Real-life Data From Diabetic Patients on Closed-loop Pumps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 5
- 主要终点
- HbA1c Level
研究概览
简要总结
To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.
详细描述
In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes mellitus (T1DM). Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type I diabetic
- •with a closed-loop insulin pump
排除标准
- •under legal protection order
- •patient or legal guardian objecting to the use of the data in the research
研究组 & 干预措施
Type I diabetic patient
干预措施: closed-loop insulin pump (Device)
结局指标
主要结局
HbA1c Level
时间窗: At 3 months
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
次要结局
- HbA1c Level(At 6 months)
- HbA1c Level(At 12 months)
- Time in Range(At 3 months)
- Time in Range(At 6 months)
- Time in Range(At 12 months)
- Time Below Range(At 3 months)
- Time Below Range(At 6 months)
- Time Below Range(At 12 months)
- Time Above Range(At 3 months)
- Time Above Range(At 6 months)
- Time Above Range(At 12 months)
- Coefficient of Variation(At 3 months)
- Coefficient of Variation(At 6 months)
- Coefficient of Variation(At 12 months)
- HbA1c Level(at 18 months)
- Time in Range(at 18 months)
- Time Below Range(at 18 months)
- Time Above Range(at 18 months)
- Coefficient of Variation(at 18 months)