NCT03966911已完成不适用
Performance Evaluation of an Advanced Algorithm With CGM 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
- 335
- 试验地点
- 29
- 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 Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
详细描述
The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
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
- •A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- •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 ratio. Subjects without ratios may participate under observation only
排除标准
- •Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) 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 (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- •Subject is female and has a positive pregnancy screening test
- •Female of child bearing age and who is sexually active should be excluded if she 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
- •Subject has a hematocrit (Hct) lower than the 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 if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.
次要结局
未报告次要终点
研究者
研究点 (29)
Loading locations...
相似试验
已完成
不适用
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in ChinaDiabetes MellitusNCT03710083Medtronic Diabetes72
已完成
不适用
Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal DialysisDiabetes Mellitus (Diagnosis)End Stage Renal DiseaseDialysisNCT04776811Elaine Chow30
已完成
不适用
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in ChinaDiabetes MellitusNCT03417466Medtronic Diabetes72
已完成
不适用
The New Golden Standard: the Early Warning Score AlgorithmEarly Warning ScoreNCT04292158University of Liege80
已完成
不适用
A study to test a sensor for giving early warning of urinary catheter blockagePatients requiring catheterisingUrological and Genital DiseasesISRCTN51644058niversity of Bath35