Effect of Continuous Subcutaneous Insulin Injection in Pediatric Patients With Type 1 Diabetes Using Multiple Daily Insulin Injections
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
Prospective, randomized, open-label, two-sequence crossover study to investigate the effects of continuous subcutaneous insulin injection (CSII, using DIA:CONN G8 insulin pump) in pediatric patients with type 1 diabetes using multiple daily insulin (MDI) injection
详细描述
This trial consists of two crossover periods of 5 weeks each (MDI to CSII or CSII to MDI), followed by an extended period of 12 weeks (MDI or CSII). Each intervention period has wash-out period (5 days) excluded from the outcome measurements.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is aged 2-17
- •The subject with one or more of the below at diagnosis
- •serum c-peptide < 0.6 ng/mL
- •positive glutamic acid decarboxylase (GAD) antibody
- •positive Islet cell antibody
- •positive anti-Insulin antibody
- •positive anti-Islet Antigen-2 (IA-2) antibody
- •The subject was diagnosed with type 1 diabetes ≥ 1 year
- •The subject is treated with multiple daily insulin injection
- •The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.
排除标准
- •Subjects who were treated with insulin pump therapy within 12 weeks prior to trial
- •Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
- •Subjects with underlying hematologic disorders that can affect the HbA1c levels
- •Subjects with underlying medical disorders that can affect glucose metabolism
- •Subjects with a neuropsychiatric disorder such as depression or eating disorder
- •Subjects with underlying thyroid disorders and abnormal thyroid function
研究组 & 干预措施
Continuous subcutaneous insulin infusion
Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring
干预措施: DIA:CONN G8 insulin pump (Device)
Multiple daily insulin injection
Multiple daily insulin injection with continuous glucose monitoring
干预措施: Multiple daily insulin injection (Other)
结局指标
主要结局
Time in range
时间窗: 30 days
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
次要结局
- Coefficient of variation(30 days)
- Glycated albumin(Changes from baseline to after 30 days of intervention)
- Children's Depression inventory of patients(At the end of intervention (30 days))
- Time above range(30 days)
- Mean sensor glucose(30 days)
- Quality of life measurements (diabetes-specific) of patients and parents(At the end of intervention (30 days))
- Perceived stress scale of parents(At the end of intervention (30 days))
- Quality of life measurements (general) of patients and parents(At the end of intervention (30 days))
- Time below range(30 days)
- Glucose management indicator(30 days)
研究者
Choong Ho Shin
Professor
Seoul National University Hospital