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

May 6, 2026 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients
Behavioral: Questionnaire and Physical Exam
Patients will be asked to complete questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (single assessment during usual care visit, within 3 days from inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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.
Baseline (single assessment during usual care visit, within 3 days from inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Philippe CAROLI-BOSC, Dr, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-PP-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Questionnaire and Physical Exam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe