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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Ramzi Ajjan
-
r.ajjan@leeds.ac.uk


Dr Rebecca Birch
-
r.j.birch@leeds.ac.uk


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Be Part of Research - Trial Details - Blood sugar monitoring in people with type 2 diabetes and cancer
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Blood sugar monitoring in people with type 2 diabetes and cancer

Recruiting

Open to: All Genders

Age: Adult

Leeds

Medical Conditions

Type 2 diabetes and cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This research is looking at the ways in which chemotherapy affects the glucose levels in patients with type 2 diabetes. It uses two different ways of monitoring blood glucose (blood sugar) to see if they improve the control of blood glucose levels and if this helps patients complete their planned chemotherapy.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2024 01 Sep 2026

Participants will be assigned to one of two study groups at random by a computer program. The intervention group will be given Freestyle Libre devices to wear for a total of 6 months, and the control group will be asked to monitor their blood sugar exactly as they normally would (with the exception of the first and last 7 days of their involvement in the study when they will be given a “blinded” Freestyle Libre device to wear). Participants in both arms of the study will also be asked to complete some questionnaires which will ask how they are feeling and how easy or difficult they are finding it to manage their diabetes. These questionnaires should take less than an hour to complete in total.
When participants join the study they will be asked some questions about their health and have routine blood tests taken (to check their HbA1c, kidney function and natural fat levels [lipids]). This will be repeated 6 months after they join. If they are in the intervention group they will have an additional blood test at 90 days from the start of their involvement in the study.
Participants will then be seen by the research team at out-patient clinics, or via telephone depending on preference, on days 14, 21, 28, 90 and 180. Any changes in the chemotherapy that were planned and the reasons for these will also be recorded.
The research team will also call participants by telephone on day 365 (month 12) to check how their health has been. At this time they will also be asked to repeat the questionnaires they completed throughout the study.


Patients aged 18 years and over who have type 2 diabetes and are going to receive chemotherapy for colorectal, breast or lung cancer.

You can take part if:



You may not be able to take part if:


1. Diabetes mellitus diagnosed during the course of active cancer treatment2. Any diabetes other than T2D3. Already using the FreeStyle Libre device4. Inability to give informed consent5. Known sensitivity to medical adhesives likely to result in an adverse reaction to the Libre device6. Deemed not suitable for inclusion by study investigators7. Previous treatment with chemotherapy within 6 months8. Have a pacemaker or any other neurostimulator


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF

The researchers cannot guarantee that the study will help participants personally. However, the data collected will provide additional information about the benefit of using different blood glucose monitoring systems in patients with diabetes who are undergoing chemotherapy, and so will hopefully benefit future patients with this condition.
Both sensors use a delivery unit that places the flexible tip into the skin. Participants may experience some mild or moderate symptoms associated with the sensor insertion or the adhesive used to keep the sensor in place. These include redness, swelling, rash, itching, bruising, pain and bleeding. Sensors have to be removed before any medical appointments that include strong magnetic or electromagnetic radiation e.g. an X-ray, radiotherapy, MRI or CT scan and a new sensor applied afterwards.

Dr Ramzi Ajjan
-
r.ajjan@leeds.ac.uk


Dr Rebecca Birch
-
r.j.birch@leeds.ac.uk



The study is sponsored by University of Leeds and funded by Abbott Laboratories; Grant Codes: ADC-OUS-IIS-20-51.



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What will you do next?
Read full details for Trial ID: ISRCTN14005743

Or CPMS 56740

Last updated 17 July 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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