Aspects of Diabetes Technology (Insulin Pumps) Children Perspective, a Cross - Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Confidence in diabetes self care questionnaire (CIDS)
研究概览
简要总结
This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level )
Hypothesis:
Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy.
Aim of the Work:
To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Type 1 diabetes mellitus.
- •2.Patients who are on insulin pumps must be for at least 3 months on them
排除标准
- •Other types of DM e.g., T2DM, MODY.
- •Patients with other comorbidities; cardiac, renal, neurological, hepatic ....etc.
结局指标
主要结局
Confidence in diabetes self care questionnaire (CIDS)
时间窗: 10 min
the CIDS scale, assessment included HbA1c, emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons.
socioeconomic level of the family scale
时间窗: 5 minutes
Assessment of family socioeconomic standard
MINI-KID (Mini International Neuropsychiatric Interview )
时间窗: 25 minutes
Mini International Neuropsychiatric Interview for Children and Adolescents
Evaluation of health-related quality of life (HRQL)
时间窗: 5 minutes
HRQL was measured by the Peds-QL 4.0 11,22. The 23-item Peds-QL 4.0 generic core scales encompass (a) physical functioning (eight items), (b) emotional functioning (five items), (c) social functioning (five items), and (d) school functioning (five items). The physical health summary score (eight items) is the same as the physical functioning scale. To create the psychosocial health summary score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the emotional, social, and school functioning scales.
次要结局
未报告次要终点