NCT05096325已完成不适用
YpsoPump Occlusion Detection Algorithm: Collection of Real-world Data for In-silico Evaluation of a New Software Algorithm to Refine Occlusion Detection in Subjects With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
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
- 40
- 试验地点
- 2
- 主要终点
- Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system.
研究概览
简要总结
A common difficulty related to the insulin pumps are occlusions of the insulin infusion set (IIS). This study aims to evaluate the performance of a new software algorithm to detect catheter-occlusion in silico in order to refine the current automated occlusion detection algorithm of the mylife™ YpsoPump®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written Informed Consent
- •Subject is diagnosed with T1D
- •Subject on CSII (except patch pumps) for at least 6 months
- •Subject using any type of insulin approved for mylife™ YpsoPump®: Fiasp®, NovoRapid®, Humalog®, Apidra®, Lispro Sanofi
- •Subject using a CGM system for at least 6 months
- •Subject willing to continue CSII with mylife™ YpsoPump® during the study
- •Subject willing to use CGM system during the study
- •If the subject wants to use the CGM smartphone app instead of a receiver: Subject ensures to use a compatible smartphone and is willing to share CGM for the duration of the study
- •HbA1c < 9.5% (based on last measurement by treating physician)
排除标准
- •Known allergy/hypersensitivity to medical grade adhesives and/or to physical activity tracker material
- •Known severe nickel allergies
- •History of frequent catheter abscesses associated with pump therapy
- •Treatment with > 1000 mg of acetaminophen every 6 hours
- •Treatment with hydroxyurea
- •Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
- •Severe late complications of diabetes mellitus, e.g. severe macro- and/or micro-angiopathy (as determined by the investigator)
- •Known hypoglycaemia unawareness
- •Occurrence of self-reported severe hypoglycaemia event requiring third-party assistance within the last 6 months prior to study start
- •Occurrence of self-reported diabetic ketoacidosis requiring healthcare assistance within the last 6 months prior to study start
- •Participation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation
- •Female subjects: pregnancy, lactation period, lack of a negative urine pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use a contraception during the study (for sexually active subjects of childbearing potential)
- •Dependency from the sponsor or the clinical investigator
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
结局指标
主要结局
Difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system.
时间窗: 28 days
The primary outcome is the difference in the number of occlusion alarms generated by the new software algorithm compared to the currently implemented occlusion detection system throughout the study phase (28 days). The currently implemented method is considered as reference test. Missed alarms using the FIR filter algorithm are considered as false negative alarms while any additional alarm that is detected by the FIR filter algorithm but that was not triggered by the current reference method is considered as false positive.
次要结局
- Qualitative evaluation of the false positive alarms(28 days)
- Qualitative assessement of the state of the adhesive tapes after study completion(28 days)
- Retrospective description of the number of occlusions detected including the FIR Filter evaluation(28 days)
研究者
研究点 (2)
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