Trial ID: ISRCTN14005743
Other - Phase Unknown - Recruiting
Background and study aims 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. Who can participate? Patients aged 18 years and over who have type 2 diabetes and are going to receive chemotherapy for colorectal, breast or lung cancer. What does the study involve? 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. What are the possible benefits and risks of participating? 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. Where is the study run from? University of Leeds (UK) When is the study starting and how long is it expected to run for? December 2022 to January 2028 Who is funding the study? Abbott Diabetes Care (UK) Who is the main contact? Prof. Ramzi Ajjan, r.ajjan@leeds.ac.uk
University of Leeds
Source: https://www.isrctn.com/