Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly.
Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants.
Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
California
-
Escondido、California、美国、92026
- Advanced Metabolic Care and Research
-
Orange、California、美国、92868
- CHOC Children's
-
Stanford、California、美国、94305
- Stanford University
-
-
Colorado
-
Aurora、Colorado、美国、80045
- Barbara Davis Center
-
-
Idaho
-
Idaho Falls、Idaho、美国、83404
- Rocky Mountain Diabetes and Osteoporosis Center, PA
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Joslin Diabetes Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Ages 2 to 17 years ;
- Diagnosis of diabetes mellitus;
- Willing to participate in one 7-day Sensor wear period;
- Willing to wear 2 systems simultaneously;
- Willing to take a minimum of 7 fingersticks per day during home use with a blood glucose meter provided;
- Willing to attend one in-clinic session of up to 6 hours duration. Clinic procedures where blood sampling via SMBG and/or venous YSI method, depending on age;
- Subject or guardian is able to speak, read, and write English.
Exclusion Criteria:
- Extensive skin changes/diseases at sensor wear site that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis);
- Known allergy to medical-grade adhesives;
- Require a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, or diathermy during the wear period. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their continuous glucose monitoring (CGM) session, and remove their sensor.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Pediatric subjects with diabetes mellitus
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
System Performance Effectiveness
大体时间：7 days
|
The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
|
7 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
System Performance at Alternate Wear Site
大体时间：7 days
|
An additional objective is to evaluate System performance at an alternate wear site.
The System performance will be assessed, using the same statistical methodology as the primary wear site.
|
7 days
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.