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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950477
• Other study ID #: 5733
• Status: Recruiting
• Start date: June 12, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Dario Pitocco
• Phone: +390630154071
• Email: dario.pitocco[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent before any activity foreseen by the protocol

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:

1. Type 2 diabetes mellitus or other forms of diabetes, such as steroid-induced or secondary to pancreatectomy, pancreatitis, or secondary to endocrinological disorders

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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)

Locations

Country	Name	City	State
Italy	Università Cattolica del Sacro Cuore	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In 100 subjects with type 1 diabetes it will be evaluated the relationship between time in range, assessed though continuous glucose monitoring, and the score of the depression questionnaire CES-D	Evaluation of the relationship between time in optimal glycemic range (70-180 mg/dl) and scores at depression questionnaire	14 days