Clinical Efficacy of OneTouch® Verio™IQ Meter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- number of hypoglycemic events
研究概览
简要总结
Diabetes mellitus is one of the most prevalent disease in the western world. The control of glucose levels has a big impact in the prevention of diabetes complications. The measure of glucose levels in capillary blood with glucometers is the gold standard to measure and control the glucose levels. Nowadays the glucometers become to more precise and sophisticated devices. One of the most notables advance is the inclusion of software that cam predicts glucose trends. This software has not be tested in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with diabetes mellitus 1 or 2
- •Treatment with insulin regimen during at least 12 months
- •Capability of performed 3 glucose measurement per day
- •Levels of glycated hemoglobin (A1C) less than 10%
排除标准
- •Patients diagnosed of mental disorders
- •Patients included in structured therapeutic health 6 months before the inclusion
- •Patients included in any clinical trial in the 4 months before the inclusion
研究组 & 干预措施
Verio Pattern Alert® activated
In this cohort, the patients will monitoring the glucose levels with capillar glucometer and they have activated the software Verio Pattern Alert® that could predict the glucose trends.
干预措施: Verio Pattern Alert® activated (Device)
Verio Pattern Alert® deactivated
In this cohort, the patients will monitoring the glucose levels with capillar glucometer.
干预措施: Verio Pattern Alert® deactivated (Device)
结局指标
主要结局
number of hypoglycemic events
时间窗: 20 months
Glucose levels under 70 mg/dL with or without clinical manifestation
次要结局
未报告次要终点