Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT2 inhibitor Therapy Using a Novel Continuous Ketone Sensor

This Phase 2 trial at St Vincent's Hospital Melbourne is testing whether dapagliflozin — a medication used in type 2 diabetes called an SGLT2 inhibitor — can improve blood sugar control in people with type 1 diabetes, while keeping them safe from diabetic ketoacidosis (DKA). DKA is a serious complication where the body produces too many ketones (acidic byproducts of fat burning), and it has been a concern with this class of drug in type 1 diabetes. The study uses a continuous ketone sensor — a new wearable device that monitors ketone levels in real time — alongside education to help participants detect and respond to early ketone rises. Participants will try both dapagliflozin and a placebo in two 3-month periods (in random order), separated by a washout break. You may be eligible if you are 18 or older, have had type 1 diabetes for more than a year, are on stable insulin therapy, and have an HbA1c below 10%. You would not be eligible if you are pregnant, have significant kidney problems, have had DKA in the last 3 months, follow a very low carbohydrate diet, or have major medical or psychiatric conditions.