NCT06414564招募中不适用
Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time In Range (TIR)
研究概览
简要总结
Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes
详细描述
This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is age 7-19
- •The subject with one or more of the below
- •serum c-peptide ≤ 0.6 ng/mL at diagnosis
- •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 has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods [insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)]
- •The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study
排除标准
- •Any systemic treatment with drugs known to interfere with glucose metabolism within 8 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
结局指标
主要结局
Time In Range (TIR)
时间窗: baseline (3 weeks) and intervention (12 weeks) period
glucose level between 70-180 mg/dL derived from continuous glucose monitoring
次要结局
- Coefficient of variation (CV)(baseline (3 weeks) and intervention (12 weeks) period)
- Time Above Range (TAR)(baseline (3 weeks) and intervention (12 weeks) period)
- Glycated albumin(before and at the end of intervention, which in average lasts 12 weeks)
- HbA1c(before and at the end of intervention, which in average lasts 12 weeks)
- Time Below Range (TBR)(baseline (3 weeks) and intervention (12 weeks) period)
- mean sensor glucose(baseline (3 weeks) and intervention (12 weeks) period)
- Quality of life measurements (general) of patients and parents(baseline (3 weeks) and intervention (12 weeks) period)
- Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients(baseline (3 weeks) and intervention (12 weeks) period)
- Glucose management indicator (GMI)(baseline (3 weeks) and intervention (12 weeks) period)
- Quality of life measurements (diabetes-specific) of patients and parents(baseline (3 weeks) and intervention (12 weeks) period)
研究者
Lee Young Ah
Associate professor
Seoul National University Hospital
研究点 (2)
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