Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Time spent in glucose target (%) (3.9 - 10 mmol/l)
研究概览
简要总结
This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep
详细描述
Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metabolic control . This study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control.
It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (CL) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting in poorly controlled type 1 diabetes adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents
排除标准
- •Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
- •Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.
- •More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months
研究组 & 干预措施
closed loop glucose control system
Closed loop glucose control system
干预措施: closed loop glucose control system (Device)
CSII Pump treatment
CSII Pump treatment without the integrated algorithm and glucose sensor
结局指标
主要结局
Time spent in glucose target (%) (3.9 - 10 mmol/l)
时间窗: 4 week treatment arms
Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.
次要结局
- User experience after the 4 week treatment(4 week intervention)
- Quality of life perception in adolescents(4 week treatment periods)
- Severe hypoglycaemic events(4 week treatment arms)
- Severe Diabetes ketoacidosis(4 week treatment arms)
- Family Responsibility perception(4 week treatment periods)
- Use of the automated closed loop system (% time)(4 week treatment arm)
- Use of the CGM during closed loop(4 week treatment arm)
- Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)(4 week treatment arms)
- Time spent above glucose target (%) (> 10 mmol/l)(4 week treatment arms)
研究者
Carine de Beaufort
Guest professor
Centre Hospitalier du Luxembourg