DRKS00024861已完成未知
Randomized controlled trial to evaluate the digital health application My Dose Coach
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 251
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
- •Diagnosed type 2 diabetes (E11)
- •- Indication for therapy with basal insulin in combination with oral antidiabetic agents
- •- Age = 18 years
- •- HbA1c value> 7.5% or 58.5 mmol / mol and <10.0% or 85.6 mmol / mol (last measured HbA1c value from the patient file)
- •- Use of a smartphone compatible with the My Dose Coach app (iPhone models 5 and higher with iOS 10 or higher; Android version 4.4 or higher)
- •- Willingness to consent to the terms and conditions of the My Dose Coach app
- •- Knowledge of German, spoken and written
- •- Existence of a written declaration of consent for participation in the study
排除标准
- •- Treatment with prandial insulin (mealtime insulin)
- •- Body Mass Index (BMI) <25 kg / m2
- •- Renal insufficiency (GFR <30 ml / min)
- •- The presence of an acute psychiatric illness which, in the opinion of the investigator, affects the patient's ability to properly carry out the diabetes therapy or the study
- •- Use of another titration app
- •- Lack of consent due to limited legal capacity or legal support
- •- Dependency on the sponsor or the clinical investigator (e.g. employees of the sponsor or a trial center and their family members)
- •- Simultaneous participation in another clinical study
研究者
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