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
- 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
- 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
- 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)
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 insulin requirements(Three months)
- changes in time below range (TBR)(Three months)
- changes in coefficient of variation (CV)(Three months)
- changes in time in range (TIR) levels(Three months)
- changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization(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