Use of MiniMed 780G System in Children and Adolescents, a French Real Life Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time spent with glucose levels below range
研究概览
简要总结
Hybrid closed-loop technology have shown that it improves glycemic control parameters, but the investigators do not have sufficient data at more than 6 months of follow-up, allowing us to describe the effectiveness of these systems in the long term.
All MiniMed 780G system users from November 2020 to March 2022 were included (n=32) For every time points, there was a significant difference in Time In Range between the pre-AHCL and post-AHCL. Noted difference were +14.5% and, +10.8% at respectively 3 months and 1 year. No more hypoglycemia were identified.
This "real-life" analysis shows that the algorithm is effective in improvement of metabolic control for T1 diabetic children and adolescents, at one year of follow-up.
However, an effect of breathlessness is observed which underlined the need for a solid therapeutic education program.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time spent with glucose levels below range
时间窗: 1 year
Time spent with glucose levels inferior to 70mg/dL
Time spent with glucose levels above range
时间窗: 1 year
Time spent with glucose levels superior to 180 mg/dL
Glycated hemoglobin
时间窗: 1 year
Percentage of glycated hemoglobin measured by the MiniMed 780G system
Time spent in range Level with glucose levels within the norm
时间窗: 1 year
Time spent with glucose levels between 70 and 180 mg/dL
次要结局
未报告次要终点