A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 11
- 主要终点
- Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
研究概览
简要总结
The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance in pediatric patients with insulin requiring diabetes at the beginning, middle and end of sensor wear.
详细描述
This study is a prospective, single arm, multi-center, in-clinic study.. There will be two consecutive phases of the study:
A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational centers
Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™ and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement is for subjects 2-6 years of age and cannot tolerate YSI.
Study has a run-in period and a study period with a total of 10 visits
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 2-18 years of age at time of screening
- •Subject has been diagnosed with insulin requiring diabetes mellitus for at least one year.
- •Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
- •Subject is willing to perform required sensor calibrations
- •Subject is willing to wear the system (Guardian Mobile application, pumps, sensors, meter) continuously throughout the study
- •Adequate venous access as assessed by investigator or appropriate staff
排除标准
- •Subject is unable to tolerate tape adhesive in the area of sensor placement
- •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
- •Females of child-bearing potential who have a positive pregnancy test at screening or plans to become pregnant during the course of the study
- •Subjects with hematocrit lower than the normal age specific reference range per central or local lab testing
研究组 & 干预措施
Enlite sensors
Each subject will first wear enlite sensors and will come for clinic visit for YSI (Yellow Spring Instruments). Then each subject will wear enlite 3 sensors and will come for clinic visit for YSI (Yellow Spring Instruments) or SMBG (Self-Monitoring of Blood Glucose) testing. SMBG testings are for subjects 2-6 years of age and cannot tolerate YSI. In addition. In addition, subjects aged 2-6 years old will not participate in Enlite phase. They only participate in Enlite 3 phase.
干预措施: Enlite sensors (Device)
结局指标
主要结局
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
时间窗: 6 days
Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System
时间窗: 7 days
Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
次要结局
- Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST(6 Days)
- Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump(6 Days)
- Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter(7 days)
- Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST(6 Days)
- Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST(7 Days)
- Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST(7 Days)