评估罗马尼亚 1 型糖尿病儿童过渡到先进混合闭环胰岛素泵治疗的疗效和生活质量影响
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Sector 1
-
Bucharest、Sector 1、罗马尼亚、011461
- Elias University Emergency Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：780G
Patients in this arm will receive a 780G for three months. |
Patients using a Medtronic 740G insulin pump will receive the 780G model for three months |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Variations in HbA1c
大体时间：Three months
|
Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
changes in insulin requirements
大体时间：Three months
|
changes in insulin requirements between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in time in range (TIR) levels
大体时间：Three months
|
changes in time in range (TIR) levels between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in time below range (TBR)
大体时间：Three months
|
changes in time below range (TBR) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in coefficient of variation (CV)
大体时间：Three months
|
changes in coefficient of variation (CV) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization
大体时间：Three months
|
changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores
大体时间：Three months
|
changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Scores are transformed on a scale from 0 to 100. Higher scores = Better Quality of Life |
Three months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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