Effects of Metformin and Automated Insulin Delivery on Kidney and Heart Health in Youth Aged 12 to 25 With Type 1 Diabetes

What this Trial Is About

Researchers are studying youth aged 12 to 25 years with type 1 diabetes to evaluate how metformin combined with automated insulin delivery systems affects kidney and cardiovascular health. This phase 1 trial addresses concerns about diabetic kidney disease and cardiovascular disease, which are major complications for people with type 1 diabetes. The study aims to understand if these treatments can improve insulin sensitivity, renal vascular resistance, and blood vessel function. Participants using automated insulin delivery systems may be randomly assigned to take either metformin or a placebo pill for 4 months. A control group using multiple daily injections or manual insulin pumps plus continuous glucose monitors will not receive medication but will be assessed similarly. Various diagnostic tests, including injections to measure kidney function and clamps to evaluate insulin sensitivity, will be used along with assessments of blood vessel stiffness and endothelial function. During the trial, participants will undergo detailed evaluations such as renal plasma flow, glomerular filtration rate, and insulin sensitivity tests. Cardiovascular and endothelial function will be monitored, and safety will be carefully tracked. The main outcomes measured after 4 months include changes in renal vascular resistance and kidney filtration rate. This comprehensive monitoring helps researchers understand the effects of metformin and insulin delivery technologies on important health markers in youth with type 1 diabetes.

MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes