An Open, Multicenter, Randomized, Controlled Pilot Trial Evaluating the Metronom Continuous Glucose Monitoring System in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy
研究概览
简要总结
The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Informed consent obtained after being advised of the nature of the study
- •Male or female aged ≥18 years
- •Type 1 diabetes for at least 6 months according to the WHO definition treated with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months (for T1D only)
- •Body Mass Index (BMI) <35 kg/m²
- •Flash or continuous glucose monitoring (FGM, CGM) user
- •Willing and able to wear the Metronom CGM System for the duration of the study and undergo all study procedures
- •HbA1c ≤86 mmol/mol
排除标准
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
- •Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- •Any mental condition rendering the subject incapable of giving his consent
- •Subject is using any medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
- •Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- •Subject is actively enrolled in another clinical trial
- •Known adrenal gland problem, pancreatic tumour, or insulinoma
- •Known bleeding disorder
- •Known hypersensitivity to adhesive or skin lesions that hinder sensor insertion
- •Inability of the subject to comply with all study procedures
- •Inability of the subject to understand the subject information
- •Subject donated blood in the last 3 months
研究组 & 干预措施
Induction day 1, 4, 7, 14
Patient will come to the hospital on day 1, 4, 7 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
干预措施: Metronom CGM device (Other)
Induction day 1, 7, 10, 14
Patient will come to the hospital on day 1, 7, 10 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
干预措施: Metronom CGM device (Other)
结局指标
主要结局
Accuracy
时间窗: 14 days
Overall percentage of sensor values which fall within ± 20 mg/dl of the mean reference values at glucose concentrations \<100 mg/dl and within ± 20% at glucose concentrations ≥100 mg/dl
次要结局
- Accuracy(14 days)
- Reliability(14 days)