Glycemic Outcomes and Safety With Minimed 780G System in Children With Type 1 Diabetes Aged 2-6 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Time in range (glucose between 3.9-10 mmol/l) before and during hybrid close loop insulin pump treatment
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of advanced hybrid-closed loop system, Minimed 780G to glycemic control and safety in children aged 2-6 years with type 1 diabetes.
Additionally, the study evaluates the perceived burden of the diabetes treatment to families during the advanced hybrid-closed loop system treatment (diabetes distress).
This is a prospective, non-randomized, single-arm study, where primary endpoint is the change in TIR after hybrid-closed loop system initiation. Secondary endpoints are safety (number of severe hypoglycaemias and diabetic ketoacidosis, DKA), HbA1c, time below range (TBR), mean sensor glucose (SG), standard deviation of SG, and coefficient of variation (CV).
The inclusion criteria are 1) TDD (total insulin daily dose) ≥ 8 units, 2) HbA1c < 10%, 3) capability to use pump and the CGM, and 4) time from diabetes diagnosis more than 6 months. The exclusion criteria are hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial.
详细描述
BACKGROUND
The treatment of small children's type 1 diabetes (T1D) is challenging. There is often great day-to-day and within-day variability in glucose levels and HbA1c targets are hard to achieve. The results on hybrid closed loop systems (HCL) in children have been encouraging, suggesting that an algorithm, which automatically doses basal insulin based on sensor glucose (SG) levels, improves time in range (TIR) (3.9-10 mmol/l / 71-180 mg/dl) and reduces the time spent below range (TBR). Despite of these improvements, the target level of TIR (70%) has not been reached in these studies.
In pivotal studies, Minimed 780G advanced HCL system has helped children over 7 years old to reach higher TIR and improve mealtime glycaemia without increasing TBR, severe hypoglycaemias or ketoacidosis.
This study evaluates the effectiveness to glycemic control and safety of advanced hybrid-closed loop system, Minimed 780G, in children aged between 2.0-6.99 years, with type 1 diabetes.
The study protocol is explained to the participants (2.0-6.99 year-old children) orally. Informed consent from participants' caregivers and those participants who can write will be taken by investigators, clinicians or diabetes nurses. The investigator will explain the nature of the study to the subject, and answer all questions regarding this study. Prior to any study-related screening procedures being performed on the participant, the informed consent statement will be reviewed and signed and dated by participant's caregiver.
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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total insulin daily dose ≥ 8 units
- •HbA1c < 10%
- •capability to use pump and the CGM
- •time from diabetes diagnosis more than 6 months
排除标准
- •hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial
结局指标
主要结局
Time in range (glucose between 3.9-10 mmol/l) before and during hybrid close loop insulin pump treatment
时间窗: Up to 12 months
Time in range (%) derived from continuous glucose monitoring
次要结局
- The number of severe hypoglycemia before and during hybrid close loop insulin pump treatment(Up to 12 months)
- Diabetes distress before and during hybrid close loop insulin pump treatment(Up to 12 months)
- Number of diabetic ketoacidosis in participant before and during hybrid close loop insulin pump treatment(Up to 12 months)
- HbA1c before and during hybrid close loop insulin pump treatment(Up to 12 months)
研究者
Tero Varimo, MD, PhD
MD, PhD, fellow in pediatric endocrinology, principal investigator
Helsinki University Central Hospital