A Pilot Study to Assess Closed-loop Insulin Delivery to Regulate Glucose Levels in Children With Type 1 Diabetes in Outpatient Free-living Settings.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
The objective of this clinical trial is to assess the safety of our insulin dosing algorithm in children with type 1 diabetes in a free-living study.
详细描述
This is a preliminary pilot study to generate data to optimize an insulin dosing algorithm to regulate glucose levels in children with type 1 diabetes. There will be up to two 40-hour test in outpatient settings, in which we will assess an insulin dosing algorithm. The two tests will allow us to compare different tunings in the same patient (this allows easier interpretation of the data). For example, if in a specific participant, the dosing algorithm reduced insulin delivery at night to avoid low blood glucose levesl but led to a rebound increase in glucose levels, then a second visit with a slightly different target range will help answer this question. The objective of this clinical trial is to assess the safety of our algorithm in children with type 1 diabetes in a free-living study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children between 2 and 13 years of age.
- •Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).
- •Using insulin pump therapy for at least 3 months
- •For participants aged 7-13 years: Total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. For participants aged 2-6 years: Total daily insulin dose [8, 40] units and 0.3 ≥ units/kg/day.
- •Most recent (in the last 6 months) HbA1c ≤ 12%.
排除标准
- •Using Medtronic 670G automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670G; generally overestimated by 20%).
- •Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission.
- •Medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
结局指标
主要结局
Time in range
时间窗: 40-hour intervention
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
次要结局
- Specific nighttime time in range(40-hour intervention)
- Coefficient of variance of glucose levels and insulin delivery(40-hour intervention)
- Mean glucose levels(40-hour intervention)
- Specific time in range(40-hour intervention)
- Standard deviation of glucose levels and insulin delivery(40-hour intervention)
- Total insulin delivery(40-hour intervention)