Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of sets that failed due to unexplained hyperglycemia
研究概览
简要总结
The purpose of this study is to evaluate the Extended Mio 30 infusion set (EM30IS) 7-day functioning compared to the regular Mio 30 infusion set (M30IS) 3-day functioning. The study will be carried out in adult patients with type 1 diabetes.
Secondary objective, to evaluate the differences in glucose control between the infusion set currently used by participants (Medtronic Quick set infusion sets) and the Medtronic Mio 30 Infusion Set.
详细描述
This is a 1-center, prospective, open-label, cross-over controlled study with type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM).
A total of up to 40 subjects will be enrolled in order to have 20 subjects meeting eligibility criteria. Eligible patients meeting the enrollment and randomization criteria will enter a run-in period of up to 1 month for device adaptation. After the run- in phase, The participants will enter the first study part; participants will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for 1 month. The order will be determined by the randomization process:
Arm A: Quick set infusion set- M30IS. First phase Quick set, second phase Mio 30.
Arm B: M30IS- Quick set infusion set. First phase Mio 30, second phase Quick set infusion set.
Trial Arm A: Subjects will be randomized to a group who will be using the Quick set infusion set for the initial Phase. All patients will be trained on the use of the Quick set infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 3 days or at set failure (replace with another Quick set infusion set).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of type 1 diabetes for at least one year
- •Age 18 to 80 years
- •Not currently known to be pregnant, nor planning pregnancy during the study.
- •Willingness to follow the protocol and sign the informed consent
排除标准
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- •Pregnant or lactating females
结局指标
主要结局
Percentage of sets that failed due to unexplained hyperglycemia
时间窗: 6 months
The primary outcome is to have no more than 16% of infusion set failures due to "unexplained hyperglycemia"
次要结局
未报告次要终点
研究者
Prof. Amir Tirosh
Prof. Amir Tirosh
Sheba Medical Center