NCT07227805招募中不适用
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes
Medtronic MiniMed, Inc.8 个研究点 分布在 4 个国家目标入组 116 人开始时间: 2026年7月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 8
- 主要终点
- Primary Endpoint
研究概览
简要总结
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.
详细描述
This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study.
The study consists of a run-in phase and a study phase.
Run-in Phase:
The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor.
At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is aged ≥2 years old at time of screening.
- •Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
- •Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
- •Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
- •Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
- •Willing to switch to approved insulin per insulin pump labeling.
- •Investigator has confidence that the subject, parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.
- •Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
- •Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
- •For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.
- •For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.
排除标准
- •Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
- •For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors).
- •Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement
- •Has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
- •Has active or severe retinopathy in the last 6 months before screening
- •Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- •Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- •History of 2 or more DKA events in the last 3 months before screening.
- •Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
- •Is using hydroxyurea at time of screening or plans to use it during the study
- •Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
- •Women who are breastfeeding.
- •Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before screening, as per investigator judgment.
- •Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- •Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.
- •Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.
研究组 & 干预措施
Control arm (780G)
Active Comparator
Subjects randomized to the Control arm will continue to use the MiniMed™ 780G.
干预措施: 780G (Device)
Treatment arm (NMX8)
Experimental
Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system
干预措施: NMX8 (Device)
结局指标
主要结局
Primary Endpoint
时间窗: During the 12-week study phase
The between-treatment (control arm with 780G system versus treatment arm with NMX8 system) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) with a non-inferiority testing.
次要结局
- Secondary Endpoint 1(End of 12-week Study Phase)
- Secondary endpoint 2(During the 12-week Study Phase)
- Secondary Endpoint 3(End of the 12-week Study Phase)
研究者
研究点 (8)
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