Phoenix: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- Refill accuracy of MIIPS 2020
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), and presenting with frequent, otherwise unexplained severe hyper- and/or hypoglycemia.
详细描述
This study is a premarket, interventional, prospective, open-label, multi-center study. It consists of a run-in period, a study period, and a continued access period.
Run-in Period: The purpose of the run-in period is to collect CGM baseline data while subjects are on their current therapy.
Study Period: During the 6-month study period, subjects will be implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Continued Access Period: Subjects who have completed the entire study period will continue using investigational study devices until those devices are approved for commercial use. Once CE mark is received, the subjects will continue wearing the implanted device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject is aged ≥ 18 years old.
- •Subject has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior to screening as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- •Subject with type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), presenting with frequent, otherwise unexplained severe hyper-and/or hypoglycaemia.
- •Subject has access to a reliable support person, defined as an individual who has daily contact with the subject and knows who to contact in the event of an emergency (i.e., caregiver).
- •Subject has the physical and intellectual ability (in the opinion of the study investigator) to operate the MIIP system and to comply with the data reporting requirements of the study.
- •Subject is willing and able to sign and date informed consent, comply with all study procedures as required during the study.
排除标准
- •Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device before enrollment into this study, that could impact the outcomes of this study; as per investigator and sponsor judgment.
- •Subject has any other disease or condition that may increase risks during the implant procedure or may preclude the subject from participating in the study, as determined by a physician who is not the principal investigator.
- •Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician.
- •Subject is a woman who is pregnant, or of childbearing potential, or lactating, and who is neither surgically sterile, nor using contraceptives (devices, oral, implanted or other physician-approved contraceptive), or willing to use them, at the time of enrollment.
- •Subject is vulnerable, legally incompetent or illiterate.
- •Residence or planned non-pressurized travel at elevations above 10000 feet/3048 meters (commercial airline travel is acceptable).
- •Planning to engage in activities requiring a descent greater than or equal to 10 feet/3 meters below sea level.
- •Subject has an active infection requiring antibiotic treatment.
- •Subject is a person whose body size is not sufficient to accept implantable pump bulk and weight.
- •Subject has a life expectancy of less than 9 months.
- •Subject has diagnosis of illicit drugs abuse disorder.
- •Subject has diagnosis of marijuana abuse disorder.
- •Subject has diagnosis of prescription drugs abuse disorder.
- •Subject has diagnosis of alcohol abuse disorder.
- •Subject who is unwilling or unable to monitor their glucose level or wear a personal continuous glucose monitor.
- •Subject who is unwilling or unable to make programming modifications to the pump based on glucose level readings.
研究组 & 干预措施
MIIPS 2020
Subjects implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
干预措施: Implantable Insulin Pump System (Device)
结局指标
主要结局
Refill accuracy of MIIPS 2020
时间窗: 6 months
Refill Accuracy= (Total Actual Volume Dispensed)/(Total Theoretical Volume Dispensed) after the last refill cycle
次要结局
- Refill accuracy at each refill visit(6 months)
- Percentage of pump with accuracy ratio < 85% prompting NaOH rinse(6 months)