CL4P-CF: A trial investigating an automated insulin delivery system for people with CF-related diabetes

A trial investigating whether closed-loop insulin delivery systems can improve glucose control and quality of life for people with cystic fibrosis-related diabetes (CL4P-CF)

CF-related diabetes (CFRD) is the most common complication of CF. Insulin is used to treat CFRD, either by injections several times a day or using an insulin pump. Insulin can improve body weight and lung function, but current insulin treatment needs regular checking of glucose levels and adjustment of insulin doses. This adds to the burden of CF self-management.

A closed-loop insulin delivery system is made up of three devices which communicate wirelessly via Bluetooth:
• Device 1 is a small glucose sensor which is worn on the arm or abdomen and continuously measures glucose levels.
• Device 2 is an insulin pump that delivers insulin just under the skin.
• Device 3 is a controller on a smartphone App which continuously and automatically adjusts the amount of insulin given by the pump (device 2), depending on the glucose levels measured by device 1.

The CL4P-CF study aims to find out if closed-loop systems can improve glucose control and quality of life compared to standard insulin treatment in young people (≥16 years) and adults with CFRD.

Participants will be randomly allocated to one of two groups, to either use the closed-loop system (closed-loop group) or to carry on with their normal insulin treatment with a glucose sensor (control group). The study will run for 26 weeks. The research team will then compare glucose control between the two groups, by looking at the glucose sensor data collected during the study. We will also compare body weight, lung function and the number of lung infections between the two groups. Participants will be asked about their health and quality of life through questionnaires and interviews.

Participating sites are listed below in the order of "In set-up" then "Recruiting".