCT07392437
What you commit to
- Study type: Interventional
- Planned participants: 290
- From 15 Apr 2026 to the primary completion date, 15 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with one of the following hyperglycaemic therapies: oral corticosteroids, immunosuppressive drugs, dopaminergic agonists, interferon-alpha, or protease inhibitors.
Other illness
- Any type of diabetes other than type 2 diabetes (e.g. type 1 diabetes, secondary or genetic diabetes).
- History of partial or total pancreatectomy.
- Ongoing genetic work-up for atypical diabetes.
- Major neurocognitive disorder or physical/mental disability preventing completion of the questionnaires.
- Any later paraclinical result finally revealing a type of diabetes other than type 2 diabetes.
Age
- Age \< 18 years.
Other
- Pregnant woman.
- Haemochromatosis.
- Cystic fibrosis.
- Non-French-speaking patient.
- Adult under legal protection (guardianship or curatorship).
- Refusal or subsequent withdrawal of non-opposition.
Who the study is looking for
- 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. Patients with mixed diabetes (type 2 diabetes associated with pancreatic disease) may also be included if all of the following criteria are met: pancreatic disease detected on imaging, preserved C-peptide levels (\> 200 pmol/L in the presence of normal blood glucose levels), and BMI ≥ 25 kg/m².
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.