RecruitingObservational

Hybrid closed loop insulin pumps and early worsening of diabetic retinopathy in Type 1 diabetes

This study, called INSIGHT 1, is for people with Type 1 diabetes. It looks at new insulin pumps, called hybrid closed-loop (HCL) systems, which help to manage blood sugar levels automatically. When blood sugar levels improve very quickly, sometimes there can be a temporary change in eye health called 'early worsening of diabetic retinopathy' (EWDR). While this has happened with intense diabetes treatments in the past, we don't know how often it occurs with these new HCL systems. We're comparing people starting on HCL pumps with those who continue with daily insulin injections or older pumps. The study involves eye exams and blood tests. It will help us understand eye health needs for people using these new technologies. It's funded by Breakthrough T1D and Novo Nordisk UK Research Foundation.

At a glance

Status

Recruiting

Sponsor

University of Liverpool

Enrolment target

203

Start

07 May 2025

Estimated completion

31 Jul 2027

Type 1 diabetes

What is this study about?

People with Type 1 diabetes rely on insulin to keep their blood sugar levels in check. Newer devices called hybrid closed-loop (HCL) insulin pumps are becoming more common. You might have heard them called 'artificial pancreas' systems because they automatically adjust insulin based on continuous sugar readings. These systems are very good at helping people achieve better control over their blood sugar.

However, sometimes when blood sugar levels get much better very quickly, there can be a temporary worsening of an eye condition called diabetic retinopathy. This effect has been seen before with other treatments that rapidly improve blood sugar. Doctors want to find out if this also happens with these new HCL systems and how often.

This study, called INSIGHT 1, aims to answer these questions. We will follow people with Type 1 diabetes who are either starting on a HCL insulin system or are continuing with their usual diabetes care, such as multiple daily insulin injections (MDI) or older, 'open loop' insulin pumps. By comparing these groups, we hope to learn more about how HCL systems might affect eye health.

Key takeaways

This study explores how new HCL insulin pumps affect eye health in Type 1 diabetes.
It compares HCL pump users with those on other insulin treatments.
Participation involves eye exams and blood tests.
The study aims to improve future eye care for people using HCL technology.
It's safe to take part, with no major risks expected.

Who may be eligible?

This study is looking for adults aged 18 to 100 years old with Type 1 diabetes. We are particularly interested in people who are within 28 days of starting a hybrid closed-loop (HCL) insulin pump system.

We are also looking for people who will continue with their current treatment, such as multiple daily insulin injections (MDI) or an older, 'open loop' insulin pump. You would be suitable for this control group if your blood sugar control, measured by a test called HbA1c, is at a certain level (at or above 58 mmol/mol) when you join, and you don't meet the national guidelines for getting a HCL pump yet.

Unfortunately, if you are pregnant, have Type 2 diabetes or other types of diabetes, or are unable to give your consent to take part, this study would not be right for you. We need to avoid situations that could confuse the study results.

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 100 years old?
Do you have Type 1 diabetes?
Are you about to start a hybrid closed-loop (HCL) system, or have you started one in the last 28 days?
Alternatively, are you currently on multiple daily injections (MDI) or an older, 'open loop' insulin pump?
Are you able to provide consent to take part?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several detailed eye examinations. These include special photographs and 3D scans of the back of your eye (called retinal photographs and OCT scans). We will also gently measure how the nerves in your eyes are working using a test called electroretinography (ERG). Additionally, you will be asked to provide some blood samples. These samples will help us look for tiny markers in your blood that might give us clues about how your eyes are reacting to treatment.

For those starting on a hybrid closed-loop system, your participation begins within 28 days of you getting your new pump. The study team will follow up with you. The study aims to collect information over a period of time, with the final visits expected by July 2028, and all data collection finished by July 2029.

Potential risks and benefits

Any direct benefit from taking part in this study is likely very small; however, there is a chance that we might spot an unknown health issue during your visits, and getting quick treatment could improve your health. We don't expect any major risks from taking part in the eye exams or blood tests. The information we gain from this study will be very valuable. It could help doctors and nurses improve the way they check the eye health of people with Type 1 diabetes who start using hybrid closed-loop systems in the future. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

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

Clinical Eye Research Centre (CERC) at St Paul's Eye Unit
City only
Liverpool, England

Common questions

What is a 'hybrid closed-loop insulin pump'?

It's a modern insulin pump system that works with a sugar monitor to automatically adjust your insulin doses, helping you manage your blood sugar levels.

Why is the study looking at eyes?

Sometimes, when blood sugar levels improve very quickly, there can be temporary changes in eye health for people with diabetes. We want to see if this happens with the new HCL systems.

What is 'diabetic retinopathy'?

It's an eye condition that can affect people with diabetes, where high blood sugar levels damage the blood vessels in the retina (at the back of your eye).

Where is the study taking place?

The study is based at St Paul’s Eye Unit, Royal Liverpool Hospital, in Liverpool, UK.

Who is paying for this study?

The study is funded by organisations called Breakthrough T1D and the Novo Nordisk UK Research Foundation.

How to find out more

Matthew Anson

manson1@liverpool.ac.uk +44 (0)151 529 5917 Official trial record

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