User Performance of the Styx Lancing System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)
研究概览
简要总结
The purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for Blood Glucose Meter testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 years of age and older
- •People with type 1 or type 2 diabetes
- •People who regularly perform self-tests (at least once/day) with their own lancing device
- •Able to speak, read, and understand English
- •Willing to complete all study procedures
排除标准
- •Those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol.
- •Hemophilia or any other bleeding disorder
- •Pregnancy
- •Physical, visual or neurological impairments that would make the person unable to perform testing
- •Persons who have used the Styx device in a previous clinical evaluation
- •Working for a competitive medical device company, or having an immediate family member who works for such a company
- •A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
结局指标
主要结局
Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)
时间窗: 1 hour
Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.
次要结局
- Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)(1 hour)
- Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)(1 hour)
- Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)(1 hour)
- Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device(1 hour)