Automated Insulin Delivery Systems for Improving Sleep and Heart Health in Children and Adults with Type 1 Diabetes

What this Trial Is About

Researchers are investigating whether switching to automated insulin delivery AID systems can improve sleep quality and reduce cardiovascular risk factors in children and adults with type 1 diabetes. The study compares AID treatment to usual care, which includes multiple daily injections and sensor-augmented pumps. The main goals are to see if AID improves sleep efficiency after 4 months and if it helps lower heart rate variability, blood pressure, and inflammatory markers related to cardiovascular health. Participants are randomly assigned to either start using an AID system or continue their current treatment. The AID devices studied include closed-loop insulin pumps such as MiniMed 780G, Tandem T2-slim x2, and YpsoCamAPS. Those starting AID receive education on using the systems. The study includes baseline assessments and a 4-month follow-up period with virtual visits at weeks 1, 5, and 9 for all participants. During the study, participants undergo various tests including blood and urine samples, digital cognitive testing with CANTAB software, and multiple questionnaires about quality of life, hypoglycemia awareness, eating habits, and sleep quality. Sleep is monitored at home using a HomeSleepTest over three nights, and participants wear devices such as a blinded continuous glucose monitor for 10 days, a Holter monitor for 24 hours to track heart rate variability, a 24-hour blood pressure monitor, and an ActiGraph for 7 days to assess sleep and activity. Researchers will compare changes in sleep efficiency and other health measures from baseline to study end.

Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics