Closed-loop for People Living With Cystic Fibrosis Related Diabetes

To join this study, you need to be at least 16 years old and have diabetes related to cystic fibrosis, for which you've been using insulin for at least three months. It's important that your current blood sugar control, specifically your 'time in target range', is less than 80% when using a CGM. Your lung function also needs to be at a certain level, specifically your FEV1 should be more than 30% of what's expected for someone your age and height.

You should be prepared to wear study devices like a glucose monitor, insulin pump, and smartphone all the time, and be willing to follow the study instructions carefully. If you've recently had an organ transplant or are on a waiting list, or if you've recently started a new cystic fibrosis medication (called a CFTR modulator) in the last month, you likely won't be able to take part.

Other reasons you might not be able to join include severe vision or hearing problems, a known allergy to insulin or plaster adhesives, serious skin conditions where the sensors would be placed, or if you are pregnant, breastfeeding, or planning to become pregnant in the next year. The study team will review all of these details with you to ensure it's safe and appropriate for you to participate.

If you join this study, you'll first have a 'run-in' period to get everything set up. After that, you'll be randomly assigned to one of two groups for about 26 weeks (roughly six months). One group will use the new CamAPS FX system, which is a 'closed-loop' system that helps manage insulin automatically. The other group will continue with their usual insulin treatment, along with a Continuous Glucose Monitor (CGM) to track blood sugar.

Everyone will receive proper training on how to use their assigned devices safely. Throughout the 26-week period, you'll have access to the study team for support, including 24/7 telephone help if you need it. We'll regularly check your blood sugar levels using the CGM, and also look at other health markers like lung function (using a breathing test), your weight, and your HbA1c (a measure of average blood sugar). You'll also be asked to complete questionnaires about your quality of life and your experiences with managing diabetes. There will be regular visits to the study clinic during these 26 weeks, but the exact number will be explained by the study team.