Active not recruitingOBSERVATIONAL

Continuous Glucose Monitoring in People With Diabetes on Dialysis

This study is for adults with diabetes who are treated with insulin and are also on dialysis. It uses a small device worn on the skin, called a continuous glucose monitor (CGM), which constantly checks blood sugar levels. The main goal is to understand how blood sugar levels change during and between dialysis sessions over two weeks. Researchers also want to see if these blood sugar changes are connected to the amount of fluid removed during dialysis. Over a longer period (up to five years), the study will investigate if certain blood sugar patterns are linked to outcomes like hospital admissions or other health issues. They hope to learn more about managing diabetes when someone is also undergoing dialysis.

At a glance

Status

Active not recruiting

Sponsor

University of Nottingham

Enrolment target

Start

31 Dec 2024

Estimated completion

01 Oct 2030

Diabetes Mellitus End-Stage Renal Disease

What is this study about?

This study is looking at how blood sugar levels act in people who have diabetes and also need dialysis for their kidneys. For people with diabetes, especially those who use insulin, a continuous glucose monitor (CGM) is a helpful tool. It's a small sensor that sticks to your skin and shows your blood sugar levels all day and night. This helps them, and their doctors, understand how much insulin or other treatment they might need to keep their blood sugar in a healthy range.

When someone is on dialysis, their kidney problems and the dialysis treatment itself can cause their blood sugar levels and insulin needs to change quite a lot. This study wants to get a clearer picture of these changes. For two weeks, participants will use a CGM to track their blood sugar during dialysis sessions and in the time between them. The researchers will then look at this information to see if blood sugar patterns are related to how much fluid is removed during dialysis.

Beyond the two weeks, the study will follow participants for up to five years. This longer-term look will help the researchers understand if particular blood sugar trends are connected to important health outcomes, like whether someone needs to go to the hospital more often. By doing this, they hope to learn more about how to best care for people with diabetes who are also on dialysis, aiming to improve their health and well-being.

Key takeaways

This study focuses on people with diabetes who are on dialysis.
It uses a device called a continuous glucose monitor (CGM) to track blood sugar.
The goal is to understand how dialysis affects blood sugar levels.
Researchers will look for links between blood sugar patterns and long-term health.
Participating involves sharing existing health data, not new treatments.
The findings could help improve care for people with diabetes and kidney disease.

Who may be eligible?

To join this study, you must be at least 18 years old. You need to have diabetes that is treated with insulin and you must already be using a continuous glucose monitor (CGM) that is provided by the NHS as part of your usual care. You also need to have been diagnosed with diabetes for more than six months and be currently receiving kidney dialysis (either in a clinic or at home).

It's important that you are able to understand the study and give your agreement to take part. Also, if you are currently involved in another medical study or trial that might conflict with this one, you wouldn't be able to join.

Finally, if you have a serious illness that doctors believe means you have less than three months to live, or another significant health problem that the study doctor thinks would make it unsafe for you to participate, then 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 18 years old or older?
Do you have diabetes and use insulin?
Do you already use an NHS-funded continuous glucose monitor (CGM)?
Have you had diabetes for more than 6 months?
Are you currently receiving kidney dialysis?
Are you able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means you won’t be given new medications or treatments specially for the study. Instead, the researchers will be collecting information about your health as part of your usual care. You will already be using a Continuous Glucose Monitor (CGM) for your diabetes, and the study will use the data from this device for two weeks. They will also look at your blood sugar levels and the results of a blood test called HbA1c, which you'll have as part of your normal care. They will also gather information about things like changes in your body weight during dialysis, your body composition (how much muscle and fat you have), and your blood pressure. After the initial two weeks of data collection from your CGM, the study will continue to follow your health records for up to five years to see if there are any long-term connections to your blood sugar patterns, such as hospital visits or other health events. There are no extra hospital visits or special assessments required specifically for this study.

Potential risks and benefits

Because this study is observational, meaning it only collects information from your routine care and doesn't involve any new treatments or procedures, there are no direct medical risks associated with taking part beyond those already linked to your usual diabetes and dialysis care. There are no immediate direct benefits to you as an individual, but the information collected will be very important. It will help doctors and researchers better understand how diabetes and dialysis interact, which could lead to improved care for people like you in the future. You always have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

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

University Hospitals of Derby and Burton
Verified postcode
Derby, United Kingdom

Common questions

What is a continuous glucose monitor (CGM)?

It's a small sensor you wear on your skin that automatically checks and records your blood sugar levels throughout the day and night.

Why is this study important?

It helps us learn how blood sugar levels change in people with diabetes who are on dialysis, and if these changes affect their health in the long run.

Do I need to do anything extra if I join?

No, this study mainly collects information from your existing NHS care, including your CGM data. There are no new tests or medications added specifically for the study.

How long will the study follow me?

The main blood sugar monitoring happens over two weeks, but researchers will look at your health records for up to five years.

Will my care change if I join or don't join?

No, your medical care will not be affected whether you decide to join the study or not.