Study of Continuous Ketone Monitoring and Empagliflozin Use in Adults With Type 1 Diabetes

What this Trial Is About

Type 1 diabetes is an autoimmune condition where the body attacks insulin-producing cells, leading to high blood sugar and a lifelong need for insulin therapy. This study focuses on people with type 1 diabetes using empagliflozin, a sodiumglucose cotransporter 2 inhibitor that lowers blood sugar but may raise ketone levels, risking diabetic ketoacidosis. Researchers aim to understand ketone level patterns during various activities and diets while using empagliflozin. Participants will take part in a single-arm study using continuous ketone monitoring for a 4-week run-in period, followed by empagliflozin 2.5 mg daily for four weeks and then 10 mg daily for nine weeks. During the study, participants will engage in an exercise sub-study during the run-in and at the higher dose stage. Some participants will also follow a low-carbohydrate diet near the studys end. Throughout the trial, 24 adults with type 1 diabetes will have their ketone levels continuously monitored, alongside their insulin therapy and glucose control. Researchers will track the frequency and duration of elevated ketone events and observe responses to exercise and diet changes. This study aims to develop new ketone thresholds and provide data to support safe empagliflozin use in type 1 diabetes over time.

Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors