Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07392437

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-05-07

246

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with type 2 diabetes according to national (HAS) criteria
  • Managed for type 2 diabetes at Nice University Hospital (hospitalization, day hospital, or outpatient)
  • Able to understand the study and complete self-administered questionnaires
  • Affiliated to the French social security system
  • Has not objected to participation in the study (non-opposition procedure)
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Pregnant women
  • Any diabetes type other than type 2 (e.g., type 1, secondary, genetic diabetes)
  • Haemochromatosis
  • Cystic fibrosis
  • Current treatment with 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 patients
  • Major neurocognitive disorder or physical/mental disability preventing questionnaire completion
  • Adults under legal protection (guardianship or curatorship)
  • Refusal or withdrawal of non-opposition
  • Later paraclinical results showing a diabetes type other than type 2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Nice

Nice, France

Actively Recruiting

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Research Team

P

Philippe CAROLI-BOSC, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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