NCT05950477

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Type 1 Diabetes

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-06-12
• Primary completion: 2024-06-01
• Completion: 2024-06-30
• First posted: 2023-07-18
• Last updated: 2024-05-29

Locations

1 site across 1 country: Italy