RecruitingNAINTERVENTIONAL

Avoidance of Insulin-induced Lipohypertophy in People With Diabetes Using Ultrasound Scanning Within Diabetes Clinics

A common issue for people using insulin is developing fatty lumps, called 'lipos', at injection sites. These lumps can stop insulin from working properly, leading to unstable blood sugar levels. Currently, doctors usually feel for these lumps, but ultrasound scans can find more of them. This study aims to see if changing injection sites based on ultrasound results can help people with diabetes control their blood sugar more effectively. We're focusing on individuals who use continuous glucose monitors and struggle with unstable blood sugar. Participants will have scans and get advice, and their blood sugar levels will be tracked for 24 weeks.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

01 Jan 2026

Estimated completion

31 May 2027

Type 1 Diabetes (T1D)Type 2 Diabetes, Insulin Requiring

What is this study about?

If you have diabetes and use insulin, you might know about a common problem called 'lipohypertrophy', or 'lipos' for short. These are fatty lumps that can form where you inject your insulin. While they might not seem like a big deal, lipos can actually affect how your body absorbs insulin, making it harder to keep your blood sugar levels steady. This can lead to your blood sugar going too high or too low more often.

At the moment, doctors often check for these lumps by feeling your skin. However, research suggests that feeling by hand might miss a lot of them. Ultrasound scans, which use sound waves to create pictures inside your body, are much better at spotting these hidden fatty areas. In fact, studies have found that a lot more people have lipos than doctors can feel with their hands.

This study wants to find out if using these more accurate ultrasound scans to locate lipos, and then helping people avoid injecting into those areas, can improve blood sugar control. We're especially interested in people who use continuous glucose monitors (CGM) and find their blood sugar levels difficult to manage, with lots of ups and downs. By focusing on this group, we hope to clearly see the benefits of avoiding injection sites with lipos. We'll also be teaching diabetes healthcare staff how to use the ultrasound scanner, and we might even use the information to help develop new computer programs that can spot lipos in the future.

Key takeaways

Fatty lumps (lipos) from insulin injections can make blood sugar harder to control.
Ultrasound scans are better than feeling for these lumps.
This study will see if avoiding these lumps helps blood sugar management.
Participants will get scans, advice, and blood sugar tracking for 24 weeks.
It could lead to better injection practices and new ways to detect lipos.

Who may be eligible?

To join this study, you need to be 18 years or older and have had diabetes for at least a year. You must be using insulin, either through multiple daily injections or an insulin pump. You also need to be regularly using a continuous glucose monitor (CGM) at least 70% of the time over the last month.

Your blood sugar levels should show some difficulty in control, meaning you have a lot of ups and downs (high "coefficient of variation" on your CGM) and spend less than 70% of your time with blood sugar between 3.9 and 10.0 mmol/l. It's important that you don't expect major changes to your diabetes treatment in the next six months and are happy to have two ultrasound scans of your injection sites.

There are some reasons you couldn't take part. These include having other serious health conditions, severe mental health issues that might affect the study, specific conditions called lipodystrophy or Dercum's disease, or if you are pregnant or planning to become pregnant. Also, if you have a life-threatening illness that limits your life expectancy to less than six months, or if your kidney function is very low, you wouldn't be able to join.

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 use insulin (injections or a pump) and a continuous glucose monitor (CGM)?
Are your blood sugar levels often quite high or low, or hard to keep in a good range?
Do you not expect big changes to your diabetes treatment in the next 6 months?
Are you able and willing to have two ultrasound scans of your injection areas?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a 'run-in' period of two weeks. During this time, we'll collect some basic health information about you. You'll have a physical check-up and an ultrasound scan of your insulin injection sites. We'll also get information from your own continuous glucose monitor (CGM) and do a blood test called HbA1c, if you haven’t had one recently.

Based on the ultrasound results, we'll create a map showing where the fatty lumps (lipos) are, and we'll advise you to avoid injecting insulin into these areas for the next 24 weeks. We'll collect your CGM data again at 4 weeks and 12 weeks after your initial ultrasound scan to see how your blood sugar control is doing. After 24 weeks, you'll come back for a follow-up ultrasound scan.

Potential risks and benefits

Taking part in this study may offer the benefit of better insulin absorption and potentially improved blood sugar control, especially if you have fatty lumps that are currently affecting your insulin's effectiveness. The main risk involves the time commitment for appointments and scans, and there's always the possibility that the changes suggested may not significantly improve your blood sugar. You are free to withdraw from the study at any time without giving a reason, and your regular medical care will not be affected.

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 are 'lipos'?

Lipos are short for lipohypertrophy, which are fatty lumps that can form under your skin where you often inject insulin. They can make your insulin less effective.

Why is an ultrasound scan better than a doctor feeling for lumps?

Ultrasound scans can detect these fatty lumps more accurately and spot ones that a doctor might not feel by hand, giving a clearer picture of where they are.

Will I have to change my insulin type or dose?

The study's main focus is on changing injection sites, not your insulin type or dose. We don't expect major treatment changes for you during the study.

How long will the study last for me?

You'll have an initial two-week period, followed by 24 weeks where you'll be avoiding certain injection sites. You'll have check-ins and a final scan at the end of the 24 weeks.

What happens if I decide to stop participating?

You can leave the study at any time. This won't affect the medical care you receive from your healthcare team.

How to find out more

Lalantha Leelarathna, PhD FRCP (UK)

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

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