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Measuring emotional distress about diabetes in adults with type 2 diabetes

Looks at how common diabetes-related distress is in adults with type 2 diabetes.

Plain-language title generated from the registry record
Registry title: Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.

Key facts

Where
Nice, FranceSee the site

Where in France

  • CHU de NiceNice, FranceTaking people

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Trial details

Who runs it
Centre Hospitalier Universitaire de Nice
Trial code
NCT07392437
Record updated
28 October 2026
Original description
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.Read full original descriptionShow less

Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.

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.

Inclusion: 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: Current treatment with one of the following hyperglycaemic therapies: oral corticosteroids, immunosuppressive drugs, dopaminergic agonists, interferon-alpha, or protease inhibitors; 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 < 18 years; Pregnant woman; Haemochromatosis; Cystic fibrosis; Non-French-speaking patient; Adult under legal protection (guardianship or curatorship); Refusal or subsequent withdrawal of non-opposition.

ClinicalTrials.gov NCT07392437