Multivariable Automated Insulin Delivery System for Handling Planned and Spontaneous Physical Activities

Abstract

Background: Hybrid closed-loop control of glucose levels in people with type 1 diabetes mellitus (T1D) is limited by the requirements on users to manually announce physical activity (PA) and meals to the artificial pancreas system. Multivariable automated insulin delivery (mvAID) systems that can handle unannounced PAs and meals without any manual announcements by the user can improve glycemic control by modulating insulin dosing in response to the occurrence and intensity of spontaneous physical activities. Methods: An mvAID system is developed to supplement the glucose measurements with additional physiological signals from a wristband device, with the signals analyzed using artificial intelligence algorithms to automatically detect the occurrence of PA and estimate its intensity. This additional information gained from the physiological signals enables more proactive insulin dosing adjustments in response to both planned exercise and spontaneous unanticipated physical activities. Results: In silico studies of the mvAID illustrate the safety and efficacy of the system. The mvAID is translated to pilot clinical studies to assess its performance, and the clinical experiments demonstrate an increased time in range and reduced risk of hypoglycemia following unannounced PA and meals. Conclusions: The mvAID systems can increase the safety and efficacy of insulin delivery in the presence of unannounced physical activities and meals, leading to improved lives and less burden on people with T1D.