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

Study acronym: DIAMIND
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Enrollment increased: 246 → 290 participants
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Primary and study completion dates: Jan 2, 2027 to Jan 15, 2027
    • Start date changed from estimate of Mar 2, 2026 to Apr 15, 2026
    v3
  3. Recruitment opened
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07392437
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions
(from sponsor)		 Diabetes Mellitus, Psychological Distress
Related terms Diabetes Mellitus
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov