NCT04436822已完成不适用
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 31
- 主要终点
- Percentage of Readings Within 20% Agreement
研究概览
简要总结
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
详细描述
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
This is a multi-center study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is 2 - 80 years of age at time of enrollment.
- •Subject has a clinical diagnosis of type 1 or type 2 diabetes:
- •If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
- •If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
- •If subject is participating in YSI™* FST , subject has adequate venous access as assessed by investigator or appropriate staff.
- •Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may participate under observation only.
排除标准
- •Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
- •Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
- •Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit
- •(Please note participation in an observational study is acceptable.)
- •Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
- •Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.
- •Subject is female and plans to become pregnant during the course of the study.
- •Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.
- •Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
- •Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- •Subject has a history of a seizure disorder.
- •Subject has central nervous system or cardiac disorder resulting in syncope.
- •Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- •If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
- •Subject has a history of adrenal insufficiency.
- •Subject is a member of the research staff involved with the study.
结局指标
主要结局
Percentage of Readings Within 20% Agreement
时间窗: 7 days (170 hours)
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
次要结局
未报告次要终点
研究者
研究点 (31)
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