DRKS00027405已完成未知
Evaluation of the Impact of Vitadio on HbA1c in Patients with Type 2 Diabetes mellitus in daily practice - EIVE
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 149
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Type 2 diabetes patients benefitting from improved self-management
- •Patients not having used Vitadio in the past
- •Patients using/willing to use Vitadio as part of their diabetes management
- •HbA1c at baseline = 7.5 % and = 11.0 %
- •Patients with internet access and a computer and/or smartphone compatible with Vitadio
- •Digital literacy to use a smartphone adequately and willing to use it for their diabetes self-management
- •Sufficient understanding of user interface (UI) of Vitadio
- •Patients currently adjusting their diabetes management and lifestyle based on the self-testing of blood glucose at home
- •Participants willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures
- •Participants capable of giving personal signed informed consent
排除标准
- •Patients using other Apps for their diabetes management
- •Patients who have been using Vitadio in the past twelve months
- •Patients with impairments – including mental or psychic impairments – or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study
- •Patients under 18 years of age
- •Patients already using an insulin pump
- •Patients currently participating in a weight loss program
- •Steroid therapy within the last three months; topic or inhaled use is no exclusion criterion when not used regularly (more than five times a week)
- •Uncontrolled blood pressure = 200 mmHg at screening
- •Body mass index (BMI) > 40 kg/m²
- •Current pregnancy or pregnancy planned during the study, or breastfeeding women
- •Alcohol or drug abuse within the last three months
- •Patients with home health aides who assist with their BG testing and/or insulin adjustment
- •Current participation in another trial or study
- •Employees of Vitadio s. r. o., or any other institution carrying out the study or being involved in conducting/ organizing/ coordinating/ financing the trial
研究者
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