DRKS00011246已完成不适用
Performance of mylife YpsoPump in routine care of adults and adolescents with type 1 diabetes: Effectiveness and Safety of a touch screen based insulin infusion pump in a non-interventional Study (The YES-Study) - YES-Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ypsomed AG
- 入组人数
- 82
研究概览
简要总结
CSII therapy was safe and effective in adult user of the mylife YpsoPump system in this observational, multicentre study with a follow-up duration of 12 months. Metabolic control and treatment satisfaction improved in patients switching from Multiple Daily Injection to CSII therapy. Metabolic control was stable and treatment satisfaction was maintained in patients switching from competitive insulin infusion pumps to mylife YpsoPump. Study results do not indicate safety issues that need to be addressed. Overall study results confirm that the YpsoPump system is safe for use and performs as intended under everyday conditions.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 Years 至 one（—）
- 性别
- All
入选标准
- •Male or female with type 1 diabetes
- •- Age at least 12 years
- •- Indikation for a insulin pump
- •- Patient has decided for the mylife YpsoPump and has a prescription for this pump
- •- Patient is expected for visits each 3 months within the next 12 months at the study center
- •- Signed informed consent
排除标准
- •- Not cured malignant diseases
- •- Chronic systemic glucocorticoid therapy
- •- Contraindications for insulin pump use:
- •– Lack of motivation or reliability (e.g. lack of blood glucose self-monitoring)
- •– Missing documentation of blood glucose self-monitoring and self-therapy
- •– Severe psychiatric problems or problems caused by an addiction (alcohol, drugs)
- •– Patients who the investigator believes to be ineligible for participating in the study or using the YpsoPump (e. g. visual acuity, hearing capacity, therapy compliance, etc.)
- •- Individuals who are either dependent on or employed by sponsor or investigator
- •- Prisoners or adults under guardianship
研究者
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