Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
研究概览
简要总结
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
详细描述
The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 1 or type 2 diabetes
- •Be >18<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age
- •Be willing to complete all study procedures
- •Be routinely testing their blood sugar at home (at least once per day)
- •Be able to speak, read, and understand English and understand the Informed Consent document
- •Be able to read the labeling instructions
排除标准
- •Minors <18 years of age and adults >75 years of age
- •Pregnancy
- •Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
- •Disorders in the fingertip lancing areas
- •Acute or chronic infections, particularly skin infections
- •Infection with a blood borne pathogen
- •Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion.
- •Hemophilia or any other bleeding disorder
- •Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
- •Working for a competitive medical device company
结局指标
主要结局
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
时间窗: One hour
Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP
次要结局
- Percentage of Participants Rated as <=3 (Labeling Comprehension)(One hour)
- Percentage of Participant Ratings for Overall Testing Experience With This Meter(One hour)