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

NCT05950477 | Unknown

• 1 other identifier: 5733
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Depression Questionnaires DIAGNOSTIC_TEST

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 diabetic patients at risk of developing a mood disorders and who meet the inclusion criteria will be enrolled. It is estimated that it is necessary to enroll 100 subjects in order to identify an expected correlation coefficient equal to 0.30, with a power of 85% and a probability value α (two-tailed) of 0.05.

You may qualify if:

• Informed consent before any activity foreseen by the protocol
• Age \> 18 years
• 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

You may not qualify if:

• Type 2 diabetes mellitus or other forms of diabetes, such as steroid-induced or secondary to pancreatectomy, pancreatitis, or secondary to endocrinological disorders
• Previous diagnosis of major depression, bipolar disorder, psychotic disorder, eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
• Chronic treatment with corticosteroids
• BMI \<19kg/m2
• Known history of substance or alcohol abuse
• Patients who have recently been admitted to the psychiatry ward or are being treated with psycho-drugs
• Conditions that do not allow participation in the activities envisaged by the protocol

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Università Cattolica del Sacro Cuore

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dario Pitocco

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Pitocco

CONTACT

+390630154071; dario.pitocco@policlinicogemelli.it

Dario Pitocco

CONTACT

+390630155701; dario.pitocco@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: June 12, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2023-06

Locations

IT (1)