DRKS00022923已完成未知
Randomized controlled trial to evaluate the digital health application mySugr PRO
Roche Diabetes Care GmbH - DCSDB0 个研究点目标入组 424 人开始时间: 2020年10月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 424
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
- 16 Years 至 one（—）
- 性别
- All
入选标准
- •? Diagnosed type 1 diabetes (E10) or type 2 diabetes (E11) or gestational diabetes (O24.4)
- •? Carrying out regular, daily blood sugar measurements and using the blod glucose values to carry out or adjust diabetes therapy
- •? Age = 16 years
- •? Last measured HbA1c value <12% or 107.6 mmol / mol
- •? Use of a smartphone compatible with the mySugr PRO (Android 5.0 or higher; iOS 11.4 or higher)
- •? Willingness to consent to the terms and conditions of the mySugr PRO
- •? Knowledge of spoken and written German
- •? Given written declaration of consent to participate in the study.
- •For adolescents: a written declaration of consent for participation in the study must be available both from the adolescent himself and from a legal guardian
排除标准
- •? Use of continuous glucose measurement systems (rtCGM, isCGM)
- •? Use of a digital diabetes diary or a (diabetes) app for digital therapy documentation in the last 3 months
- •? Existence of an acute psychiatric illness which, in the opinion of the investigator, impairs the patient's ability to properly carry out the diabetes therapy or the study
- •? In adults (= 18 years): Lack of consent due to restricted legal capacity or legal support
- •? Dependency on the sponsor or the clinical investigator (e.g. employees of the sponsor or a test center and their family members)
- •? Simultaneous participation in another clinical study
研究者
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