Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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
时间窗: 14 days
Evaluation of the relationship between time in optimal glycemic range (70-180 mg/dl) and scores at depression questionnaire
次要结局
未报告次要终点