RecruitingNAINTERVENTIONAL

Automated Insulin Delivery in Adults With Advanced Kidney Disease

This study is investigating a new way to manage diabetes for people who also have advanced kidney disease and inject insulin. Many people in this situation struggle with keeping their blood sugar levels steady and are at risk of very low blood sugar. The study uses a system called Automated Insulin Delivery (AID), which combines a continuous glucose monitor (to track sugar levels without finger pricks) and an insulin pump (to give insulin automatically). While AID is used for type 1 diabetes, its benefits for people with both diabetes and advanced kidney disease, including those on dialysis, are not well understood. This small study, taking place in London, will compare AID with usual diabetes care to see if it helps improve blood sugar control and quality of life for participants.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

01 Nov 2025

Estimated completion

01 Feb 2027

Chronic Kidney Diseases Diabetes Mellitus

What is this study about?

This study aims to find out if a new technology called Automated Insulin Delivery (AID) can help people with diabetes who also have advanced kidney disease. Diabetes is unfortunately the main reason why people develop kidney failure in the UK. When you have both diabetes and advanced kidney disease, managing your blood sugar levels can be very tricky. Levels can swing up and down a lot, and there's a higher chance of your blood sugar dropping too low, which can be dangerous.

Currently, many people in this situation have to inject insulin and frequently check their blood sugar using finger-prick tests. This study looks at using a system that combines a sensor, which continuously monitors your glucose (sugar) levels without constant finger pricks, with an insulin pump that automatically gives you the right amount of insulin. This is called an Automated Insulin Delivery (AID) system. These systems are used for some people with type 1 diabetes, but we don't know much about how well they work for people with type 2 diabetes or those with kidney problems, especially if they are on dialysis.

By taking part, you would help researchers understand if this AID system can improve your blood sugar control and make your life better. This is a small, careful study that will involve only 12 people and be carried out at Imperial College in London. The results will help decide if this technology should be studied on a larger scale to help more people in the future.

Key takeaways

Tests a new 'Automated Insulin Delivery' system for diabetes and advanced kidney disease.
Compares the new system to usual insulin treatment for blood sugar control and quality of life.
A small study with 12 participants at Imperial College, London.
Participation lasts about 22 weeks, involving periods with both treatments.
Aims to improve unstable blood sugar levels and reduce the risk of low blood sugar.
Helps understand if this technology could benefit more people in the future.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old. You must have type 1 diabetes for at least a year, or type 2 diabetes that requires you to inject insulin multiple times a day or use an insulin pump. Your average blood sugar level (HbA1c) shouldn't be too high (below 10.5%). You also need to be managing your diabetes with less than 200 units of insulin each day.

Crucially, you must have advanced kidney disease. This includes those with moderate to severe kidney failure, or those who are on dialysis (either peritoneal dialysis or haemodialysis). It's important that you can understand and speak English well enough for the study, and that you have internet access or a smartphone to share your system data.

There are some reasons why you wouldn't be able to join. For example, if you already use an AID system, have had dangerous low blood sugar episodes recently, or have certain other health conditions or are taking specific medications that could interfere with the study. Also, if you are pregnant or planning to become pregnant, you won't be able to participate.

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 between 18 and 70 years old?
Do you have type 1 or type 2 diabetes and inject insulin?
Do you have advanced kidney disease or are you on dialysis?
Can you speak and understand English well enough for study instructions?
Do you have internet or smartphone access for data upload?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last about 22 weeks (roughly five and a half months) for you. Before the study starts, you will wear a glucose sensor for a short period to get a baseline reading of your sugar levels.

The study uses a 'cross-over design'. This means you will spend eight weeks using the Automated Insulin Delivery (AID) system and eight weeks on your usual diabetes treatment. The order in which you do these will be decided randomly – some people will start with AID then switch to usual care, while others will do usual care first then switch to AID. During both phases, you will continue to use a continuous glucose monitor (CGM).

Throughout the study, researchers will compare your blood sugar levels during the AID phase with your usual care phase to see if there's a difference. You'll also be asked to complete questionnaires and have interviews. These will help the researchers understand your experiences and how the AID system affected your quality of life. Your safety will be carefully monitored throughout the entire study.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as gaining experience with a new technology that could improve your blood sugar control and potentially enhance your quality of life. However, as with any medical study, there are potential risks. The AID system might not work as well for everyone, and there could be discomfort from wearing the sensors or pump, or reactions to adhesives. Researchers will carefully check your safety throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Automated Insulin Delivery (AID)?

It's a system that combines a sensor to track your sugar levels and an insulin pump to automatically give you insulin to keep your blood sugar steady.

Where is this study taking place?

This study is being conducted at Imperial College in London.

How long will I be in the study if I participate?

Each participant will be involved in the study for about 22 weeks, which is about five and a half months.

Will I still need finger-prick tests?

The study uses continuous glucose monitors (CGM) which help you monitor glucose without painful finger-prick tests. However, some finger-prick tests may still be required, as advised by the study team.

What if I change my mind after joining?

You can decide to leave the study at any time, for any reason, and it will not affect your usual medical care.

How to find out more

Lalantha Leelarathna, FRCP PhD

e.leelarathna@imperial.ac.uk +447984477771 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.