NCT06053593已完成不适用
Ketostix® and Keto-Diastix® Performance Study
Ascensia Diabetes Care1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年7月24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
- 126
- 试验地点
- 1
- 主要终点
- Testing of self collected urine
研究概览
简要总结
Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. The products are: Ketostix and Keto-Diastix.
详细描述
Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products.
- Demonstrate that untrained PWDs can successfully read the Instructions for Use and use Ketostix and Keto-Diastix reagent strips for Urinalysis with no training. Urine samples from the PWDs will be collected and then tested by the PWD and will be compared to the reference assay results.
- Demonstrate Ease of Use by PWDs with a Labeling Evaluation Survey for Ketostix and Keto-Diastix reagent strips. Participants will respond to a survey using a 5 point Likert scale with 5= Strongly Agree, 4= Agree, 3=Neutral, 2=Disagree, 3=Strongly Disagree.
- Demonstrate that persons with diabetes (PWDs) can successfully test urinalysis control solutions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 over 18 years of age.
- •Diagnosed with Diabetes Mellitus (Type 1 or Type 2)
- •Able to speak, read and understand English (subjects must demonstrate ability to read a paragraph from the first page of the package insert to qualify for the study).
- •Willing to complete all study procedures.
排除标准
- •Physical, visual, or neurological impairments that would make the person unable to perform urine collection and testing with the urine strips as determined by the PI.
- •Intake of Vitamin C supplements (multi-vitamins are permitted)
- •Prior experience testing glucose or ketones in urine with Ketostix and Keto-Diastix Reagent strips.
- •Currently taking compounds such as mesna (Mesnex)
- •Currently taking any medications containing azo dyes (e.g., Pyridium, Gantrisin, Gantanol), nitrofurantoin (Macrodantin, Furadantin).
- •Currently taking medications such as levodopa.
- •Working for a medical laboratory, hospital or other clinical setting that involves training in the urinalysis lab or use of urinalysis test strips.
- •Working for a competitive medical device company (Urine Strip manufacturer) or having an immediate family member or living with someone 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 (reason for exclusion will be clearly documented by investigator or designee on the study form).
结局指标
主要结局
Testing of self collected urine
时间窗: Day 1
Number of Participants with results from self collected urine that are within one color block of reference analyzer
Labeling evaluation
时间窗: Day 1
Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale.
Testing of Urine controls
时间窗: Day 1
Number of Participants with Reponses that read within one color block.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Diabetic Kidney Alarm (DKA) StudyType 1 Diabetes MellitusDiabetic KetoacidosisNCT03128229University of Colorado, Denver41
已完成
不适用
Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic AgentsDiabetes Mellitus, Type 2NCT02636192Janssen Research & Development, LLC200,000
已完成
1 期
A Study To Compare Effects Of GSK189075 In Combination With Either Furosemide Or HydrochlorothiazideType 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00671424GlaxoSmithKline48
招募中
不适用
Ketogenic Diet and Diabetes Demonstration ProjectKetogenic DietingPreDiabetesObesityType 2 DiabetesNCT06115265University of New Mexico40
已完成
不适用
Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)Type 1 DiabetesNCT00970567Charite University, Berlin, Germany19