Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Variations in HbA1c
研究概览
简要总结
The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).
Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age 7 years or older at baseline
- Diagnosis of type 1 diabetes
- Current use of a predictive low glucose suspend insulin pump (740G)
- At least 30% of subjects must have an HbA1c > 7,5% (58 mmol/mol)
排除标准
- Age < 7 years or ≥ 18 years at baseline
- Diabetes duration < 1 year at baseline
- HbA1c ≤ 7% (53 mmol/mol)
- Not meeting the Romanian national standards for closed-loop insulin pump therapy
- Other criteria deemed inappropriate by the principal investigator (to be documented)
研究组 & 干预措施
780G
Patients in this arm will receive a 780G for three months.
干预措施: Switching to the Medtronic 780G insulin pump (Device)
结局指标
主要结局
Variations in HbA1c
时间窗: Three months
Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
次要结局
- changes in time in range (TIR) levels(Three months)
- changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization(Three months)
- changes in insulin requirements(Three months)
- changes in time below range (TBR)(Three months)
- changes in coefficient of variation (CV)(Three months)
- changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores(Three months)
研究者
Ioacara Sorin
Assoc. Prof. Dr.
ELIAS Emergency University Hospital
研究点 (2)
标识符
- NCT 编号
- NCT06326489
- 其他研究编号
- 105122023-1/05.12.2023, ERP-2023-13520
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否