Evaluation of the Association Between Depression and Glyc... | NCT05950477

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

NCT05950477

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

May 29, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Type 1 Diabetes

Interventions

Depression Questionnaires

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2023Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Jul 10, 2023

First Submission Date that Met QC Criteria

Jul 10, 2023

First Posted Date

Jul 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2024

Last Update Posted Date

May 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dario Pitocco	Contact	+390630154071		dario.pitocco@policlinicogemelli.it
Dario Pitocco	Contact	+390630155701		dario.pitocco@policlinicogemelli.it

Overall Officials

Name	Affiliation	Role
Dario Pitocco	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Università Cattolica del Sacro Cuore	Recruiting	Roma		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided