Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [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
- 102
- 试验地点
- 2
- 主要终点
- Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
研究概览
简要总结
The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.
详细描述
The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.
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 year 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 (81 mg 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 Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
时间窗: One hour
Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.
次要结局
- Percentage of Participants Rated as <=3 (Labeling Comprehension)(One hour)
- Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter(One hour)