NCT03436212已完成不适用
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study
Air Liquide Santé International2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Relationships between glucose levels and insulin doses
研究概览
简要总结
This study aims at describing the glucose level by automated glucose sensors and correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in real-life conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit)
- •Daily insulin requirement ≤ 1.5U/kg/day
- •Having been compliant to take pictures of his/her meals and snacks over the 3 days prior to the inclusion visit
- •Non-selection/Non-inclusion criteria:
- •Pregnant or breastfeeding woman
- •Comorbidity which, in the investigator's opinion, could jeopardize the study completion
- •Patient with difficulties to understand the study procedures or deemed unfit, by the Investigator, to comply with operating instructions of CGM equipment.
排除标准
- 未提供
结局指标
主要结局
Relationships between glucose levels and insulin doses
时间窗: 14 days
To describe the relationships between glucose levels and insulin doses between meals and at meal-times in T2D patients using pumps over 14 days.
次要结局
未报告次要终点
研究者
研究点 (2)
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