Psychological Aspects and Continuous Subcutaneous Insulin Infusion in Type 1 Diabetic Adults.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline glycosylated haemoglobin (HbA1c) at 6th, 12th and 24th months after transition to CSII.
研究概览
简要总结
The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological distress and some psychological factors might be predictors of metabolic control; however, very few studies conducted so far were specifically focused on the psychological aspects of CSII therapy in adults affected by T1DM.
详细描述
The aim of this project is to study the psychological effect of Continuous Subcutaneous Insulin Infusion (CSII) in a cohort of type 1 diabetic patients and to explore the influence of psychological factors (coping style, locus of control, self-efficacy) on glycaemic control. A sample of 36 type 1 diabetic patients will be recruited at Endocrinology, Diabetes and Metabolism Division of Verona City Hospital.
Among T1DM patients routinely followed by our Institution the study will be proposed to those starting the CSII therapy based on the inclusion and exclusion criteria.
Each study participants will provide a written informed consent and will undergo a set of 4 psychological evaluation assessing depression, anxiety, self-efficacy, perceived interference caused by diabetes, family support, locus of control and coping strategies on top of routine medical examination and laboratory testing for outcome measures at baseline and after 6, 12 and 24 months after study entry.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes
- •Transition to CSII
- •Age >18 years
排除标准
- •Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
- •Pregnancy
结局指标
主要结局
Change from baseline glycosylated haemoglobin (HbA1c) at 6th, 12th and 24th months after transition to CSII.
时间窗: Baseline, 6, 12 and 24 months
Glycosylated haemoglobin (HbA1c) is a lab test that shows the average level of blood glucose over the previous 3 months. HbA1c is used in the present study as measure of the glycaemic control: it will be assessed at baseline, after 6, 12 and 24 months.
次要结局
- Change from baseline glucose variability as measured by standard deviation (SD) and coefficient of variation (CV) of capillary blood glucose test [mg/dL] at 6th, 12th and 24th months after transition to CSII.(Baseline, 6, 12, 24 months)
- Change from baseline glucose variability as measured by the Low Blood Glucose Index (%LBGI) at 6th, 12th and 24th months after transition to CSII.(Baseline, 6, 12, 24 months)
- Change from baseline glucose variability as measured by High Blood Glucose Index (%HBGI) at 6th, 12th and 24th months after transition to CSII.(Baseline, 6, 12, 24 months)
- Change from baseline depressive symptoms at 6th,12th and 24th months (BDI-II score)(Baseline, 6, 12, 24 months)
- Change from baseline anxiety symptoms at 6th,12th and 24th months (BAI score)(Baseline, 6, 12, 24 months)
- Change from baseline general perceptions of diabetes at 6th, 12th and 24th months (MDQ Section 1 score)(Baseline, 6, 12, 24 months)
- Change from baseline family support at 6th, 12th and 24th months (MDQ section II score)(Baseline, 6, 12 and 24 months)
- Change from baseline Diabetes Self-Efficacy at 6th, 12th and 24th months (MDQ section III score)(Baseline, 6, 12, 24 months)
- Determination of Health Locus of Control (MHLC) at Baseline(Baseline)
- Measures of Coping Strategies at Baseline(Baseline)
研究者
Maddalena Trombetta
MD, PhD
Universita di Verona