Presenter of 1 Presentation
A DUAL-HORMONE ARTIFICIAL PANCREAS IN A PRE-TRIAL VIRTUAL CLINICAL TRIAL
Abstract
Background and Aims
Single-hormone closed-loop treatment of type 1 diabetes is becoming more and more common. However, dual-hormone systems are still not available on the market. A dual-hormone artificial pancreas (AP) consists of 1) a continuous glucose monitor, 2) two pumps (one for insulin and one for glucagon) and 3) a control algorithm. The aim of this work is to develop a dual-hormone AP as well as to perform pre-trial in silico tests (of both the closed-loop system and the model identification).
Methods
The AP is based on nonlinear model predictive control (NMPC) and heuristics, and the model is identified using maximum likelihood estimation. In the pre-trial virtual clinical trial, we test the AP in closed-loop simulations of virtual persons. In reality, the AP does not know the true dynamics. Therefore, we generate the virtual individuals from a simulation model that is different from the control model in the AP.
Results
We present the results of closed-loop simulations on virtual persons using the dual-hormone AP as well as model identification. Furthermore, we demonstrate how it can be used to indicate if the system is ready for a real clinical trial. The system achieves time in range (TIR) (3.9 – 10 mmol/L) above the 70% TIR standard of care with a limited number of hypoglycemic events (< 3.9 mmol/L).
Conclusions
The pre-trial virtual clinical trial of the AP shows 1) time in range above the guideline-recommended target, 2) a limited number of hypoglycemic events, and 3) the safety heuristics function as expected and prevent undesired behavior.