Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Study device acceptance
研究概览
简要总结
This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus type 1
- •Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
- •Age below 6 years
- •Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
- •Signing on an Inform Consent Form
排除标准
- •Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
- •primary care giver not skilled enough to comment in a qualitative way
结局指标
主要结局
Study device acceptance
时间窗: after 12 weeks
We will assess study device acceptance using a distinct Acceptance Questionnaire
Diabetes Treatment Satisfaction
时间窗: after 12 weeks
we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires
次要结局
- postprandial SMBG (self monitoring blood glucose)(after 12 weeks)
- Number of Diabetic Ketoacidosis (DKA) events(after 12 weeks)
- Overall number of BG (Blood glucose) measurements(after 12 weeks)
- Mean Blood Glucose level(after 12 weeks)
- Number of Hyperglycemia Events(after 12 weeks)
- HbA1c(after 12 weeks)
- Number of Hypoglycemia Events(after 12 weeks)
- Number of ketosis events(after 12 weeks)
- preprandial SMBG (self monitoring blood glucose)(after 12 weeks)