Active not recruitingOBSERVATIONAL

User Evaluation of a Home-collection Kit for People With Diabetes

This study is looking at a new home test kit for blood sugar control (called HbA1c) for people living with diabetes. Both Type 1 and Type 2 diabetes can lead to high blood sugar, and keeping this under control is very important for your long-term health. Regular checks of your HbA1c help you and your doctor understand how well your diabetes is managed. However, going to a clinic for blood tests can sometimes be difficult or inconvenient. This study wants to find out if a home-based testing kit, where you can collect a small blood sample yourself and mail it back to the lab, could be a good solution. The goal is to make it easier for people with diabetes to monitor their condition regularly and at the right times, which can lead to better health outcomes.

At a glance

Status

Active not recruiting

Sponsor

University Hospitals of North Midlands NHS Trust

Enrolment target

Start

20 Feb 2024

Estimated completion

31 Dec 2026

Diabetes

What is this study about?

Diabetes is a common condition where your body either doesn't make enough insulin or can't use it properly. This leads to high sugar levels in your blood. Over time, high blood sugar can cause serious health problems. To help prevent these problems, it's really important to keep your blood sugar levels as stable as possible.

One of the main ways doctors check how well your diabetes is being managed over several months is with a blood test called HbA1c. You usually have regular appointments to get this test and discuss your results. However, we know that sometimes it can be hard to get to these appointments or blood tests at the right time. Things like busy schedules or transport can make it tricky, and sometimes people miss their recommended check-ups. When HbA1c isn't checked regularly, it can be harder to keep diabetes under good control, which isn't ideal for your health.

This study is trying to solve this problem by looking at a new home test kit for HbA1c. Imagine being able to collect a small blood sample yourself, perhaps from a finger prick, and then send it off to the lab, all from the comfort of your own home. We want to develop a kit that's easy to use and gives accurate results, just like the blood tests you have at the clinic. By doing this, we hope to make it much easier for people with diabetes to stay on top of their monitoring, helping them to achieve the best possible health outcomes.

Key takeaways

This study is testing a new home blood sample kit for diabetes monitoring.
It aims to make checking your HbA1c (blood sugar control) easier and more convenient.
The home kit uses a small 'dried blood spot' sample, collected by you.
The goal is to improve how often and accurately people with diabetes can monitor their condition.
Better monitoring can lead to better long-term health outcomes for people with diabetes.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older, and have either Type 1 or Type 2 diabetes. You also need to have had a standard blood test for your HbA1c at the clinic within the two weeks before your study appointment. Finally, it's important that you can understand and agree to take part in the study after we explain everything clearly.

We won't be able to include you in the study if you have severe eyesight problems that would make it difficult to use the kit or complete the study tasks. Also, if you don't speak English and we can't provide clear translations of all the study information, you unfortunately won't be able to join, as it's very important you fully understand what's involved.

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 18 years old or older?
Do you have Type 1 or Type 2 diabetes?
Have you had an HbA1c blood test at your clinic within the last two weeks?
Can you understand information in English and agree to participate knowingly?
Do you have good enough eyesight to use a small home test kit?

Answer every question to see your result.

What does participation involve?

The specific details of what your participation involves are still being developed based on feedback from patients. However, the main idea is that if you join, you would receive a home test kit. This kit would allow you to collect a small blood sample yourself, likely from your fingertip, at home. You would then send this sample back to a laboratory for testing. The study aims to compare the results from this home kit with your usual clinic blood tests to make sure it's accurate and easy to use. The total duration of your participation would depend on how many times you are asked to use the home kit and give feedback.

Potential risks and benefits

By taking part, you could benefit by helping to develop a convenient new way for people with diabetes to monitor their condition, potentially making regular checks easier for many. There are very few risks expected, mainly just the slight discomfort from a finger prick to collect the blood sample, similar to what you might do if you check your blood sugar at home. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals of North Midlands NHS Trust
Verified postcode
Stoke-on-Trent, United Kingdom

Common questions

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's a key way to check how well your diabetes is being controlled.

Why is regular HbA1c monitoring important?

Regular HbA1c checks help you and your doctor adjust your treatment if needed, reducing the risk of long-term health problems linked to diabetes.

What is a 'dried blood spot' sample?

It's a way of collecting a very small amount of blood, often from a finger prick, onto a special piece of paper or card. This is then dried and can be sent to a lab for testing.

Will this kit replace my regular doctor visits?

No, this home kit is being explored as an additional tool to make monitoring easier. You would still have your routine appointments to discuss your overall health and treatment.

Who is running this study?

This study is being run by researchers looking into improving care for people with diabetes, in collaboration with healthcare professionals.