NCT01447940Unknown3 期
Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients
University Hospital, Grenoble16 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 720
- 试验地点
- 16
- 主要终点
- HbA1c measured at 12 months in Meos ePoral group versus conventional care group. Non-inferiority level is defined at a 0.15% threshold for an expected HbA1c of 8.5% at 12 months
研究概览
简要总结
Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.
详细描述
Meos is the name of the website (Telemedicine ePortal) tested in this trial ; it is used to share informations between diabetologist and type 1 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient with type 1 diabetes mellitus for ≥ 12 months or more
- •Age > 18 years old
- •Patient who is followed since 6 month into investigator hospital
- •Patient with available internet access at least once a week, and ability to understand MEOS website navigation
- •Patient using a compatible glucose meter (One touch ultra, Optium xceed, or BG star)
排除标准
- •Patient with no easy and regular access to the Internet;
- •Patient found to be unfit for use of the telematic tools or e-mail tools
- •Patient with toxicomania, alcoholism or psychological troubles
- •Type 2 diabetic patients
- •Patient who does not need strict metabolic objectives
- •Pregnant or parturient women
- •Person with no freedom (prisoner)
结局指标
主要结局
HbA1c measured at 12 months in Meos ePoral group versus conventional care group. Non-inferiority level is defined at a 0.15% threshold for an expected HbA1c of 8.5% at 12 months
时间窗: 12 months
次要结局
- Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire(12 months)
- HbA1c measured at 6 months in each group(6 months)
- HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)(6 months)
- HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)(12 months)
- Definition of failure: study withdraws or emergency hospitalization linked to diabetes or HbA1c increase of 0.5 % up to 12 months of follow up(12 months)
- Quality of life at inclusion and 12 months, using the Diabetes Health Profile (DHP-1) scale and the Satisfaction items of the Diabetes Quality of Life (DQOL) questionnaire(12 months)
- Annual cost of diabetes care from hospital and health insurance' points of view(12 months)
- HbA1c measured at 12 months in each group(12 months)
研究者
研究点 (16)
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