Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery: The RENEW Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in glycated haemoglobin (HbA1c)
研究概览
简要总结
The Medtrum TouchCare Nano system with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic. However, until now, no prospective clinical study has evaluated its efficacy and safety under real-world conditions. The RENEW study is the first to address this topic.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with T1D
- •type 1 diabetes for ≥1 years
- •≥ 18 years old
- •written informed consent prior to starting study related activity
排除标准
- •severe noncompliance
- •lactation, pregnancy, intending to become pregnant during study
- •use of medication with effects on carbohydrate metabolism
研究组 & 干预措施
Patients with TouchCare Nano A8 insulin pump with the APGO system
Patients with type 1 diabetes, who initiated use of the TouchCare Nano A8 insulin pump with the APGO system.
干预措施: Device: Insulin pump TouchCare Nano A8 with the APGO system (Device)
结局指标
主要结局
Changes in glycated haemoglobin (HbA1c)
时间窗: Up to 24 months
Differences between HbA1c values in the Visit 0 and Visit 24
Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl)
时间窗: Up to 24 months
Differences between percentage of time in target ranges in the Visit 0 and Visit 24
次要结局
- Changes in glycemic variability expressed as the coefficient of variation (%)(Up to 24 months)
- Changes in percentage of time in hypoglycemic ranges <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)(Up to 24 months)
- Changes in percentage of time in hyperglycemic ranges >10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)(Up to 24 months)
- Changes in percentage of time in tight target ranges 3,9-7,8 mmol/L (70-140 mg/dl)(Up to 24 months)
- Changes in average glycemia (mmol/L)(Up to 24 months)
- Changes in estimated glycated haemoglobin GMI (%)(Up to 24 months)
- Time spent in automated insulin delivery mode(Up to 24 months)