Portable Artificial Pancreas Applied for Youth and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared.
This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.
详细描述
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In previous studies, we tested the performance and safety of this bi-hormonal closed-loop system in an outpatient setting in patients with type 1 diabetes mellitus (T1DM) for a duration up to 2 weeks, leading to CE-marking of the system. The device is currently intended for insulin-dependent adult patients with diabetes. However, there is great need to improve glycaemic control in youth and adolescents with diabetes.
Objective of the study:
The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: to assess the safety of the closed-loop system; to determine the time that the closed-loop algorithm is active; and to assess expectations and treatment satisfaction of the closed-loop system.
Study design:
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
- •Diagnosed with type 1 diabetes mellitus
- •Twelve to eighteen years old;
- •Treated with insulin therapy for at least 6 months;
- •Willing and able to sign informed consent or to assent to study participation.
排除标准
- •Impaired awareness of hypoglycaemia (score ≥ 4) according to Gold and/or Clarke questionnaire[6,7];
- •BMI ≥ 35 kg/m2;
- •Pregnancy and/or breastfeeding;
- •HbA1c > 97 mmol/mol (11.0%);
- •Use of acetaminophen (paracetamol) during the open loop or closed-loop period,as this may influence the sensor glucose measurements;
- •Limited ability to see, hear or feel the alarm signals of the closed-loop system;
- •Unwillingness to act in response to the alarm signals;
- •Living alone during the night during the closed-loop period (the patient may ask someone to stay over temporarily);
- •Expected poor internet connectivity regarding 24/7 tele monitoring;
- •Any condition that the local investigator feels would interfere with trial participation or evaluation of the results.
结局指标
主要结局
Time in range
时间窗: 2 weeks
The proportion of time spent in the range of 3.9-10.0 mmol/L in %
次要结局
- Time in hypoglycemia 2(2 weeks)
- Median glucose concentration(2 weeks)
- Median glucose concentration during the day (6AM - 12PM)(2 weeks)
- Time in hypoglycemia 1(2 weeks)
- Time in hyperglycemia 2(2 weeks)
- Time in hyperglycemia 1(2 weeks)
- Mean glucose concentration(2 weeks)
- Mean glucose concentration during the day(2 weeks)
- Time spent in hyperglycemia during the night(2 weeks)
- Time spent in euglycemia during the day(2 weeks)
- Algorithm active time(2 weeks)
- Glycemic variability - Coefficient of variation(2 weeks)
- Glycemic variability - Interquartile range(2 weeks)
- Mean glucose concentration during the night (12PM - 6AM)(2 weeks)
- Median glucose concentration during the night (12PM - 6AM)(2 weeks)
- Time spent in hypoglycemia during the night(2 weeks)
- Time spent in euglycemia during the night(2 weeks)
- Time spent in hypoglycemia during the day(2 weeks)
- Time spent in hyperglycemia during the day(2 weeks)
- Expectations(2 weeks)
- Trust(2 weeks)
- Satisfaction(2 weeks)