NCT04155996终止不适用
Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
ValoTec1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Data collection - Number of steps
研究概览
简要总结
The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patient (T2D) with HbA1c ≥ 8% in the month prior to inclusion
- •Patient is treated with oral anti-diabetics and / or analogous combined with basal insulin therapy (1 injection of slow-acting insulin in the evening)
- •Age ≥ 35 years
- •Diabetes diagnosis done over 1 year ago
- •Patient accepting for 2 periods of 14 days spaced at most 3 days to wear a Freestyle glucose meter, a bracelet for measuring physical activity and to log daily life events in a dedicated smartphone application
- •Patient is able to use a smartphone
- •Patient is affiliated to the French health insurance system
排除标准
- •Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
- •Patient is treated with a rapid-acting insulin
- •Patient has had a severe hypoglycaemia in the year preceding inclusion
- •Patent has a severe renal insufficiency (defined by a Glomerular Filtration Rate below 30 ml/min)
- •Patient has had a myocardial infarction or other life-threatening medical condition in the last 6 months
- •Patient has cognitive disorders or evolutionary psychiatric pathology
- •Pregnant woman or woman likely to be pregnant, breastfeeding woman
- •Patient plans to travel outside europe during the study
- •Patient is participating to another clinical study
结局指标
主要结局
Data collection - Number of steps
时间窗: 28 days
Patients wear an activity tracker that will record their number of steps over time.
Data collection - Blood glucose levels
时间窗: 28 days
Patients wear a continuous glucose monitoring patch and record blood glucose level measurements (in mg/dl) over time.
Data collection - Sleep hours
时间窗: 28 days
Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime.
次要结局
- Data collection - Medical treatment information(28 days)
- Data collection - Daily meals information(28 days)
- Data collection - Physical activity information(28 days)
研究者
研究点 (1)
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