NCT00985257已完成不适用
Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults
Ascensia Diabetes Care4 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method
研究概览
简要总结
The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 diabetes
- •Age 4 to 24 years
- •Routinely performs blood glucose testing at home
- •If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
- •If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
- •Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate
排除标准
- •Currently pregnant
- •Hemophilia or any other bleeding disorder
- •Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
- •Infection with a blood borne pathogen (e.g., HIV, hepatitis)
- •Subject or parent/guardian is employee of competitive medical device company
- •Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
结局指标
主要结局
Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method
时间窗: 1-2 hours
Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG values \>/=75mg/dL) of the reference method results.
次要结局
未报告次要终点
研究者
研究点 (4)
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