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

NCT07392437 | Recruiting

• 1 other identifier: 25-PP-21
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetes Mellitus; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Prevalence of severe diabetes-related distress (PAID-20 score ≥ 40)

  Diabetes-related distress will be assessed using the Problem Areas In Diabetes scale (PAID-20). The PAID-20 includes 20 items scored from 0 to 4; the total raw score (0-80) is multiplied by 1.25 to obtain a total score ranging from 0 to 100, with higher scores indicating greater diabetes-related distress. Severe diabetes-related distress is defined as a PAID-20 total score ≥ 40. The primary endpoint is the proportion of participants with PAID-20 ≥ 40.

  Baseline (single assessment during usual care visit, within 3 days from inclusion)

Secondary Outcomes (2)

• Prevalence of severe diabetes-related distress by care setting (ambulatory vs hospitalized)

  Baseline (single assessment during usual care visit, within 3 days from inclusion)

• Factors associated with diabetes-related distress (PAID-20 score)

  Baseline (single assessment during usual care visit, within 3 days from inclusion)

Study Arms (1)

Patients

OTHER

Behavioral: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam BEHAVIORAL

Patients will be asked to complete questionnaires.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Philippe CAROLI-BOSC, Dr

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CAROLI-BOSC, Dr

CONTACT

+33 4 92 03 21 87; caroli-bosc.p@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 6, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)