A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability
This study is looking at a new device called the Egoo Phe System. It's a home test that measures phenylalanine (Phe) levels in the blood of people with Phenylketonuria (PKU). Currently, people with PKU send blood samples by post, which can take several days to get results. This new device aims to provide quicker results, helping people manage their diet better and keep their Phe levels stable. We are checking how accurate this new home test is when compared to the usual lab tests. We also want to understand how easy it is for patients and their families, or healthcare professionals, to use. The goal is to see if this new system could help make managing PKU easier and more effective.
At a glance
What is this study about?
Imagine being able to check your blood phenylalanine (Phe) levels at home, quickly and easily! This study is all about a new device called the Egoo Phe System that lets people with Phenylketonuria (PKU) do just that. PKU is a condition where your body can't properly break down a substance called phenylalanine, found in protein. Too much Phe can be harmful, so people with PKU need to carefully manage their diet.
Right now, people with PKU usually take blood samples at home by pricking their finger, and then send these samples to a hospital lab by post. It can take several days to get the results back, which means there's a delay in knowing if your diet needs adjusting. This new Egoo Phe System is designed to give you results much faster, potentially right away, helping you and your care team make dietary changes quickly to keep your Phe levels in a healthy range.
We want to make sure this new device is just as accurate as the current lab tests and is simple for people to use. If successful, this could be a big step forward in making it easier for people with PKU to manage their condition, especially for children and their families, by giving them more control and real-time information about their health.
Key takeaways
- A new home test for PKU is being studied for accuracy and ease of use.
- This device aims to provide fast blood phenylalanine (Phe) results at home.
- Could help people with PKU manage their diet and health more effectively.
- The study compares the new test to standard lab methods.
- Both people with PKU (aged 3+) and healthy adults are needed.
- Participation involves providing blood samples and trying out the device.
Who may be eligible?
To join this study, you need to be at least 3 years old and have a confirmed diagnosis of PKU. We are also looking for healthy adults (over 18) who don't have PKU to help us with this research. Both men and women can take part.
There are some reasons why someone might not be able to join. For example, children under 3 years old cannot participate. If you have a strong fear of needles (needle phobia) or other health problems that would make taking blood samples difficult, such as certain developmental conditions like autism, this study might not be suitable for you.
Also, if you're currently unwell with an infection (like chickenpox or tonsillitis needing antibiotics) or have a long-term illness that requires ongoing medication (like diabetes), you wouldn't be able to join this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 3 years old or older?
- Do you have a confirmed diagnosis of Phenylketonuria (PKU)?
- Are you comfortable with giving blood samples (no strong fear of needles)?
- Are you currently generally well (not acutely ill or managing a chronic illness like diabetes)?
- Are you either a man or a woman?
- If you don't have PKU, are you a healthy adult over 18?
What does participation involve?
This part of the study involves comparing the new Egoo Phe System with the standard blood test. You would be asked to provide some small blood samples. This might involve using the new Egoo Phe System and also having a standard finger-prick blood sample taken. The exact number of samples and how often will be explained in detail by the study team. You won't need to take any new medication as part of this study. The main focus is on testing the new device and gathering feedback on how easy it is to use. The total duration of your involvement in the study will be discussed with you, but it's designed to be straightforward and not take up too much of your time. Full instructions and training on how to use the Egoo Phe System will be provided by healthcare professionals.
Potential risks and benefits
Locations (1)
- Birmingham Women's and Children's NHS Foundation TrustVerified postcodeBirmingham, United Kingdom
Common questions
What is the main goal of this study?
The main goal is to see how accurate and easy to use a new home blood test for PKU, called the Egoo Phe System, is compared to current lab tests.
Will I have to take any new medicines?
No, this study only involves testing a new device for measuring blood levels, not taking new medicines.
How will the study help people with PKU?
If successful, this device could offer a much faster and more convenient way for people with PKU to monitor their blood levels, helping them manage their diet and health better.
Who can join the study?
People with PKU aged 3 and over, as well as healthy adults without PKU, can potentially join. There are some specific reasons why someone might not be able to participate.
What if I decide I don't want to continue?
You can leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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