Closed-loop in Adults With Type 2 Diabetes

To be considered for this study, you need to be an adult aged 18 or over. You must have been diagnosed with type 2 diabetes for at least a year and have been using insulin treatment for at least six months. You should also be taking certain diabetes medications (SGLT2 inhibitors and/or GLP-1 receptor agonists) or have been offered them previously. Your average blood sugar (HbA1c) should be 15% or less. It's important that you are willing to wear the study devices and follow the study instructions, and you must be able to understand and agree to take part.

There are some reasons why you might not be able to join. For example, if you have type 1 diabetes, currently use an insulin pump or another 'closed-loop' system, or have serious health conditions (physical or mental) that might affect the study. If you are pregnant, planning to get pregnant, or breastfeeding, you cannot participate. Also, severe problems with your eyesight or hearing, allergies to insulin or certain glues, serious skin conditions where sensors might be placed, or problems with drug or alcohol abuse would also mean you couldn't take part.

If you join this study, you will first have a 'run-in' period, followed by a 26-week period using either the new CamAPS HX system or your usual insulin treatment with a glucose sensor. Which group you are in will be decided by chance (like flipping a coin). You'll need to wear devices for monitoring your blood sugar. You'll receive training on how to use any new equipment safely. Throughout the 26 weeks, the research team will regularly check your blood sugar levels, insulin use, body weight, and kidney and liver function. They will also ask you to complete questionnaires and have interviews about your experience with the system. The total duration of active participation, including the run-in and intervention period, is about 7 months.