Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ
研究概览
简要总结
This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.
详细描述
Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials.
To date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology.
Given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 16 years
- •Patient with diabetes type
- •Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/
- •Follow-up patient in Centre Hospitalier Sud Francilien
排除标准
- •Women who had pregnancy within 12 months of system initiation.
- •Patient who have been treated with both systems within 12 months.
- •Patient or parental authority objecting the use of data
结局指标
主要结局
Comparison of glycemic control obtained under closed loop according to the system used: SG versus CIQ
时间窗: at 12 months
Time spent in target range (between 70 and 180 mg/dL) after 12 months following initiation of the closed-loop system, as measured by continuous glucose monitoring (CGM).system, as measured by continuous glucose monitoring (CGM).
次要结局
- Glycemic coefficient of variation (CV)(at 12 months)
- Time below target (< 70 mg/dL)(at 12 months)
- glucose management indicator(at 12 months)
- HBA1c(at 12 months)
- weight daily insulin dose(at 12 months)
- daily insulin dose(at 12 months)