Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets - The Steno780G Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin. Only few studies have described long-term use of AID systems over several years. Real-world studies suggest that the beneficial effects of AID systems on glycemic outcomes are sustained over time; however, a modest increase in body weight has been observed in some users, raising concerns about the metabolic trade-offs of improved glycemia. We aim to explore wether the improvements in glycemic outcomes and treatment satisfaction achieved with AID systems remain stable over multiple years, and secondly, if long-term treatment with AID systems may be associated with an increase in body weight.
详细描述
40 participants, who have completed the Steno780G trial, will be invited to attend a follow-up visit at Steno Diabetes Center Copenhagen between 3.5 - 4.5 years after start of AID treatment to assess the long-term effects of the MiniMed 780G system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous participation in the Steno780G study
排除标准
- •Lack of compliance with key study procedures at the discretion of the investigator.
研究组 & 干预措施
Cohort of 780G users
Cohort of 780G users who previously participated in the Steno780G trial
干预措施: 780G AID pump (Device)
结局指标
主要结局
Time in range
时间窗: Last 2 weeks compared with 2 weeks before 780G start
次要结局
- Glycemic variability(last 2 weeks compared with 2 weeks before 780G start)
- Time above and below range(Last 2 weeks compared with 2 weeks before 780G start)
- HbA1c(Compared with HbA1c before 780G)
- Body weight(Compared with bodyweight before 780G start)
- Mean sensor glucose(Last 2 weeks compared with 2 weeks before 780G start)
- Diabetes treatment satisfaction score(compared with DTQS before 780G start)
- Hypoglycaemia Fear Survey scores(Compared with before 780G start)
- Diabetes Distress Scale scores(compared with before 780G start)