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Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes

NCT05950477 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-05-29

No results posted yet for this study

Summary

Single-center prospective observational pilot study

The aim of the study is to evaluate the potential association between the percentage of time spent in the optimal glycemia range and the score obtained in the questionnaires used to screen for depression.

The study involves only one visit for each participant. Each participant will be asked to sign the informed consent to the study and, during the visit, the following information will be acquired: parameters, history of diabetes, concomitant diseases and medications, and CGM metrics.

The participant will be administered the following questionnaires for the evaluation of depression, patient-reported outcome measure (PROMs) and treatment satisfaction:

* Patient Health Questionnaire (PHQ-9)
* Center of Epidemiological Studies-Depression Scale (CES-D)
* Diabetes Treatment Satisfaction Questionnaire (DTSQ)
* Well-Being Index (WHO-5)
* Problem Areas In Diabetes (PAID-5)
* European Quality of Life, Five Dimension, Five Level (EQ5D5L)

Conditions

Interventions

DIAGNOSTIC_TEST

Depression Questionnaires

Center of Epidemiological Studies-Depression Scale (CES-D) Patient Health Questionnaire (PHQ-9) Diabetes Treatment Satisfaction Questionnaire (DTSQ) Well-Being Index (WHO-5)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Dario Pitocco · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2024-06-01
Completion
2024-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05950477 on ClinicalTrials.gov