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Clinical Trial 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)


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05950477
Study type Observational
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Dario Pitocco
Phone +390630154071
Email dario.pitocco@policlinicogemelli.it
Status Recruiting
Phase
Start date June 12, 2023
Completion date June 30, 2024

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