How common severe diabetes-related distress is in adults with type 2 diabetes at Nice University Hospital

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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. 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).

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.