Egoo Phe System - A Blood Phenylalanine Self-Test Measuring System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcome measure is blood phenylalanine.
研究概览
简要总结
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with phenylketonuria (PKU). This home monitor is intended to be an adjunct to current clinical practice in the management of individuals with PKU. The objective of this investigation is to perform multi blood comparison studies between the Egoo Phe System and the standard analytical methods (finger prick blood spots) to demonstrate the Egoo Phe System's accuracy.
详细描述
The Egoo Phe System is intended to be used by Healthcare Professionals in the hospital, for near-patient testing in the home of the PKU patients, and for self-testing guided by the manufacturer's instructions-for-use and after being trained by healthcare professionals.
Currently, no home-based method exists for convenient and timely monitoring of blood phenylalanine (Phe) levels. The standard practice is for patients to collect their own blood samples on a sample collection filter paper. These dried blood spot samples are posted to the hospital. The laboratories then give the results to the dietitians within 2 working days. The dietitians report the results to the patients' caregivers the same day the results become available. However, the process may take anything from 3 to 7 days, dependent on the reliability of the postal system. This delay in feedback prevents timely adjustment of dietary treatment.
Research studies, clinical guidelines, and the PKU patient organizations have highlighted a need for more frequent blood Phe testing and more timely/real-time results for the better management and treatment of PKU. Many of these studies and reports have outlined the critical need for a simple, rapid, and accurate method for monitoring Phe blood levels, especially during the first years of life. A number of these studies have also indicated that a home monitor could make management of the condition easier and more effective. In particular, the immediate, and possibly daily, feedback supplied by such a monitor would allow for better dietary adjustments so that Phe blood levels could be more consistently maintained. A survey of PKU patients and their primary caregivers have highlighted the potential utility of a home monitor in managing PKU. A large majority of the respondents believed a home monitor would facilitate better management of PKU through more regular and timely feedback. Therefore, a more accessible and convenient method of testing and monitoring blood Phe levels on a regular schedule with immediate results at home would greatly improve the management of PKU.
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
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All individuals with PKU aged 3 years and over
- •Subjects with a confirmed diagnosis of PKU detected from newborn screening
- •Healthy adult volunteers (>18 years of age) without PKU
- •Male and female subjects will be included in this study.
排除标准
- •Children under the age of 3 years
- •Individuals with needle phobia
- •Patients with comorbidities that may affect tolerance of blood sampling e.g. autism or other neurodiversity disorders
- •Patients with acute illness e.g. chicken pox, tonsillitis requiring antibiotics
- •Patients with chronic illness and taking long term medications e.g. diabetes.
结局指标
主要结局
The primary outcome measure is blood phenylalanine.
时间窗: Monitoring of patient phenylalanine levels for 6 months.
A drop of blood (40ul) is collected by the patient using a patient led home testing device (study device). The result is compared with a parallel collected blood sample on a dried blood spot (DBS) card which is analyzed in a lab using tandem mass spectrometry (standard practice).
次要结局
未报告次要终点