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

September 28, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 14 days
Evaluation of the relationship between time in optimal glycemic range (70-180 mg/dl) and scores at depression questionnaire
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5733

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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