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NCT Number: NCT07392437

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire and Physical Exam

Behavioral

Patients will be asked to complete questionnaires.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. 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)

    Using the PAID-20 total score (0-100; higher scores indicate greater distress, severe distress defined as ≥ 40), the proportion of participants with severe diabetes-related distress will be calculated in two predefined subgroups: ambulatory patients (outpatient clinic and day hospital) and hospitalized patients (conventional hospitalization in endocrinology).

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

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

    The PAID-20 total score (0-100; higher scores indicate greater diabetes-related distress) will be analysed as a continuous variable. Decision-tree models (CHAID/CRT) will be used to explore associations between diabetes-related distress and predefined clinical, psychosocial and lifestyle variables.

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe CAROLI-BOSC, Dr

CONTACT

[email protected]

+33 4 92 03 21 87

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: DIAMIND

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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