A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis

To be considered for this study, you need to be at least 18 years old. You should have type 2 diabetes and currently be taking insulin injections more than once a day, or using an insulin pump. It's also important that you have advanced kidney failure and are regularly receiving kidney dialysis in a hospital, typically three times a week. Your kidney dialysis should be happening through a common method like a fistula, graft, or central line.

If you already use a continuous glucose monitor (CGM), we'll look at your recent blood sugar readings. If you don't use a CGM, we'll check your general blood sugar level (HbA1c) which should be between 7.0% and 12%. Your total daily insulin dose should be between 10 and 200 units. You also need to be able to read and understand English well enough to safely follow the study instructions, and be willing to wear study devices like glucose sensors and the Omnipod 5 system. If you're a woman who could become pregnant, you'll need to be using reliable contraception or not be sexually active.

There are also some reasons why you might not be able to join. These include having other serious health conditions or significant mental health issues that could affect the study, or if you're currently on a different type of dialysis (peritoneal dialysis) or have plans to change your treatment in the next 18 weeks. You also can't participate if you're only taking a background (basal) insulin, are already using an automated insulin delivery system, or have a known allergy to insulin. Certain medications like sulphonylureas or hydroxyurea (which can interfere with sensors) would also prevent you from joining, as would unstable eye problems due to diabetes or severe vision loss. The study also cannot include pregnant women or those planning pregnancy.

If you join this study, it will involve about 18 weeks of your time. At the very beginning, everyone will wear a glucose sensor for a period to get a baseline reading of their blood sugar levels. After this, you will be randomly placed into one of two groups. Being 'randomly placed' means it's like flipping a coin – you have an equal chance of being in either group.

One group will receive the Omnipod 5 automated insulin delivery system. This involves wearing the system, which includes a continuous glucose sensor and an insulin pump that works automatically. The other group will continue with their usual insulin injections, but they will also wear a continuous glucose monitor to help them keep track of their sugar levels more easily. Each of these treatment stages will last for 12 weeks.

Throughout the study, we will be carefully monitoring your safety. We will compare the blood sugar levels between the two groups to see if the Omnipod 5 system makes a difference. You will also be asked to complete questionnaires and might be invited for interviews. This will help us understand your experiences with whichever treatment you receive and how it affects your daily life.