Clinical trial NCT05950477: Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
Official title: Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Dario Pitocco
role: PRINCIPAL_INVESTIGATOR
References: