A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 4
- 主要终点
- Exact and ±1 agreement to compared device
研究概览
简要总结
The objectives of the Healthy.io Method Comparison and User Performance Study are:
- To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer.
- To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female, 18-80 years of age
- •Subjects who are healthy or pregnant; or
- •Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite (examples of such diseases include the following):
- •diabetes Type I, Type II, or gestational diabetes (Type III) or,
- •urinary tract infection (UTI)
- •heart disease
- •kidney disease
- •liver disease
- •pregnant women with preeclampsia, gestational diabetes or UTI
- •any pathological findings which might be identified by the urine test (according to the physician discretion)
- •Subject is capable and willing to provide informed consent.
- •Subject has facility with both hands.
- •Subject is capable and willing to adhere to the study procedures
- •Subject is familiar with the use of a smartphone.
排除标准
- •Subject has dementia.
- •Subject has mental disorders.
- •Subject is visually impaired (cannot read the user manual).
- •Subject cannot collect urine in receptacle.
- •Any other reason that might preclude the subject from the study.
研究组 & 干预措施
All participants (single arm)
All study participants once enrolled into the study were asked to collect their midstream urine in the designated device urine cups. The urine sample was then tested sequentially; first by the Dip.io Home Based Dipstick Analyzer (first intervention) and by the ACON U500 Mission® U500 Urine Analyzer (comparative device - second intervention). Part of the participants (100 out of 302) were asked to perform the Dip.io urine test by themselves for the user performance evaluation.
干预措施: Dip.io Home Based Dipstick Analyzer (Device)
All participants (single arm)
All study participants once enrolled into the study were asked to collect their midstream urine in the designated device urine cups. The urine sample was then tested sequentially; first by the Dip.io Home Based Dipstick Analyzer (first intervention) and by the ACON U500 Mission® U500 Urine Analyzer (comparative device - second intervention). Part of the participants (100 out of 302) were asked to perform the Dip.io urine test by themselves for the user performance evaluation.
干预措施: ACON U500 Mission® U500 Urine Analyzer (Device)
结局指标
主要结局
Exact and ±1 agreement to compared device
时间窗: Through study completion, an average of 1 month
The primary objective of the study is to evaluate the exact agreement and the ±1 color block match of the Dip.io compared to the predicate device, for each analyte concentration (block).
次要结局
- User performance(Through study completion, an average of 1 month)