Evaluation of Dual-hormone Artificial Pancreas With Closed-loop Glucose Control Versus Single-hormone With Carbohydrate Recommendations Under Unannounced Exercise and Meal Challenge in Adults With Type 1 Diabetes.
The present clinical trial aims to examine alternative strategies for preventing/mitigating hypoglycemic events among adults with type 1 diabetes utilizing a highly personalized control system. This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations (sHC) and a dual-hormone configuration with subcutaneously administered glucagon boluses (dHmG). The main question addressed in this study focuses on determining whether the dHmG outperforms the sHC in terms of minimizing the time spent below the target range and number of hypoglycemic events. Each participant will undergo two 12-hour controlled inpatient studies, including each an unannounced 30-min aerobic exercise session and a meal challenge. The order of these studies, comparing the dHmG to the sHC, will be randomized.
• Age between 18 and 65 years.
• CSII treatment for a minimum of 6 months prior to Visit 1.
• Body mass index between 18 and 30 kg/m2.
• HbA1c level below 9.0% at Visit 1.
• Physical examination, laboratory data, and ECG (electrocardiogram) results are within normal limits. Clinically insignificant abnormalities, as determined by the investigator, will not be considered exclusion criteria.
• Postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit.