Extended Wear of a Steel and a Teflon Insulin Infusion Set
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
- Time to infusion set failure due to an occlusion
研究概览
简要总结
This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of type 1 diabetes for at least 12 months
- •Using an insulin pump for at least 12 months
- •Age ≥18 years
- •Hemoglobin A1c level less than or equal to 8.5%
- •Willing to use mylife™ YpsoPump® system while they are participating in the study
- •Willing to use NovoRapid® insulin while they are participating in the study
- •An understanding of and willingness to follow the protocol and sign the informed consent
排除标准
- •Diabetic ketoacidosis in the past 3 months prior to enrollment
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- •Urea, Creatinine, ALT more than three times the upper limit of normal, or thrombocytopenia (<150 G/l)
- •Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use an acceptable form of contraception during the study (for sexually active subjects of childbearing potential)
- •Known severe tape reactions or allergies
- •Known severe nickel allergies
- •History of frequent catheter abscesses associated with pump therapy
- •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
- •Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse
- •Dependency from the sponsor or the clinical investigator
研究组 & 干预措施
Soft cannula first
Subjects will be randomized (50%) to the soft cannula infusion set for two weeks and then will be switched to the steel needle infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the soft cannula infusion set.
干预措施: YpsoPump Orbit soft (Device)
Soft cannula first
Subjects will be randomized (50%) to the soft cannula infusion set for two weeks and then will be switched to the steel needle infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the soft cannula infusion set.
干预措施: YpsoPump Orbit micro (Device)
Steel cannula first
Subjects will be randomized (50%) to the steel cannula infusion set for two weeks and then will be switched to the soft cannula infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the steel cannula infusion set.
干预措施: YpsoPump Orbit soft (Device)
Steel cannula first
Subjects will be randomized (50%) to the steel cannula infusion set for two weeks and then will be switched to the soft cannula infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the steel cannula infusion set.
干预措施: YpsoPump Orbit micro (Device)
结局指标
主要结局
Time to infusion set failure due to an occlusion
时间窗: up to 7 days
an occlusion is defined by blood ketone concentration is \> or = 0.6 mmol/l with blood glucose (BG) concentration \>250 mg/dl, or BG concentration is \>250 mg/dl for more than 2 h and a subsequent correction bolus failed, or pump occlusion alarm that cannot be fixed.
次要结局
- Median infusion set wearing time(up to 7 days)
- Time to early infusion set changes(up to 7 days)
- Frequency of early infusion set changes due to infusion site infection(up to 7 days)
- Frequency of early infusion set changes(up to 7 days)
- Total daily insulin dose(day 1, 2, 3, 4, 5, 6, 7)
- Glucose variability(day 1, 2, 3, 4, 5, 6, 7)
- Daily mean glucose(day 1, 2, 3, 4, 5, 6, 7)