NCT02655666终止不适用
Qingdao: Insulin Pump Follow-up Program
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (A1C)
研究概览
简要总结
The purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.
详细描述
This is a prospective, multi-center, non-randomized and noninterventional post-market release study. Subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (CSII) pump over the course of the study. During the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (RT) data to the pump. The duration of each study phase is approximately 6 months.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age < 18 years at time of screening
- •Subject has a clinical diagnosis of type 1 diabetes
- •Subject is willing to perform required sensor calibrations
- •Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study
- •Subject is a participant in the Qingdao project.
排除标准
- •Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks
- •Subject has known hypersensitivity to insulin or insulin infusion set(including tape)
- •Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting:
- •For example, subjects who have used insulin pump and/or real time CGM/sensor in the inpatient setting will still be eligible for enrollment.
- •For example, subjects who have used insulin pump and/or real time CGM/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment.
- •For example, subjects who have worn the insulin pump and/or real time CGM/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment
- •Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral anti-diabetic agents.
- •Subject has any systemic disease or medical condition found on screening that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study.
- •Subject is being treated for hyperthyroidism at time of screening
- •Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- •Subject is currently abusing alcohol
- •Any condition that either the Investigator believes would interfere with study participation or evaluation of results.
结局指标
主要结局
Change in Glycosylated Hemoglobin (A1C)
时间窗: Change in A1C from baseline to end of study (1 year)
The change of A1C from baseline to end of study (1 year) will be presented
次要结局
- Number of Events in the Hypoglycemic Range(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Number of Events in the Hyperglycemic Range(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Area Under Curve in the Hypoglycemic Range(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Average Glucose Values Based on Continuous Glucose Monitoring Data(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data(Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).)
- Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Area Under Curve in the Hyperglycemic Range(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Percentage of Time in the Hypoglycemic Range(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
- Percentage of Time in the Hyperglycemic Range(Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).)
研究者
研究点 (1)
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