An AI-enabled dual-hormone model predictive control algorithm that delivers insulin and pramlintide

Abstract

Current closed-loop insulin delivery algorithms need to be informed of carbohydrate intake disturbances. This can be a burden on people using these systems. Pramlintide is a hormone that delays gastric emptying, which enables insulin kinetics to align with the kinetics of carbohydrate absorption. Integrating pramlintide into an automated insulin delivery system can be helpful in reducing the postprandial glucose excursion and may be helpful in enabling fully-closed loop whereby meals do not need to be announced. We present an AI-enabled dual-hormone model predictive control (MPC) algorithm that delivers insulin and pramlintide without requiring meal announcements that uses a neural network to automatically detect and deliver meal insulin. The MPC algorithm includes a new pramlintide pharmacokinetics and pharmacodynamics model that was identified using data collected from people with type 1 diabetes undergoing a meal challenge. Using a simulator, we evaluated the performance of various pramlintide delivery methods and controller models, as well as the baseline insulin-only scenario. Meals were automatically dosed using a neural network meal detection and dosing (MDD) algorithm. The primary outcome was the percent time glucose is in the target range (TIR: 70-180 mg/dL). Results show that delivering pramlintide at a fixed ratio of 6 mcg pramlintide:1 u insulin using an MPC that is aware of the pramlintide achieved the most significant improved TIR compared with an insulin-only MPC (91.6% vs. 64.1%). Delivering pramlintide as a fixed ratio was better than delivering basal pramlintide at a constant rate, indicating the benefit of the MDD algorithm. There was no advantage of independent control of insulin and pramlintide compared with insulin and pramlintide delivered as a fixed ratio. Preliminary real-world results from a human subject further indicate the benefit of pramlintide delivery.