Effectiveness and Safety Study of the Continuous Glucose Monitoring System for Home Use (Including In-clinic Sessions) in Patients With Diabetes

Lee's Pharmaceutical Limited0 个研究点目标入组 144 人开始时间: 2021年7月30日最近更新: 2021年7月16日

适应症

干预措施

试验速览

阶段: 不适用
发起方
入组人数: 144
主要终点: the percentage of MARD (Mean Absolute Relative Difference)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。

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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 1 or 2 diabetes mellitus
•Male or female age ≥ 18 years old and ≤ 70 years old
•Willingness to adopt measures to prevent water coming into contact with the device sensor (e.g. abstain from swimming, sauna, avoid hitting the sensor with direct jets of water)
•Ability to communicate with the investigators, able to operate medical device after training and comply with the testing procedures outlined in this protocol (including, but not limited to, willing to wear the continuous glucose monitor and testing capillary blood glucose)
•Subjects who show understanding of the study procedures and willing to sign a written informed consent form.

排除标准

•Hospitalization due to diabetic ketoacidosis or severe hypoglycemia, within 3 months prior to screening
•HbA1c >13% or urine ketone 3+
•Use of pacemaker
•Body Mass Index (BMI) ≤18.0kg/m2
•Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites, i.e. upper arm or abdomen (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
•Any psychiatric disease such as depression or anxiety
•Any severe hepatic, renal, cardiac, cerebral, respiratory or neurological diseases (e.g. serum ALT, AST, Creatinine level ≥3 times the upper limit of normal)
•Has a MRI scan, CT scan or other procedure requiring the subject be under strong magnetic or electromagnetic environment, scheduled during the proposed study participation
•Blood loss >400ml in the past 3 months (including blood donation)
•Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study
•Difficulty in sampling venous blood or cannot tolerate venipuncture
•Participated in other investigational studies in the past 3 months
•Currently pregnant or lactating women, or positive pregnancy test
•Any condition that, in the opinion of the investigator, renders the subject not suitable for the study.