Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire and Physical Exam.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Psychological Distress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Questionnaire and Physical Exam
Patients will be asked to complete questionnaires.
Primary outcome measures
- Prevalence of severe diabetes-related distress (PAID-20 score ≥ 40) [Time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)]
Secondary outcome measures (2)
- Prevalence of severe diabetes-related distress by care setting (ambulatory vs hospitalized) [Time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)]
- Factors associated with diabetes-related distress (PAID-20 score) [Time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)]
Eligibility criteria
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. 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).
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT07392437 · 25-PP-21