Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
NCT ID: NCT05950477
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2023-06-12
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychiatric Comorbidities in Type 1 Diabetes Mellitus.
NCT06586879
Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control (DIA-LINK Study)
NCT03811132
Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
NCT01812291
Depression and Diabetes Control Trial
NCT02675257
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity
NCT01513746
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age \> 18 years
3. Subjects with type 1 diabetes mellitus, both on multiple daily injection and with insulin pump, using glucose monitoring systems, both flash glucose monitoring and continuous glucose monitoring
Exclusion Criteria
2. Previous diagnosis of major depression, bipolar disorder, psychotic disorder, eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
3. Chronic treatment with corticosteroids
4. BMI \<19kg/m2
5. Known history of substance or alcohol abuse
6. Patients who have recently been admitted to the psychiatry ward or are being treated with psycho-drugs
7. Conditions that do not allow participation in the activities envisaged by the protocol
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dario Pitocco
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Università Cattolica del Sacro Cuore
Roma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5733
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.