All studies
CompletedNot ApplicableInterventional

Improving glucose control for patients with diabetes undergoing surgery

This study aims to understand if a continuous glucose monitor (a small patch called Freestyle Libre 2) can help people with type 2 diabetes manage their blood sugar during and after surgery. This patch often gives more frequent readings than traditional finger-prick tests. We want to discover any challenges or benefits for both patients and hospital staff in using this device. The goal is to see if this method could become a regular part of NHS care for surgical patients with type 2 diabetes, helping them feel more in control of their recovery. The findings will help plan a bigger study in the future.

At a glance

Status
Completed
Phase
Not Applicable
Sponsor
Leeds Teaching Hospitals NHS Trust
Enrolment target
30
Start
01 Apr 2025
Estimated completion
01 Dec 2025

What is this study about?

When you have surgery, especially major surgery, managing your blood sugar levels carefully is really important if you have type 2 diabetes. High or low blood sugar can slow down your recovery and potentially lead to other problems. This study is looking at a new way to keep an eye on blood sugar levels using a small device called a continuous glucose monitor, specifically the Freestyle Libre 2.

Currently, in NHS hospitals, blood sugar is often checked a few times a day by a finger-prick test. The continuous monitor is a patch worn on your skin that automatically checks your sugar levels throughout the day and night. We want to find out if using this patch during and after surgery is practical and helpful for both patients and the healthcare team. This is a "feasibility study," which means we're checking if the idea works well and identifying any difficulties before planning a much larger study.

By taking part, you could help us understand if this technology makes it easier for patients to manage their own blood sugar after surgery, giving them more control and potentially leading to a smoother recovery. It also helps us learn what staff think about using it. Your experience will help shape how diabetes care during surgery might improve for many people in the future.

Key takeaways

  • It's about trying a new blood sugar monitor (Freestyle Libre 2) during surgery for type 2 diabetes.
  • The goal is to see if the monitor is useful and easy for patients and staff.
  • You'll wear a patch and still have regular finger-prick checks.
  • Possible side effect is skin irritation from the patch.
  • Could give you more control over your blood sugar after surgery.
  • This study helps plan future, larger research.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a diagnosis of type 2 diabetes. You must also be scheduled for certain types of surgery (urology or gynaecological-oncology) within the next six weeks, and expect to stay in hospital for at least 24 hours after your operation.

You cannot take part if you can't understand or agree to join the study, or if you can't follow simple instructions. Also, if your type 2 diabetes is currently managed only by diet, or if you already use a continuous glucose monitor, or if you are having a 'day case' procedure where you go home the same day, you won't be able to join.

People with other types of diabetes besides type 2, or those with memory problems or dementia, are also not able to participate in this particular 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.

  1. Are you 18 years old or older?
  2. Do you have type 2 diabetes?
  3. Are you having a planned urology or gynaecological-oncology surgery soon?
  4. Do you expect to stay in hospital for at least one full day after your surgery?
  5. Do you currently NOT use a continuous glucose monitor?
  6. Is your diabetes NOT managed only by diet?
Answer every question to see your result.

What does participation involve?

If you decide to join, the study team will explain everything and get your permission over the phone, so you won't need an extra hospital visit. You will then be fitted with a Freestyle Libre 2 patch. This is a small, non-invasive sensor that sticks to your skin and needs to be replaced every two weeks. It will constantly measure your blood sugar levels.

During your hospital stay, you (or the nurses) will continue to check your blood sugar with the usual finger-prick tests, just as you would normally. This is so the researchers can compare the readings from the patch with the finger-prick results to see how accurate the patch is. The study will also keep track of how you recover in the hospital.

Towards the end of your time in the study, you'll be asked to complete a short questionnaire about your experiences. The study aims to look at your experience from when you agree to take part until you complete the questionnaire after your discharge from hospital, probably lasting a few weeks.

Potential risks and benefits

The researchers don't expect this study to have high risks. The main possible side effect from the continuous glucose monitor (Freestyle Libre 2) is that the patch might cause a bit of redness, itching, or mild discomfort where it's attached to your skin. The specialist diabetes nurse team will keep an eye on this area, and if it becomes too irritating, they can remove the device. A benefit is that the patch could help you monitor your blood sugar more often after surgery, giving you and the staff more immediate information. This could help make quicker adjustments to your treatment if needed and give you more control over your recovery. If you are too unwell after surgery to use the device, the nurses will simply go back to checking your blood sugar in the usual way. 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.
  • United Leeds Teaching Hospitals NHS Trust
    City only
    Leeds, United Kingdom

Common questions

What is a continuous glucose monitor?

It's a small patch you wear that constantly measures your blood sugar levels without needing finger-pricks, giving you readings all day and night.

Will I still have finger-prick tests?

Yes, you will continue with your usual finger-prick tests so the researchers can compare the results with the new patch.

What kind of surgery do I need to be having?

You need to be scheduled for elective urology or gynaecological-oncology surgery.

Where is the study taking place?

The study is being run by the University of Leeds and Leeds Teaching Hospitals NHS Trust in the UK.

Will I have to pay to be in the study?

No, you will not have to pay to participate in this research study.

How to find out more

Simon Howell

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

Discussion

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